diff --git "a/data_raw/prescription_drugs.csv" "b/data_raw/prescription_drugs.csv" new file mode 100644--- /dev/null +++ "b/data_raw/prescription_drugs.csv" @@ -0,0 +1,3847 @@ +Manufacturer Name,NDC Number,Drug Product Description,Date Introduced to Market,WAC at Introduction,Marketing/Pricing Plan Description,Marketing/Pricing Plan Non-Public Indicator,Estimated Number of Patients,Breakthrough Therapy Indicator,Priority Review Indicator,Acquisition Date,Acquisition Price,Acquisition Price Non-Public Indicator,Acquisition Price Comment,General Comments,Supporting Documents,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,47335093640,"Leuprolide Acetate Injection 1Mg/0.2Ml, 2.8Ml",2019-03-01,705.67,,1,,,,,,,,"ESTIMATED_PATIENTS: unknown to Sun; MARKETING_PRICING_NONPUBLIC:This information is proprietary to Sun and as such, is non-public.",,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,47335023683,Ambrisentan 5 mg Tabs 30ct,2019-04-25,7500,"This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,0,,,,,,,"Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space.",,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,47335023783,Ambrisentan 10 mg Tabs 30ct,2019-04-25,7500,"This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for teneric sales, do not promote to health care providers.",,0,,,,,,,"Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space.",,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,47335003886,Bosentan Tablets 62.5mg 60ct,2019-06-14,6281.07,"This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,0,,,,,,,"Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space.",,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,47335003986,Bosentan Tablets 125mg 60ct,2019-06-14,6281.07,"This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,0,,,,,,,"Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space.",,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304073410,Esomeprazole 20mg DR Cap 1000ct,2019-05-15,826.71,"This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,0,,,,,,,"Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space.",,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304073510,Esomeprazole 40mg DR Cap 1000ct,2019-05-07,826.71,"This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,0,,,,,,,"Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space.",,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,47335037983,Cinacalcet HCL Oral Tablet 30MG,2019-08-27,685.7,"This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,0,,,,,,,Estimated average of patients per month is unknown to Sun Pharma; Sun received FDA approval for the drug’s ANDA application (Application number A207008),,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,47335038083,Cinacalcet HCL Oral Tablet 60MG,2019-08-27,1371.39,"This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,0,,,,,,,Estimated average of patients per month is unknown to Sun Pharma; Sun received FDA approval for the drug’s ANDA application (Application number A207008),,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,47335060083,Cinacalcet HCL Oral Tablet 90MG,2019-08-27,2057.09,"This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,0,,,,,,,Estimated average of patients per month is unknown to Sun Pharma; Sun received FDA approval for the drug’s ANDA application (Application number A207008),,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304009530,Erlotinib Tab 25mg/30ct,2019-11-11,2481,"This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,,,,,,,,Estimated average of patients per month is unknown to Sun; the reason for leaving the acquisition-related fields blank was because Sun Pharmaceuticals developed the drugs.,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304009630,Erlotinib Tab 100mg/30ct,2019-11-11,6445.82,"This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,,,,,,,,Estimated average of patients per month is unknown to Sun; the reason for leaving the acquisition-related fields blank was because Sun Pharmaceuticals developed the drugs,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304013530,Erlotinib Tab 150mg/30ct,2019-11-11,7302.01,"This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,,,,,,,,Estimated average of patients per month is unknown to Sun; the reason for leaving the acquisition-related fields blank was because Sun Pharmaceuticals developed the drugs,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,62756009045,MEDROXYPROGESTERONE 150 mg/ml 1 ml Vial 25pk,2019-10-02,2036.38,"This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,,,,,,,,1. Estimated average of patients per month is unknown to Sun 2. A limited amount of this NDC11 was only sold to a single Wholesaler on 10/2/2019 prior to the official commercial launch date of 11/20/19. ON 11/20/19 both the trade and the compendia were notified of the launch as of that date 3. The reason for leaving the acquisition-related fields blank was because Sun Pharmaceuticals developed the drugs,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,62756057083,Deferasirox OS Tab 500mg 30ct,2019-12-17,760.08,"This product is being marketed in the generic, multi source space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,0,,,,,,,Estimated average of patients per month is unknown to Sun Pharma. This drug was not acquired.,https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=333,,,,,,,,,,,,,, +Pfizer,409111201,Busulfan Injection 60 mg/10mL (6mg/mL),2019-02-28,7786,,1,70000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c) Comment regarding Field 7 - The number entered in field 7 is the estimated number of patients in the U.S. for 2010. The projected number of patients in the U.S. for 2030 is 144,000. Patients with this condition may or may not use this product. Source: https://www.cancernetwork.com/chronic-myeloid-leukemia/chronic-myeloid-leukemia Comment regarding Fields 10-13 - The product was not acquired.",,,,,,,,,,,,,,, +Pfizer,69197540,VYNDAQEL® (tafamidis meglumine) 20MG CAP 4X30 BLST US,2019-05-06,187500,,1,,1,1,2010-10-06,,1,"On October 6, 2010, we completed our acquisition of FoldRx Pharmaceuticals, Inc. (FoldRx), a privately held drug discovery and clinical development company, whose portfolio included clinical and preclinical programs for investigational compounds to treat diseases caused by protein misfolding. The total consideration for the acquisition was approximately $400 million, which consisted of an upfront payment to FoldRx’s shareholders of about $200 million and contingent consideration with an estimated acquisition-date fair value of about $200 million. The contingent consideration consists of up to $455 million in additional payments that are contingent upon the attainment of future regulatory and commercial milestones.","Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - ATTR-CM is significantly under or misdiagnosed, and as a result, it is difficult to characterize prevalence. Based on our internal estimates and existing literature, we believe U.S. prevalence is approximately 100,000 with a diagnosis range of approximately 1-2%.",,,,,,,,,,,,,,, +Pfizer,69873030,VYNDAMAX™ 61MG CAP 3X10 BLST US,2019-08-27,18750,,1,3000,,,2010-10-06,,1,"On October 6, 2010, we completed our acquisition of FoldRx Pharmaceuticals, Inc. (FoldRx), a privately held drug discovery and clinical development company, whose portfolio included clinical and preclinical programs for investigational compounds to treat diseases caused by protein misfolding. The total consideration for the acquisition was approximately $400 million, which consisted of an upfront payment to FoldRx’s shareholders of about $200 million and contingent consideration with an estimated acquisition-date fair value of about $200 million. The contingent consideration consists of up to $455 million in additional payments that are contingent upon the attainment of future regulatory and commercial milestones.","Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - ATTR-CM is significantly under or misdiagnosed, and as a result, it is difficult to characterize prevalence. Based on our internal estimates and existing literature, we believe U.S. prevalence is approximately 100,000 with a diagnosis range of approximately 3%.",,,,,,,,,,,,,,, +Pfizer,409139051,MEROPENEM 500mg SPO 1x10 GVIAL US,2019-10-08,145,,1,,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - The estimated number of patients solely for Meropenem is not available.",,,,,,,,,,,,,,, +Pfizer,409139122,MEROPENEM 1gm SPO 1x10 GVIAL US,2019-10-08,291.4,,1,,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - The estimated number of patients solely for Meropenem is not available.",,,,,,,,,,,,,,, +Pfizer,409110301,CISATRACURIUM 200MG/20ML SSOL 1X10 GVL,2019-11-06,2705,,1,,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - The estimated number of patients solely for Cisatracurium is not available. Comment regarding Fields 10 -13: The cost for Cisatracurium Besylate Injection alone is not available. On September 3, 2015, Pfizer acquired Hospira, a leading provider of sterile injectable drugs and infusion technologies as well as a provider of biosimilars, for approximately $16.1 billion in cash ($15.7 billion, net of cash acquired). The acquisition cost of $16,100,000,000 reflects the total cost of the entire Hospira acquisition. Cisatracurium Besylate Injection received FDA approval associated with a new ANDA.",,,,,,,,,,,,,,, +Pfizer,69034201,ZIRABEV™ 400MG/16ML SSOL 1x1 GVL US,2019-12-31,2453.6,,1,75000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Based on our internal estimates of the size of the bevacizumab market based on Avastin's usage across tumor types, we estimate 85,000 patients currently being treated on Avastin. Note this includes ovarian cancer; please note that Zirabev is not indicated for use in that patient population (12% of patients). Comment regarding Fields 10-13: Zirabev was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,69031501,ZIRABEV™ 100MG/4ML SSOL 1X1 GVL US,2019-12-31,613.4,,1,75000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Based on our internal estimates of the size of the bevacizumab market based on Avastin's usage across tumor types, we estimate 85,000 patients currently being treated on Avastin. Note this includes ovarian cancer; please note that Zirabev is not indicated for use in that patient population (12% of patients). Comment regarding Fields 10-13: Zirabev was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Sanofi,5846802271,Cablivi (caplacizumab-yhdp),2019-04-02,7300,"Marketing initiatives include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with acquired thrombotic thrombocytopenic purpura (aTTP), materials to be used by sales representatives to share information on caplacizumab with prescribers, and materials to educate patients about aTTP. Sanofi’s commitment to pricing rests on three principles: a holistic assessment of value when setting launch prices, year-over-year price increases that are limited to National Health Expenditure projections, and disclose our aggregate gross and net prices changes to provide greater transparency about the pricing of our medicines. These comprehensive principles were drafted to address questions around the price of medicines in the United States. Our goal is to make our medicines accessible and affordable to all patients. We share concerns about the affordability of medicines, and we believe deeply in the important role we play in providing treatments for serious illnesses. We are determined to do our part in pricing our medicines with greater transparency and according to their value, while continuing to advance scientific knowledge and bringing life-saving treatments to patients worldwide.",,1800,,1,,,,,"Ablynx, a Sanofi Company, was acquired by Sanofi in 2018.",,,,,,,,,,,,,,, +AstraZeneca,310183030,Name- Fasenra Pen (benralizumab) Dosage- 30mg/mL solution Form- Injection: In a single dose pre-filled autoinjector,2019-10-28,4895.74,"AstraZeneca will engage 20 sales representative(s) to cover the state of California. Patient brochures, clinical data, dosing/administration guides, and samples may be left behind in offices for informational purposes. In addition to sales representative promotion, Fasenra® commercials are televised on the national broadcast networks. AstraZeneca provides online resources via FasenraHCP.com for US healthcare professionals and Fasenra.com for patients and consumers. Patients may register for the FASENRA 360 support program via the website which will enroll them in a digital relationship marketing program to receive materials such as disease state education, patient brochures, and dosing reminders. The FASENRA® patient savings program for eligible commercially insured patients will be available for patients in California and can be found on Fasenra.com. FASENRA® is currently marketed in 47 countries.",,1000000,,,,,,,FASENRA® (Benralizumab) is indicated as an add-on maintenance treatment of patients 12 years and older with severe eosinophilic asthma. FASENRA® (Benralizumab) is not indicated for treatment of other eosinophilic conditions or for the relief of acute bronchospasm or status asthmaticus. The reason for the blank fields related to acquisition of the product (columns 10-13) is due to the fact that AstraZeneca did not acquire the drug.,,,,,,,,,,,,,,, +Janssen,50458002802,SPRAVATO Estekamine Nasal Spray 56mg (2X28mg),2019-03-08,590,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising in the mental health community, as well as promoting to appropriate healthcare professionals, systems of care and behavioral health clinics who treat individuals living with treatment resistant depression. The pricing plan has WAC set at $590 per package of 2 inhalers. The list price of SPRAVATO™ is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. SPRAVATO™ will also be discounted as required under the 340B program, the Federal Supply Schedule, and other government programs. Internationally, we are pursuing regulatory approvals for SPRAVATO for the treatment of treatment resistant depression. No approvals have been granted at this time.",,,1,1,,,,,"While Janssen's estimated volume of patients who may be prescribed SPRAVATO is not available in the public domain, according to the National Institute of Mental Health, there are approximately 16.2 million patients with major depressive disorder (MDD) in the United States, and approximately 1/3 of MDD patients have treatment resistant depression (TRD). SPRAVATO will be clinically appropriate for a subset of patients with TRD.",,,,,,,,,,,,,,, +Janssen,50458002803,SPRAVATO Estekamine Nasal Spray 84mg (3X28mg),2019-03-08,885,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising in the mental health community, as well as promoting to appropriate healthcare professionals, systems of care and behavioral health clinics who treat individuals living with treatment resistant depression. The pricing plan has WAC set at $885 per package of 3 inhalers. The list price of SPRAVATO™ is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. SPRAVATO™ will also be discounted as required under the 340B program, the Federal Supply Schedule, and other government programs. Internationally, we are pursuing regulatory approvals for SPRAVATO for the treatment of treatment resistant depression. No approvals have been granted at this time.",,,1,1,,,,,"While Janssen's estimated volume of patients who may be prescribed SPRAVATO is not available in the public domain, according to the National Institute of Mental Health, there are approximately 16.2 million patients with major depressive disorder (MDD) in the United States, and approximately 1/3 of MDD patients have treatment resistant depression (TRD). SPRAVATO will be clinically appropriate for a subset of patients with TRD.",,,,,,,,,,,,,,, +Janssen,59676003056,BALVERSA Erdafitinib 3mg 56 tablets,2019-04-15,15120,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals living with metastatic urothelial cancer (mUC). The pricing plan has WAC set for 3mg 56 tablets at $15,120.00. The list price of BALVERSA is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. BALVERSA will also be discounted as required under the Federal Supply Schedule, and other government programs. There are no International approvals for BALVERSA.",,,1,1,,,,,"While Janssen's estimated volume of patients who may be prescribed BALVERSA is not available in the public domain, BALVERSA is approved specifically for the treatment of patients with locally mUC harboring FGFR3 or FGFR2 genetic alterations. In the U.S., it is estimated that up to 3,000 people with urothelial carcinoma will test FGFR positive on an annual basis. Balversa was developed by Janssen.",,,,,,,,,,,,,,, +Janssen,59676003084,BALVERSA Erdafitinib 3mg 84 tablets,2019-04-15,22680,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals living with metastatic urothelial cancer (mUC). The pricing plan has WAC set for 3mg 84 tablets at $22,680.00. The list price of BALVERSA is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. BALVERSA will also be discounted as required under the Federal Supply Schedule, and other government programs. There are no International approvals for BALVERSA.",,,1,1,,,,,"While Janssen's estimated volume of patients who may be prescribed BALVERSA is not available in the public domain, BALVERSA is approved specifically for the treatment of patients with locally mUC harboring FGFR3 or FGFR2 genetic alterations. In the U.S., it is estimated that up to 3,000 people with urothelial carcinoma will test FGFR positive on an annual basis. Balversa was developed by Janssen.",,,,,,,,,,,,,,, +Janssen,59676004028,BALVERSA Erdafitinib 4mg 28 tablets,2019-04-15,10080,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals living with metastatic urothelial cancer (mUC). The pricing plan has WAC set for 4mg 28 tablets at $10,080.00. The list price of BALVERSA is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. BALVERSA will also be discounted as required under the Federal Supply Schedule, and other government programs. There are no International approvals for BALVERSA.",,,1,1,,,,,"While Janssen's estimated volume of patients who may be prescribed BALVERSA is not available in the public domain, BALVERSA is approved specifically for the treatment of patients with locally mUC harboring FGFR3 or FGFR2 genetic alterations. In the U.S., it is estimated that up to 3,000 people with urothelial carcinoma will test FGFR positive on an annual basis. Balversa was developed by Janssen.",,,,,,,,,,,,,,, +Janssen,59676004056,BALVERSA Erdafitinib 4mg 56 tablets,2019-04-15,20160,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals living with metastatic urothelial cancer (mUC). The pricing plan has WAC set for 4mg 56 tablets at $20,160.00. The list price of BALVERSA is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. BALVERSA will also be discounted as required under the Federal Supply Schedule, and other government programs. There are no International approvals for BALVERSA.",,,1,1,,,,,"While Janssen's estimated volume of patients who may be prescribed BALVERSA is not available in the public domain, BALVERSA is approved specifically for the treatment of patients with locally mUC harboring FGFR3 or FGFR2 genetic alterations. In the U.S., it is estimated that up to 3,000 people with urothelial carcinoma will test FGFR positive on an annual basis. Balversa was developed by Janssen.",,,,,,,,,,,,,,, +Janssen,59676005028,BALVERSA Erdafitinib 5mg 28 tablets,2019-04-15,12600,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals living with metastatic urothelial cancer (mUC). The pricing plan has WAC set for 5mg 28 tablets at $12,600.00. The list price of BALVERSA is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. BALVERSA will also be discounted as required under the Federal Supply Schedule, and other government programs. There are no International approvals for BALVERSA.",,,1,1,,,,,"While Janssen's estimated volume of patients who may be prescribed BALVERSA is not available in the public domain, BALVERSA is approved specifically for the treatment of patients with locally mUC harboring FGFR3 or FGFR2 genetic alterations. In the U.S., it is estimated that up to 3,000 people with urothelial carcinoma will test FGFR positive on an annual basis. Balversa was developed by Janssen.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93526398,SOLIFENACIN SUCCINATE TABLETS 5MG 90,2019-04-22,999.24,,1,80000,,,,,,,"Estimated patient volume of approximately 80,000 patients per month for 5mg dosage, based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93526498,SOLIFENACIN SUCCINATE TABLETS 10MG 90,2019-04-22,999.24,,1,86000,,,,,,,"Estimated patient volume of approximately 86,000 patients per month for 10mg dosage, based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93766356,ERLOTINIB HCL TABLETS EQ 100MG 30,2019-05-09,6455.82,,1,660,,,,,,,"Estimated patient volume of approximately 660 patients per month for 100mg dosage, based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93765256,VARDENAFIL HCL TABLETS 2.5MG 30,2019-01-03,704.59,,1,101361,,,,,,Acquisition date and acquisition price not applicable; Teva developed this product.,"Projected count of 101,361 patients in 2018, based on IQVIA data.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93765356,VARDENAFIL HCL TABLETS 5MG 30,2019-01-03,704.59,,1,101361,,,,,,Acquisition date and acquisition price not applicable; Teva developed this product.,"Projected count of 101,361 patients in 2018, based on IQVIA data.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93765456,VARDENAFIL HCL TABLETS 10MG 30,2019-01-03,704.59,,1,101361,,,,,,Acquisition date and acquisition price not applicable; Teva developed this product.,"Projected count of 101,361 patients in 2018, based on IQVIA data.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93765556,VARDENAFIL HCL TABLETS 20MG 30,2019-01-03,704.59,,1,101361,,,,,,Acquisition date and acquisition price not applicable; Teva developed this product.,"Projected count of 101,361 patients in 2018, based on IQVIA data.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591385101,VIGABATRIN 500MG TABLETS 100,2019-02-06,11487.3,,1,5000,,1,,,,Acquisition date and acquisition price not applicable; Teva developed this product.,"Estimated count of approximately 5,000 patients per year.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,45963045430,DEFERASIROX 125MG TABLETS 30,2019-03-22,750.99,,1,900,,,,,,,"Projected count of approximately 900 patients annually, based on IQVIA data as of February 2019. Also, acquisition date and acquisition price not applicable; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,45963045530,DEFERASIROX 250MG TABLETS 30,2019-03-22,1501.95,,1,900,,,,,,,"Projected count of approximately 900 patients annually, based on IQVIA data as of February 2019. Also, acquisition date and acquisition price not applicable; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,45963045630,DEFERASIROX 500MG TABLETS 30,2019-03-22,3003.84,,1,900,,,,,,,"Projected count of approximately 900 patients annually, based on IQVIA data as of February 2019. Also, acquisition date and acquisition price not applicable; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591240530,AMBRISENTAN 5MG FC TABLETS 30,2019-04-30,2766.81,,1,650,,1,,,,,"Estimated patient volume of approximately 650 patients per month for 5mg dosage, based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591240630,AMBRISENTAN 10MG FC TABLETS 30,2019-04-30,2766.81,,1,1600,,1,,,,,"Estimated patient volume of approximately 1,600 patients per month for 10mg dosage, based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93766456,ERLOTINIB HCL TABLETS EQ 150MG 30,2019-05-09,7302.01,,1,1120,,,,,,,"Estimated patient volume of approximately 1,120 patients per month for 150mg dosage, based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,45963041850,RANOLAZINE 500MG ER TABLETS 500,2019-05-28,711.25,,1,145000,,,,,,,"Approximately 145,000 total prescriptions per month, based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,45963041950,RANOLAZINE 1000MG ER TABLETS 500,2019-05-28,1167.75,,1,145000,,,,,,,"Approximately 145,000 total prescriptions per month, based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591251160,BOSENTAN 62.5MG FC TABLETS 60,2019-06-20,1326,,1,375,,1,,,,,"Average of approximately 375 total prescriptions per month (both dosages), based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591251260,BOSENTAN 125MG FC TABLETS 60,2019-06-20,1326,,1,375,,1,,,,,"Average of approximately 375 total prescriptions per month (both dosages), based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591417101,PENCILLAMINE 250MG CAPSULES 100,2019-06-24,22626.99,,1,310,,1,,,,,"Average of approximately 310 prescriptions per month, based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93306634,ICATIBANT ACETATE 10MG/ML PFS SOL 3ML 1,2019-07-15,5083.26,,1,720,,,,,,,"Average of approximately 720 total prescriptions per month (both pack sizes), based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93306693,ICATIBANT ACETATE 10MG/ML PFS SOL 3ML 3,2019-07-15,15249.78,,1,720,,,,,,,"Average of approximately 720 total prescriptions per month (both pack sizes), based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591455022,DOXYCYCLINE HYCLATE DR TABLET 50MG 120,2019-08-14,1134.6,,1,270,,,,,,,"Average of approximately 270 total prescriptions per month (both dosages), based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591457560,DOXYCYCLINE HYCLATE DR TABLET 200MG 60,2019-08-14,2100.51,,1,270,,,,,,,"Average of approximately 270 total prescriptions per month (both dosages), based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product. Note that although Teva's WAC on NDC 00591457560 was $2,100.51 at launch, Teva subsequently lowered the price, one week later (on August 21, 2019), to $1,500.37. See supporting documents: (1) Teva's original communication to customers and the compendia, sent on Aug. 14, announcing WAC on NDC 00591457560 at $2,100.51, and (2) Teva's follow-on communication to customers and compendia, sent on Aug. 21, noting an updated WAC on NDC 00591457560 of $1,500.37 (backdated to August 14).",https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q3-New-Drug-Public-Release-Supporting-Documents/Teva/2019-08-14-Doxy-Hyclate-DR-New-Product-Notification.pdf,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591501902,FULVESTRANT INJ 250MG/50ML INJ PFS SOL,2019-08-22,1675.35,,1,345,,,,,,,"Average of approximately 345 prescriptions per month, based on IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93363020,ACYCLOVIR CREAM 5% 5GM,2019-08-29,729.47,,1,8400,,,2016-08-02,-1,,"This product (the ""Product"") is an authorized generic version of Zovirax® Cream 5%. Watson Laboratories, Inc. (“Watson”) had an option to sell the Product, and on August 2, 2016, Teva acquired that option – which Teva would later exercise – along with Watson itself, as part of a broader deal involving other assets. The option’s acquisition price was incorporated into that broader deal’s overall purchase price and, thus, there was no one particular price that Teva paid to acquire the option. We were, nonetheless, required to enter a non-zero value in the ""Acquisition Price"" field, and so we entered $33,430,000,000, which is the total amount that Teva paid (along with roughly 100 million shares of Teva stock) in connection with the broader deal referenced above. Once again, and to be clear, this total is not representative of the amount that Teva paid for the option in particular.","Average of approximately 8,400 prescriptions per month, based on IQVIA data.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,703066601,TREPROSTINIL SODIUM INJ 1MG/ML 20ML 1,2019-09-30,1209.65,,1,550,,,,,,,"Average of approximately 550 prescriptions per month (all dosages), based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,703067601,TREPROSTINIL SODIUM INJ 2.5MG/ML 20ML 1,2019-09-30,3024.14,,1,550,,,,,,,"Average of approximately 550 prescriptions per month (all dosages), based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,703068601,TREPROSTINIL SODIUM INJ 5MG/ML 20ML 1,2019-09-30,6048.27,,1,550,,,,,,,"Average of approximately 550 prescriptions per month (all dosages), based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,703069601,TREPROSTINIL SODIUM INJ 10MG/ML 20ML 1,2019-09-30,12096.54,,1,550,,,,,,,"Average of approximately 550 prescriptions per month (all dosages), based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378713293,"Erlotinib Hydrochloride Tablets, 100mg, 30s",2019-05-09,6814.48,,1,613554,,,,,,,"According to the American Lung Association, approximately 540,000 living Americans have been diagnosed with lung cancer. Approximately 85 percent of those lung cancer cases are NSCLC. This product was not the result of an acquisition.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378713393,"Erlotinib Hydrochloride Tablets, 150mg, 30s",2019-05-09,7707.68,,1,613554,,,,,,,"According to the American Lung Association, approximately 540,000 living Americans have been diagnosed with lung cancer. Approximately 85 percent of those lung cancer cases are NSCLC. This product was not the result of an acquisition.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,63459010310,TRUXIMA® (rituximab-abbs) 100 MG / 10 ML,2019-11-11,845.55,The Wholesale Acquisition Cost (WAC or “list price”) for TRUXIMA will be 10 percent lower than the reference product. TRUXIMA is being made available through primary wholesalers at a WAC of $845.55 for 100mg vial and $4227.75 for 500mg vial. Actual costs to individual patients and providers for TRUXIMA are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patient’s insurance payer and eligibility for participation in the assistance program.,,2415,,,2016-10-04,1,,"Teva acquired rights on October 4, 2016 from Celltrion to commercialize TRUXIMA and another biosimilar product for $160M in up-front payments plus additional payments dependent on product sales. The acquisition price for the TRUXIMA rights was incorporated into the broader deal's overall purchase price, and thus, there was no one particular price that Teva paid to acquire those rights. We were, nonetheless, required to enter a non-zero value in the ""Acquisition Cost"" field, and so we entered ""1.00.""",,,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,63459010450,TRUXIMA® (rituximab-abbs) 500 MG / 50 ML,2019-11-11,4227.75,The Wholesale Acquisition Cost (WAC or “list price”) for TRUXIMA will be 10 percent lower than the reference product. TRUXIMA is being made available through primary wholesalers at a WAC of $845.55 for 100mg vial and $4227.75 for 500mg vial. Actual costs to individual patients and providers for TRUXIMA are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patient’s insurance payer and eligibility for participation in the assistance program.,,1469,,,2016-10-04,1,,"Teva acquired rights on October 4, 2016 from Celltrion to commercialize TRUXIMA and another biosimilar product for $160M in up-front payments plus additional payments dependent on product sales. The acquisition price for the TRUXIMA rights was incorporated into the broader deal's overall purchase price, and thus, there was no one particular price that Teva paid to acquire those rights. We were, nonetheless, required to enter a non-zero value in the ""Acquisition Cost"" field, and so we entered ""1.00.""",,,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93351556,DEFERASIROX TABLETS 360MG 30,2019-11-25,2021.81,,1,1950,,,,,,,"Average of approximately 1,950 prescriptions per month, based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591385330,DEFERASIROX 180MG TABLETS 30,2019-12-17,2189.07,,1,590,,,,,,,"Average of approximately 590 prescriptions per month, based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +"Acorda Therapeutics, Inc.",10144034260,INBRIJA (levodopa inhalation powder),2019-02-25,950,,,,,,350000,,,2014-10-22,525000000,,,Please see additional narrative on columns 10 & 11: o,"Acorda Therapeutics, Inc. (“Acorda”) acquired Civitas Therapeutics, Inc. (“Civitas”), which had been developing CVT-301 (now known as INBRIJA), on October 22, 2014, for an aggregate purchase price of $525 million plus combined acquisition costs of approximately $12 million. Civitas is now a wholly-owned subisidiary of Acorda. Prior to its acquisition by Acorda, Civitas had been developing INBRIJA from 2010 to 2014, before which the product was being developed by Alkermes. The ARCUS technology upon which INBRIJA is based had previously been developed in the MIT laboratory of Bob Langer. o","Of the $525 million aggregate purchase price paid by Acorda to acquire Civitas, $423 million was allocated to INBRIJA based on the estimated fair value of INBRIJA at the date of acquisition. The balance of the aggregate purchase price was allocated to acquired property and equipment and other tangible current and non-current assets. The amount of the aggregate purchase price paid in excess of the estimated fair value of the assets acquired and liabilities assumed was allocated to goodwill. Because INBRIJA required further clinical testing and development before it could be the subject of a New Drug Application to the FDA, Acorda funded additional investment above the cost that was required to acquire Civitas.",,,,,,,,,, +Bayer,50419039501,Nubeqa® (darolutamide) 300 mg tablet,2019-08-05,11550,,1,200,,1,2014-06-02,68000000,,Entered into agreement with Orion to co-develop on 6/2/2014 for $68 million upfront. Baye rwill commercialize in the US and pay $45 million at first US sale and ongoing royalties not publicly disclosed.,,,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378427093,"Ambrisentan Tablets, 5mg, 30s",2019-05-07,1152.04,,1,5270,,1,,,,,"According to the American Lung Association, 15-50 people per million in the United States are affected by pulmonary arterial hypertension. This product was not the result of an acquisition.",,,,,,,,,,,,,,, +Sandoz Inc.,781342080,TREPROSTINIL INJECTION 20MG/20ML (1MG/ML) 1LIVI,2019-03-25,1145.99,Sandoz Inc. currently only sells treprostinil in the U.S. Sandoz Inc.'s commercialization partner has sales resources in the field detailing this product to healthcare providers. The WAC is priced lower than the brand WAC.,,52000,,,,,,,"Estimated number of patients is approximately 52,000, based on patients that have been diagnosed with Pulmonary Arterial Hypertension (PAH) in the United States. Source: (DataMonitor) 2016 Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product",https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q2-New-Drug-Public-Release-Supporting-Documents/California-SB17-New-Drug-Report-Submission-ID-90776.pdf,,,,,,,,,,,,,, +Sandoz Inc.,781342580,TREPROSTINIL INJECTION 50MG/20ML (2.5MG/ML) 1LIVI,2019-03-25,2864.97,Sandoz Inc. currently only sells treprostinil in the U.S. Sandoz Inc.'s commercialization partner has sales resources in the field detailing this product to healthcare providers. The WAC is priced lower than the brand WAC.,,52000,,,,,,,"Estimated number of patients is approximately 52,000, based on patients that have been diagnosed with Pulmonary Arterial Hypertension (PAH) in the United States. Source: (DataMonitor) 2016 Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product",https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q2-New-Drug-Public-Release-Supporting-Documents/California-SB17-New-Drug-Report-Submission-ID-90776.pdf,,,,,,,,,,,,,, +Sandoz Inc.,781342780,TREPROSTINIL INJECTION 100MG/20ML (5MG/ML) 1LIVI,2019-03-25,5729.94,Sandoz Inc. currently only sells treprostinil in the U.S. Sandoz Inc.'s commercialization partner has sales resources in the field detailing this product to healthcare providers. The WAC is priced lower than the brand WAC.,,52000,,,,,,,"Estimated number of patients is approximately 52,000, based on patients that have been diagnosed with Pulmonary Arterial Hypertension (PAH) in the United States. Source: (DataMonitor) 2016 Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product",https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q2-New-Drug-Public-Release-Supporting-Documents/California-SB17-New-Drug-Report-Submission-ID-90776.pdf,,,,,,,,,,,,,, +Sandoz Inc.,781343080,TREPROSTINIL INJECTION 200MG/20ML (10MG/ML) 1LIVI,2019-03-25,11459.88,Sandoz Inc. currently only sells treprostinil in the U.S. Sandoz Inc.'s commercialization partner has sales resources in the field detailing this product to healthcare providers. The WAC is priced lower than the brand WAC.,,52000,,,,,,,"Estimated number of patients is approximately 52,000, based on patients that have been diagnosed with Pulmonary Arterial Hypertension (PAH) in the United States. Source: (DataMonitor) 2016 Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product",https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q2-New-Drug-Public-Release-Supporting-Documents/California-SB17-New-Drug-Report-Submission-ID-90776.pdf,,,,,,,,,,,,,, +Sandoz Inc.,781307912,FULVESTRANT 250MG/5ML 2LISY,2019-05-29,1745.15,This launch is specific to the U.S. Sandoz Inc. is currently contracting within the oncology space. The WAC is priced lower than the WAC of the reference product.,,187628,,,,,,,"Sandoz’s Fulvestrant Injection is a hormonal therapy medicine used to treat breast cancer in women with: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, who have gone through menopause and have not been previously treated with endocrine therapy, HR-positive advanced breast cancer, who have gone through menopause and whose disease has progressed after endocrine therapy, HR-positive, HER2-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), in combination with palbociclib or abemaciclib in women whose disease has progressed after endocrine therapy. According to Kantar Health, there is an estimated 187,628 patients with this condition in the United States. Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product.",https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q2-New-Drug-Public-Release-Supporting-Documents/California-SB17-New-Drug-Report-Submission-ID-103955.pdf,,,,,,,,,,,,,, +Sandoz Inc.,61314086601,ZIEXTENZO 6MG/0.6ML 1LISY,2019-11-12,3925.53,"This launch is specific to the U.S., however, Sandoz biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018. Sandoz Inc. is currently contracting within the oncology space. The WAC is priced lower than the WAC of the reference product.",,108419,,,,,,,">650,000 patients with cancer receive chemotherapy annually in the United States. Treatment of cancer with chemotherapy may lead to bone marrow suppression, which can mask the early signs and symptoms of an infection as well as diminish the patient’s capacity to fight infections. Neutropenia and subsequent infectious complications are some of the most serious treatment-related toxicities of chemotherapy for cancer and result in preventable morbidity and mortality. Previous estimates indicate that >60,000 persons with cancer are hospitalized with neutropenia and >4,000 persons die of febrile neutropenia each year in the United States. To decrease the incidence of infection to Patients with cancer receiving myelosuppressive chemotherapy . For 2012, sources identified 91,560 cancer-related neutropenia hospitalizations among adults and 16,859 cancer-related neutropenia hospitalizations among children in the NIS and KID data. (Source: CDC,https://www.cdc.gov/cancer/dcpc/research/articles/neutropenia.htm) . Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Servier Pharmaceuticals LLC,72694051501,Asparlas 750 U/mL 5 mL vials,2019-11-29,24000,,1,,,,,,,,"The “Estimated Number of Patients” field was left blank because the estimated number of patients is not known to Servier. While the estimated volume of patients who may be prescribed Asparlas is not known to Servier, Asparlas is approved specifically for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. In the U.S., the National Cancer Institute estimates that approximately 5,930 people (of all ages) will be diagnosed with acute lymphoblastic leukemia in 2019. Regarding the estimated number of patients in the US that may be prescribed Asparlas for acute lymphoblastic leukemia, Servier has not released this information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). The “Acquisition Date” and “Acquisition Price” fields were left blank because the product was approved under a new drug application for Servier and Servier is the first manufacturer to market the product. Also, please note that the Introduced to Market Date"" should read 11/13/2019.",,,,,,,,,,,,,,, +GlaxoSmithKline,173089201,NUCALA INJ 100 MG/ML,2019-06-17,2954.73,,1,,,,,,,,"Regarding estimated number of patients in the US that may be prescribed NUCALA (NDC: 00173089201) for severe eosinophilic asthma, GSK has not released this information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). Regarding estimated number of patients in the US that may be prescribed NUCALA (NDC: 00173089201) for its second indication, Eosinophilic Granulomatosis with Polyangiitis (EGPA), approximately five people out of every one million will be diagnosed with EGPA each year worldwide. Diagnosed patients may or may not be prescribed NUCALA (NDC: 00173089201) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with NUCALA (NDC: 00173089201). GSK has not released NUCALA's (NDC: 00173089201) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). NUCALA (NDC: 00173089201) was developed by GSK.",,,,,,,,,,,,,,, +GlaxoSmithKline,173089242,NUCALA INJ 100 MG/ML,2019-06-17,2954.73,,1,,,,,,,,"Regarding estimated number of patients in the US that may be prescribed NUCALA (NDC: 00173089242) for severe eosinophilic asthma, GSK has not released this information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). Regarding estimated number of patients in the US that may be prescribed NUCALA (NDC: 00173089242) for its second indication, Eosinophilic Granulomatosis with Polyangiitis (EGPA), approximately five people out of every one million will be diagnosed with EGPA each year worldwide. Diagnosed patients may or may not be prescribed NUCALA (NDC: 00173089242) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with NUCALA (NDC: 00173089242). GSK has not released NUCALA's (NDC: 00173089242) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). NUCALA (NDC: 00173089242) was developed by GSK.",,,,,,,,,,,,,,, +Novo,169430313,Rybelsus Oral Tablet 3mg,2019-10-22,772.43,,1,1400000,,1,,,,,RYBELSUS® is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.  The estimated patients figure is based on the total estimated number of patients in the United States who utilize GLP-1 RA therapies and therefore are likely candidates for RYBELSUS®.  It is not an estimate of prescriptions that might be written for each available dose of RYBELSUS®. RYBELSUS® will represent a portion of the broader market for GLP-1 RA therapies.,,,,,,,,,,,,,,, +Novo,169430713,Rybelsus Oral Tablet 7mg,2019-10-22,772.43,,1,1400000,,1,,,,,RYBELSUS® is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.  The estimated patients figure is based on the total estimated number of patients in the United States who utilize GLP-1 RA therapies and therefore are likely candidates for RYBELSUS®.  It is not an estimate of prescriptions that might be written for each available dose of RYBELSUS®. RYBELSUS® will represent a portion of the broader market for GLP-1 RA therapies.,,,,,,,,,,,,,,, +Novo,169431413,Rybelsus Oral Tablet 14mg,2019-10-22,772.43,,1,1400000,,1,,,,,RYBELSUS® is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.  The estimated patients figure is based on the total estimated number of patients in the United States who utilize GLP-1 RA therapies and therefore are likely candidates for RYBELSUS®.  It is not an estimate of prescriptions that might be written for each available dose of RYBELSUS®. RYBELSUS® will represent a portion of the broader market for GLP-1 RA therapies.,,,,,,,,,,,,,,, +Genentech USA,50242014301,Actemra Pen - 162mg (0.9mL),2019-01-07,984.72,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,,1,1,,,,,Genentech does not publicly disclose the estimated volume of patients who may be prescribed Actemra Pen - 162mg (0.9mL).,,,,,,,,,,,,,,, +Genentech USA,50242091801,Tecentriq 840 mg (14mL),2019-03-23,6216.38,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,0,,,,,,,Genentech does not publicly disclose the estimated volume of patients who may be prescribed Tecentriq – 840mg (14mL). Tecentriq – 840mg (14mL) was developed by Genentech.,,,,,,,,,,,,,,, +Genentech USA,50242007701,Herceptin Hylecta - 600mg (5mL) Inject Sol,2019-04-08,4675.24,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,0,,,,,,,Genentech does not publicly disclose the estimated volume of patients who may be prescribed Herceptin Hylecta - 600mg (5mL) Inject Sol. Herceptin Hylecta - 600mg (5mL) Inject Sol. was developed by Genentech USA Inc.,,,,,,,,,,,,,,, +Genentech USA,50242010501,Polivy 140mg Vial,2019-06-10,15000,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,0,1,1,,,,,Genentech does not publicly disclose the estimated volume of patients who may be prescribed Polivy 140mg Vial. Polivy 140mg Vial was developed on Genentech USA Inc,,,,,,,,,,,,,,, +Genentech USA,50242009130,Rozlytrek 100 mg 30 capsules,2019-08-22,5600,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,0,1,1,,,,,Rozlytrek 100mg 30 capsules was not acquired from a third party. Genentech does not publicly disclose the estimated volume of patients who may be prescribed Rozlytrek 100mg 30 capsules.,,,,,,,,,,,,,,, +Genentech USA,50242009490,Rozlytrek 200 mg 90 capsules,2019-08-21,16800,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,0,1,1,,,,,Rozlytrek 200mg 90 capsules was not acquired from a third party. Genentech does not publicly disclose the estimated volume of patients who may be prescribed Rozlytrek 200mg 90 capsules.,,,,,,,,,,,,,,, +"AMAG Pharmaceuticals, Inc.",64011070104,Vyleesi (bremelanotide Injection) 1.75 mg/0.3mL,2019-08-19,899,"Promotion of Vyleesi to physicians or other health professionals will be limited to AMAG's sales force, digital media, and relevant medical conferences. Direct to consumer media will be used to help create awareness of Vyleesi among the indicated patient population who could experience generalized and acquired Hypoactive Sexual Desire Disorder (HSDD). Media will be limited to non-TV digital display and video advertising on social media and web sites. A copay program will be offered to commercially insured eligible patients to help offset patient OOP costs not covered by their insurer.Consistent with government regulations, government insured patients (e.g. Medicaid) will not be eligible for the copay program. AMAG is also evaluating the potential opportunity of offering samples of this product by rolling out a small pilot samples program.",,,,,,,,,"Response on estimated volume of patients who may be prescribed the drug (see Cal. Health & Saf. Code § 96076(b)(2): Approximately 5.8 million premenopausal women have hypoactive sexual desire disorder (HSDD). Vyleesi was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Mylan Institutional Inc,42292005105,"Erlotinib Hydrochloride Tablets, 25mg, Unit Dose, 20s",2019-05-29,1654,,1,540000,,,,,,,"According to the American Lung Association, approximately 540,000 living Americans have been diagnosed with lung cancer. Approximately 85 percent of those lung cancer cases are NSCLC. This product was not a result of an acquisition.",,,,,,,,,,,,,,, +Mylan Institutional Inc,42292005205,"Erlotinib Hydrochloride Tablets, 100mg, Unit Dose, 20s",2019-05-29,4542.99,,1,540000,,,,,,,"According to the American Lung Association, approximately 540,000 living Americans have been diagnosed with lung cancer. Approximately 85 percent of those lung cancer cases are NSCLC. This product was not a result of an acquisition.",,,,,,,,,,,,,,, +Mylan Institutional Inc,42292005305,"Erlotinib Hydrochloride Tablets, 150mg, Unit Dose, 20s",2019-05-29,5138.45,,1,540000,,,,,,,"According to the American Lung Association, approximately 540,000 living Americans have been diagnosed with lung cancer. Approximately 85 percent of those lung cancer cases are NSCLC. This product was not a result of an acquisition.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378427193,"Ambrisentan Tablets, 10mg, 30s",2019-05-07,1152.04,,1,5270,,1,,,,,"According to the American Lung Association, 15-50 people per million in the United States are affected by pulmonary arterial hypertension. This product was not the result of an acquisition.",,,,,,,,,,,,,,, +Mylan Institutional Inc,67457096701,Hydroxyprogesterone Caproate 250mg/mL 1mL Injection 1PK,2019-08-23,682.55,,1,29011965,,1,,,,,"Hydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation; therefore, the estimated number of patients has been calculated to include the total current population of the United States that may suffer from an indication and be prescribed this medication. In 2016, there were an estimated 772,245 women living with uterine cancer in the United States. [LINK] The prevalence of amenorrhea that is not due to pregnancy, lactation, or menopause is 3 to 4%. [LINK] Up to 14 percent of women experience irregular or excessively heavy menstrual bleeding. [LINK] Please note that Mylan did not acquire the ANDA within the meaning of Health and Safety Code (“HSC”) Section 127681(b)(4) and California Code of Regulations, Title 22, Section 96076(b)(4). Instead, Mylan executed a licensing agreement with the ANDA holder. This agreement, including the parties, terms, and financial arrangement, is confidential information that is not in the public domain or publicly available. As such, pursuant to HSC 127681(c) and California Code of Regulations, Title 22, Section 96076(c), the information in this report is limited to that which is otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Mylan Institutional Inc,67457031105,Fulvestrant 50mg/mL 5mL PFS 2PK,2019-09-09,1745.15,,1,179962,,1,,,,,"Fulvestrant 50mg/mL 5mL Injection is indicated for (1) Monotherapy: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy; and (2) Combination Therapy: HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy, or HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. In 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. (LINK) According to the National Institute of Cancer the total percentage of breast cancer that is the subtype HR+/HER2- is 67%. (LINK) Therefore, an estimated 179,962 (67% of 268,600) women in the United States may be prescribed the product. Note, there is difficultly in further defining a number of patients that may be prescribed as (1) the number of new cases state above includes both pre-menopausal (out of scope of indication) and post-menopausal women, and (2) does not account for how many may become post-menopausal during treatment or how many patients may be added year after year that may be in progression. The acquisition date and price fields are not applicable for this submission as the Product was not the result of an acquisition.",https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q3-New-Drug-Public-Release-Supporting-Documents/Mylan-Fulvestrant-FDA-Ack-Letter.pdf,,,,,,,,,,,,,, +Mylan Institutional Inc,67457084744,"Ogivri (trastuzumab-dkst) for Injection 420mg/vial, 1 vial",2019-11-29,3697.26,,1,40151,,,,,,,"Ogivri is indicated for (1) Adjuvant Breast Cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, as part of a treatment regimen with docetaxel and carboplatin, or as a single agent following multi-modality anthracycline based therapy; (2) Metastatic Breast Cancer in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer, or as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.; and (3) Metastatic Gastric Cancer in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. In 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. (LINK) According to the National Institute of Cancer, the total percentage of breast cancer that is the subtype HR+/HER2+ is 12.9%. (LINK) Therefore, an estimated 34,649 (12.9% of 268,600) women in the United States may be prescribed the product. In 2019, an estimated 27,510 new cases of gastric cancer are expected to be diagnosed in the U.S. (LINK) According to a 2017 study, gastric cancer that is the subset HER2-positive is 20% (LINK). Therefore, an estimated 5,502 (20% of 27,510) patients in the United States may be prescribed this product. Overall, a total of (34,649 HR+/HER2+ and 5,502 HER2+ gastric cancer patients = 40,151 estimated patients that may be prescribed the product in the US).",,,,,,,,,,,,,,, +Mylan Institutional Inc,67457099115,"Ogivri (trastuzumab-dkst) for Injection 150mg/vial, 1 vial",2019-11-29,1324.66,,1,40151,,,,,,,"Ogivri is indicated for (1) Adjuvant Breast Cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, as part of a treatment regimen with docetaxel and carboplatin, or as a single agent following multi-modality anthracycline based therapy; (2) Metastatic Breast Cancer in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer, or as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.; and (3) Metastatic Gastric Cancer in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. In 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. (LINK) According to the National Institute of Cancer, the total percentage of breast cancer that is the subtype HR+/HER2+ is 12.9%. (LINK) Therefore, an estimated 34,649 (12.9% of 268,600) women in the United States may be prescribed the product. In 2019, an estimated 27,510 new cases of gastric cancer are expected to be diagnosed in the U.S. (LINK) According to a 2017 study, gastric cancer that is the subset HER2-positive is 20% (LINK). Therefore, an estimated 5,502 (20% of 27,510) patients in the United States may be prescribed this product. Overall, a total of (34,649 HR+/HER2+ and 5,502 HER2+ gastric cancer patients = 40,151 estimated patients that may be prescribed the product in the US).",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378713193,"Erlotinib Hydrochloride Tablets, 25mg, 30s",2019-05-09,2481,,1,613554,,,,,,,"According to the American Lung Association, approximately 540,000 living Americans have been diagnosed with lung cancer. Approximately 85 percent of those lung cancer cases are NSCLC. This product was not the result of an acquisition.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378619793,"Cinacalcet Hydrochloride Tablets, 30mg, 30s",2019-05-23,685.7,,1,,,,,,,,"Approximately 30,000,000 people in the United States are living with chronic kidney disease, according to the American Kidney Fund. This product was not the result of an acquisition.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378619693,"Cinacalcet Hydrochloride Tablets, 60mg, 30s",2019-05-23,1371.39,,1,,,,,,,,"Approximately 30,000,000 people in the United States are living with chronic kidney disease, according to the American Kidney Fund. This product was not the result of an acquisition.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378619593,"Cinacalcet Hydrochloride Tablets, 90mg, 30s",2019-05-23,2057.09,,1,,,,,,,,"Approximately 30,000,000 people in the United States are living with chronic kidney disease, according to the American Kidney Fund. This product was not the result of an acquisition.",,,,,,,,,,,,,,, +Asegua Therapeutics LLC,72626260101,agLDV/SOF (ledipasvir 90 mg/sofosbuvir 400 mg) tablets,2019-01-02,8000,"Consistent with Section 127681(c) of the California Health and Safety Code, Asegua is limiting its response to that which is otherwise in the public domain or publicly available. The authorized generics launched at a list price of $24,000 for the most common course of therapy. In the Medicare Part D setting, the authorized generics could save patients up to $2,500 in out-of-pocket costs per course of therapy. The authorized generics will also offer substantial savings to state managed Medicaid plans that do not currently benefit from negotiated rebates and that represent a significant number of people in need, potentially opening up access to beneficiaries who were previously denied coverage.",,,,,,,,Response to “Acquisition Date” and “Acquisition Price”: These questions are not relevant to the authorized generic scenario.,"Response to ""Estimated Number of Patients"": Consistent with Section 127681(c) of the California Health and Safety Code, Asegua is limiting its response to that which is otherwise in the public domain or publicly available. In the Medicare Part D setting, the authorized generics could save patients up to $2,500 in out-of-pocket costs per course of therapy. The authorized generics will also offer substantial savings to state managed Medicaid plans that do not currently benefit from negotiated rebates and that represent a significant number of people in need, potentially opening up access to beneficiaries who were previously denied coverage. Response to “Breakthrough Therapy?” and “Priority Review?”: These questions are not relevant to the authorized generic scenario.",,,,,,,,,,,,,,, +Asegua Therapeutics LLC,72626270101,agSOF/VEL (sofosbuvir 400 mg/velpatasvir 100 mg) tablets,2019-01-02,12000,"Consistent with Section 127681(c) of the California Health and Safety Code, Asegua is limiting its response to that which is otherwise in the public domain or publicly available. The authorized generics launched at a list price of $24,000 for the most common course of therapy. In the Medicare Part D setting, the authorized generics could save patients up to $2,500 in out-of-pocket costs per course of therapy. The authorized generics will also offer substantial savings to state managed Medicaid plans that do not currently benefit from negotiated rebates and that represent a significant number of people in need, potentially opening up access to beneficiaries who were previously denied coverage.",,,,,,,,Response to “Acquisition Date” and “Acquisition Price”: These questions are not relevant to the authorized generic scenario.,"Response to ""Estimated Number of Patients"": Consistent with Section 127681(c) of the California Health and Safety Code, Asegua is limiting its response to that which is otherwise in the public domain or publicly available. In the Medicare Part D setting, the authorized generics could save patients up to $2,500 in out-of-pocket costs per course of therapy. The authorized generics will also offer substantial savings to state managed Medicaid plans that do not currently benefit from negotiated rebates and that represent a significant number of people in need, potentially opening up access to beneficiaries who were previously denied coverage. Response to “Breakthrough Therapy?” and “Priority Review?”: These questions are not relevant to the authorized generic scenario.",,,,,,,,,,,,,,, +"Astellas Pharma US, Inc.",469133050,Prograf Granules (tacrolimus for oral suspension) 1mg,2019-03-12,388.05,,1,,,,,,,,"Astellas has not released the information requested in column 7 (estimated volume of patients that may be prescribed the drug) in the public domain. Further, Astellas does not believe this information is in the public domain or publicly available. As a result, Astellas is limiting its response to this reporting requirement pursuant to Cal. Health & Safety Code Section 127681(c). Prograf Granules was not acquired; therefore, columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +"Astellas Pharma US, Inc.",469123050,Prograf Granules (tacrolimus for oral suspension) 0.2mg,2019-03-12,260,,1,,,,,,,,"Astellas has not released the information requested in column 7 (estimated volume of patients that may be prescribed the drug) in the public domain. Further, Astellas does not believe this information is in the public domain or publicly available. As a result, Astellas is limiting its response to this reporting requirement pursuant to Cal. Health & Safety Code Section 127681(c). Prograf Granules was not acquired; therefore, columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Baxter Healthcare Corporation,338955810,EPTIFIBATIDE,2019-02-21,240,,1,,,,,,,Not aquired,This is the seventh Eptifibatide on the market in the US. The first is a flexible IV container. Marketing pricing plan and estimated patient numbers are not publicly available or in the public domain and are therefore being kept confidential.,,,,,,,,,,,,,,, +Baxter Healthcare Corporation,338006301,Doxil 20mg-10ml Vial,2019-10-02,1248.96,,1,,,,2019-10-01,,1,,"Marketing pricing plan, estimated patient numbers and the acquisition price are not publicly available or in the public domain and are therefore being kept confidential.",,,,,,,,,,,,,,, +Baxter Healthcare Corporation,338006701,Doxil 50mg-25ml Vial,2019-10-02,3122.4,,1,,,,2019-10-01,,1,,"Marketing pricing plan, estimated patient numbers and the acquisition price are not publicly available or in the public domain and are therefore being kept confidential.",,,,,,,,,,,,,,, +Baxter Healthcare Corporation,338008001,"Doxorubicin HCL, 2mg/ml x 10ml vial",2019-10-02,969,,1,,,,2019-10-01,,1,,"Marketing pricing plan, estimated patient numbers and the acquisition price are not publicly available or in the public domain and are therefore being kept confidential.",,,,,,,,,,,,,,, +Baxter Healthcare Corporation,338008601,"Doxorubicin HCL, 2mg/ml x 25ml vial",2019-10-02,2422.55,,1,,,,2019-10-01,,1,,"Marketing pricing plan, estimated patient numbers and the acquisition price are not publicly available or in the public domain and are therefore being kept confidential.",,,,,,,,,,,,,,, +"Paratek Pharmaceuticals, Inc.",71715000221,NUZYRA 150mg omadacycline tablets 6ct blister pack,2019-02-01,1185,,1,12000,,1,,,,,,,,,,,,,,,,,,,, +"Paratek Pharmaceuticals, Inc.",71715000223,NUZYRA 150mg omadacycline tablets 14ct Blister Pack,2019-02-01,2765,,1,12000,,1,,,,,,,,,,,,,,,,,,,, +"Paratek Pharmaceuticals, Inc.",71715000224,NUZYRA 150mg omadacycline tablets 16ct blister pack,2019-02-01,3160,,1,12000,,1,,,,,,,,,,,,,,,,,,,, +"Paratek Pharmaceuticals, Inc.",71715000102,NUZYRA 150mg single dose vial 10ct carton,2019-02-01,3450,,1,12000,,1,,,,,,,,,,,,,,,,,,,, +"Titan Pharmaceuticals, Inc.",52440010014,Probuphine Implant,2019-03-01,4950,,1,800,,,,,1,"Product was marketed previously under the Braeburn labeler code, but Braeburn had a contract to market this product for Titan. Titan then took this back and started marketing the product again under their labeler code. The first shipment was available to consumers on 3/1/2019 for the Titan labeler code.",,,,,,,,,,,,,,,, +Theratechnologies Inc.,62064024130,EGRIFTA SV (tesamorelin for injection) - sterile lyophilized powder 2mg/vial,2019-11-25,5300,Parity pricing to original Egrifta. Print Ad In-office detailing On-line advertising,,108,,,,,,,Estimated volume of patients in CA is 108,,,,,,,,,,,,,,, +"Kyowa Kirin, Inc.",42747060290,"20 mg 90 Tablet, Film Coated in 1 Bottle",2019-09-19,4500,,1,,,,,,,,The estimated number of patients is unknown at this time and an analysis has not been done at this level. An Acquisition Price is N/A as Kyowa Kirin developed the drug.,,,,,,,,,,,,,,, +"Kyowa Kirin, Inc.",42747060490,"40 mg 90 Tablet, Film Coated in 1 Bottle",2019-09-19,4500,,1,,,,,,,,The estimated number of patients is unknown at this time and an analysis has not been done at this level. An Acquisition Price is N/A as Kyowa Kirin developed the drug.,,,,,,,,,,,,,,, +Ferring Pharmaceuticals,55566100001,ganirelix,2019-02-14,184.02,,1,,1,,2018-12-14,,1,,1) report previously submitted so we do not agree we are delinquent 2)number of patients is non public,,,,,,,,,,,,,,, +ViiV Healthcare,49702024613,DOVATO TAB 50-300MG,2019-04-23,2295,,1,,,,,,,,"Regarding Marketing/Pricing Plan Description, ViiV has not released DOVATO's marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). Regarding estimated number of patients in the US that may be prescribed DOVATO, ViiV has not released this information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). DOVATO was not granted breakthrough therapy designation or priority review by the federal Food And Drug Administration. Note on Acquisition Fields: This drug was developed by ViiV Healthcare, therefore the following fields related to drug acquisition have been left blank: ACQUISITION_DATE, ACQUISITION_PRICE, ACQUISITION_PRICE_NONPUBLIC, ACQUISITION_PRICE_COMMENT.",,,,,,,,,,,,,,, +"Otsuka America Pharmaceutical, Inc.",59148002985,ABILIFY MYCITE 2mg (aripiprazole tablets with sensor),2019-03-04,1650,,1,,,,,,,,please see attached document,https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/California-SB17_NewDrug30-DayInformation_OAPI2019.pdf,,,,,,,,,,,,,, +"Otsuka America Pharmaceutical, Inc.",59148003085,ABILIFY MYCITE 5mg (aripiprazole tablets with sensor),2019-03-04,1650,,1,,,,,,,,please see attached document,https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/California-SB17_NewDrug30-DayInformation_OAPI2019.pdf,,,,,,,,,,,,,, +"Otsuka America Pharmaceutical, Inc.",59148003185,ABILIFY MYCITE 10mg (aripiprazole tablets with sensor),2019-03-04,1650,,1,,,,,,,,please see attached document,https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/California-SB17_NewDrug30-DayInformation_OAPI2019.pdf,,,,,,,,,,,,,, +"Otsuka America Pharmaceutical, Inc.",59148003285,ABILIFY MYCITE 15mg (aripiprazole tablets with sensor),2019-03-04,1650,,1,,,,,,,,please see attached document,https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/California-SB17_NewDrug30-DayInformation_OAPI2019.pdf,,,,,,,,,,,,,, +"Otsuka America Pharmaceutical, Inc.",59148003385,ABILIFY MYCITE 20mg (aripiprazole tablets with sensor),2019-03-04,1650,,1,,,,,,,,please see attached document,https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/California-SB17_NewDrug30-DayInformation_OAPI2019.pdf,,,,,,,,,,,,,, +"Otsuka America Pharmaceutical, Inc.",59148003485,ABILIFY MYCITE 30mg (aripiprazole tablets with sensor),2019-03-04,1650,,1,,,,,,,,please see attached document,https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/California-SB17_NewDrug30-DayInformation_OAPI2019.pdf,,,,,,,,,,,,,, +Amgen,55513088002,Evenity 210 mg/2.34 mL (105 mg/1.17 mL x 2),2019-04-15,1825,,1,,,,,,,,"The estimated number of patients is not available in the public domain. In the U.S., 10 million Americans suffer from osteoporosis, and the disease is responsible for an estimated two million fractures per year. However, only 20 percent of patients who have had one or more osteoporotic-related fractures are treated. Acquisition date and acquisition price not applicable; Amgen co-developed this product with UCB",,,,,,,,,,,,,,, +Amgen,55513013201,KANJINTI (420 mg multi dose vial),2019-07-19,3697.26,"US Marketing Plan: There will be no direct-to-consumer marketing for KANJINTI such as TV ads, magazine or journal ads. The only platform directed to patients is a section of the KANJINTI.com website entitled “For Patients – Getting to Know KANJINTI”. This section of the website is designed to educate patients about HER2+ breast or gastric cancer and potential treatment with KANJINTI, including important safety information. Promotional activities to physicians will include professional detailing by Amgen sales representatives. Amgen is utilizing its existing oncology sales force to educate health care professionals about KANJINTI, including the requirements for establishing biosimilarity to the reference product, Herceptin, and important safety information. Professional detailing entails resources such as a core visual aid, clinical reprints, and promotional leave-behind literature. There is no free drug or sample program. Amgen also contracts with payors and providers such as hospitals and clinics to offer KANJINTI at a competitive price and ensure access to the product for appropriate patients. International Marketing Plan: marketing plan information is not in the public domain. Reg. § 96076(c). US Pricing Plan: The U.S. Wholesale Acquisition Cost (WAC or ""list price"") of KANJINTI will be 15% lower than their reference products. KANJINTI is being made available at a WAC of $3,697.26 per 420 mg multi-dose vial, 15% below the WAC of Herceptin. At launch, KANJINTI is priced 13% below the current Herceptin Average Selling Price (ASP). International Pricing Plan: pricing plan information is not in the public domain. Reg. § 96076(c).",,,,,,,,,Our estimate of appropriate patients potentially treatable with the class of drug to which KANJINTI belongs is ~42K a year and we intend to compete with other drugs in this class for a share of that patient population. Acquisition date and acquisition price not applicable as Amgen developed this drug product,,,,,,,,,,,,,,, +Amgen,55513020601,MVASI (100 mg/4mL single dose vial),2019-07-19,677.4,"US Marketing Plan: There will be no direct-to-consumer marketing for MVASI such as TV ads, magazine or journal ads. The only platform directed to patients is a section of the MVASI.com website entitled “For Patients – Getting to Know MAVSI”. This section of the website is designed to educate patients about potential cancer treatment with MVASI, specifically for metastatic colorectal cancer (mCRC), advanced non-squamous non-small cell lung cancer (NSCLC), recurrent glioblastoma (rGBM), metastatic renal cell carcinoma (mRCC), and advanced cervical cancer (CC), including important safety information. Promotional activities to physicians will include professional detailing by Amgen sales representatives. Amgen is utilizing its existing oncology sales force to educate health care professionals about MVASI, including the requirements for establishing biosimilarity to the reference product, Avastin, and important safety information. Professional detailing entails resources such as a core visual aid, clinical reprints, and promotional leave-behind literature. There is no free drug or sample program. Amgen also contracts with payors and providers such a hospitals and clinics to offer MVASI at a competitive price and ensure access to the product for appropriate patients. International Marketing Plan: marketing plan information is not in the public domain. Reg. § 96076(c). US Pricing Plan: The U.S. Wholesale Acquisition Cost (WAC or ""list price"") of MVASI will be 15% lower than their reference products. MVASI is being made available at a WAC of $677.40 per 100 mg and $2,709.60 per 400 mg single-dose vial, 15% less than the WAC for Avastin. At launch, MVASI is priced 12% below the current Avastin Average Selling Price (ASP). International Pricing Plan: pricing plan information is not in the public domain. Reg. § 96076(c).",,,,,,,,,Our estimate of appropriate patients potentially treatable with the class of drug to which MVASI belongs is ~40K a year and we intend to compete with other drugs in this class for a share of that patient population Acquisition date and acquisition price not applicable as Amgen developed this drug product,,,,,,,,,,,,,,, +Amgen,55513020701,MVASI (400 mg/16mL single dose vial),2019-07-19,2709.6,"US Marketing Plan: There will be no direct-to-consumer marketing for MVASI such as TV ads, magazine or journal ads. The only platform directed to patients is a section of the MVASI.com website entitled “For Patients – Getting to Know MAVSI”. This section of the website is designed to educate patients about potential cancer treatment with MVASI, specifically for metastatic colorectal cancer (mCRC), advanced non-squamous non-small cell lung cancer (NSCLC), recurrent glioblastoma (rGBM), metastatic renal cell carcinoma (mRCC), and advanced cervical cancer (CC), including important safety information. Promotional activities to physicians will include professional detailing by Amgen sales representatives. Amgen is utilizing its existing oncology sales force to educate health care professionals about MVASI, including the requirements for establishing biosimilarity to the reference product, Avastin, and important safety information. Professional detailing entails resources such as a core visual aid, clinical reprints, and promotional leave-behind literature. There is no free drug or sample program. Amgen also contracts with payors and providers such a hospitals and clinics to offer MVASI at a competitive price and ensure access to the product for appropriate patients. International Marketing Plan: marketing plan information is not in the public domain. Reg. § 96076(c). US Pricing Plan: The U.S. Wholesale Acquisition Cost (WAC or ""list price"") of MVASI will be 15% lower than their reference products. MVASI is being made available at a WAC of $677.40 per 100 mg and $2,709.60 per 400 mg single-dose vial, 15% less than the WAC for Avastin. At launch, MVASI is priced 12% below the current Avastin Average Selling Price (ASP). International Pricing Plan: pricing plan information is not in the public domain. Reg. § 96076(c).",,,,,,,,,Our estimate of appropriate patients potentially treatable with the class of drug to which MVASI belongs is ~40K a year and we intend to compete with other drugs in this class for a share of that patient population Acquisition date and acquisition price not applicable as Amgen developed this drug product,,,,,,,,,,,,,,, +"TWi Pharmaceuticals USA, Inc.",24979003504,Cyclobenzaprine Hydrochloride ER Capsule 15mg-60’s,2019-03-01,900,,1,3534,,,,,1,,Estimated number of patient is actually estimated number of bottles. We currently do not have an estimated number of patients that will be taking this product.,,,,,,,,,,,,,,, +"TWi Pharmaceuticals USA, Inc.",24979003604,Cyclobenzaprine HCl ER Oral Capsule Extended Release 24 Hour 30 MG,2019-03-01,900,,1,1485,,,,,1,,Estimated number of patients is actually estimated number of bottles. TWI does not currently have an estimated number of patients that will be taking this product on an annual basis.,,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923046502,VYONDYS 53 Golodirsen 100MG/2ML Injection vial in carton,2019-12-12,1600,,1,,,1,,,,,"Response to ""Estimated Number of Patients"": VYONDYS 53 is an antisense oligonucleotide from Sarepta’s phosphorodiamidate morpholino oligomer platform, indicated for the treatment of Duchenne muscular dystrophy in patients with a confirmed mutation amenable to exon 53 skipping. Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 53 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.)",,,,,,,,,,,,,,, +Mayne Pharma Inc,51862060602,Halobetasol Propionate 0.05% Foam - Hydroalcoholic,2019-01-14,1473.46,,1,,,,2018-10-25,15000000,,Total Halobetasol acquisition cost: $15million plus additional contingent earnout payments,"For additional information, please visit: https://www.maynepharma.com/media/2211/myx-announces-acquisition-of-fda-approved-halobetasol-foam.pdf *Please also be advised that the estimated number of patients is not currently reported as we do not have the full scope of this data yet",,,,,,,,,,,,,,, +Mayne Pharma Inc,51862060650,Halobetasol Propionate 0.05% Foam - Hydroalcoholic,2019-01-14,770.72,,1,,,,2018-10-25,15000000,,Total Halobetasol acquisition cost: $15million plus additional contingent earnout payments,"For additional information, please visit: https://www.maynepharma.com/media/2211/myx-announces-acquisition-of-fda-approved-halobetasol-foam.pdf *Please also be advised that the estimated number of patients is not currently reported as we do not have the full scope of this data yet",,,,,,,,,,,,,,, +Mayne Pharma Inc,51862063428,Fentanyl Buccal 100mcg Tabs 28,2019-06-19,1300.51,,1,,,,,,,,License deal June 2019. Please be advised that the number of patients reported is not reported as Mayne Pharma does not have this data.,,,,,,,,,,,,,,, +Mayne Pharma Inc,51862063528,Fentanyl Buccal 200mcg Tabs 28,2019-06-19,1643.14,,1,,,,,,,,License deal June 2019. Please be advised that the number of patients reported is not reported as Mayne Pharma does not have this data.,,,,,,,,,,,,,,, +Mayne Pharma Inc,51862063628,Fentanyl Buccal 400mcg Tabs 28,2019-06-19,2384.06,,1,,,,,,,,License deal June 2019. Please be advised that the number of patients reported is not reported as Mayne Pharma does not have this data.,,,,,,,,,,,,,,, +Mayne Pharma Inc,51862063728,Fentanyl Buccal 600mcg Tabs 28,2019-06-19,3095.21,,1,,,,,,,,License deal June 2019. Please be advised that the number of patients reported is not reported as Mayne Pharma does not have this data.,,,,,,,,,,,,,,, +Mayne Pharma Inc,51862063828,Fentanyl Buccal 800mcg Tabs 28,2019-06-19,3813.17,,1,,,,,,,,License deal June 2019. Please be advised that the number of patients reported is not reported as Mayne Pharma does not have this data.,,,,,,,,,,,,,,, +"Daiichi Sankyo, Inc.",65597040601,Enhertu,2019-12-20,2295.97,,1,,1,1,,,,,Average patient will need 4 vials each 3 week cycle. Estimated patient count forecasts are not made public.,,,,,,,,,,,,,,, +Novartis,78098615,"MAYZENTTM is available as 2 mg tablet (equivalent to 2.224mg siponimod fumaric acid): pale yellow, unscored, round biconvex film-coated tablet with beveled edges, debossed with Novartis symbol on one side and “T” on other side.",2019-03-27,7273.97,"Novartis considered many factors in determining the price of Mayzent. As the first oral drug to delay disability progression in RRMS, CIS, and active SPMS, Mayzent is poised to substantially reduce the burden of the condition on patients, caregivers, employers, insurers, the US healthcare system and society as a whole. We are focused on access to Mayzent for this patient population.",,320000,,1,,,,,"Novartis used a priority review voucher. Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Novartis,78097950,"MAYZENTTM is available as 0.25 mg tablet (equivalent to 0.278mg siponimod fumaric acid): Pale red, unscored, round biconvex film-coated tablet with beveled edges, debossed with Novartis symbol on one side and “T” on other side.",2019-03-27,1697.26,"Novartis considered many factors in determining the price of Mayzent. As the first oral drug to delay disability progression in RRMS, CIS, and active SPMS, Mayzent is poised to substantially reduce the burden of the condition on patients, caregivers, employers, insurers, the US healthcare system and society as a whole. We are focused on access to Mayzent for this patient population.",,320000,,1,,,,,"Novartis used a priority review voucher. Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Novartis,78070802,Piqray 300 mg /56 tablets (150mg tabs),2019-05-24,15500,"Novartis considered many factors in determining the price of Piqray. We consider the value the medicine brings to the patient population, the healthcare system, and society. We also consider the research and development costs, as well as ongoing costs for marketing, regulatory commitments, ongoing pharmacovigilance, and market conditions and dynamics. Piqray is the first and only treatment specifically for the approximately 40% of HR+/HER2- advanced breast cancer patients with a PIK3CA mutation, bringing a biomarker-driven therapy option to people with HR+/HER2- advanced breast cancer for the first time. Advanced breast cancer is incurable, and patients with all types need more treatment options. With this approval, physicians can now use an FDA-approved test to determine if their patients’ HR+/HER2- advanced breast cancer has a PIK3CA mutation and may benefit from Piqray combination therapy. We are focused on access to Piqray for this patient population.",,43000,,,,,,,"Novartis developed Piqray. Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Novartis,78071502,Piqray 250 mg / 56 tablets (28 of the 200 mg tabs & 28 of the 50 mg tabs),2019-05-24,15500,"Novartis considered many factors in determining the price of Piqray. We consider the value the medicine brings to the patient population, the healthcare system, and society. We also consider the research and development costs, as well as ongoing costs for marketing, regulatory commitments, ongoing pharmacovigilance, and market conditions and dynamics. Piqray is the first and only treatment specifically for the approximately 40% of HR+/HER2- advanced breast cancer patients with a PIK3CA mutation, bringing a biomarker-driven therapy option to people with HR+/HER2- advanced breast cancer for the first time. Advanced breast cancer is incurable, and patients with all types need more treatment options. With this approval, physicians can now use an FDA-approved test to determine if their patients’ HR+/HER2- advanced breast cancer has a PIK3CA mutation and may benefit from Piqray combination therapy. We are focused on access to Piqray for this patient population.",,43000,,,,,,,"Novartis developed Piqray. Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Novartis,78070184,Piqray 200 mg / 28 tablets (28 of the 200mg tabs),2019-05-24,15500,"Novartis considered many factors in determining the price of Piqray. We consider the value the medicine brings to the patient population, the healthcare system, and society. We also consider the research and development costs, as well as ongoing costs for marketing, regulatory commitments, ongoing pharmacovigilance, and market conditions and dynamics. Piqray is the first and only treatment specifically for the approximately 40% of HR+/HER2- advanced breast cancer patients with a PIK3CA mutation, bringing a biomarker-driven therapy option to people with HR+/HER2- advanced breast cancer for the first time. Advanced breast cancer is incurable, and patients with all types need more treatment options. With this approval, physicians can now use an FDA-approved test to determine if their patients’ HR+/HER2- advanced breast cancer has a PIK3CA mutation and may benefit from Piqray combination therapy. We are focused on access to Piqray for this patient population.",,43000,,,,,,,"Novartis developed Piqray. Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Novartis,78082761,BEOVU® (brolucizumab-dbll),2019-10-08,1850,"Novartis considered many factors in determining the price of Beovu®.  We believe Beovu is poised to substantially reduce the burden of Neovascular (Wet) Age-Related Macular Degeneration (AMD) on patients, caregivers, insurers, the US healthcare system and society as a whole. With our pricing methodology, we are focused on access to BEOVU® for this patient population.",,700000,,1,,,,,"There are 700,000 patients with wAMD in the US for whom Beovu® may be prescribed; however, it is most likely only 53,000 US patients may potentially be prescribed Beovu® in 2020. Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710102108,Albendazole 200mg Tablets,2019-01-18,366.28,,1,0,,,,0,,,This is an AB rated generic product that was developed by Zydus.,,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710117903,Ambrisentan 5mg Tablets,2019-04-15,2500,,1,0,,,,0,,,This is an AB rated generic product that was developed by Zydus.,,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710118003,Ambrisentan 10mg Tablets,2019-04-15,2500,,1,0,,,,0,,,This is an AB rated generic product that was developed by Zydus,,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710101401,Phytonadione 5mg Tablet,2019-03-01,5358.91,,1,0,,,,0,,,This is an AB rated generic product that was developed by Zydus,,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,68382044614,Bosentan 62.5mg Tablet,2019-06-03,10038.54,,1,0,,,,0,,,"This is an AB rated generic product that was developed by Zydus. As Zydus manufactures generic products, we do not estimate the number of patients that may be prescribed our products. We manufacture volume based on an estimated market share along with IQVIA EUTRx data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level.",,,,,,,,,,,,,,, +Novartis,78088361,"ADAKVEO® (crizanlizumab-tmca) injection is a sterile, clear to opalescent, colorless to slightly brownish-yellow solution for intravenous infusion supplied as:",2019-11-18,2357.14,"Novartis considered many factors in determining the price of Adakveo® including the value the medicine brings to the patient population, the healthcare system, and society.   Adakveo® is the first targeted therapy to prevent the painful vaso-occlusive crises (VOCs) that patients with sickle cell disease endure. We believe Adakveo® is posed to reduce the burden of VOCs on patients with sickle cell disease, caregivers, the US healthcare system and society as a whole. We are focused on access to Adakveo® for this patient population. For marketing, we anticipate multi-channel advertising & promotion for Adakveo®.",,2048,1,1,2016-11-18,665000000,,"Reprixys Pharmaceuticals Corporation, formerly known as Selexys Pharmaceutical Corporation, was acquired by Novartis for $665M. This product was a part of the portfolio acquired by Novartis.","Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +"Sigmapharm Laboratories, LLC",42794005108,Ambrisentan 5 mg tab 30ct,2019-04-29,5980,"Sigmapharm’s pricing and marketing plan for its products is not in the public domain or otherwise publicly available. Therefore, Sigmapharm is limiting the information reported pursuant to § 96076(c).",,,,,,,,,"Field 7: Ambrisentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): (i) To improve exercise ability and delay clinical worsening; and (ii) In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability. Sigmapharm Laboratories, LLC (Sigmapharm), lacks sufficient information to determine the total number of patients who may be prescribed its Ambrisentan Tablets products given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of 6 other approved AB-rated generics as well as the RLD. Fields 10-13: Sigmapharm developed its Ambrisentan Tablets products in-house. The fields are therefore inapplicable.",,,,,,,,,,,,,,, +"Sigmapharm Laboratories, LLC",42794005208,Ambrisentan 10 mg tab 30ct,2019-04-29,5980,"Sigmapharm’s pricing and marketing plan for its products is not in the public domain or otherwise publicly available. Therefore, Sigmapharm is limiting the information reported pursuant to § 96076(c).",,,,,,,,,"Field 7: Ambrisentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): (i) To improve exercise ability and delay clinical worsening; and (ii) In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability. Sigmapharm Laboratories, LLC (Sigmapharm), lacks sufficient information to determine the total number of patients who may be prescribed its Ambrisentan Tablets products given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of 6 other approved AB-rated generics as well as the RLD. Fields 10-13: Sigmapharm developed its Ambrisentan Tablets products in-house. The fields are therefore inapplicable.",,,,,,,,,,,,,,, +"Cameron Pharmaceuticals, LLC",42494042810,LORZONE (CHLORZOXAZONE 750 MG),2019-11-27,832.25,"Selling to wholesalers and retailers as a less expensive alternative to the brand, Lorzone.",,2000000,,,,,,,"Cameron co-developed this product. Novitium Pharma, LLC is the manufacturer and Cameron Pharmaceuticals, LLC is acting as the Distributor.",,,,,,,,,,,,,,, +AbbVie,74204202,"SKYRIZI (risankizuman-rzaa) 150mg (carton containing two 75mg/0.83mL single-dose, pre-filled syringes)",2019-04-29,14750,"SKYRIZI will be marketed to adult patients with moderate-to-severe psoriasis who are candidates for systemic therapy or phototherapy. SKYRIZI is dosed four times per year. The price of SKYRIZI is $14,750 per dose. The maintenance price of SKYRIZI is lower than the most widely-prescribed biologic treatments for moderate to severe plaque psoriasis. AbbVie recently received approval of SKYRIZI from: --Japanese Ministry of Health, Labour and Welfare for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis; --Health Canada for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy; and --The European Commission for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.",,,,,,,,,"Response on estimated volume of patients who may be prescribed the drug (see Cal. Health & Saf. Code § 96076(b)(2): SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Based upon an academic analysis of data from the CDC National Health and Nutrition Examination Survey, it is estimated that approximately 1 million adults in the United States have chronic plaque psoriasis that is deemed to be moderate or severe. See e.g., Helmick C., et al., Prevalence of Psoriasis Among Adults in the U.S., 2003-2006 and 2009-2010 National Health and Nutrition Examination Surveys, Am. J. of Prev. Med., 47(1):37–45 (2014). SKYRIZI may be prescribed for that fraction of adults with moderate-to-severe psoriasis who are candidates for systemic therapy or phototherapy. SKYRIZI was developed by AbbVie, with research and development costs funded in part by AbbVie. On April 1, 2016, AbbVie acquired all rights to risankizumab, which was in Phase 3 development for psoriasis, from Boehringer Ingelheim pursuant to a global collaboration agreement. Since that date, all development costs have been funded by AbbVie, and AbbVie is responsible for all development going forward. AbbVie is studying the potential of risankizumab in other chronic conditions, including Crohn’s disease, psoriatic arthritis, ulcerative colitis and atopic dermatitis.",,,,,,,,,,,,,,, +AbbVie,74230630,"RINVOQ (upadacitinib); 15mg extended-release tablets, 30 count bottle",2019-08-20,4916.67,"RINVOQ will be marketed to adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The recommended dose of RINVOQ is 15mg once daily. The WAC price of a thirty-tablet bottle of RINVOQ is $4,916.47. The annual wholesale acquisition cost of RINVOQ is $59,000, which is lower than the current leading treatments for moderate to severe rheumatoid arthritis. RINVOQ is under review by the European Medicines Agency, as well as regulatory authorities in Canada and Japan, for the treatment of adult patients with moderately to severely active rheumatoid arthritis.",,,,,,,,,"RINVOQ was developed by AbbVie. Response on estimated volume of patients who may be prescribed the drug (see Cal. Health & Saf. Code § 96076(b)(2): Based upon an observational, retrospective, cross-sectional study using data from the US administrative health insurance claims databases (Truven Health MarketScan and IMS PharMetrics Plus database), it is estimated that approximately 1.3 million adults in the United States have rheumatoid arthritis. See e.g., Hunter T., et al., Prevalence of rheumatoid arthritis in the United States adult population in healthcare claims databases, 2004–2014, Rheumatol. Int., 37(9): 1551-1557 (2017). RINVOQ may be prescribed for that fraction of adults with moderately to severely active rheumatoid arthritis who have had inadequate response or intolerance to methotrexate.",,,,,,,,,,,,,,, +"EMD Serono, Inc.",44087040004,Mavenclad (cladribine) 10 mg per tablet (4),2019-04-02,28428.56,,1,,,,,,,,"This information is applicable to all submitted Mavenclad NDCs. Mavenclad was approved for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. According to the National Multiple Sclerosis Society, MS is believed to affect nearly 1 million adults over the age of 18 in the United States. Approximately 85% of people with MS are initially diagnosed with relapsing-remitting MS. (www.nationalmssociety.org)",,,,,,,,,,,,,,, +"EMD Serono, Inc.",44087040005,Mavenclad (cladribine) 10 mg per tablet (5),2019-04-02,35535.7,,1,,,,,,,,"This information is applicable to all submitted Mavenclad NDCs. Mavenclad was approved for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. According to the National Multiple Sclerosis Society, MS is believed to affect nearly 1 million adults over the age of 18 in the United States. Approximately 85% of people with MS are initially diagnosed with relapsing-remitting MS. (www.nationalmssociety.org)",,,,,,,,,,,,,,, +"EMD Serono, Inc.",44087040006,Mavenclad (cladribine) 10 mg per tablet (6),2019-04-02,42642.84,,1,,,,,,,,"This information is applicable to all submitted Mavenclad NDCs. Mavenclad was approved for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. According to the National Multiple Sclerosis Society, MS is believed to affect nearly 1 million adults over the age of 18 in the United States. Approximately 85% of people with MS are initially diagnosed with relapsing-remitting MS. (www.nationalmssociety.org)",,,,,,,,,,,,,,, +"EMD Serono, Inc.",44087040007,Mavenclad (cladribine) 10 mg per tablet (7),2019-04-02,49749.98,,1,,,,,,,,"This information is applicable to all submitted Mavenclad NDCs. Mavenclad was approved for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. According to the National Multiple Sclerosis Society, MS is believed to affect nearly 1 million adults over the age of 18 in the United States. Approximately 85% of people with MS are initially diagnosed with relapsing-remitting MS. (www.nationalmssociety.org)",,,,,,,,,,,,,,, +"EMD Serono, Inc.",44087040008,Mavenclad (cladribine) 10 mg per tablet (8),2019-04-02,56857.12,,1,,,,,,,,"This information is applicable to all submitted Mavenclad NDCs. Mavenclad was approved for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. According to the National Multiple Sclerosis Society, MS is believed to affect nearly 1 million adults over the age of 18 in the United States. Approximately 85% of people with MS are initially diagnosed with relapsing-remitting MS. (www.nationalmssociety.org)",,,,,,,,,,,,,,, +"EMD Serono, Inc.",44087040009,Mavenclad (cladribine) 10 mg per tablet (9),2019-04-02,63964.26,,1,,,,,,,,"This information is applicable to all submitted Mavenclad NDCs. Mavenclad was approved for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. According to the National Multiple Sclerosis Society, MS is believed to affect nearly 1 million adults over the age of 18 in the United States. Approximately 85% of people with MS are initially diagnosed with relapsing-remitting MS. (www.nationalmssociety.org)",,,,,,,,,,,,,,, +"EMD Serono, Inc.",44087040010,Mavenclad (cladribine) 10 mg per tablet (10),2019-04-02,71071.4,,1,,,,,,,,"This information is applicable to all submitted Mavenclad NDCs. Mavenclad was approved for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. According to the National Multiple Sclerosis Society, MS is believed to affect nearly 1 million adults over the age of 18 in the United States. Approximately 85% of people with MS are initially diagnosed with relapsing-remitting MS. (www.nationalmssociety.org)",,,,,,,,,,,,,,, +"EMD Serono, Inc.",44087353501,Bavencio (avelumab) Injection,2019-05-14,1572.7,,1,,1,1,,,,,"The monthly estimated patient total is internal information that is aspirational, is not publicly available, and is subject to market adoption. BAVENCIO was approved in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). According to the American Cancer Society, about 73,820 new cases of kidney cancer will occur in the United States in 2019 (https://www.cancer.org/cancer/kidney-cancer/about/key-statistics.html, last visited June 12, 2019). Approximately 90% of kidney cancers are renal cell carcinomas (https://www.cancer.org/cancer/kidney-cancer/about/what-is-kidney-cancer.html, last visited June 12, 2019). Approximately 30% of RCC patients are first diagnosed with RCC at the advanced stage (https://seer.cancer.gov/statfacts/html/kidrp.html, last visited June 12, 2019).",,,,,,,,,,,,,,, +"Daiichi Sankyo, Inc.",65597040228,Turalio,2019-08-06,19800,,1,,1,1,,,,,"WAC based on monthly price assuming 400mg daily. As this is an oncology product, a ""course of treatment may vary."" The estimated patient population has not been made public. Turalio was developed by Daiichi Sankyo, Inc. There was no acquisition.",,,,,,,,,,,,,,, +"Daiichi Sankyo, Inc.",65597040220,Turalio,2019-08-06,19800,,1,,1,1,,,,,"WAC based on monthly price assuming 400mg daily. As this is an oncology product, a ""course of treatment may vary."" The estimated patient population has not been made public. Turalio was developed by Daiichi Sankyo, Inc. There was no acquisition.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,68382044714,Bosentan 125mg Tablet,2019-06-03,10038.54,,1,0,,,,0,,,"This is an AB rated generic product that was developed by Zydus. As Zydus manufactures generic products, we do not estimate the number of patients that may be prescribed our products. We manufacture volume based on an estimated market share along with IQVIA EUTRx data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710120301,Trientine HCl 250mg Capsules,2019-05-29,15618.34,,1,0,,,,0,,,"This is an AB rated generic product that was developed by Zydus. As Zydus manufactures generic products, we do not estimate the number of patients that may be prescribed our products. We manufacture volume based on an estimated market share along with IQVIA EUTRx data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710161006,Arsenic Trioxide Inj 12mg/6ml (10x6ml),2019-09-16,7698.24,,1,0,,,,,,,"This is an AP rated injectable generic product that was developed by Zydus. Acquisition date and price are not applicable. Additionally, as Zydus manufactures generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We manufacture volume based on an estimated market share along with IQVIA EUTRx data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710127703,Deferasirox Tab 90mg 30 Count,2019-11-21,1093.3,,1,,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Additionally, as Zydus manufactures generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We manufacture volume based on an estimated market share along with IQVIA EUTRx data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710115201,Isosorbide Dinitrate Tab 40mg 100 Ct,2019-12-11,1335.37,,1,,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Additionally, as Zydus manufactures generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We manufacture volume based on an estimated market share along with IQVIA EUTRx data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients.",,,,,,,,,,,,,,, +Akorn Inc,17478044708,"Aminocaproic Acid Oral Solution, USP",2019-11-04,2549.02,,1,1800,,,,,,,"Akorn indicated the 11/4/2019 date as the introduced to market date as that is when we first had product available to ship, the date we informed customers of the price and availability. This date was loaded into First Data Bank with WAC pricing.",,,,,,,,,,,,,,, +"Seattle Genetics, Inc.",51144002001,PADCEV (enfortumab vedotin-ejfv) 20 mg,2019-12-18,2110,"With regard to marketing plans, efforts to ensure that healthcare providers with appropriate patients are aware of PADCEV™ include customary digital and print media campaigns, oncology account managers sharing information with healthcare providers, and engagement of healthcare providers at congresses. With regard to pricing plans, Seattle Genetics has a passion for helping patients, and that passion includes ensuring that we reach as many of the patients with cancers that our products treat as we can. Our pricing considerations are informed by that passion, and we incorporate diverse perspectives of stakeholders in the healthcare system. We also consistently seek to balance rewarding innovation while providing appropriate access for patients. Finally, we consider the clinical value our products deliver to patients, the severity of the cancers we treat, availability of alternative treatments, market dynamics, our continued ability to deliver new state-of-the-art innovations in response to other deadly cancers, and the meaningful impact we make on patient’s lives.",,,1,1,,,,,"Seattle Genetics does not believe the estimated number of patients in the United States with a condition for which this product may be prescribed is in the public domain. Thus, consistent with 22 C.C.R. §96076(c), Seattle Genetics has left that field blank. Seattle Genetics notes this product is indicated for metastatic urothelial carcinoma, a type of bladder cancer, and we are able to provide the following publicly available information on bladder cancer more generally. Specifically, in 2018, more than 82,000 people were diagnosed with bladder cancer in the U.S. However, this data does not include patients who progress to metastatic stage or recur. According to SEER statistics from 2009-2015, 5% of urinary bladder cancers were metastatic (distant), and 7% were locally advanced (regional). Please note that this data is out of date. According to a retrospective analysis of 1,703 metastatic bladder cancer patients from 2004 to 2011, 42% of patients received a first-line treatment, and 35% of that population received a second-line treatment. This data likely underestimates the percentage of treated patients, as the data was gathered prior to the introduction of checkpoint inhibitors. Because this drug was not acquired, the fields ""acquisition date,"" ""acquisition price"" and ""acquisition price comment"" have been left blank. Seattle Genetics co-developed PADCEV™ with Astellas.",,,,,,,,,,,,,,, +Karyopharm Therapeutics Inc.,72237010105,XPOVIO (selinexor) 100mg (20 Tablets),2019-07-03,22000,,1,6000,,1,,,,,,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010004101,"Amphetamine Sulfate Tablets USP 10 MG, 100 count",2019-10-07,465.5,,1,0,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +"Seattle Genetics, Inc.",51144003001,PADCEV (enfortumab vedotin-ejfv) 30 mg,2019-12-18,3165,"With regard to marketing plans, efforts to ensure that healthcare providers with appropriate patients are aware of PADCEV™ include customary digital and print media campaigns, oncology account managers sharing information with healthcare providers, and engagement of healthcare providers at congresses. With regard to pricing plans, Seattle Genetics has a passion for helping patients, and that passion includes ensuring that we reach as many of the patients with cancers that our products treat as we can. Our pricing considerations are informed by that passion, and we incorporate diverse perspectives of stakeholders in the healthcare system. We also consistently seek to balance rewarding innovation while providing appropriate access for patients. Finally, we consider the clinical value our products deliver to patients, the severity of the cancers we treat, availability of alternative treatments, market dynamics, our continued ability to deliver new state-of-the-art innovations in response to other deadly cancers, and the meaningful impact we make on patient’s lives.",,,1,1,,,,,"Seattle Genetics does not believe the estimated number of patients in the United States with a condition for which this product may be prescribed is in the public domain. Thus, consistent with 22 C.C.R. §96076(c), Seattle Genetics has left that field blank. Seattle Genetics notes this product is indicated for metastatic urothelial carcinoma, a type of bladder cancer, and we are able to provide the following publicly available information on bladder cancer more generally. Specifically, in 2018, more than 82,000 people were diagnosed with bladder cancer in the U.S. However, this data does not include patients who progress to metastatic stage or recur. According to SEER statistics from 2009-2015, 5% of urinary bladder cancers were metastatic (distant), and 7% were locally advanced (regional). Please note that this data is out of date. According to a retrospective analysis of 1,703 metastatic bladder cancer patients from 2004 to 2011, 42% of patients received a first-line treatment, and 35% of that population received a second-line treatment. This data likely underestimates the percentage of treated patients, as the data was gathered prior to the introduction of checkpoint inhibitors. Because this drug was not acquired, the fields ""acquisition date,"" ""acquisition price"" and ""acquisition price comment"" have been left blank. Seattle Genetics co-developed PADCEV™ with Astellas.",,,,,,,,,,,,,,, +Epic Pharma,42806005030,Meperidine Hcl 50mg 30 Tab Epic,2019-12-30,783,,1,,,,,,,,lauching new size-30 count Epic Pharma developed the drugs,,,,,,,,,,,,,,, +"Valeant Pharmaceuticals North America, LLC",187065301,Duobrii External Lotion 0.01-0.045 %,2019-06-03,825,,1,5240000,,,,,,,"This product was developed internally, not acquired",,,,,,,,,,,,,,, +Biogen,64406002001,VUMERITY™ (diroximel fumarate) 231mg Starter Bottle (106 capsules),2019-11-22,6388.62,"Vumerity will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences for use in patients with Relapsing forms of Multiple Sclerosis. Biogen has a set of Pricing Principles that inform pricing decisions for its products. Those principles are: 1. Value to Patients 2. Present and Future Benefit to Society 3. Fullfilling our commitment to Innovation 4. Evolution toward Value Based Care and 5. Affordability & Sustainability. Further information can found at: https://www.biogen.com/content/dam/corporate/en_us/pdfs/BIOGEN_PricingPrinciplesInfographic_4-26-19.pdf",,344000,,,,,,,"Vumerity is not an acquired product, nor was it granted breakthrough status or given a priority review by the FDA.",,,,,,,,,,,,,,, +Biogen,64406002003,VUMERITY™ (diroximel fumarate) 231mg Maintenance Bottle (120 capsules),2019-11-22,7232.88,"Vumerity will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences for use in patients with Relapsing forms of Multiple Sclerosis. Biogen has a set of Pricing Principles that inform pricing decisions for its products. Those principles are: 1. Value to Patients 2. Present and Future Benefit to Society 3. Fullfilling our commitment to Innovation 4. Evolution toward Value Based Care and 5. Affordability & Sustainability. Further information can found at: https://www.biogen.com/content/dam/corporate/en_us/pdfs/BIOGEN_PricingPrinciplesInfographic_4-26-19.pdf",,344000,,,,,,,"Vumerity is not an acquired product, nor was it granted breakthrough status or given a priority review by the FDA.",,,,,,,,,,,,,,, +"Cameron Pharmaceuticals, LLC",42494042510,LORZONE (CHLORZOXAZONE 375 MG),2019-11-27,744.29,"Selling to wholesalers and retailers as a less expensive alternative to the brand, Lorzone.",,2000000,,,,,,,"Cameron co-developed this product. Novitium Pharma, LLC is the manufacturer and Cameron Pharmaceuticals, LLC is acting as the Distributor.",,,,,,,,,,,,,,, +Par Pharmaceutical,49884082011,Alosetron HCl Tablets 1mg 30s,2019-04-12,950,,1,,1,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","Par does not believe the estimated number of patients with a condition for which this product may be prescribed, consistent with its label, is in the public domain. As a result, Par has left the estimated number of patients data field blank. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,49884035362,Ambrisentan Oral Tablet 5 MG 10s,2019-04-29,2588.82,,1,,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","Par does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. As a result, Par has left the estimated number of patients data field blank. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,49884035311,Ambrisentan Oral Tablet 5 MG 30s,2019-04-29,7766.47,,1,,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","Par does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. As a result, Par has left the estimated number of patients data field blank. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,49884035462,Ambrisentan Oral Tablet 10 MG 10s,2019-04-29,2588.82,,1,,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","Par does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. As a result, Par has left the estimated number of patients data field blank. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,49884035411,Ambrisentan Oral Tablet 10 MG 30s,2019-04-29,7766.47,,1,,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","Par does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. As a result, Par has left the estimated number of patients data field blank. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,49884005802,Bosentan Tablets 62.5mg 60s,2019-06-03,1163.16,,1,,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","Par does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. As a result, Par has left the estimated number of patients data field blank. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,49884005902,Bosentan Tablets 125mg 60s,2019-06-03,1163.16,,1,,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","Par does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. As a result, Par has left the estimated number of patients data field blank. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,254302002,Nitisinone Capsules 2 mg 60 Capsules,2019-09-20,4359.51,,1,150,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","This product is indicated for Tyrosinemia Type 1. Publicly available information indicates that between 100-200 cases have been diagnosed in the United States. See, e.g., https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/765/orfadin-nitisinone; https://www.orfadin.com/support; https://www.businesswire.com/news/home/20181119005482/en/Longer-shelf-life-NITYR-nitisinone-tablets-HT-1. Based on estimates from the above sources, Par has provided 150 as the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label. Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. The reported figure is the median of the 100-200 diagnosed Tyrosinemia Type 1 cases in the United States, since Par is unable to provide a range in the “estimated number of patients” data field. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,254302102,Nitisinone Capsules 5 mg 60 Capsules,2019-09-20,10898.71,,1,150,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","This product is indicated for Tyrosinemia Type 1. Publicly available information indicates that between 100-200 cases have been diagnosed in the United States. See, e.g., https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/765/orfadin-nitisinone; https://www.orfadin.com/support; https://www.businesswire.com/news/home/20181119005482/en/Longer-shelf-life-NITYR-nitisinone-tablets-HT-1. Based on estimates from the above sources, Par has provided 150 as the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label. Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. The reported figure is the median of the 100-200 diagnosed Tyrosinemia Type 1 cases in the United States, since Par is unable to provide a range in the “estimated number of patients” data field. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,254302202,Nitisinone Capsules 10 mg 60 Capsules,2019-09-20,21797.45,,1,150,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","This product is indicated for Tyrosinemia Type 1. Publicly available information indicates that between 100-200 cases have been diagnosed in the United States. See, e.g., https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/765/orfadin-nitisinone; https://www.orfadin.com/support; https://www.businesswire.com/news/home/20181119005482/en/Longer-shelf-life-NITYR-nitisinone-tablets-HT-1. Based on estimates from the above sources, Par has provided 150 as the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label. Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. The reported figure is the median of the 100-200 diagnosed Tyrosinemia Type 1 cases in the United States, since Par is unable to provide a range in the “estimated number of patients” data field. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,42023020601,Treprostinil Injection 20 mg/20 mL (1 mg/mL),2019-09-25,1209.65,,1,750,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","This product is indicated to treat pulmonary arterial hypertension, which the National Organization for Rare Disorders (“NORD”) indicates between 500-1000 patients are diagnosed each year in the United States. See https://rarediseases.org/rare-diseases/pulmonary-arterial-hypertension/ . Based on this estimate, Par has provided 750 as the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label. Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. This product is the median of the 500-1000 diagnosed pulmonary arterial hypertension cases in the United States each year, since Par is unable to provide a range in the “estimated number of patients” data field. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,42023020701,Treprostinil Injection 50 mg/20 mL (2.5 mg/mL),2019-09-25,3024.14,,1,750,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","This product is indicated to treat pulmonary arterial hypertension, which the National Organization for Rare Disorders (“NORD”) indicates between 500-1000 patients are diagnosed each year in the United States. See https://rarediseases.org/rare-diseases/pulmonary-arterial-hypertension/ . Based on this estimate, Par has provided 750 as the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label. Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. This product is the median of the 500-1000 diagnosed pulmonary arterial hypertension cases in the United States each year, since Par is unable to provide a range in the “estimated number of patients” data field. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,42023020801,Treprostinil Injection 100 mg/20 mL (5 mg/mL),2019-09-25,6048.27,,1,750,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","This product is indicated to treat pulmonary arterial hypertension, which the National Organization for Rare Disorders (“NORD”) indicates between 500-1000 patients are diagnosed each year in the United States. See https://rarediseases.org/rare-diseases/pulmonary-arterial-hypertension/ . Based on this estimate, Par has provided 750 as the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label. Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. This product is the median of the 500-1000 diagnosed pulmonary arterial hypertension cases in the United States each year, since Par is unable to provide a range in the “estimated number of patients” data field. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,42023020901,Treprostinil Injection 200 mg/20 mL (10 mg/mL),2019-09-25,12096.54,,1,750,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","This product is indicated to treat pulmonary arterial hypertension, which the National Organization for Rare Disorders (“NORD”) indicates between 500-1000 patients are diagnosed each year in the United States. See https://rarediseases.org/rare-diseases/pulmonary-arterial-hypertension/ . Based on this estimate, Par has provided 750 as the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label. Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. This product is the median of the 500-1000 diagnosed pulmonary arterial hypertension cases in the United States each year, since Par is unable to provide a range in the “estimated number of patients” data field. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,49884006001,"Trientine Hydrochloride Capsules, USP 250 mg 100 Capsules",2019-10-07,5000,,1,2500,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","This product is indicated to treat Wilson Disease, which the National Organization for Rare Disorders (“NORD”) indicates between 2,000 – 3,000 cases have been diagnosed in the United States. See https://rarediseases.org/rare-diseases/wilson-disease/. However, NORD indicates as many as 9,000 people in the United States may be actually affected by Wilson Disease. Based on NORD’s data, Par has provided 2,500 as the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label. This figure is the median of the 2,000-3,000 diagnosed Wilson Disease cases NORD estimates, since Par is unable to provide a range in the “estimated number of patients” data field. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,49884011991,Everolimus Tablets 2.5mg 28s,2019-12-10,12012.98,,1,,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","This product is indicated for numerous types of cancer. Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Because of the product’s widespread indications, and because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to provide an estimated number of patients who will be prescribed the products in the “estimated number of patients” data field. As a result, Par has left the estimated number of patients data field blank. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,49984012591,Everolimus Tablets 5mg 28s,2019-12-10,12565.37,,1,,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","This product is indicated for numerous types of cancer. Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Because of the product’s widespread indications, and because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to provide an estimated number of patients who will be prescribed the products in the “estimated number of patients” data field. As a result, Par has left the estimated number of patients data field blank. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,49884012791,Everolimus Tablets 7.5mg 28s,2019-12-10,12565.37,,1,,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","This product is indicated for numerous types of cancer. Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Because of the product’s widespread indications, and because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to provide an estimated number of patients who will be prescribed the products in the “estimated number of patients” data field. As a result, Par has left the estimated number of patients data field blank. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +Par Pharmaceutical,49884072308,Zileuton Extended Release Tablets 600mg 120s,2019-12-16,3007.23,,1,,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2)","Zileuton is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. The CDC estimates that, as of 2017, 25,191,000 individuals in the United States have asthma. See Most Recent National Asthma Data, CDC, https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm. Because of the high prevalence of asthma in the United States, and because Par does not know, and does not have access to, the prescribing habits of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. (3)","Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,, +"Ajanta Pharma USA, Inc.",27241017529,"Sildenafil Citrate For Suspension 10 MG/ML, 112 ML, Bottle",2019-12-11,3000,,1,197,,,,,,,This drug was not acquired,,,,,,,,,,,,,,, +Biocodex USA,68418793906,Stiripentol Oral Capsule 250 MG,2019-04-26,1500,,1,196,,,,,,,This drug was not acquired,,,,,,,,,,,,,,, +Biocodex USA,68418794006,Stiripentol Oral Capsule 500 MG,2019-04-26,3000,,1,196,,,,,,,This drug was not acquired,,,,,,,,,,,,,,, +Biocodex USA,68418794106,Stiripentol Oral Packet 250 MG,2019-04-26,1500,,1,196,,,,,,,This drug was not acquired,,,,,,,,,,,,,,, +Biocodex USA,68418794206,Stiripentol Oral Packet 500 MG,2019-04-26,3000,,1,196,,,,,,,This drug was not acquired,,,,,,,,,,,,,,, +"Sage Therapeutics, Inc.",72152054720,ZULRESSO (brexanolone) injection CIV,2019-06-20,7450,,1,,1,1,,,,,"Comment regarding fields 5, 7, and 12: Sage Therapeutics has not released information on the marketing/pricing plan for ZULRESSO, or the estimated number of patients in the public domain and does not believe this information is publicly available. The acquisition date and acquisition price are not applicable. Sage Therapeutics developed ZULRESSO.",,,,,,,,,,,,,,, +"Sentynl Therapeutics, Inc.",42358010310,Levorphanol Tartrate Tablets 3mg,2019-01-21,6675,,1,,,,,,,,"The product is a new 3 mg strength of levorphanol tartrate tablets developed by Sentynl Therapeutics, Inc. between 2015 and 2018 and not acquired from a third party. The WAC reflects various factors, including, but not limited to, the cost of the Active Pharmaceutical Ingredient and the expenses associated with developing, manufacturing and offering the product for sale in the United States. The product is currently indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Thus, it is impossible to accurately estimate the number of patients in the United States with a condition for which this new prescription drug may be prescribed.",,,,,,,,,,,,,,, +AveXis,7189412002,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a patient weight of 2.6 – 3.0kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189412103,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 3.1 – 3.5kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189412203,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 3.6 – 4.0kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189412303,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 4.1 – 4.5kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189412404,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 4.6 – 5.0kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189412504,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 5.1 – 5.5kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189412604,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 5.6 – 6.0kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189412705,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 6.1 – 6.5kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189412805,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 6.6 – 7.0kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189412905,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 7.1 – 7.5kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189413006,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 7.6 – 8.0kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189413106,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 8.1 – 8.5kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189413206,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 8.6 – 9.0kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189413307,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 9.1 – 9.5kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189413407,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 9.6 – 10.0kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189413507,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 10.1 – 10.5kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189413608,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 10.6 – 11.0kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189413708,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 11.1 – 11.5kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189413808,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 11.6 – 12.0kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189413909,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 12.1 – 12.5kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189414009,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 12.6 – 13.0kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +AveXis,7189414109,Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 13.1 – 13.5kg,2019-05-24,2125000,"The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)",,150,1,1,,,,,"From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +"Progenics Pharmaceuticals, Inc.",71258001502,AZEDRA (iobenguane I 131) injection,2019-06-03,9060,,1,380,1,1,,,,,"Azedra is priced at $302 per mCi. 71258001502 is a dosimetric presentation containing 30 mCi at calibration time Estimated of the average number of patients who will be prescribed AZERDA: AZEDRA is the first and only FDA-approved systemic treatment for advanced PPGL and the only drug approved by the FDA to treat PPGL that cannot be surgically removed (i.e., are unresectable), are locally advanced, or have spread beyond the original tumor site, and require systemic anticancer therapy. Prior to FDA’s approval of AZEDRA, patients with advanced PPGL had no FDA-approved treatment option for systemic anticancer therapy. As FDA stated in its Review Summary for AZEDRA, “Clearly, there is a patient population who could potentially benefit from effective systemic therapy. To date, there are limited options for such patients (e.g., either compounded I-131 MIBG or off- label cytotoxic chemotherapy).” PPGL are ultra-rare tumors, and the ultra-rare category is that with the smallest of patient populations. We estimate there will be approximately 400-800 Azedra-eligible patients in the US each year (or 32-65 per month), based on the following epidemiology statistics: •",US population of approximately 330M (US Census Bureau) •,Annual incidence of Pheochromocytoma and Paraganglioma is 2-8 per million (NCI Pheochromocytoma PDQ ) •,15%-20% malignant upon initial presentation will be initial candidates for AZEDRA (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3921052/#b9-conc-21-e8) •,Prevalence of 150-400 per million (https://www.ncbi.nlm.nih.gov/books/NBK278970/) •,"Lifetime relapse rate 6-16% (https://www.ncbi.nlm.nih.gov/pubmed/25456947) 50% malignant upon relapse (https://www.ncbi.nlm.nih.gov/books/NBK278970/) Low-end Estimate = 380 Azedra-eligible patients per year = [330M population * 5 incident cases per million * 15% malignancy rate] + [330M population * 200 prevalent cases per million + 0.4% annual relapse rate * 50% malignancy rate] High-end Estimate = 776 Azedra-eligible patients per year = [330M population * 8 incident cases per million * 20% malignancy rate] + [330M * 300 prevalent cases per million * 0.5% annual relapse rate * 50% malignancy rate] Of course, not all eligible patients will receive Azedra. Allowances must be made for patients who are not MIBG-avid (sensitive), opt not to receive systemic therapy, etc.",https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q2-New-Drug-Public-Release-Supporting-Documents/20150726-Letter-from-FDA-IND-070663-Grant-Breakthrough-Therapy-Designation-COR-BREAK-02-Final-7-24-15-Submission-ID-103962.pdf ; https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q2-New-Drug-Public-Release-Supporting-Documents/20171228-Letter-from-FDA-NDA-209607-Filing-communication-Submission-ID-103962.pdf,,,,,,,,, +"Progenics Pharmaceuticals, Inc.",71258001522,AZEDRA (iobenguane I 131) injection,2019-06-03,101925,,1,380,1,1,,,,,"Azedra is priced at $302 per mCi. 71258001502 is a therapeutic presentation containing 337.5 mCi at calibration time Estimated of the average number of patients who will be prescribed AZERDA: AZEDRA is the first and only FDA-approved systemic treatment for advanced PPGL and the only drug approved by the FDA to treat PPGL that cannot be surgically removed (i.e., are unresectable), are locally advanced, or have spread beyond the original tumor site, and require systemic anticancer therapy. Prior to FDA’s approval of AZEDRA, patients with advanced PPGL had no FDA-approved treatment option for systemic anticancer therapy. As FDA stated in its Review Summary for AZEDRA, “Clearly, there is a patient population who could potentially benefit from effective systemic therapy. To date, there are limited options for such patients (e.g., either compounded I-131 MIBG or off- label cytotoxic chemotherapy).” PPGL are ultra-rare tumors, and the ultra-rare category is that with the smallest of patient populations. We estimate there will be approximately 400-800 Azedra-eligible patients in the US each year (or 32-65 per month), based on the following epidemiology statistics: •",US population of approximately 330M (US Census Bureau) •,Annual incidence of Pheochromocytoma and Paraganglioma is 2-8 per million (NCI Pheochromocytoma PDQ ) •,15%-20% malignant upon initial presentation will be initial candidates for AZEDRA (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3921052/#b9-conc-21-e8) •,Prevalence of 150-400 per million (https://www.ncbi.nlm.nih.gov/books/NBK278970/) •,"Lifetime relapse rate 6-16% (https://www.ncbi.nlm.nih.gov/pubmed/25456947) 50% malignant upon relapse (https://www.ncbi.nlm.nih.gov/books/NBK278970/) Low-end Estimate = 380 Azedra-eligible patients per year = [330M population * 5 incident cases per million * 15% malignancy rate] + [330M population * 200 prevalent cases per million + 0.4% annual relapse rate * 50% malignancy rate] High-end Estimate = 776 Azedra-eligible patients per year = [330M population * 8 incident cases per million * 20% malignancy rate] + [330M * 300 prevalent cases per million * 0.5% annual relapse rate * 50% malignancy rate] Of course, not all eligible patients will receive Azedra. Allowances must be made for patients who are not MIBG-avid (sensitive), opt not to receive systemic therapy, etc.",https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q2-New-Drug-Public-Release-Supporting-Documents/20150726-Letter-from-FDA-IND-070663-Grant-Breakthrough-Therapy-Designation-COR-BREAK-02-Final-7-24-15-Submission-ID-103962.pdf ; https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q2-New-Drug-Public-Release-Supporting-Documents/20171228-Letter-from-FDA-NDA-209607-Filing-communication-Submission-ID-103962.pdf,,,,,,,,, +Perrigo Pharmaceuticals,45802004475,Acyclovir 5% Cream 5gm,2019-02-11,759.86,,1,23360000,,,,,,,Perrigo developed this product. It was not an acquisition.,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238147101,Erythromycin Tab Delayed Release 250 MG Bottle 100 x1,2019-07-18,671.08,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238147201,Erythromycin Tab Delayed Release 333 MG Bottle 100 x1,2019-07-18,844.96,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238147301,Erythromycin Tab Delayed Release 500 MG Bottle 100 x1,2019-07-18,1040.35,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238179701,Hydroxyprogesterone Caproate IM in Oil 250 MG/ML Vial 1 x1,2019-03-08,682.55,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121158505,Verapamil HCl IV Soln 2.5 MG/ML Vial 2 x25,2019-03-06,759,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121163705,Ephedrine Sulfate IV Soln 50MG/ML Vial 1 x25,2019-10-28,726,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238159403,Sirolimus Oral Soln 1 MG/ML Kit Bottle 60 x1,2019-10-28,1052.62,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238159406,Sirolimus Oral Soln 1 MG/ML Bottle 60 x1,2019-10-28,1052.62,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,65162028303,Paliperidone Tab ER 24HR 9 MG Bottle 30 x1,2019-10-10,825.17,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121146302,Fulvestrant Inj 250 MG/5ML Syringe 5 x2,2019-10-01,1745.15,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,65162087406,Bosentan Tab 125 MG Bottle 60 x1,2019-06-03,10608.02,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,65162087306,Bosentan Tab 62.5 MG Bottle 60 x1,2019-06-03,10608.02,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238159608,Aminocaproic Acid Oral Soln 0.25 GM/ML Bottle 236.5 x1,2019-09-05,2549.02,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238154501,Trientine HCl Cap 250 MG Bottle 100 x1,2019-08-21,5000,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121164707,Tigecycline For IV Soln 50 MG Vial 1 x10,2019-08-09,1040,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238105103,Phytonadione Tab 5 MG Bottle 30 x1,2019-02-26,1607.68,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238116507,Abiraterone Acetate Tab 250 MG Bottle 120 x1,2019-01-08,3499.4,This is a generic product this is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238157401,Sildenafil Oral Susp 10MG/ML,2019-12-02,3500.5,This is a generic product that is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598041311,Daptomycin 500mg Powder for Injection,2019-05-06,445,,1,0,,,,,,,1) DRL does not estimate the number of patients for this drug. 2) Dr. Reddy’s did not acquire daptomycin.,https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q2-New-Drug-Public-Release-Supporting-Documents/DRL-Drug-Price-Transparency-3-Day-Notice-Daptomycin-2019-06-21-14-Submission-ID-103939.pdf,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598069858,Carboprost Tromethamine 250mcg/1mL Solution for injection,2019-07-02,3189.9,,1,0,,,,,,,1) DRL does not estimate the number of patients for this drug. 2) Dr. Reddy’s did not acquire Carboprost. 3) Dr. Reddy’s Laboratories does not believe this information is publicly available and has not released this information in the public domain,,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598069750,"Vigabatrin for Oral Solution,USP 500 mg",2019-08-19,3652.94,,1,0,,1,,,,,1) Dr. Reddy's does not estimate the number of patients for this drug. 2) Dr. Reddy’s did not acquire the product. 3) Dr. Reddy’s does not believe this information is publicly available and has not released this information in the public domain.,,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598086560,Bortezomib for Injection 3.5mg/vial,2019-12-03,1602.98,,1,0,,,,,,,"1) Dr. Reddy's Laboratories, Inc. does not estimate the number of patients for this drug. 2) Dr. Reddy’s Laboratories, Inc. did not acquire the product. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598085330,Deferasirox Film coated tablets 90MG,2019-12-05,190.03,,1,1,,,,,,,"Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis. Specifically, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Deferasirox FCT 90MG product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of 3 other approved AB-rated generics as well as the reference listed drug. Dr. Reddy’s Laboratories, Inc. did not acquire the product.This product has been in-licensed from the ANDA holder, MSN Labs, by Dr Reddy’s Laboratories, Inc. for the purpose of commercial marketing and distribution.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598085130,Deferasirox Film coated tablets 360MG,2019-12-05,760.08,,1,1,,,,,,,"Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis. Specifically, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Deferasirox FCT 360MG product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of 3 other approved AB-rated generics as well as the reference listed drug. Dr. Reddy’s Laboratories, Inc. did not acquire the product. This product has been in-licensed from the ANDA holder, MSN Labs, by Dr Reddy’s Laboratories, Inc. for the purpose of commercial marketing and distribution.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598085530,Deferasirox Tablets for Oral Suspension 125MG,2019-12-05,190.03,,1,1,,,,,,,"Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis. Specifically, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Deferasirox TFOS product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of 5 other approved AB-rated generics as well as the reference listed drug. Dr. Reddy’s Laboratories, Inc. did not acquire the product. This product has been in-licensed from the ANDA holder, MSN Labs, by Dr Reddy’s Laboratories, Inc. for the purpose of commercial marketing and distribution.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598085630,Deferasirox Tablets for Oral Suspension 250MG,2019-12-05,380.05,,1,1,,,,,,,"Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis. Specifically, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Deferasirox TFOS product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of 5 other approved AB-rated generics as well as the reference listed drug. Dr. Reddy’s Laboratories, Inc. did not acquire the product. This product has been in-licensed from the ANDA holder, MSN Labs, by Dr Reddy’s Laboratories, Inc. for the purpose of commercial marketing and distribution.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598085430,Deferasirox Tablets for Oral Suspension 500MG,2019-12-05,760.08,,1,1,,,,,,,"Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis. Specifically, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Deferasirox TFOS product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of 5 other approved AB-rated generics as well as the reference listed drug. Dr. Reddy’s Laboratories, Inc. did not acquire the product. This product has been in-licensed from the ANDA holder, MSN Labs, by Dr Reddy’s Laboratories, Inc. for the purpose of commercial marketing and distribution.",,,,,,,,,,,,,,, +Karyopharm Therapeutics Inc.,72237010101,XPOVIO (selinexor) 60mg (12 Tablets),2019-07-03,22000,,1,6000,,1,,,,,,,,,,,,,,,,,,,, +Karyopharm Therapeutics Inc.,72237010102,XPOVIO (selinexor) 80mg (16 Tablets),2019-07-03,22000,,1,6000,,1,,,,,,,,,,,,,,,,,,,, +Karyopharm Therapeutics Inc.,72237010104,XPOVIO (selinexor) 160mg (32 Tablets),2019-07-03,22000,,1,6000,,1,,,,,,,,,,,,,,,,,,,, +American Regent,517656025,SELENIOUS ACID INJECTION,2019-07-09,8575,"The prices negotiated with customers are confidential and not in the public domain or publicly available. American Regent sells its products directly to wholesalers, distributors and closed door pharmacies. American Regent also sells it product indirectly to several entities, including independent pharmacies, managed care organizations, hospitals, etc. These customers, called, ""indirect customers,"" purchase our products primarily through our wholesale customers. The Product has not yet launched in any international jurisdiction.",,,,,,,,,Estimated Volume of patients: No information specific to the estimated number of patients that may be prescribed by American Regent's Product is in the public domain or publicly available. Breakthrough Therapy: The product did not receive a breakthrough therapy designation or priority review. Acquisition Price - Not Applicable. American Regent developed the product.,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,63323082320,"Ertapenem for Injection, 1g Vial. (10 vials per pack)",2019-12-09,1286.6,,1,,,,2019-09-16,,1,"The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed.",The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA believes is otherwise in the public domain or publicly available, as of the date of this submission. (2)","Fresenius Kabi USA’s marketing and pricing plans for this product are not in the public domain or otherwise publicly available. Consistent with the relevant statutes and regulations, Fresenius Kabi USA has left the “marketing and pricing plan description” data field blank. (3)","Fresenius Kabi USA does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. Further, Fresenius Kabi USA does not know this information and has not put this information in the public domain. As a result, Fresenius Kabi USA has left the “estimated number of patients” data field blank. (4)","The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed.",,,,,,,,,,, +Fresenius Kabi USA LLC,65219016010,Busulfan Injection 60mg 10mL Vial (8 vials per pack),2019-12-04,2500,,1,,,,2019-05-21,,1,"The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed.",The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA believes is otherwise in the public domain or publicly available, as of the date of this submission. (2)","Fresenius Kabi USA’s marketing and pricing plans for this product are not in the public domain or otherwise publicly available. Consistent with the relevant statutes and regulations, Fresenius Kabi USA has left the “marketing and pricing plan description” data field blank. (3)","Fresenius Kabi USA does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. Further, Fresenius Kabi USA does not know this information and has not put this information in the public domain. As a result, Fresenius Kabi USA has left the “estimated number of patients” data field blank. (4)","The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed.",,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462042121,Atovaquone Oral Suspension USP,2019-01-15,800,,1,,,,,,,,Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. Acquisition fields left blank as drug was developed by Glenmark.,,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462044626,Sevelamer Hydrochloride Tablets,2019-02-08,1158.32,,1,,,,,,,,Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. Acquisition fields left blank as drug was developed by Glenmark.,,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462044718,Sevelamer Hydrochloride Tablets,2019-02-08,1158.32,,1,,,,,,,,Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. Acquisition fields left blank as drug was developed by Glenmark.,,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462060994,"Pimecrolimus Cream, 1%",2019-09-24,845.43,,1,,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known, however IQVIA data for the 12 months ending August 2019 is 445,483 prescriptions for Pimecrolimus cream,1%. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462031732,"Fulvestrant Injection, 250 mg/5 mL (50 mg/mL)",2019-11-04,1745.15,,1,,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, according to the American Cancer Society’s Breast Cancer Facts & Figures 2019-2020 report, in 2019, an estimated 268,600 new cases of invasive breast cancer will be diagnosed among women. Acquisition fields left blank as drug was co-developed by Glenmark and Glenmark is the ANDA holder.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462052001,Metformin Hydrochloride Extended-Release Tablets USP 500 mg,2019-12-27,1615,,1,,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, however IQVIA data for the 12 months ending November 2019 is 170,821 prescriptions for Metformin Extended Release Tablets. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462052190,Metformin Hydrochloride Extended-Release Tablets USP 1000 mg,2019-12-27,2625,,1,,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, however IQVIA data for the 12 months ending November 2019 is 170,821 prescriptions for Metformin Extended Release Tablets. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Pharmaceutical Associates, Inc",121168040,Potassium Chloride Oral Solution,2019-04-05,507.2,Marketing is done periodically in Pharmaceutical Trade Magazines Pricing plan is to remain competitive as determined by our pricing committee,,,,,,,,,"Pharmaceutical Associates, Inc did not acquire the drug. This is our formulation that we submitted an ANDA to manufacture",,,,,,,,,,,,,,, +"Pharmaceutical Associates, Inc",121168000,Potassium Chloride Oral Solution,2019-04-05,1205,Marketing is done periodically in Pharmaceutical Trade Magazines Pricing plan is to remain competitive as determined by our pricing committee,,,,,,,,,"Pharmaceutical Associates, Inc did not acquire the drug. This is our formulation that we submitted an ANDA to manufacture",,,,,,,,,,,,,,, +"Pharmaceutical Associates, Inc",121252000,Potassium Chloride Oral Solution,2019-04-05,1849,Marketing is done periodically in Pharmaceutical Trade Magazines Pricing plan is to remain competitive as determined by our pricing committee,,,,,,,,,"Pharmaceutical Associates, Inc did not acquire the drug. This is our formulation that we submitted an ANDA to manufacture",,,,,,,,,,,,,,, +"Pharmaceutical Associates, Inc",121252040,Potassium Chloride Oral Solution,2019-04-05,779.6,Marketing is done periodically in Pharmaceutical Trade Magazines Pricing plan is to remain competitive as determined by our pricing committee,,,,,,,,,"Pharmaceutical Associates, Inc did not acquire the drug. This is our formulation that we submitted an ANDA to manufacture",,,,,,,,,,,,,,, +BeiGene USA,72579001102,Brukinsa 80MG CAPSULES 120,2019-11-18,12935,"BeiGene considered a number of factors in deciding the price, including how BRUKINSA performed in clinical trials, the price of other therapies in the BTK inhibitor class, and the feedback we received when speaking to payers about a range of potential price points. In the U.S., BRUKINSA will be marketed to appropriate patients and physicians consistent with FDA-approved indications.",,150,1,1,,,,,"MCL indication has limited patient population. MCL prevalence was 3.0 per 100,000 persons in the UK (year 2011) and 3.6 per 100,000 persons in Belgium (year 2013).",,,,,,,,,,,,,,, +Celgene,59572072012,INREBIC (fedtratinib) 100mg CAPSULES 120ct,2019-08-16,21000,,1,,,1,2018-02-12,1100000000,,Please see the attached press release for the full deal terms for Celgene's acquisition of Impact Biomedicines.,"No information regarding the volume of patients who may be prescribed this drug is in the public domain or publicly available. INREBIC is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). There are no marketing or pricing plans in the United States or internationally that are in the public domain or publicly available. As with the launch of any new medicine, Celgene actively seeks to educate key stakeholders – including physicians, payers and patients – around the medicine’s indication(s), efficacy, and safety profile. Generating this awareness for INREBIC® will be a critical component of Celgene’s marketing efforts. Additionally, as with all of its products, Celgene determined the price of INREBIC® with strong consideration of its benefit to patients, health systems and society and in accordance with Celgene’s publicized Pricing Principles that focus on access, value, innovation and flexibility.",https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q3-New-Drug-Public-Release-Supporting-Documents/Celgene-Acquisition-of-Impact-Biomedicines_Press-Release.pdf,,,,,,,,,,,,,, +Celgene,59572071101,REBLOZYL (luspatercept-aamt) 25 mg powder for solution for injection,2019-11-08,3441.18,,1,,,1,2011-08-02,25000000,,"In 2011, Celgene made an upfront payment to Acceleron of $25 million as part of a joint development and commercialization agreement for Reblozyl. Under this agreement, Acceleron is eligible to receive up to $217 million if specific development, regulatory and commercial milestones are reached for REBLOZYL.","No information regarding the volume of patients who may be prescribed this drug is in the public domain or publicly available. REBLOZYL® is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. There are no marketing or pricing plans in the United States or internationally that are in the public domain or publicly available. As with the launch of any new medicine, Celgene actively seeks to educate key stakeholders – including physicians, payers and patients – around the medicine’s indication(s), efficacy, and safety profile. Generating this awareness for REBLOZYL® will be a critical component of Celgene’s marketing efforts. Additionally, as with all of its products, Celgene determined the price of REBLOZYL® with strong consideration of its benefit to patients, health systems and society and in accordance with Celgene’s publicized Pricing Principles that focus on access, value, innovation and flexibility.",,,,,,,,,,,,,,, +Celgene,59572077501,REBLOZYL (luspatercept-aamt) 75 mg powder for solution for injection,2019-11-08,10323.53,,1,,,1,2011-08-02,25000000,,"In 2011, Celgene made an upfront payment to Acceleron of $25 million as part of a joint development and commercialization agreement for Reblozyl. Under this agreement, Acceleron is eligible to receive up to $217 million if specific development, regulatory and commercial milestones are reached for REBLOZYL.","No information regarding the volume of patients who may be prescribed this drug is in the public domain or publicly available. REBLOZYL® is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. There are no marketing or pricing plans in the United States or internationally that are in the public domain or publicly available. As with the launch of any new medicine, Celgene actively seeks to educate key stakeholders – including physicians, payers and patients – around the medicine’s indication(s), efficacy, and safety profile. Generating this awareness for REBLOZYL® will be a critical component of Celgene’s marketing efforts. Additionally, as with all of its products, Celgene determined the price of REBLOZYL® with strong consideration of its benefit to patients, health systems and society and in accordance with Celgene’s publicized Pricing Principles that focus on access, value, innovation and flexibility.",,,,,,,,,,,,,,, +"Ascend Laboratories, LLC",67877050330,Cinacalcet 30mg 30 Tabs,2019-06-17,685.5,,1,468000,,,2019-06-17,0,1,,"While Ascend's estimated volume of patients who may be prescribed Cinacalcet is not available in the public domain, Cinacalcet is approved specifically for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. In the U.S., it is estimated that approximately 468,000 patients with chronic kidney disease (CKD) on dialysis have secondary hyperparathyroidism (HPT).",,,,,,,,,,,,,,," Regarding the estimated number of patients in the US that may be prescribed Cinacalcet for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis, Ascend has not released this information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). Also, note that Ascend is the US distributor for our parent company Alkem located in India." +"Ascend Laboratories, LLC",67877050430,Cinacalcet 60mg 30 Tabs,2019-06-17,1371.25,,1,468000,,,2019-06-17,,1,,"While Ascend's estimated volume of patients who may be prescribed Cinacalcet is not available in the public domain, Cinacalcet is approved specifically for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. In the U.S., it is estimated that approximately 468,000 patients with chronic kidney disease (CKD) on dialysis have secondary hyperparathyroidism (HPT).",,,,,,,,,,,,,,," Regarding the estimated number of patients in the US that may be prescribed Cinacalcet for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis, Ascend has not released this information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). Also, note that Ascend is the US distributor for our parent company Alkem located in India." +"Ascend Laboratories, LLC",67877050530,Cinacalcet 90mg 30 Tabs,2019-06-17,2057,,1,468000,,,2019-06-17,,1,,"While Ascend's estimated volume of patients who may be prescribed Cinacalcet is not available in the public domain, Cinacalcet is approved specifically for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. In the U.S., it is estimated that approximately 468,000 patients with chronic kidney disease (CKD) on dialysis have secondary hyperparathyroidism (HPT).",,,,,,,,,,,,,,," Regarding the estimated number of patients in the US that may be prescribed Cinacalcet for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis, Ascend has not released this information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). Also, note that Ascend is the US distributor for our parent company Alkem located in India." +Vertex Pharmaceuticals,51167033101,"TRIKAFTA™ (elexacaftor 100 mg, tezacaftor 50 mg, ivacaftor 75 mg per tablet and ivacaftor 150 mg per tablet) is supplied as an 84-count tablet carton containing a 28-day supply (4 weekly wallets, each with 21 tablets).",2019-10-25,23896.13,"MARKETING PLAN: Vertex’s commercial field team in the United States is composed of a small number of individuals, and we focus our United States marketing activities for TRIKAFTA™ towards a limited number of physicians and health care professionals who are located at Cystic Fibrosis (CF)-focused accredited centers in the United States. The objective of these activities is to raise awareness and understanding about the approved indication, dosing, efficacy and safety data that are consistent with TRIKAFTA’s FDA approved label. Specific activities related to physicians and health care professionals include print distribution by the commercial field team to CF care centers, digital advertising (e.g., TRIKAFTA’s product website), and other educational programs. Specific activities related to people living with CF and their caregivers include print distribution of patient materials to CF care centers and digital advertising (e.g., TRIKAFTA’s product website and social media pages). Vertex does not engage in traditional direct-to-consumer advertising (e.g., television or mass media). Vertex also operates a comprehensive patient support program, known as Vertex Guidance & Patient Support (Vertex GPS™), which helps eligible patients who have been prescribed TRIKAFTA (elexacaftor, tezacaftor, ivacaftor and ivacaftor), access their medication and help them stay on track with treatment. PRICING PLAN: At Vertex, our mission is ambitious: to discover medicines that can prevent, cure or fundamentally change the outcomes of serious diseases for patients and their families. Our pricing philosophy supports this mission and reflects the transformative clinical value of our medicines, our commitment to patient access and the investment required to bring new medicines to Cystic Fibrosis (CF) and other serious diseases. When determining the price of TRIKAFTA, we considered a combination of factors, including: • Efficacy of the medicine and the benefit to patients of treating the underlying cause of CF, therefore having the potential to modify the course of the disease • Ease for patients to access medicine • Impact on a serious orphan disease that places significant burden on the healthcare system and society • Commitment by Vertex to invest in the resources required to support the discovery and development of new medicines for those waiting for treatments and cures TRIKAFTA is a significant clinical advancement in the treatment of people with CF aged 12 years and older with at least one F508del mutation. The benefits and risks of TRIKAFTA were evaluated in two Phase 3 studies. In both studies, people taking TRIKAFTA experienced significant improvement in lung function and CF respiratory symptoms. • One study compared TRIKAFTA with an active comparator, tezacaftor/ivacaftor and ivacaftor, in people with two F508del mutations. The results showed a significant incremental improvement in lung function and CF respiratory symptoms in the people taking TRIKAFTA. • The other study compared TRIKAFTA with placebo in people with an F508del mutation and another mutation defined in the study. The results showed significant improvement in lung function, reduction in pulmonary exacerbations, and improvements in CF respiratory symptoms in the people taking TRIKAFTA.",,17300,1,1,,,,,"Based on patient registry data (2017), in the United States, up to 17,300 total patients aged 12 years and older may be eligible for treatment with TRIKAFTA™.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=330,,,,,,,,,,,,,, +Circassia Pharmaceuticals,72124000101,Inhalation Powder,2019-10-17,995,"Marketing to support the launch of Duaklir will focus on educating HCPs and patients on the approved indication as well as safety information, all included within the FDA approved label. This education will occur in the form of: the Duaklir website, interactive core visual aids, banner ads, email promotions and HCP and patient leave-behind materials. Pricing is evaluated by Circassia's Pricing Committee and approved by its Board of Directors.",,15000000,,,2019-06-17,218840450,,The acquisition price amount entered reflects the price of a combination portfolio acquisition which includes future royalties based on estimated sales.,,,,,,,,,,,,,,,, +"Grifols USA, LLC",13553081005,"Xembify immune globulin subcutaneous, human-klhw, 20% 1GM",2019-11-12,171,,1,500000,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Grifols believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Grifols has left the marketing and pricing plan description data field blank. (2)","[This product is indicated to treat primary humoral immunodeficiency (“PI”). According to The National Institute of Health there are more than 200 different forms of primary immune deficiency diseases (PIDDs) affecting approximately 500,000 people in the United States. See https://www.niaid.nih.gov/diseases-conditions/primary-immune-deficiency-diseases-pidds. Based on this estimate, Grifols has provided 500,000 as the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label.] (3)","Grifols did not acquire this product. As a result, Grifols has left the acquisition related data fields blank.",,,,,,,,,,,, +"Grifols USA, LLC",13553081010,"Xembify immune globulin subcutaneous, human-klhw, 20% 2GM",2019-11-12,342,,1,500000,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Grifols believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Grifols has left the marketing and pricing plan description data field blank. (2)","[This product is indicated to treat primary humoral immunodeficiency (“PI”). According to The National Institute of Health there are more than 200 different forms of primary immune deficiency diseases (PIDDs) affecting approximately 500,000 people in the United States. See https://www.niaid.nih.gov/diseases-conditions/primary-immune-deficiency-diseases-pidds. Based on this estimate, Grifols has provided 500,000 as the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label.] (3)","Grifols did not acquire this product. As a result, Grifols has left the acquisition related data fields blank.",,,,,,,,,,,, +"Grifols USA, LLC",13553081020,"Xembify immune globulin subcutaneous, human-klhw, 20% 4GM",2019-11-12,684,,1,500000,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Grifols believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Grifols has left the marketing and pricing plan description data field blank. (2)","[This product is indicated to treat primary humoral immunodeficiency (“PI”). According to The National Institute of Health there are more than 200 different forms of primary immune deficiency diseases (PIDDs) affecting approximately 500,000 people in the United States. See https://www.niaid.nih.gov/diseases-conditions/primary-immune-deficiency-diseases-pidds. Based on this estimate, Grifols has provided 500,000 as the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label.] (3)","Grifols did not acquire this product. As a result, Grifols has left the acquisition related data fields blank.",,,,,,,,,,,, +"Grifols USA, LLC",13553081050,"Xembify immune globulin subcutaneous, human-klhw, 20% 10GM",2019-11-12,1710,,1,500000,,,,,,,The information contained in this report is subject to the following limitations and assumptions. (1),"Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Grifols believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Grifols has left the marketing and pricing plan description data field blank. (2)","[This product is indicated to treat primary humoral immunodeficiency (“PI”). According to The National Institute of Health there are more than 200 different forms of primary immune deficiency diseases (PIDDs) affecting approximately 500,000 people in the United States. See https://www.niaid.nih.gov/diseases-conditions/primary-immune-deficiency-diseases-pidds. Based on this estimate, Grifols has provided 500,000 as the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label.] (3)","Grifols did not acquire this product. As a result, Grifols has left the acquisition related data fields blank.",,,,,,,,,,,, +"Kadmon Pharmaceuticals, LLC",66435070010,"Trientine Hydrochloride Capsules, USP 250 mg (100 capsules)",2019-10-21,15618,"Kadmon announced the product’s approval and also made a copay savings card available to eligible patients through healthcare professionals. Kadmon did not otherwise engage in direct-to-consumer marketing, or offer direct-to-consumer promotional incentives or other promotions or advertising to consumers, physicians, or other health professionals with respect to this product. Pricing methodology is based on cost (including development and manufacturing costs) and the market (including the current number of generic competitors and the number of generic competitors expected to enter the market).",,7000,,,,,,,"The prevalence of Wilson’s disease in the US is approximately 7000-9000 patients. Reference: Ferenci P, Askari F. Whom and how to screen for Wilson disease. Expert Rev. Gastroenterol. Hepatol. 8(5), 513-520 (2014). Kadmon developed this product, so acquisition columns have been left blank.",,,,,,,,,,,,,,, +"Kadmon Pharmaceuticals, LLC",66435070020,"Clovique™ (Trientine Hydrochloride Capsules, USP) 250 mg (120 capsules)",2019-10-21,18741.6,"Kadmon announced the product’s approval and also made a copay savings card available to eligible patients. Marketing initiatives include print and digital media, engagement at scientific meetings attended by healthcare providers most likely to manage patients with Wilson’s disease, materials to be used by sales representatives to share information on Clovique with prescribers, and materials to educate patients about Clovique and Wilson’s disease. Pricing methodology is based on cost (including development and manufacturing costs) and the market (including the current number of generic competitors and the number of generic competitors expected to enter the market).",,7000,,,,,,,"The prevalence of Wilson’s disease in the US is approximately 7000-9000 patients. Reference: Ferenci P, Askari F. Whom and how to screen for Wilson disease. Expert Rev. Gastroenterol. Hepatol. 8(5), 513-520 (2014). Kadmon developed this product, so acquisition columns have been left blank.",,,,,,,,,,,,,,, +"Celltrion USA, Inc.",72606000201,Temixys (lamivudine and tenofovir disoproxil fumarate,2019-09-03,850,"Celltrion USA is a new pharmaceutical company and has not yet begun direct-to-consumer marketing activities. We will be working towards increasing awareness of the availability of a new branded generic product to healthcare providers (HCPs) through speaker engagements and seminars, and provide FDA approved medication information through print material, mobile application, and website. A copay card will be offered to eligible commercially-insured patients.",,3000,,,,,,,"The acquisition-related fields blank was because Celltrion developed the drug. The first sale of Temixys was made on 9/30/2019, and it was a direct sale to an independent pharmacy. This product is currently not offered through the wholesalers, because Celltrion is negotiating the distribution service agreements. Our Trade Contracts Team is confident that the negotiations will wrap up in the next week or two. Temixys needed to be uploaded onto Medispan because some of the wholesalers that Celltrion intends to contract with informed us that they needed to see the information on that database before moving forward with negotiations. At the time of the compendia submissions, Celltrion had believed that since our product was available for direct sale, indicating 9/3/2019 as the effective date would not be of an issue.",,,,,,,,,,,,,,, +"Alnylam Pharmaceuticals, Inc.",71336100101,GIVLAARI (givosiran)(189 mg/ml single dose vial),2019-12-12,39000,"Marketing Plan in the U.S. GIVLAARI will be marketed to healthcare professionals for the treatment of adults with acute hepatic porphyria (AHP) by a team of field-based sales professionals and its expenditures will include spending on the following areas. Alnylam has announced a U.S. gastrointestinal (GI) disease education and promotional agreement for GIVLAARI with Ironwood Pharmaceuticals, Inc., a GI healthcare company. Under the agreement, Alnylam will leverage Ironwood’s leading capabilities in GI to promote GIVLAARI to certain healthcare practitioners, augmenting Alnylam’s commercialization activities. GIVLAARI is currently being reviewed under accelerated assessment by the European Medicines Agency (EMA) for the treatment of patients with AHP, after receiving Priority Medicines (PRIME) Designation and Orphan Drug Designation from the EMA. Alnylam has also filed for marketing authorization in Brazil and intends to file in Japan and other countries in 2020. Alnylam’s marketing initiatives will focus on raising awareness of the ultra-rare disease acute hepatic porphyria (AHP) and supporting the launch of GIVLAARI and may include multiple comprehensive education and training initiatives that will be provided by Alnylam’s and Ironwood’s employees. Examples include the development of websites, webcasts and other digital media on the disease state AHP as well as GIVLAARI. In addition, Alnylam anticipates that it will participate at scientific meetings attended by Healthcare Providers (HCPs) and may engage with HCPs through booth attendance at scientific meetings, printed materials, speaker programs and one on one meetings. Pricing Plan in the U.S. When determining the price for GIVLAARI, the following factors influenced our decision-making: Treatment Effect - GIVLAARI has the potential to substantially benefit patients’ quality of life by reducing the frequency of AHP attacks by >70% compared to placebo. Potential to Offset Other Healthcare Costs - In the absence of GIVLAARI, an AHP patient can cost $400,000 - $650,000 annually for treatment of attacks, including hospitalization, hemin administration, and other medical interventions. GIVLAARI has been shown to reduce the frequency of attacks thereby providing the potential to reduce or avoid the costs of hospitalization and other interventions. Alnylam is estimating that the annual average effective net price will be $442,000 based on the average weight-based monthly dose of 1.2 vials per patient in the ENVISION study and before mandatory rebates to government institutions. Price may vary per individual insurance coverage and dosing. Ultra-Rare Patient Population - GIVLAARI is an RNAi therapeutic for the adult portion of a population of approximately 3,000 AHP patients with diagnosed, active disease in the U.S. and Europe. Existing Treatments Are Limited (Unmet Need) - GIVLAARI is a first-of-its-kind FDA-approved therapy available in the U.S. for the treatment of adults with AHP. Innovative Pricing - Value Based Agreements - Alnylam has announced a framework for value-based agreements (VBAs) designed to help patients with AHP gain access to GIVLAARI. Under this innovative framework for VBAs, participating government and commercial payers will pay the full value for GIVLAARI only when it delivers patient outcomes in the real-world setting similar to results demonstrated in clinical trials. An additional and newly designed Prevalence-Based Adjustment (PBA) feature will trigger rebates to participating payers if the number of diagnosed patients they cover exceeds current epidemiologic estimates for AHP. There are often uncertainties in diagnosis rates and disease prevalence estimates in ultra-rare diseases, making it challenging for payers to predict the number of patients who will be covered within their plans. This innovative approach offers greater certainty to payers that their overall financial risk will be adjusted if a substantially larger number of patients than currently estimated are identified, diagnosed, and treated with GIVLAARI. Alnylam’s Patient Access Philosophy - Alnylam’s VBA framework for ultra-rare diseases such as AHP builds upon Alnylam’s Patient Access Philosophy. As part of Alnylam’s Access Philosophy, the Company commits to not increase the price of GIVLAARI by more than the consumer price index for urban consumers (CPI-U), a measure of inflation, in the absence of significant investment associated with a meaningful label expansion. Commercially insured patients are expected to have little-to-no out-of-pocket costs for GIVLAARI.",,3000,1,1,,,,,"Cal. Health & Safety Code §127681 does not currently define “release of the drug in the commercial market” and Alnylam is not aware of any guidance issued by California or any California regulation that defines “release of the drug in the commercial market” for the purpose of Cal. Health & Safety Code §127681. As a result, for the purposes of compliance with Cal. Health & Safety Code §127681, Alnylam considers a drug to be “release[d] . . . in the commercial market” when Alnylam makes product available for shipment to its Wholesalers, Specialty Pharmacies and other customers who purchase directly from Alnylam. As authorized by Cal. Health & Safety Code §127681, this disclosure contains only information that Alnylam has identified as being in the public domain or publicly available. Alnylam provides this report consistent with its good faith understanding and interpretation of Cal. Health & Safety Code § 127681 and its provisions. In providing this report, Alnylam does not waive any rights, claims, or legal challenges with respect to Cal. Health & Safety Code § 127681 and related legislation or any implementing regulations thereof.",,,,,,,,,,,,,,, +"Global Blood Therapeutics, Inc.",72786010101,"Oxbryta™ (voxelotor) 500 mg Tablets 90ct (recommended dosage of 1,500 mg/day)",2019-12-04,10417,,1,,1,1,,,,,"California law provides that manufacturers may limit the information reported to that which is otherwise in the public domain or publicly available. Global Blood Therapeutics, Inc. (GBT) has publicly stated that it will not increase the list price of OXBRYTA for three years and that any future price increases will be tied to inflation. GBT’s marketing and pricing plans used in the launch of OXBRYTA are not otherwise in the public domain or publicly available.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=332,,,,,,,,,,,,,, +"Harmony Biosciences, LLC",72028004503,WAKIX™ (pitolisant) 4.45 MG  30 Tablets,2019-10-01,2842.5,,1,,1,1,,,,,"Harmony does not have patented marketing information. Any marketing information related to this product is know only to Harmony’s Commercial team. Marketing information has potential commercial value and allowing this information to remain non-public and confidential, allows Harmony to obtain a business advantage over its competitors who do not have or know Harmony’s marketing information. Making the marketing information public would not serve the public interest and therefore disclosure is not required. Harmony does not have an estimate of the number of patients, and therefore, we cannot provide this information. Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States.",,,,,,,,,,,,,,, +"Harmony Biosciences, LLC",72028017803,WAKIX™ (pitolisant) 17.8 MG 30 Tablets,2019-10-01,5685,,1,,1,1,,,,,"Harmony does not have patented marketing information. Any marketing information related to this product is know only to Harmony’s Commercial team. Marketing information has potential commercial value and allowing this information to remain non-public and confidential, allows Harmony to obtain a business advantage over its competitors who do not have or know Harmony’s marketing information. Making the marketing information public would not serve the public interest and therefore disclosure is not required. Harmony does not have an estimate of the number of patients, and therefore, we cannot provide this information. Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States.",,,,,,,,,,,,,,, +"Coherus BioSciences, Inc.",70114010101,UDENYCA (pegfilgrastim-cbqv) 6mg/.06mL solution in a single-dose prefilled syringe,2019-01-03,4175,"While specific marketing & pricing plans are not available in the public domain, generally Coherus plans to market UDENYCA (pegfilgrastim-cbqv) in the US as a high quality, lower cost biosimilar option to the referenced biologic, Neulasta (pegfilgrastim). As of 2019, Coherus offers UDENYCA at 32% discount off the WAC price of Neulasta. Coherus seeks to deliver choice-without-compromise by delivering the high-quality treatment & outcomes patients and providers expect, while reducing overall costs for patients, providers and the healthcare system.",,11000,,,,,,,The drug UDENYCA (pegfilgrastim-cbqv) was not acquired.,,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729035192,Busulfan 6 mg/ml injection 8 pk,2019-07-22,4000,"Marketing: Accord markets generic Busulfan 6 mg/ml in an 8 pack of vials. This product is therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share. Pricing: In order to set the wholesale acquisition price (“WAC”) of Busulfan, Accord reviewed the WACs available at the time of its launch. Accord discovered that the generic WACs were clustered right around $8,000 with one high and one low outlier. The brand WAC was $4,000 at the time. Accord reviewed market share data and evaluated whether the outliers had a disproportionate share of the market. Finding none, because the brand WAC was lower, consistent with Accord’s commitment to bringing affordable, safe medicine to market, Accord chose to match the brand WAC for Busulfan. Accord uses subscription-based services, such as Medi-Span Price Rx and purchased data from IQVIA to obtain this information.",,0,,,,,,,"Until receipt of a notice from the State of California on January 6, Accord was not aware that the California drug pricing transparency laws applied to launches of drugs that were previously on the market and new solely as to Accord. Accord is timely reporting pricing after being informed that the laws apply to generic launches. Accord did not acquire the NDC for Busulfan, the generic product was developed in house. Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of the Busullfan injection, but is instead reporting the WAC of an 8 pack of vials as this is the unit in which the vials are sold by Accord.",,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729042101,Tacrolimus Ointment 0.03%/100g tube,2019-06-05,694.53,"Marketing: Accord markets generic Tacrolimus ointment in two strengths that are each therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share. Pricing: In order to set the wholesale acquisition price (“WAC”) of Tacrolimus ointment, Accord matched the lowest generic WACs available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information.",,0,,,,,,,"Until receipt of a notice from the State of California on January 6, Accord was not aware that the California drug pricing transparency laws applied to launches of drugs that were previously on the market and new solely as to Accord. Accord is timely reporting pricing after being informed that the laws apply to generic launches. Accord did not acquire the NDC for Tacrolimus Ointment, the generic product was developed in house. Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Tacrolimus ointment but is reporting the WAC of a single tube of ointment.",,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729042201,Tacrolimus Ointment 0.10%/100g tube,2019-06-05,694.53,"Marketing: Accord markets generic Tacrolimus ointment in two strengths that are each therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share. Pricing: In order to set the wholesale acquisition price (“WAC”) of Tacrolimus ointment, Accord matched the lowest generic WACs available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information.",,0,,,,,,,"Until receipt of a notice from the State of California on January 6, Accord was not aware that the California drug pricing transparency laws applied to launches of drugs that were previously on the market and new solely as to Accord. Accord is timely reporting pricing after being informed that the laws apply to generic launches. Accord did not acquire the NDC for Tigecycline, the generic product was developed in house. Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Tacrolimus ointment but is reporting the WAC of a single tube of ointment.",,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729036468,Tigecycline SDV 50 mg 10 pack,2019-03-28,1252,"Marketing: Accord markets generic Tigecycline in a ten pack of 50 mg vials. The drug is therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share. Pricing: In order to set the wholesale acquisition price (“WAC”) of Tigecycline, Accord matched the lowest generic WAC available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information.",,0,,,,,,,"Until receipt of a notice from the State of California on January 6, Accord was not aware that the California drug pricing transparency laws applied to launches of drugs that were previously on the market and new solely as to Accord. Accord is timely reporting pricing after being informed that the laws apply to generic launches. Accord did not acquire the NDC for Tigecycline, the generic product was developed in house. Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Tigecycline but is reporting the WAC of 10 pack of vials, which is the unit by which Accord sells the drug.",,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010049101,"Metformin Hydrochloride Extended-Release Tablets USP 500 MG, 100 count",2019-03-21,4.75,,1,0,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010049105,"Metformin Hydrochloride Extended-Release Tablets USP 500 MG, 500 count",2019-03-21,21.45,,1,0,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010049201,"Metformin Hydrochloride Extended-Release Tablets USP 750 MG, 100 count",2019-03-21,7.22,,1,0,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010049205,"Metformin Hydrochloride Extended-Release Tablets USP 750 MG, 500 count",2019-03-21,36.12,,1,0,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010001201,Methylphenidate Hydrochloride Extended-Release Capsules 10 MG 100 count,2019-09-19,305,,1,0,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010001301,Methylphenidate Hydrochloride Extended-Release Capsules 20 MG 100 count,2019-09-10,204.02,,1,0,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010001401,Methylphenidate Hydrochloride Extended-Release Capsules 30 MG 100 count,2019-09-16,208.91,,1,0,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010001501,Methylphenidate Hydrochloride Extended-Release Capsules 40 MG 100 count,2019-09-16,213.81,,1,0,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010001603,Methylphenidate Hydrochloride Extended-Release Capsules 60 MG 30 count,2019-09-19,322.93,,1,0,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010004201,Methylphenidate Hydrochloride Extended-Release Tablets USP 10 MG 100 count,2019-05-16,55.44,,1,0,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010004301,Methylphenidate Hydrochloride Extended-Release Tablets USP 20 MG 100 count,2019-05-16,57.11,,1,0,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010004001,"Amphetamine Sulfate Tablets USP 5 MG, 100 count",2019-10-15,465.5,,1,0,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +AbbVie,74101756,"ORIAHNN (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) copackaged for oral use--56 capsules; 4 blister-pack carton: 28 capsules of elagolix 300 mg, estradiol 1 mg, norethindrone acetate 0.5 mg; 28 capsules of elagolix 300mg",2020-06-22,907.39,"* ORIAHNN will be marketed for premenopausal women suffering from heavy menstrual bleeding associated with uterine leiomyomas (fibroids). + +* The Wholesale Acquisition Cost (WAC) of ORIAHNN is $907.39 per a month supply. Pricing is the same for ORIAHNN as the previously approved AbbVie elagolix product, ORILISSA, which is indicated for moderate-to-severe endometriosis related pain. + +* To date AbbVie has not filed for regulatory approval of ORIAHNN in jurisdictions outside the United States.",,,,,,,,,"Response on estimated volume of patients who may be prescribed the drug (see Cal. Health & Saf. Code § 96076(b)(2): + +ORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Based upon a review of published analyses of uterine fibroid prevalence approximately .3% of pre-menopausal women suffer from heavy menstrual bleeding associated with uterine fibroids, have not had a hysterectomy, and are seeking treatment for their condition: approximately 200,000 women. See Fuldeore et al, Patient-reported prevalence and symptomatic burden of uterine fibroids among women in the United States: findings from a cross-sectional survey analysis. Int J Women’s Health. 2017; 9: 403–411; Borah et al, The Impact of Uterine Leiomyomas: A National Survey of Affected Women. Am J Obstet Gynecol. 2013 Oct; 209(4): 319.e1–319.e20; Wang et al. Burden of Heavy Menstrual Bleeding Associated with Uterine Fibroids: Retrospective Analysis of A Large Commercially Insured Population in the US. Poster presented at Academy of Managed Care Pharmacy (AMCP) Nexus Annual Meeting 2019. Journal of Managed Care & specialty Pharmacy, Supplement. Vol 25; Number 10-a. October 2019. ORIAHNN may be prescribed for that fraction of those patients for whom a physician and patient in consultation may consider this treatment appropriate. + +Additional Context for Report + +ORIAHNN was developed by AbbVie under its collaboration agreement with Neurocrine Biosciences, with research and development funded and conducted in part by AbbVie. On June 16, 2010 AbbVie publicly announced its collaboration with Neurocrine Biosciences for the development of elagolix. The parties worked together on a collaborative development program through 2012 with funding provided by AbbVie, after which time AbbVie assumed sole responsibility for all development and commercialization activities. AbbVie made an upfront payment of $75 million and funded all ongoing development activities. Under the agreement, Neurocrine is eligible to receive additional milestone payments of approximately $530 million for the achievement of development, regulatory and commercial milestones, funding for certain internal collaboration expenses, and royalty payments on any future product sales.",,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729043445,Daptomycin (SDV); 350 mg; 10 pk [lyo] Vial,2020-02-27,680,"Marketing: Accord markets generic Daptomycin in a ten pack of 350 mg vials. The drug is therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share. + +Pricing: In order to set the wholesale acquisition price (“WAC”) of Daptomycin, Accord matched the lowest generic WAC available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information. Accord launched single vials of this product last year and set the WAC for the new NDC of 10 packs at equivalent pricing.",,,,,,,,,"Accord did not acquire the ANDA for Daptomycin, the generic product was developed in house. + +Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Daptomycin but is reporting the WAC of 10 pack of vials, which is the unit by which Accord sells the drug. + +Accord does not have data related to Estimated Number of Patients for Daptomycin 10 packs. Although there may be publications that show statistical data in previous years, Accord does not use this data to make business decisions. Further, Accord has not been informed of the methods or procedures as to how this statistical information was developed, nor does Accord have internal methods or procedures to estimate a reasonable number of patients with a disease state and, therefore, cannot answer this question with any level of accuracy that is needed in order to comply with the requirement. In making decisions about whether to market a product, Accord does not consider patient number, it considers total market size based on dollar amount. It is a generic manufacturer and as such does not manufacture or market products based upon specific conditions or to sets of patients, but based upon price and availability only. Finally, the specific details regarding number of patients treated by a given drug in the previous year are not freely available to the public.",,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729044210,Cinacalcet Tab; 90 mg; 30 ct,2020-06-16,925.69,"Marketing: Accord markets generic Cinacalcet in both 30 and 90 tablet count bottles. The drug is therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share. + +Pricing: In order to set the wholesale acquisition price (“WAC”) of Cinacalcet, Accord matched the lowest generic WAC available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information.",,0,,,,,,,"Accord did not acquire the NDC for Cinacalcet, the generic product was developed in house. + +Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Cinacalcet but is reporting the WAC of both 30 and 90 tablet count bottles, which are the units by which Accord sells the drug.",,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729044015,Cinacalcet Tab; 30 mg; 90 ct,2020-06-19,925.71,"Marketing: Accord markets generic Cinacalcet in both 30 and 90 tablet count bottles. The drug is therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share. + +Pricing: In order to set the wholesale acquisition price (“WAC”) of Cinacalcet, Accord matched the lowest generic WAC available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information.",,0,,,,,,,"Accord did not acquire the NDC for Cinacalcet, the generic product was developed in house. + +Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Cinacalcet but is reporting the WAC of both 30 and 90 tablet count bottles, which are the units by which Accord sells the drug.",,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729044115,Cinacalcet Tab; 60 mg; 90 ct,2020-06-19,1851.39,"Marketing: Accord markets generic Cinacalcet in both 30 and 90 tablet count bottles. The drug is therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share. + +Pricing: In order to set the wholesale acquisition price (“WAC”) of Cinacalcet, Accord matched the lowest generic WAC available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information.",,0,,,,,,,"Accord did not acquire the NDC for Cinacalcet, the generic product was developed in house. + +Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Cinacalcet but is reporting the WAC of both 30 and 90 tablet count bottles, which are the units by which Accord sells the drug.",,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729044215,Cinacalcet Tab; 90 mg; 90 ct,2020-06-25,2777.07,"Marketing: Accord markets generic Cinacalcet in both 30 and 90 tablet count bottles. The drug is therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share. + +Pricing: In order to set the wholesale acquisition price (“WAC”) of Cinacalcet, Accord matched the lowest generic WAC available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information.",,0,,,,,,,"Accord did not acquire the NDC for Cinacalcet, the generic product was developed in house. + +Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Cinacalcet but is reporting the WAC of both 30 and 90 tablet count bottles, which are the units by which Accord sells the drug.",,,,,,,,,,,,,,, +"Acella Pharamceuticals, LLC",42192061916,Naproxen Suspension: 125 mg/5 mL (contains 39 mg sodium): Available in 1 pint (473 mL) light-resistant bottles; Type 0: Not a Combination Product,2020-11-12,837,,1,7250,,,2020-11-11,0,1,"This product is a licensed Authorized Generic. There was no acquisition price paid by Acella, however, Acella does share revenues with the Licensor. Factors affecting the acquisition price are only know to a small group of individuals at Acella – namely the Commercial, Government Pricing, Compliance and Legal departments consisting of less than 10 people within those departments with access to that information.","This product was not launched on November 12, 2020 as indicated in Medispan, the various compendiums and our recent New Drug Notice filed with OSHPD. While we did sign the license agreement to market this product on November 11, 2020, we did not have the labeling or inventory ready to market/sell until December 2, 2020. The incorrect Marketing Start Date listed in DailyMed and in the compendiums was a result of confusion in our regulatory department regarding the business realities of the execution of the license agreement versus truly marketing the product with available inventory. Our understanding is that the “introduced to market date” for OSHPD should be consistent with the FDA “Marketing Start Date” reported to the FDA and reflected in DailyMed and the compendiums.",,,,,,,,,,,,,,, +Acerus Pharmaceuticals Corporation,42667551101,Natesto Nasal Gel 5.5 MG/ACT/7.32GM,2020-07-20,275,,1,634211,,,,,,,This Drug was not acquired. 30 day supply is 3 packs @ a WAC of $275.08 each,,,,,,,,,,,,,,, +Aimmune Therapeutics,71881011313,PALFORZIA Initial Dose Escalation Card -- 0.5 mg-6 mg,2020-03-10,30,"Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label. +Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients.",,1600000,1,,,,,,"In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens.",,,,,,,,,,,,,,, +Aimmune Therapeutics,71881011130,"PALFORZIA Maintenance Dosing Pack -- 300 mg, 30 count sachet",2020-03-10,890,"Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label. +Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients.",,1600000,1,,,,,,"In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens.",,,,,,,,,,,,,,, +Aimmune Therapeutics,71881010345,PALFORZIA Up-Dosing Pack -- 12 mg,2020-03-10,445,"Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label. +Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients.",,1600000,1,,,,,,"In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens.",,,,,,,,,,,,,,, +Aimmune Therapeutics,71881010730,PALFORZIA Up-Dosing Pack -- 120 mg,2020-03-10,445,"Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label. +Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients.",,1600000,1,,,,,,"In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens.",,,,,,,,,,,,,,, +Aimmune Therapeutics,71881010860,PALFORZIA Up-Dosing Pack -- 160 mg,2020-03-10,445,"Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label. +Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients.",,1600000,1,,,,,,"In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens.",,,,,,,,,,,,,,, +Aimmune Therapeutics,71881010415,PALFORZIA Up-Dosing Pack -- 20 mg,2020-03-10,445,"Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label. +Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients.",,1600000,1,,,,,,"In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens.",,,,,,,,,,,,,,, +Aimmune Therapeutics,71881010930,PALFORZIA Up-Dosing Pack -- 200 mg,2020-03-10,445,"Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label. +Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients.",,1600000,1,,,,,,"In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens.",,,,,,,,,,,,,,, +Aimmune Therapeutics,71881011060,PALFORZIA Up-Dosing Pack -- 240 mg,2020-03-10,445,"Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label. +Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients.",,1600000,1,,,,,,"In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens.",,,,,,,,,,,,,,, +Aimmune Therapeutics,71881010145,PALFORZIA Up-Dosing Pack -- 3 mg,2020-03-10,445,"Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label. +Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients.",,1600000,1,,,,,,"In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens.",,,,,,,,,,,,,,, +Aimmune Therapeutics,71881011115,"PALFORZIA Up-Dosing Pack -- 300 mg, 15 count sachet",2020-03-10,445,"Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label. +Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients.",,1600000,1,,,,,,"In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens.",,,,,,,,,,,,,,, +Aimmune Therapeutics,71881010530,PALFORZIA Up-Dosing Pack -- 40 mg,2020-03-10,445,"Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label. +Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients.",,1600000,1,,,,,,"In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens.",,,,,,,,,,,,,,, +Aimmune Therapeutics,71881010290,PALFORZIA Up-Dosing Pack -- 6 mg,2020-03-10,445,"Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label. +Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients.",,1600000,1,,,,,,"In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens.",,,,,,,,,,,,,,, +Aimmune Therapeutics,71881010660,PALFORZIA Up-Dosing Pack -- 80 mg,2020-03-10,445,"Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label. +Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients.",,1600000,1,,,,,,"In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens.",,,,,,,,,,,,,,, +"Ajanta Pharma USA, Inc.",27241015919,Valganciclovir Hydrochlor Oral Sol 100ml,2020-02-17,800.26,,1,321,,,,,,,This drug was not acquired. Please note that Ajanta has no information as to what the total market may be and no has no way currently of knowing what the total market may be and no data to make a reasonable guess. Ajanta is only able to certify their estimates of patients using the drugs based on their sales.,,,,,,,,,,,,,,, +Alexion Pharmaceuticals,25682002501,ULTOMIRIS is a complement inhibitor indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).,2020-10-09,6404,"Alexion prices both 3 mL and 11 mL vials at-parity-per-milligram to the existing ULTOMIRIS 10mg (300 mg/30 mL) vial that is available on the market.  We have an established commercial organization that supports our marketed products in the U.S., Europe, Japan, Latin America, Asia Pacific countries, and other territories. We employ a sales force and commercial marketing functions to ensure that health care providers are informed about our products.",,3936,,,,,,,"Based on reports in the published medical literature, the prevalence of PNH ranges from 0.5 to 2 per million people, and the prevalence of aHUS ranges from 2 to 10 per million people. Based on a US population of 328 million, the treatable population for each condition may be as large as 656 people for PNH and 3280 people for aHUS.",,,,,,,,,,,,,,, +Alexion Pharmaceuticals,25682002801,"ULTOMIRIS is a complement inhibitor indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). The dosage form and strength is 1,100 mg/11 mL (100 mg/mL) in a single-dose vial. Package size is 11 ml",2020-10-09,23481.33,"Alexion prices both 3 mL and 11 mL vials at-parity-per-milligram to the existing ULTOMIRIS 10mg (300 mg/30 mL) vial that is available on the market.  We have an established commercial organization that supports our marketed products in the U.S., Europe, Japan, Latin America, Asia Pacific countries, and other territories. We employ a sales force and commercial marketing functions to ensure that health care providers are informed about our products.",,3936,,,,,,,"Based on reports in the published medical literature, the prevalence of PNH ranges from 0.5 to 2 per million people, and the prevalence of aHUS ranges from 2 to 10 per million people. Based on a US population of 328 million, the treatable population for each condition may be as large as 656 people for PNH and 3280 people for aHUS.",,,,,,,,,,,,,,, +Allergan,23650110,"Ubrelvy Oral Tablet 100 MG, 10 tabs per Pack",2020-01-21,850,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising in the migraine community, as well as promoting to appropriate healthcare professionals and patients. The pricing plan has a WAC/ list price set at $850 per 10ct package. The list price of Ubrelvy is not reflective of discounts and rebates which may be available to patients and payers including but not limited to, Medicaid, Medicare, and commercial insurance.",,31000000,,,2015-07-06,250000000,,"Allergan acquired exclusive worldwide rights to develop and commercialize certain products, including Ubrelvy (ubrogepant), from Merck Sharp & Dohme Corp. on July 6, 2015 for $250M. Allergan remained responsible for Phase III Clinical Trials and continues to remain responsible for further development of Ubrelvy (ubrogepant).","Migraine is a chronic disease with episodic attacks defined by neurological symptoms such as headache pain, sensitivity to light and sound, and nausea. Migraine is highly prevalent, affecting approximately 31 million Americans, and is associated with significant disability leading to high personal, family, occupational, societal, and economic burden. Based on the current standard of care, there are still unmet needs for new acute treatments for migraine.Each NDC could be used for any eligible patient.",,,,,,,,,,,,,,, +Allergan,23649810,"Ubrelvy Oral Tablet 50 MG, 10 tabs per Pack",2020-01-21,850,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising in the migraine community, as well as promoting to appropriate healthcare professionals and patients. The pricing plan has a WAC/ list price set at $850 per 10ct package. The list price of Ubrelvy is not reflective of discounts and rebates which may be available to patients and payers including but not limited to, Medicaid, Medicare, and commercial insurance.",,31000000,,,2015-07-06,250000000,,"Allergan acquired exclusive worldwide rights to develop and commercialize certain products, including Ubrelvy (ubrogepant), from Merck Sharp & Dohme Corp. on July 6, 2015 for $250M. Allergan remained responsible for Phase III Clinical Trials and continues to remain responsible for further development of Ubrelvy (ubrogepant).","Migraine is a chronic disease with episodic attacks defined by neurological symptoms such as headache pain, sensitivity to light and sound, and nausea. Migraine is highly prevalent, affecting approximately 31 million Americans, and is associated with significant disability leading to high personal, family, occupational, societal, and economic burden. Based on the current standard of care, there are still unmet needs for new acute treatments for migraine. Each NDC could be used for any eligible patient.",,,,,,,,,,,,,,, +Allergan,23965201,Durysta Intraocular Implant 10 MCG,2020-06-22,1950,"• DURYSTA will be marketed to adults for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT). + +• The Wholesale Acquisition Cost (WAC) of DURYSTA is $1950 per implant. + +• To date Allergan has not filed for regulatory approval of DURYSTA in jurisdictions outside the United States.",,,,,,,,,"Response on estimated volume of patients who may be prescribed the drug (see Cal. Health & Saf. Code § 96076(b)(2): + +DURYSTA is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT). A 2012 published study identified 2.71 million patients in the US with open angle glaucoma and projected greater than 3 million patients in 2020. See Vajaranant, T et al., The Changing Face of Primary Open-Angle Glaucoma in the United States: Demographic and Geographic Changes From 2011 to 2050, Am. J. of Ophthalmology, 154:303-314 (2012). See also Glaucoma Research Foundation website, at https://www.glaucoma.org/glaucoma/glaucoma-facts-and-stats.php. DURYSTA may be prescribed for that fraction of patients for whom a physician and patient in consultation may consider this treatment appropriate. + +Additional Context for Report + +DURYSTA was developed by Allergan. On May 8, 2020 AbbVie Inc. completed its acquisition of Allergan plc at a cost of approximately $63 billion.",,,,,,,,,,,,,,, +ALVOGEN,47781065289,TERIPARATIDE INJECTION 250MCG/ML,2020-06-11,2475,"Alvogen is committed to the highest quality standards for all products and services with the continuous focus on operational efficiency and cost optimization. Alvogen has invested $350,000 nationally in marketing this product, having created and distributed to physicians and pharmacies a detailed flyer with information regarding indications, safety information, contraindications, and the Alvogen Savings Program. Alvogen has also launched an informative, product-specific website for patients and providers alike (http://www.alvogenteriparatide.com). Alvogen utilizes a pricing methodology that takes into account a number of factors, including the cost of the product's acquisition, utilization estimates, the value rendered by this innovative product to patients and their providers, as well as the health care system, and ongoing marketing, manufacturing, and other operational costs. Alvogen also takes into account current market dynamics including competitor products along with the potential entry of generics into the drug class. Alvogen is committed to transparency and access for its products, and undertakes all of its marketing and pricing decisions with those goals in mind.",,10200000,,,2018-06-30,2000000,,Pfenex received an upfront payment of $2.5M for the license and rights. They may be eligible for an additional $25M in support and regulatory milestone payments.,"The price listed in a published compendium does not necessarily reflect the actual price that a particular patient, provider, or payer will pay for this product, which may vary based on mandatory and negotiated discounts, and in accordance with actual patient dosing. + +The National Osteoporosis Foundation has estimated approximately 10.2M adults in the United States has osteoporosis, the condition for which this product may be prescribed. That number does not reflect the number of patients who will be prescribed this product, which will be a much lower number (which is not in the public domain or publicly available).",,,,,,,,,,,,,,, +American Health Packaging,60687045901,PALIPERIDONE ER TABLET3MG100UD,2020-01-14,1445.62,Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice,,3500000,,,,,,,"The acquisition fields do not need to be filled out because the drug was not acquired within the previous 5 years. Number of patients based on treatment of schizophrenia (https://www.webmd.com/drugs/2/drug-146718/paliperidone-oral/details) and cross referenced at ( https://sardaa.org/resources/about-schizophrenia/#:~:text=Approximately%203.5%20million%20people%20in,is%20at%20least%20partially%20genetic). All the fields that are left blank are due to ""Not Applicable"".",,,,,,,,,,,,,,, +American Health Packaging,60687047001,PALIPERIDONE ER TABLET6MG100UD,2020-01-14,1445.62,Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice,,3500000,,,,,,,"The acquisition fields do not need to be filled out because the drug was not acquired within the previous 5 years. Number of patients based on treatment of schizophrenia (https://www.webmd.com/drugs/2/drug-146718/paliperidone-oral/details) and cross referenced at ( https://sardaa.org/resources/about-schizophrenia/#:~:text=Approximately%203.5%20million%20people%20in,is%20at%20least%20partially%20genetic). All the fields that are left blank are due to ""Not Applicable"".",,,,,,,,,,,,,,, +American Health Packaging,60687044901,SEVELAMER HCL TABLET800MG100UD,2020-01-22,743.75,Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice,,6000000,,,,,,,"The acquisition fields do not need to be filled out because the drug was not acquired within the previous 5 years. Number of patients based on treatment of kidney disease (https://www.webmd.com/drugs/2/drug-16748/sevelamer-hcl-oral/details) and cross referenced at (https://www.cdc.gov/nchs/fastats/kidney-disease.htm). All the fields that are left blank are due to ""Not Applicable"".",,,,,,,,,,,,,,, +American Health Packaging,68001042485,FULVESTRANT INJECTION250MG (50MG/5ML) 25 syr,2020-02-28,1939.05,"Gathering Market Intelligence, Setting Competitive pricing for PRxO, executing product launches, managing master data files.",,325000,,,2020-02-25,1372,,BluePoint Laboratories and AHP are both owned by AmerisourceBergen - the acquisition price listed is the quarter total for all units received within the date listed. AHP is the US distributor for Bluepoint product. Amount represented for acquisition is in total US dollars.,"Bluepoint Laboratories is a sibling company with AHP as its sole distributor and is the responsible party for distribution of their products. + +Number of patients based on treatment of breast cancer (https://medlineplus.gov/druginfo/meds/a607031.html) and cross referenced at (https://www.breastcancer.org/symptoms/understand_bc/statistics), it is not a representation of AHP's estimated market capture.",,,,,,,,,,,,,,, +American Health Packaging,60687050525,AMINOCAPROIC ACID TABLET500MG30UD,2020-05-18,800,Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice,,4500000,,,,,,,"The acquisition fields do not need to be filled out because the drug was not acquired within the previous 5 years. Number of patients based on treatment of severe liver disease (https://www.medicinenet.com/aminocaproic_acid-oral/article.htm) and cross referenced at CDC.gov (https://www.cdc.gov/nchs/fastats/liver-disease.htm). All the fields that are left blank are due to ""Not Applicable"".",,,,,,,,,,,,,,, +American Health Packaging,60687052321,POSACONAZOLE DR TABLET100MG30UD,2020-06-11,1415,Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice,,650000,,,,,,,"The acquisition fields do not need to be filled out because the drug was not acquired within the previous 5 years. Number of patients based on treatment with chemotherapy (https://www.webmd.com/drugs/2/drug-145142-1598/posaconazole-oral/posaconazole-delayed-release-oral/details) and cross referenced at (https://www.cdc.gov/cancer/preventinfections/providers.htm#:~:text=Each%20year%2C%20about%20650%2C000%20cancer,chemotherapy%20schedules%2C%20and%20even%20death.). All the fields that are left blank are due to ""Not Applicable"".",,,,,,,,,,,,,,, +American Health Packaging,60687053478,Atovaquone Oral Sus 750mg/5mL  5mL,2020-10-21,1245,Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice,,,,,2020-09-21,112176,,"As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC.  There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC.",ESTIMATED # PATIENTS: Patient Information - CANNOT BE DETERMINED: Atovaquone is used for treatment of Pneumocystis pneumonia (reference: https://www.webmd.com/drugs/2/drug-6077/atovaquone-oral/details) and number of patients cannot be quantified per CDC (https://www.cdc.gov/fungal/diseases/pneumocystis-pneumonia) as this information isn’t widely tracked.,,,,,,,,,,,,,,, +American Regent ,517800525,"ZINC SULFATE INJECTION USP, 25MG/5ML (5MG/ML), PKG OF 25",2020-01-28,1753.13,"We do not have plans to conduct any substantial marketing activities related to the new product. We do not have any plans to conduct any direct-to-consumer advertising for the product. Our marketing efforts to promote the new drug to physicians and other health care professionals are limited to marketing on our website as well as a digital announcement to announce the availability of the new product. The prices negotiated with customers are confidential and not in the public domain or publicly available. American Regent sells its products directly to wholesalers, distributors and closed door pharmacies. American Regent also sells it product indirectly to several entities, including independent pharmacies, managed care organizations, hospitals, etc. These customers, called, ""indirect customers,"" purchase our products primarily through our wholesale customers. The Product has not yet launched in any international jurisdiction.",,26250,,,,,,,"The new product line is approved by the FDA to treat Zinc deficiency. It is administered intravenously as part of a parental nutrition regiment. It is estimated that the volume of patients that receive parental nutrition is over 290,000 hospital stays per year and that an additional 25,000 patients receive parental nutrition at home. If we assume that each hospital stay represents one unique patient then this total is 315,000 patients annually or 26,250 per month. We do not know how many of those potential patients might be prescribed the drug.",,,,,,,,,,,,,,, +American Regent ,517610325,"ZINC SULFATE INJECTION, USP 30MG/10ML (3MG/ML), PKG OF 25",2020-01-28,2107.5,"We do not have plans to conduct any substantial marketing activities related to the new product. We do not have any plans to conduct any direct-to-consumer advertising for the product. Our marketing efforts to promote the new drug to physicians and other health care professionals are limited to marketing on our website as well as a digital announcement to announce the availability of the new product. The prices negotiated with customers are confidential and not in the public domain or publicly available. American Regent sells its products directly to wholesalers, distributors and closed door pharmacies. American Regent also sells it product indirectly to several entities, including independent pharmacies, managed care organizations, hospitals, etc. These customers, called, ""indirect customers,"" purchase our products primarily through our wholesale customers. The Product has not yet launched in any international jurisdiction.",,26250,,,,,,,"The new product line is approved by the FDA to treat Zinc deficiency. It is administered intravenously as part of a parental nutrition regiment. It is estimated that the volume of patients that receive parental nutrition is over 290,000 hospital stays per year and that an additional 25,000 patients receive parental nutrition at home. If we assume that each hospital stay represents one unique patient then this total is 315,000 patients annually or 26,250 per month. We do not know how many of those potential patients might be prescribed the drug.",,,,,,,,,,,,,,, +American Regent ,517610125,"Zinc Sulfate Injection, USP 1mg/mL 10mL",2020-05-18,701.25,"We do not intend to engage in, nor have we engaged in to date, any substantial marketing activities relating to the Zinc Sulfate Products in the U.S. or internationally. Our marketing efforts to promote the new drug are generally limited to marketing on our website as well as digital announcements (including those at professional society events) to announce the availability of the new Zinc Sulfate Products. Our pricing plans are not in the public domain.",,315000,,,,,,,"We provide the following comment regarding the patient estimate: The new product line is approved by the FDA for adult and pediatric patients, as a source of zinc for parenteral nutrition, when oral or enteral nutrition is not indicated. It is administered intravenously as part of a parental nutrition regimen. It is estimated that the volume of patients that receive parental nutrition is over 290,000 hospital stays per year and that an additional 25,000 patients receive parental nutrition at home. If we assume that each hospital and each home stay represents one unique patient then this total is 315,000 patients annually. We do not know how many of those potential patients might be prescribed the drug. + +We provide the following comment regarding the acquisition fields: This product was not acquired and the acquisition fields are not applicable. We provide the following general comment: We have limited the information included in this submission to that which is otherwise in the public domain or publicly available, as the California requirements permit.",,,,,,,,,,,,,,, +Amgen,55513067001,AVSOLA 100mg Vial,2020-07-06,500,"United States: There will be no direct-to-consumer marketing for AVSOLA such as TV ads, magazine or journal ads. The only platforms directed to patients is patient education brochure and a section of the AVSOLA.com website entitled “For Patients – Getting to Know AVSOLA”. This content is designed to educate patients about the 8 inflammation diseases aligned with the AVSOLA indications and potential treatment with AVSOLA, including important safety information. + +Promotional activities to physicians will include professional detailing by Amgen sales representatives. Amgen is utilizing its existing inflammation sales force to educate health care professionals about AVSOLA, including the requirements for establishing biosimilarity to the reference product, Remicade, and important safety information. Professional detailing entails resources such as a core visual aid and promotional leave-behind literature. There is no free drug or sample program. Amgen also contracts with payors and providers such a hospitals and clinics to offer AVSOLA at a competitive price and ensure access to the product for appropriate patients. + +AVSOLA’s Wholesale Acquisition Cost (WAC, sometimes referred to as list price) will be lower than its reference product, Remicade. The WAC of AVSOLA has been set at $50.00 per 10 mg or $500.00 per 100 mg single-dose vial, 57 percent less than the WAC of Remicade.",,12800000,,,,,,,"Rheumatoid arthritis (RA) is the most common form of autoimmune arthritis, affecting more than 1.3 million Americans.Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory disease of the gastrointestinal tract that mostly affect patients in their late adolescence and early adulthood. In 2018, the U.S. prevalence of CD and UC was ~900K and ~1.0M respectively. The National Psoriasis Foundation states more than 8M Americans have psoriasis, and CDC’s NHANES estimates that 6.7 million adults have psoriasis. Current estimates of the prevalence of ankylosing spondylitis in the United States range between 0.2% and 0.5%, or an estimated 0.6-1.6 million (based on 328M US population).",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238148803,Deferasirox Tablets 360mg,2020-01-02,837.61,This is a generic product that is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238173102,"Pyridostigmine Bromide Oral Solution, USP 60mg/5mL",2020-01-17,1071.54,This is a generic product that is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,60219168101,Fluphenazine HCl 10mg,2020-07-09,869.9,This is a generic product that is not marketed.,,1500000,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,60219168001,Fluphenazine HCl 5mg,2020-07-09,689.95,This is a generic product that is not marketed.,,1500000,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,60219162101,Metyrosine Capsule 250mg (100 in 1 BOTTLE),2020-07-27,35005.39,This is a generic product that is not marketed.,,41,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238173002,Naproxen 125MG/5ML,2020-08-03,896.44,This is a generic product that is not marketed.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,60219150201,Phenoxybenzamine HCl,2020-10-27,3000,This is a generic product that is not marketed.,,1000000,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505619702,SIROLIMUS O/SLN,2020-05-22,1052.62,"Market analysis efforts are not performed at this level. The macro approach applied is evaluation of aggregated scripts in the market basket, by quarter, for the therapeutic class of the drug. Please note figured entered into the Estimated Avg. Number of Patients per month, is the monthly average aggregated scripts for this product in the market basket analyzed for launch.",,23401,,,,,,,Apotex received FDA approval for the drug.,,,,,,,,,,,,,,, +AstraZeneca ,310061060,Name- Koselugo (selumetinib) Dosage- 25mg/m2 Form- Capsules: 10mg 60 count bottle,2020-04-10,4362,"AstraZeneca will engage 2 sales representatives to cover the state of California. Patient brochures as well as therapy management guides, may be left behind in offices for informational purposes. +AstraZeneca provides online resources via KOSELUGO™ US healthcare professionals and patient websites. Patients may register for the KOSELUGO™ support program via the website which will enroll them in a digital relationship marketing program to receive materials such as welcome letters, patient brochures, etc. The KOSELUGO™ patient savings program for eligible commercially insured patients will be available for patients in California and can be found via AstraZeneca’s Product website. +The KOSELUGO™ is currently only marketed in the United States. + +When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. +Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers.",,1556,1,1,2003-12-18,,1,AstraZeneca licensed Selumetinib from Array BioPharma Inc. in 2003 for a publicly undisclosed amount.,"KOSELUGO™ is an orally available, inhibitor of mitogen-activated protein kinases 1 and 2 (MEK1/2) and is indicated for the treatment of pediatric patients 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).",,,,,,,,,,,,,,, +AstraZeneca ,310062560,Name- Koselugo (selumetinib) Dosage- 25mg/m2 Form- Capsules: 25mg 60 count bottle,2020-04-10,10905,"AstraZeneca will engage 2 sales representatives to cover the state of California. Patient brochures as well as therapy management guides, may be left behind in offices for informational purposes. +AstraZeneca provides online resources via KOSELUGO™ US healthcare professionals and patient websites. Patients may register for the KOSELUGO™ support program via the website which will enroll them in a digital relationship marketing program to receive materials such as welcome letters, patient brochures, etc. The KOSELUGO™ patient savings program for eligible commercially insured patients will be available for patients in California and can be found via AstraZeneca’s Product website. +The KOSELUGO™ is currently only marketed in the United States. + +When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. +Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers.",,1556,1,1,2003-12-18,,1,AstraZeneca licensed Selumetinib from Array BioPharma Inc. in 2003 for a publicly undisclosed amount.,"KOSELUGO™ is an orally available, inhibitor of mitogen-activated protein kinases 1 and 2 (MEK1/2) and is indicated for the treatment of pediatric patients 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).",,,,,,,,,,,,,,, +AuroMedics Pharma LLC,55150031825,"Chlorpromazine Hydrochloride Injection USP, Ampules 25mg/1mL - 25s",2020-09-01,722.25,we plan to market the drug to hospital customers.,,500000,,,2020-07-07,0,1,acquisition price is proprietary,"number of patients is an ESTIMATE. we do not know how many people will be admitted to a hospital and will require treatment with this drug. additionally, there are 2 manufacturers of the injectable form of chlorpromazine and 6 manufacturers of the ORAL form (which we can assume is the preferred treatment).",,,,,,,,,,,,,,, +AuroMedics Pharma LLC,55150031925,"Chlorpromazine Hydrochloride Injection USP, Ampules 50mg/2mL - 25s",2020-09-01,827.5,we plan to market the drug to hospital customers.,,500000,,,2020-07-07,0,1,acquisition price is proprietary,"number of patients is an ESTIMATE. we do not know how many people will be admitted to a hospital and will require treatment with this drug. additionally, there are 2 manufacturers of the injectable form of chlorpromazine and 6 manufacturers of the ORAL form (which we can assume is the preferred treatment).",,,,,,,,,,,,,,, +AvKare,50268016515,Chlorpromazine Tab 100mg,2020-04-01,725.26,"This drug is marketed as a typical generic drug would be, through the use of wholesalers to distributor the product. There is not a significant marketing campaign or active patient facing marketing.",,274,,,,,,,"This is a generic drug - acquisition price doesn't appear to be relevant since it's not a typical situation in which there was a one time purchase payment for the development/acquisition rights to manufacturer the drug. + +Monthly usage based on AvKare's expected sale volume and patient base. This is a generic drug - AvKare does not have information related to overall market usage.",,,,,,,,,,,,,,, +Banner Life Sciences LLC,69387000101,BAFIERTAM 95mg,2020-09-01,5790,"Specific marketing and pricing plans for Bafiertam™ are not available in the public domain. Generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with multiple sclerosis. + +Marketing: Promotional activities include detailing of the product by sales representatives, limited print distribution and digital resources to health care professionals. + +Pricing: As a bioequivalent to Tecfidera, BAFIERTAM™ provides a market-based solution to health care spending with opportunity to deliver cost savings. The US wholesaler acquisition cost (WAC) of $5,790.00, represents a 30% discount to the current WAC of Tecfidera. The WAC is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. BAFIERTAM™ will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. WAC does not include discounts that may be paid on this product to payers, providers, distributors.",,1000000,,,,0,,,"Drug was developed by Banner Life Sciences, therefore no acquisition data exists + +A recently completed (2017) prevalence study, funded by the National MS Society, has estimated that nearly 1 million people over the age of 18 live with a diagnosis of MS.",,,,,,,,,,,,,,, +"Bionpharma, Inc",69452016113,Deferasirox Oral Tablet Soluble 500 MG,2020-01-20,760.08,Generic drug - Wholesaler Acquisition Cost,,,,,,,,,"The estimated number of patients is unknown to Bionpharma. +Bionpharma did not acquire this product; these fields are not relevant.",,,,,,,,,,,,,,, +Blueprint Medicines Corporation,72064011030,"AYVAKIT (avapritinib) Tablets 100 MG, 30 tablets per bottle",2020-01-16,32000,,1,,1,1,,,,,"Acquisition Cost +Not applicable. Drug was not acquired. + +FDA Approval Designation +On January 9, 2020, the U.S. Food and Drug Administration (FDA) approved AYVAKIT™ (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. AYVAKIT has FDA Breakthrough Therapy and Fast Track Designations for the treatment of patients with unresectable or metastatic GIST harboring PDGFRA D842V mutations and was approved under Priority Review. + +Expected Utilization +GIST is a rare, genomically driven sarcoma of the gastrointestinal (GI) tract. There are approximately 5,000 patients diagnosed with primary GIST in the U.S. annually, and approximately five to six percent of patients with newly diagnosed GIST have PDGFRA exon 18 mutations. The most common PDGFRA exon 18 mutation is the D842V mutation, which is resistant to all other approved therapies. These incidence estimates are based on external data sources, and GIST epidemiology data are imprecise. We do not have state-specific estimates for anticipated AYVAKIT utilization. + +Marketing Plan Disclosure +The company’s marketing plan is not in the public domain nor is this information otherwise publicly available, and therefore, not subject to disclosure. + +Pricing Plan Disclosure +The company’s pricing plan is not in the public domain nor is this information otherwise publicly available, and therefore, not subject to disclosure.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=340,,,,,,,,,,,,,, +Blueprint Medicines Corporation,72064012030,"AYVAKIT (avapritinib) Tablets 200 MG, 30 tablets per bottle",2020-01-16,32000,,1,,1,1,,,,,"Acquisition Cost +Not applicable. Drug was acquired. + +FDA Approval Designation +On January 9, 2020, the U.S. Food and Drug Administration (FDA) approved AYVAKIT™ (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. AYVAKIT has FDA Breakthrough Therapy and Fast Track Designations for the treatment of patients with unresectable or metastatic GIST harboring PDGFRA D842V mutations and was approved under Priority Review. + +Expected Utilization +GIST is a rare, genomically driven sarcoma of the gastrointestinal (GI) tract. There are approximately 5,000 patients diagnosed with primary GIST in the U.S. annually, and approximately five to six percent of patients with newly diagnosed GIST have PDGFRA exon 18 mutations. The most common PDGFRA exon 18 mutation is the D842V mutation, which is resistant to all other approved therapies. These incidence estimates are based on external data sources, and GIST epidemiology data are imprecise. We do not have state-specific estimates for anticipated AYVAKIT utilization. + +Marketing Plan Disclosure +The company’s marketing plan is not in the public domain nor is this information otherwise publicly available, and therefore, not subject to disclosure. + +Pricing Plan Disclosure +The company’s pricing plan is not in the public domain nor is this information otherwise publicly available, and therefore, not subject to disclosure.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=341,,,,,,,,,,,,,, +Blueprint Medicines Corporation,72064013030,"AYVAKIT (avapritinib) Tablets 300 MG, 30 tablets per bottle",2020-01-16,32000,,1,,1,1,,,,,"Acquisition Cost +Not applicable. Drug was not acquired. + +FDA Approval Designation +On January 9, 2020, the U.S. Food and Drug Administration (FDA) approved AYVAKIT™ (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. AYVAKIT has FDA Breakthrough Therapy and Fast Track Designations for the treatment of patients with unresectable or metastatic GIST harboring PDGFRA D842V mutations and was approved under Priority Review. + +Expected Utilization +GIST is a rare, genomically driven sarcoma of the gastrointestinal (GI) tract. There are approximately 5,000 patients diagnosed with primary GIST in the U.S. annually, and approximately five to six percent of patients with newly diagnosed GIST have PDGFRA exon 18 mutations. The most common PDGFRA exon 18 mutation is the D842V mutation, which is resistant to all other approved therapies. These incidence estimates are based on external data sources, and GIST epidemiology data are imprecise. We do not have state-specific estimates for anticipated AYVAKIT utilization. + +Marketing Plan Disclosure +The company’s marketing plan is not in the public domain nor is this information otherwise publicly available, and therefore, not subject to disclosure. + +Pricing Plan Disclosure +The company’s pricing plan is not in the public domain nor is this information otherwise publicly available, and therefore, not subject to disclosure.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=342,,,,,,,,,,,,,, +Blueprint Medicines Corporation,72064021060,GAVRETO (pralsetinib) Capsule Bottle of 60 100MG,2020-09-08,9621.6,,1,2946,1,,,,,,,https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=446,,,,,,,,,,,,,, +Blueprint Medicines Corporation,72064021090,GAVRETO (pralsetinib) Capsule Bottle of 90 100MG,2020-09-08,14432.4,,1,2946,1,,,,,,,https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=445,,,,,,,,,,,,,, +Bristol Myers Squibb,59572082030,ZEPOSIA ® (ozanimod) 0.92 mg 30 count bottle,2020-06-01,7068.49,"We consider multiple factors when setting a list price for a medicine, including: +• The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. +• Market and business considerations, including: +• Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world; +• Medical- and patient-service costs; this includes funding growing patient assistance programs; +• Inflationary and capital-investment costs associated with manufacturing, storage and supply.",,280000,,,2019-11-20,74000000000,,BMS obtained rights for Zeposia as part of Celgene acquisition. This acquisition did not consist of costs for individual assets,"Total class of RRMS (Relapsing-remitting multiple sclerosis) and SPMS (Secondary-progressive multiple sclerosis) is estimated at 280,000 patients. BMS is unable to provide an estimate of the number of patients who will be prescribed Zeposia each month",,,,,,,,,,,,,,, +Bristol Myers Squibb,59572089091,ZEPOSIA ® (ozanimod) starter kit (7 day titration pack + 0.92 mg 30 count bottle),2020-06-01,8717.81,"We consider multiple factors when setting a list price for a medicine, including: +• The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. +• Market and business considerations, including: +• Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world; +• Medical- and patient-service costs; this includes funding growing patient assistance programs; +• Inflationary and capital-investment costs associated with manufacturing, storage and supply.",,280000,,,2019-11-20,74000000000,,BMS obtained rights for Zeposia as part of Celgene acquisition. This acquisition did not consist of costs for individual assets,"Total class of RRMS (Relapsing-remitting multiple sclerosis) and SPMS (Secondary-progressive multiple sclerosis) is estimated at 280,000 patients. BMS is unable to provide an estimate of the number of patients who will be prescribed Zeposia each month",,,,,,,,,,,,,,, +Bristol Myers Squibb,59572081007,ZEPOSIA® (ozanimod) 7 day titration pack,2020-06-01,1649.32,"We consider multiple factors when setting a list price for a medicine, including: +• The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. +• Market and business considerations, including: +• Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world; +• Medical- and patient-service costs; this includes funding growing patient assistance programs; +• Inflationary and capital-investment costs associated with manufacturing, storage and supply.",,280000,,,2019-11-20,74000000000,,BMS obtained rights for Zeposia as part of Celgene acquisition. This acquisition did not consist of costs for individual assets,"Total class of RRMS (Relapsing-remitting multiple sclerosis) and SPMS (Secondary-progressive multiple sclerosis) is estimated at 280,000 patients. BMS is unable to provide an estimate of the number of patients who will be prescribed Zeposia each month",,,,,,,,,,,,,,, +Bristol Myers Squibb,59572073014,ONUREG® (azacitidine) 200mg 14 count bottle,2020-09-04,21158.11,"We consider multiple factors when setting a list price for a medicine, including: +• The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. +• Market and business considerations, including: +• Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world; +• Medical- and patient-service costs; this includes funding growing patient assistance programs; +• Inflationary and capital-investment costs associated with manufacturing, storage and supply.",,2700,,1,2019-11-20,74000000000,,BMS obtained rights for Onureg as part of Celgene acquisition. This acquisition did not consist of costs for individual assets,"Total class of AML (Acute Myeloid Leukemia) is estimated at 18,000 patients. At peak, average monthly number of patients who will be prescribed with Onureg is estimated at 2,700.",,,,,,,,,,,,,,, +Bristol Myers Squibb,59572074014,ONUREG® (azacitidine) 300mg 14 count bottle,2020-09-04,21158.11,"We consider multiple factors when setting a list price for a medicine, including: +• The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. +• Market and business considerations, including: +• Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world; +• Medical- and patient-service costs; this includes funding growing patient assistance programs; +• Inflationary and capital-investment costs associated with manufacturing, storage and supply.",,2700,,1,2019-11-20,74000000000,,BMS obtained rights for Onureg as part of Celgene acquisition. This acquisition did not consist of costs for individual assets,"Total class of AML (Acute Myeloid Leukemia) is estimated at 18,000 patients. At peak, average monthly number of patients who will be prescribed with Onureg is estimated at 2,700.",,,,,,,,,,,,,,, +"CASPER PHARMA, LLC",70199002114,HELIDAC THERAPY CHEW/TAB/CAP 224,2020-06-24,966,"Casper Pharma engages in strategic marketing to create awareness and understanding with healthcare providers and pharmacies about the approved indication, efficacy and safety data contained within the drug's FDA approved label. +We employ a comparative pricing model as compared to other H-Pylori therapies in the market. Our mission is to ensure a favorable patient cost benefit while also providing broad patient and market access.",,59000,,,2017-07-18,0,1,Trade Secret,"Additional Comments Relative to Estimated Number of Patients: + +1. Per the attached Product Insert for HELIDAC, this therapy is indicated for treatment of H-Pylori & Duodenal Ulcers. +2. Out of total US population of ~340 Million, H-Pylori prevalence pool is ~35% which is about ~119 Million people. +Source for estimates https://publichealth.arizona.edu/outreach/health-literacy-awareness/hpylori/prevalence#:~:text=pylori%20prevalence%20is%2060%20percent,those%20older%20than%2060%20years. +https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3107911/ +3. Although there is wide prevalence of H-Pylori, only ~10% of the prevalent pool are symptomatic. There are high chances of misdiagnosis based on symptoms alone and often acid suppressants or OTCs are prescribed for prevention of ulcers. +4. Our source of the market data is the industry standard, IQVIA data. During the time period Dec 2018 to Nov 2019, there have been a total of 59,534 patients diagnosed and undergoing treatment for H Pylori, with a total of 61,748 prescriptions filled with a drug from the same therapeutic class. +5. Despite high incidence and wide prevalence, the treatment choice is limited by wide spread resistance to some of the drugs and also the availability of other multi drug regimens and OTCs.",,,,,,,,,,,,,,, +"Celltrion USA, Inc.",72606055902,Busulfan Injection 60 mg/10 mL,2020-02-04,1496.01,N/A - generic product,,33000,1,,,,,,"Celltrion USA has confirmed that they are responsible for setting the WAC. Also, there are or may be other manufacturers selling these products under a different labeler code.",,,,,,,,,,,,,,, +Chiesi USA,10122010401,FERRIPROX tablets twice-a-day 1000mg,2020-07-02,8590.15,,1,650,,,,,,,Acquired while in development; Approved while owned by Chiesi USA.,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097096453,"Vigabatrin Powd Pack 500 MG, 50 Each, Unit-Dose, Box",2020-04-30,1337.06,,1,7500000,,1,,,,,Product was not acquired,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097082037,"Plazomicin Sulfate IV Soln 500 MG/10ML (50 MG/ML) (Base Eq), 10 ML, Unit-Dose, Vial",2020-05-01,315,,1,20,,,,,,,Estimated number of patients is considered a trade secret and non-public information. This information is not generally known or disclosed publicly and is of a highly sensitive and competitive nature that are confidential and proprietary trade secrets. Cipla provides this information solely for purposes of compliance with applicable reporting requirements mandated by state law. Any authorized disclosure of this sensitive information would be against Cipla’s express objection and a misappropriation of Cipla’s trade secrets.,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097082096,"Plazomicin Sulfate IV Soln 500 MG/10ML (50 MG/ML) (Base Eq), 10 ML, Unit-Dose, Vial Qty 10",2020-05-01,3150,,1,20,,,,,,,Estimated number of patients is considered a trade secret and non-public information. This information is not generally known or disclosed publicly and is of a highly sensitive and competitive nature that are confidential and proprietary trade secrets. Cipla provides this information solely for purposes of compliance with applicable reporting requirements mandated by state law. Any authorized disclosure of this sensitive information would be against Cipla’s express objection and a misappropriation of Cipla’s trade secrets.,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097050327,"Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL",2020-05-23,3426.84,,1,1700,,,,,,,"Drug was not acquired. Estimated number of patients is 1,700 per month",,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097066434,Icatibant Acetate Subcutaneous Solution 30 MG/3ML,2020-07-20,5083.26,,1,10000,,,,,,,Product not acquired,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097032303,Dimethyl Fumarate Oral Capsule Delayed Release 240 MG,2020-09-25,2607.16,,1,1000000,,,,,,,Drug not acquired,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097055203,Dimethyl Fumarate Starter Pack Oral Miscellaneous 120 & 240 MG,2020-09-25,2607.16,,1,1000000,,,,,,,Drug not acquired,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097066468,Icatibant Acetate Subcutaneous Solution 30 MG/3ML 3x3ml,2020-11-03,15249.78,,1,10000,,,,,,,Product was not acquired,,,,,,,,,,,,,,, +"Deciphera Pharmaceuticals, LLC",73207010130,Qinlock (ripretinib) 50mg,2020-05-20,32000,"Marketing Plan in the U.S. + +QINLOCK™ is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. For additional information about Qinlock, please see the full Prescribing Information, available at www.qinlock.com. + +Qinlock will be marketed to healthcare professionals (HCPs) by a team of field-based professionals and its expenditures will include spending on the following areas. + +Deciphera’s marketing initiatives will focus on raising awareness of this ultra-rare cancer, GIST, and its potential treatment. Supporting the launch of Qinlock may include comprehensive education and training initiatives that will be provided by Deciphera’s employees to HCPs about the approved indication, dosing administration, mechanism of action (MOA), efficacy and safety data contained within the FDA approved label. Deciphera will have available and provide to HCPs, various printed materials, patient brochures as well as offer peer to peer educational programs (in-person and virtual) depicting both the GIST disease state and the FDA-approved clinical profile of Qinlock. Additional activities may include the development of websites, webcasts, and other digital media offerings. Deciphera will participate in scientific meetings and congresses that will be attended by HCPs and may engage with HCPs through such attendance. + +Pricing Plan in the U.S. + +Deciphera is committed to ensuring patient access and the price for Qinlock was set after doing extensive research and understanding the value of Qinlock relative to other available treatments, as well as the unmet medical need, and disease burden of a gastrointestinal stromal tumor. Our research also entailed evaluating the competitive landscape, and payer environment, as well as business operational continuation needs. Deciphera is committed to supporting GIST patients and removing barriers to access. As part of that commitment, Deciphera has established Deciphera AccessPoint, a patient support program that provides reimbursement and financial assistance programs for eligible patients.",,1100,1,1,,,,,"Cal. Health & Safety Code §127681 does not currently define “release of the drug in the commercial market” and Deciphera is not aware of any guidance issued by California or any California regulation that defines “release of the drug in the commercial market” for the purpose of Cal. Health & Safety Code §127681. As a result, for the purposes of compliance with Cal. Health & Safety Code §127681, Deciphera considers a drug to be “release[d] . . . in the commercial market��� when Deciphera makes product available for shipment to its Wholesalers, Specialty Pharmacies and other customers who purchase directly from Deciphera. +As authorized by Cal. Health & Safety Code §127681, this disclosure contains only information that Deciphera has identified as being in the public domain or publicly available. +Deciphera provides this report consistent with its good faith understanding and interpretation of Cal. Health & Safety Code § 127681 and its provisions. In providing this report, Deciphera does not waive any rights, claims, or legal challenges with respect to Cal. Health & Safety Code § 127681 and related legislation or any implementing regulations thereof.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598045901,"Trientine Hydrochloride Capsules, USP 250 mg",2020-02-06,5000,,1,,,,,,,,"1) Although only about 2,000-3,000 cases have been diagnosed in the United States, other affected individuals may be misdiagnosed with other neurological, liver or psychiatric disorders. According to one estimate, there may actually be 9,000 people affected by Wilson’s disease in the United States. However, Trientine is used for a sub population of Wilson’s disease who are intolerant to penicillamine. We can therefore not be certain of the actual number of such patients. 2) Dr. Reddy’s Laboratories, Inc. did not acquire the product. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",55111028960,"Naproxen and Esomeprazole Magnesium 375-20mg Delayed-Release Tablet, 60 ct",2020-02-26,1613.43,,1,1300000,,,,,,,"1) As this is a generic product, with other generics available, Dr. Reddy’s cannot estimate the estimated patient population. Notwithstanding, the total US patient population for rheumatoid arthritis is 1.3 million. However, Naproxen Esomeprazole is used for a sub population of patients who are at a high risk of stomach bleeding/ulcer. Indications of Naproxen Esomeprazole is also wider and can be substituted by taking the two products separately or even using OTC versions, so it is difficult to estimate the actual number. 2) Dr. Reddy’s Laboratories, Inc. did not acquire the product. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",55111070160,"Naproxen and Esomeprazole Magnesium 500-20mg Delayed-Release Tablet, 60 ct",2020-02-26,1613.43,,1,1300000,,,,,,,"1) As this is a generic product, with other generics available, Dr. Reddy’s cannot estimate the estimated patient population. Notwithstanding, the total US patient population for rheumatoid arthritis is 1.3 million. However, Naproxen Esomeprazole is used for a sub population of patients who are at a high risk of stomach bleeding/ulcer. Indications of Naproxen Esomeprazole is also wider and can be substituted by taking the two products separately or even using OTC versions, so it is difficult to estimate the actual number. 2) Dr. Reddy’s Laboratories, Inc. did not acquire the product. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598067201,"Pyrimethamine 25mg Tablet, USP 100ct",2020-03-19,29250,,1,4000,,,,,,,"1) Dr. Reddy’s Laboratories, Inc. did not acquire the product. 2) Between 400-4000 cases of toxoplasmosis are reported in the US each year. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Pyrimethamine given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) lack of data reported by the brand, which typically gives a leading indication to generic volume.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598089801,"Amphetamine Sulfate 10mg Tablets,USP,100 ct",2020-04-13,279.3,,1,6300000,,,,,,,"1) Dr. Reddy's Laboratories, Inc. does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with other generics available. Notwithstanding, the total patient population for ADHD and Narcolepsy, is approximately 6.3 million. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed Dr. Reddy’s Amphetamine IR given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient. 2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from Cerovene. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598089701,"Amphetamine Sulfate 5mg Tablets,USP,100 ct",2020-04-13,279.3,,1,6300000,,,,,,,"1) Dr. Reddy’s Laboratories, Inc. does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with other generics available. Notwithstanding, the total patient population for ADHD and Narcolepsy, is approximately 6.3 million. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed Dr. Reddy’s Amphetamine IR given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient. 2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from Cerovene. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598093109,"Desmopressin Acetate Inj. USP 4mcg/mL, 10ct",2020-05-05,380,,1,33000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with other generics available.  Notwithstanding, the total patient population for: Hemophilia A is approximately 33,000; Von Willebrand Disease is approximately 14,600; Diabetes Insipidus is approximately 13,000.  However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed Dr. Reddy’s Desmopressin Acetate Injection given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient. 2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from SUNGEN. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598085230,"Deferasirox Film Coated Tablets 180MG, 30ct",2020-07-27,228.04,,1,6700,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, the total prescriptions written for Deferasirox in a yearly basis is approximately 6,700. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Deferasirox FCT 180MG product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient. +2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from MSN Labs.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598063401,"Penicillamine Oral Capsule 250 MG, 100 ct",2020-08-26,8642.25,,1,1344000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for the conditions that Penicillamine is indicated to treat is as follows: i) Wilson’s Disease – approximately 10,941 ii) Cystinuria – approximately 32,824; and iii) Rheumatoid Arthritis – approximately 1.3 million. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Penicillamine Oral Capsule 250MG product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Penicillamine in rheumatoid arthritis patients should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product. 3) Penicillamine was introduced to market on August 26, 2020. That is the date when the product was available for sale. The August 24, 2020 date in Medi-Span is simply the date that the WAC pricing was listed with the pricing compendia. However, for generic products, listing of the WAC does not trigger the statute as that date is not the date that the product is available for sale. For purchases of Penicillamine, the drug was not available for sale in California until August 26, 2020. This was the same date that was filed in our 3-day reports, as well as the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598026202,"Fulvestrant Injection 250 mg/5 mL, 2ct",2020-09-04,700,,1,276480,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the American Cancer Society's estimates for breast cancer in the United States for 2020 approximately 276,480 new cases of invasive breast cancer will be diagnosed in women. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Fulvestrant Injection 250 mg/5 mL product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescription drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598043060,Dimethyl Fumarate Capsule 240mg 60ct,2020-09-25,827.59,,1,1000000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for MS, the condition that Dimethyl Fumarate is indicated to treat is 1 million patients. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Dimethyl Fumarate 240 mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598067230,"Pyrimethamine Tablets, USP 25mg, 30ct",2020-09-26,8775,,1,4000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for Toxoplasmosis, the condition that Pyrethamine is indicated to treat is 400 to 4000 cases per year. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Pyrimethamine Tablets, USP 25 mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Pyrimethamine in rheumatoid arthritis patients should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from Cerovene.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598042952,Dimethyl Fumarate Capsule 120mg 14ct,2020-09-28,193.11,,1,1000000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for MS, the condition that Dimethyl Fumarate is indicated to treat is 1 million patients. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Dimethyl Fumarate 120 mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598074904,"Sapropterin Dihydrochloride Tablets, 100 mg, 120ct",2020-10-01,3868.8,,1,19000,,1,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Organization for Rare Disorders, the reported incidence of Phenylketonuria (PKU) from newborn screening programs ranges from one in 13,500 to 19,000 newborns in the United States However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Sapropterin dihydrochloride tablets 100mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Penicillamine in rheumatoid arthritis patients should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product. Dr. Reddy’s is commercializing a limited supply of this product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598036930,"Cinacalcet Oral Tablet 90 MG, 30 ct",2020-10-27,292.5,,1,537469,,,,,,,"Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, the total prescriptions written for Cinacalcet Oral Tablet 90MG in a yearly basis is approximately 433,615 (including all strengths). As to number of patients: approximately 445,579 Adults may have CKD on dialysis that may present with Secondary HPT. Approximately 56 Adults may develop Parathyroid Carcinoma that may present with hypercalcemia. Approximately 91,834 Adults may have Primary HPT that may present with severe hypercalcemia and are unable to undergo a parathyroidectomy, thus a total of 537,469. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Cinacalcet Oral Tablet 90MG product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient. Dr. Reddy's did not acquire the product. The WAC, although less than $670, exceeds the threshold based on the monthly therapy usage.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598034431,"Imatinib Mesylate Tablets 100mg, 30ct",2020-10-27,875,,1,35870,,,,,,,"Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for the conditions that Imatinib Mesylate 100MG tablets is indicated to treat is as follows: 1) Philadelphia chromosome positive chronic myeloid leukemia approximately 19,940 individuals worldwide, 2) myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR(platelet-derived growth factor receptor) – approximately 10,000; and 3)Lymphoblastic lymphoma - approximately 5,930. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Imatinib Mesylate 100MG tablets product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Imatinib Mesylate in myeloid leukemia should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. Dr. Reddy's did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598034531,"Imatinib Mesylate Tablets 400mg, 30ct",2020-10-27,2700,,1,35870,,,,,,,"Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for the conditions that Imatinib Mesylate 400mg tablets is indicated to treat is as follows: 1) Philadelphia chromosome positive chronic myeloid leukemia approximately 19,940 individuals worldwide, 2) myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR(platelet-derived growth factor receptor) – approximately 10,000; and 3)Lymphoblastic lymphoma - approximately 5,930. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Imatinib Mesylate 400MG tablets product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Imatinib Mesylate in myeloid leukemia should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. Dr. Reddy's did not acquire the product.",,,,,,,,,,,,,,, +"Edenbridge Pharmaceuticals, LLC",42799070815,"Miglustat Capsules, 100mg",2020-09-01,4018.53,,1,100,,,,,,,,,,,,,,,,,,,,,, +Eli Lilly and Company,2298026,Retevmo™ 80MG 120 CAPSULE,2020-05-12,20600,,1,3750,1,1,2019-02-15,,1,"Lilly acquired Loxo Oncology, Inc, on February 15, 2019 for a purchase price of approximately $6.92 billion, net of cash acquired. Under the terms of the agreement, Lilly acquired a pipeline of investigational medicines, including selpercatinib (Loxo-292). [https://investor.lilly.com/static-files/cd4a37af-ec28-449c-9bfb-ae380700209a]","Retevmo™ (selpercatinib) was approved by the FDA in May 2020 as the first therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). + +Surveillance, Epidemiology, and End Results (SEER) data were used to estimate rates of cancer incidence and metastatic disease. Publicly available peer-reviewed literature was reviewed to estimate the prevalence of RET alterations and rates of disease progression by tumor type. Based on this analysis, Lilly estimates that there are 2,500 – 5,000 patients who may be eligible for treatment with a RET kinase inhibitor such as Retevmo. The average of that range (3,750) is reflected in column H. Patients with these conditions may or may not take Retevmo. + +All information is provided by Eli Lilly and Company (""Lilly"") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Eli Lilly and Company,2298060,Retevmo™ 80MG 60 CAPSULE,2020-05-12,10300,,1,3750,1,1,2019-02-15,,1,"Lilly acquired Loxo Oncology, Inc, on February 15, 2019 for a purchase price of approximately $6.92 billion, net of cash acquired. Under the terms of the agreement, Lilly acquired a pipeline of investigational medicines, including selpercatinib (Loxo-292). [https://investor.lilly.com/static-files/cd4a37af-ec28-449c-9bfb-ae380700209a]","Retevmo™ (selpercatinib) was approved by the FDA in May 2020 as the first therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). + +Surveillance, Epidemiology, and End Results (SEER) data were used to estimate rates of cancer incidence and metastatic disease. Publicly available peer-reviewed literature was reviewed to estimate the prevalence of RET alterations and rates of disease progression by tumor type. Based on this analysis, Lilly estimates that there are 2,500 – 5,000 patients who may be eligible for treatment with a RET kinase inhibitor such as Retevmo. The average of that range (3,750) is reflected in column H. Patients with these conditions may or may not take Retevmo. + +All information is provided by Eli Lilly and Company (""Lilly"") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Eli Lilly and Company,2397760,Retevmo™ 40MG 60 CAPSULE,2020-05-14,6866.66,,1,3750,1,1,2019-02-15,6920000000,,"Lilly acquired Loxo Oncology, Inc, on February 15, 2019 for a purchase price of approximately $6.92 billion, net of cash acquired. Under the terms of the agreement, Lilly acquired a pipeline of investigational medicines, including selpercatinib (Loxo-292). Based on guidance from OSHPD, Lilly has entered the acquisition cost of Loxo Oncology, Inc. in the Acquisition Price field. [https://investor.lilly.com/static-files/cd4a37af-ec28-449c-9bfb-ae380700209a]","Retevmo™ (selpercatinib) was approved by the FDA in May 2020 as the first therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). + +Surveillance, Epidemiology, and End Results (SEER) data were used to estimate rates of cancer incidence and metastatic disease. Publicly available peer-reviewed literature was reviewed to estimate the prevalence of RET alterations and rates of disease progression by tumor type. Based on this analysis, Lilly estimates that there are 2,500 – 5,000 patients who may be eligible for treatment with a RET kinase inhibitor such as Retevmo. The average of that range (3,750) is reflected in column H. Patients with these conditions may or may not take Retevmo. + +All information is provided by Eli Lilly and Company (""Lilly"") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=438,,,,,,,,,,,,,, +"Epizyme, Inc.",72607010000,Tazverik (Tazemetostat) 200 mg Tablets,2020-01-31,15500,,1,138,,1,,,,,,,,,,,,,,,,,,,, +"Eton Pharmaceuticals, Inc.",71863011050,Alkindi Sprinkle 1mg,2020-09-29,698.64,,1,8000,,,,,,,"Eton does not have patented marketing information. Any marketing information related to this product is know only to Eton’s Commercial team. Marketing information has potential commercial value and allowing this information to remain non-public and confidential, allows Eton to obtain a business advantage over its competitors who do not have or know Eton’s marketing information. Making the marketing information public would not serve the public interest and therefore disclosure is not required. The prevalence of patients in the US that have the condition for which our prescription drug is prescribed, children between the ages of 0 -17, is estimated to be between 5,000 and 11,000. For reporting purposes, we entered the midpoint of 8,000.",,,,,,,,,,,,,,, +"Eton Pharmaceuticals, Inc.",71863011150,Alkindi Sprinkle 2mg,2020-09-29,1397.28,,1,8000,,,,,,,"Eton does not have patented marketing information. Any marketing information related to this product is know only to Eton’s Commercial team. Marketing information has potential commercial value and allowing this information to remain non-public and confidential, allows Eton to obtain a business advantage over its competitors who do not have or know Eton’s marketing information. Making the marketing information public would not serve the public interest and therefore disclosure is not required. The prevalence of patients in the US that have the condition for which our prescription drug is prescribed, children between the ages of 0 -17, is estimated to be between 5,000 and 11,000. For reporting purposes, we entered the midpoint of 8,000.",,,,,,,,,,,,,,, +"Eton Pharmaceuticals, Inc.",71863011250,Alkindi Sprinkle 5mg,2020-09-29,3493.2,,1,8000,,,,,,,"Eton does not have patented marketing information. Any marketing information related to this product is know only to Eton’s Commercial team. Marketing information has potential commercial value and allowing this information to remain non-public and confidential, allows Eton to obtain a business advantage over its competitors who do not have or know Eton’s marketing information. Making the marketing information public would not serve the public interest and therefore disclosure is not required. The prevalence of patients in the US that have the condition for which our prescription drug is prescribed, children between the ages of 0 -17, is estimated to be between 5,000 and 11,000. For reporting purposes, we entered the midpoint of 8,000.",,,,,,,,,,,,,,, +"Exelan Pharmaceuticals, Inc.",76282067630,"Cinacalcet HCl Oral Tablet 90 MG, 30ct",2020-06-15,956.49,,1,454848,,,,,,,"Full Drug Description: Cinacalcet HCl Oral Tablet 90 MG, 30ct",,,,,,,,,,,,,,, +Ferring Pharmaceuticals,55566100201,ORTIKOS(Budesonide) extended release capsules 6mg,2020-07-20,1200,,1,800000,,,2018-10-04,,1,"Ferring Pharmaceuticals Inc. acquired the Rights to Distribute Ortikos in the US from SUN on October 4, 2019","Sources +1. ORTIKOS [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc. 2. Crohn’s & Colitis Foundation. The Facts About Inflammatory Bowel Diseases. November 2014. 3. Crohn’s & Colitis Foundation. Living with Crohn’s Disease. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/living-with-crohnsdisease.pdf. Last accessed: May 2020. 4. Crohn’s & Colitis Foundation. Overview of Crohn’s Disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Last accessed: May 2020.",,,,,,,,,,,,,,, +Ferring Pharmaceuticals,55566102001,ORTIKOS(Budesonide) extended release capsules 9mg,2020-07-20,1200,,1,800000,,,2019-10-04,,1,"Ferring Pharmaceuticals Inc. acquired the Rights to Distribute Ortikos in the US from SUN on October 4, 2019","Sources +1. ORTIKOS [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc. 2. Crohn’s & Colitis Foundation. The Facts About Inflammatory Bowel Diseases. November 2014. 3. Crohn’s & Colitis Foundation. Living with Crohn’s Disease. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/living-with-crohnsdisease.pdf. Last accessed: May 2020. 4. Crohn’s & Colitis Foundation. Overview of Crohn’s Disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Last accessed: May 2020.",,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,63323082520,Decitabine for Injection 50 mg/vial,2020-04-20,394,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA believes is otherwise in the public domain or publicly available, as of the date of this submission. (2) Fresenius Kabi USA’s marketing and pricing plans for this product are not in the public domain or otherwise publicly available. Consistent with the relevant statutes and regulations, Fresenius Kabi USA has left the “marketing and pricing plan description” data field blank. (3) Fresenius Kabi USA does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. Further, Fresenius Kabi USA does not know this information and has not put this information in the public domain. As a result, Fresenius Kabi USA has left the “estimated number of patients” data field blank. (4) The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed.",,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,63323072910,Micafungin Sodium Inj. Lyophilized 100 mg 10mL,2020-05-08,1870,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA believes is otherwise in the public domain or publicly available, as of the date of this submission. (2) Fresenius Kabi USA’s marketing and pricing plans for this product are not in the public domain or otherwise publicly available. Consistent with the relevant statutes and regulations, Fresenius Kabi USA has left the “marketing and pricing plan description” data field blank. (3) Fresenius Kabi USA does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. Further, Fresenius Kabi USA does not know this information and has not put this information in the public domain. As a result, Fresenius Kabi USA has left the “estimated number of patients” data field blank. (4) The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed.",,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,63323072810,Micafungin Sodium Inj. Lyophilized 50 mg 10mL,2020-05-08,935,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA believes is otherwise in the public domain or publicly available, as of the date of this submission. (2) Fresenius Kabi USA’s marketing and pricing plans for this product are not in the public domain or otherwise publicly available. Consistent with the relevant statutes and regulations, Fresenius Kabi USA has left the “marketing and pricing plan description” data field blank. (3) Fresenius Kabi USA does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. Further, Fresenius Kabi USA does not know this information and has not put this information in the public domain. As a result, Fresenius Kabi USA has left the “estimated number of patients” data field blank. (4) The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed.",,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,63323057486,Icatibant Injection 30 mg per 3 mL pack of 1,2020-10-21,5083.26,,1,1,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA believes is otherwise in the public domain or publicly available, as of the date of this submission. (2) Fresenius Kabi USA’s marketing and pricing plans for this product are not in the public domain or otherwise publicly available. Consistent with the relevant statutes and regulations, Fresenius Kabi USA has left the “marketing and pricing plan description” data field blank. (3) Fresenius Kabi USA does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. Further, Fresenius Kabi USA does not know this information and has not put this information in the public domain. As a result, Fresenius Kabi USA has left the “estimated number of patients” data field blank. (4) The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed.",,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,63323057493,Icatibant Injection 30 mg per 3 mL pack of 3,2020-10-21,15249.78,,1,1,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA believes is otherwise in the public domain or publicly available, as of the date of this submission. (2) Fresenius Kabi USA’s marketing and pricing plans for this product are not in the public domain or otherwise publicly available. Consistent with the relevant statutes and regulations, Fresenius Kabi USA has left the “marketing and pricing plan description” data field blank. (3) Fresenius Kabi USA does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. Further, Fresenius Kabi USA does not know this information and has not put this information in the public domain. As a result, Fresenius Kabi USA has left the “estimated number of patients” data field blank. (4) The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed.",,,,,,,,,,,,,,, +Genentech USA,50242024501,PHESGO SC - 1200mg/600mg (15mL) Inject Solution,2020-07-07,12707,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. + +We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,38600,,,,,,,"It is estimated that there are approximately 38,600 patients in the US diagnosed with HER2+ breast cancer. Physicians treating patients with this condition make the determinations on therapeutic options. + +PHESGO SC - 1200mg/600mg (15mL) Inject Solution was developed by Genentech USA Inc and was not acquired from a third party.",,,,,,,,,,,,,,, +Genentech USA,50242026001,PHESGO SC - 600mg/600mg (10mL) Inject Solution,2020-07-07,8471,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. + +We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,38600,,,,,,,"It is estimated that there are approximately 38,600 patients in the US diagnosed with HER2+ breast cancer. Physicians treating patients with this condition make the determinations on therapeutic options. + +PHESGO SC - 600mg/600mg (10mL) Inject Solution was developed by Genentech USA Inc and was not acquired from a third party.",,,,,,,,,,,,,,, +Genentech USA,50242017507,Evrysdi 60mg/80mL oral powder (constituted to 0.75 mg/mL),2020-08-17,11170.43,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. + +We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,7200,1,1,,,,,Evrysdi 60mg/80mL oral powder (constituted to 0.75 mg/mL) was developed by Genentech USA Inc. and was not acquired from a third party.,,,,,,,,,,,,,,, +Genentech USA,50242000701,Enspryng – 120mg/mL Prefilled Syringe,2020-08-24,14615.39,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. + +We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,25400,1,1,,,,,Enspryng – 120mg/mL Prefilled Syringe was developed by Genentech USA Inc and was not acquired from a third party.,,,,,,,,,,,,,,, +"Gilead Sciences, Inc.",61958180501,"HARVONI® (ledipasvir 33.75mg/sofosbuvir 150mg) oral pellets, 28 packets",2020-05-26,31500,,1,,,1,,,,,"The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Gilead believes is in the public domain or otherwise publicly available. + +HARVONI oral pellets were granted orphan drug status by the FDA since it is estimated that, for the product, less than 200,000 patients in the U.S. are affected by a condition that it may be used to treat. However, Gilead is not aware of publicly available information related to the estimated number of patients that may be treated with HARVONI oral pellets. Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is unable to provide an estimated number of patients in its report. + +Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product.",,,,,,,,,,,,,,, +"Gilead Sciences, Inc.",61958180401,"HARVONI® (ledipasvir 45mg/sofosbuvir 200mg) oral pellets, 28 packets",2020-05-26,31500,,1,,,1,,,,,"The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Gilead believes is in the public domain or otherwise publicly available. + +HARVONI oral pellets were granted orphan drug status by the FDA since it is estimated that, for the product, less than 200,000 patients in the U.S. are affected by a condition that it may be used to treat. However, Gilead is not aware of publicly available information related to the estimated number of patients that may be treated with HARVONI oral pellets. Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is unable to provide an estimated number of patients in its report. + +Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product.",,,,,,,,,,,,,,, +"Gilead Sciences, Inc.",61958150401,"SOVALDI® (sofosbuvir 150mg) oral pellets, 28 packets",2020-05-26,28000,,1,,,1,,,,,"The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Gilead believes is in the public domain or otherwise publicly available. + +SOVALDI oral pellets were granted orphan drug status by the FDA since it is estimated that, for the product, less than 200,000 patients in the U.S. are affected by a condition that it may be used to treat. However, Gilead is not aware of publicly available information related to the estimated number of patients that may be treated with SOVALDI oral pellets. Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is unable to provide an estimated number of patients in its report. + +Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product.",,,,,,,,,,,,,,, +"Gilead Sciences, Inc.",61958150501,"SOVALDI® (sofosbuvir 200mg) oral pellets, 28 packets",2020-05-26,28000,,1,,,1,,,,,"The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Gilead believes is in the public domain or otherwise publicly available. + +SOVALDI oral pellets were granted orphan drug status by the FDA since it is estimated that, for the product, less than 200,000 patients in the U.S. are affected by a condition that it may be used to treat. However, Gilead is not aware of publicly available information related to the estimated number of patients that may be treated with SOVALDI oral pellets. Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is unable to provide an estimated number of patients in its report. + +Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product.",,,,,,,,,,,,,,, +GlaxoSmithKline,173089601,BLENREP INJ 100 MG,2020-08-21,8277,,1,3500,1,1,,,,,"Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable, but not curable. In the US, more than 32,000 people are estimated to be diagnosed with multiple myeloma this year and nearly 13,000 people will die from the disease. Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments. GSK estimates that there are roughly 3,500 patients within the U.S. at a given time who suffer from multiple myeloma and would be potential candidates to use the product according to the current label. Diagnosed patients may or may not be prescribed BLENREP (NDC: 00173089601) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with BLENREP (NDC: 00173089601). +GSK has not released BLENREP's (NDC: 00173089601) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462049430,"Deferasirox Tablets for Oral Suspension, 125 mg",2020-01-17,675.89,,1,,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, however IQVIA data for the 12 months ending November 2019 is 11,313 prescriptions for Deferasirox Tablets for Oral Suspension. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462049530,"Deferasirox Tablets for Oral Suspension, 250 mg",2020-01-17,1351.76,,1,,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, however IQVIA data for the 12 months ending November 2019 is 11,313 prescriptions for Deferasirox Tablets for Oral Suspension. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462049630,"Deferasirox Tablets for Oral Suspension, 500 mg",2020-01-17,2703.46,,1,,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, however IQVIA data for the 12 months ending November 2019 is 11,313 prescriptions for Deferasirox Tablets for Oral Suspension. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462072401,"Chlorzoxazone Tablets USP, 375 mg",2020-05-27,744.29,,1,6570,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending April 2020 is 6,570 prescriptions for 375 mg , and 27,635 prescriptions for 750 mg. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462072501,"Chlorzoxazone Tablets USP, 750 mg",2020-05-27,832.25,,1,27635,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending April 2020 is 6,570 prescriptions for 375 mg , and 27,635 prescriptions for 750 mg. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462042169,"Atovaquone Oral Suspension USP,750 mg'5ml 42X5",2020-07-31,1239,,1,120846,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, however IQVIA MAT data for the 12 months ending June 2020 is 120,846 prescriptions for the total market. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462068201,"Sirolimus Tablets, .5 mg",2020-10-23,694.38,,1,213589,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending September 2020 is 213,589 prescriptions. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462068301,"Sirolimus Tablets, 1 mg",2020-10-23,1388.77,,1,213589,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending September 2020 is 213,589 prescriptions. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010005401,"Butalbital and Acetaminophen Capsules, 50 mg/300 mg, 100 Count",2020-02-19,1028.33,,1,0,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010004401,"Butalbital, Acetaminophen and Caffeine Capsules, 50 mg/300 mg/40 mg, 100 Count",2020-05-05,88.42,,1,100,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010000201,"COLCHICINE 0.6MG Tablets, 100count",2020-05-13,107.55,,1,100,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010000203,"COLCHICINE 0.6MG Tablets, 30count",2020-05-13,39.27,,1,100,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Heritage Pharmacueticals Inc. D/B/A Avet Pharmacueticals Inc,23155064941,Carmustine for Injection,2020-02-26,2637.39,,1,466000,,,2012-11-28,,1,,Estimated Number of Patients is based on information obtained from Cancer.org and represents total patients diagnosed with cancers that could be treated by this product,,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54047121,"Everolimus Tabs 0.5 mg, 60",2020-03-10,951.43,These drugs are generic products; therefore no marketing and pricing plans are available. These products are sold in the United States only.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma has not evaluated the volume of patients in the USA, as of January 2020 MAT IQVIA states a unit market size of 176,25. Hikma did not acquire this product.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54047221,"Everolimus Tabs 0.75 mg, 60",2020-03-10,1427.13,These drugs are generic products; therefore no marketing and pricing plans are available. These products are sold in the United States only.,,,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma has not evaluated the volume of patients in the USA, as of January 2020 MAT IQVIA states a unit market size of 176,25. Hikma did not acquire this product.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,143963410,Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection 20mg/200mL,2020-04-22,1016.5,These drugs are generic products; therefore no marketing and pricing plans are available. These products are sold in the United States only.,,,,,2011-04-13,,1,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma has not evaluated the volume of patients in the USA. According to CDC.gov, the estimated number of patients with hypertension is 108,000,000. + +The Nicardipine products referenced herein were transferred from Exela to Hikma in connection with a License Development, Supply, and Marketing Agreement executed on April 13, 2011. This agreement is not in the public domain and thus the acquisition price cannot be disclosed.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,143963310,Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection 40mg/200mL,2020-04-22,2033,These drugs are generic products; therefore no marketing and pricing plans are available. These products are sold in the United States only.,,,,,2011-04-13,,1,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma has not evaluated the volume of patients in the USA. According to CDC.gov, the estimated number of patients with hypertension is 108,000,000. + +The Nicardipine products referenced herein were transferred from Exela to Hikma in connection with a License Development, Supply, and Marketing Agreement executed on April 13, 2011. This agreement is not in the public domain and thus the acquisition price cannot be disclosed.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54048014,"Everolimus Tablets 2.5mg, Blister Pack of 28",2020-06-08,12012.98,These drugs are generic products; therefore no marketing and pricing plans are available. These products are sold in the United States only.,,73750,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2020 approximately 73,750 people will be diagnosed with advanced renal cell carcinoma.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54048114,"Everolimus Tablets 5mg, Blister Pack of 28",2020-06-08,12565.37,These drugs are generic products; therefore no marketing and pricing plans are available. These products are sold in the United States only.,,73750,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2020 approximately 73,750 people will be diagnosed with advanced renal cell carcinoma.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54049714,"Everolimus Tablets 7.5mg, Blister Pack of 28",2020-06-08,12565.37,These drugs are generic products; therefore no marketing and pricing plans are available. These products are sold in the United States only.,,73750,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2020 approximately 73,750 people will be diagnosed with advanced renal cell carcinoma.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54070219,Vigabatrin Oral Solution 500mg,2020-09-25,1337.06,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,3400000,,,,,,,"Hikma has not evaluated the volume of patients in the USA. Vigabatrin Oral Solution is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures. According to CDC.gov, there are approximately 3.4 million people including children with epilepsy or seizure disorders nationwide. Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54052863,"Rufinamide Oral Solution 40mg/mL, bottle of 460mL",2020-11-01,1540.37,,1,86060,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. + +Hikma has not evaluated the volume of patients in the USA. Rufinamide Oral Solution is indicated as adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (""LGS"") in pediatric patients 1 year of age and older and in adults. The incidence of LGS is estimated at approximately 26 per 100,000 people. Therefore, there are approximately 86,060 patients in the United States.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54039925,Bexarotene Capsules 75mg,2020-11-25,5885,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,77240,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. +Hikma has not evaluated the volume of patients in the USA. Bexarotene capsules are a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. The American Cancer Society estimates that approximately 77,240 people will be diagnosed with T-cell lymphoma.",,,,,,,,,,,,,,, +"Horizon Therapeutics USA, Inc.",75987013015,"Tepezza Intravenous Solution Reconstituted 500 MG, Single-Dose Vial",2020-02-03,14900,"TEPEZZA is the first and only FDA-approved medicine for the treatment of Thyroid Eye Disease (TED), a serious, progressive and vision-threatening rare autoimmune disease that is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain, inflammation and facial disfigurement. Horizon's approach will focus on educating physicians about the disease state and TEPEZZA, providing education and support that simplifies the patient journey, and helping to facilitate access to TEPEZZA. TEPEZZA is a targeted biologic that addresses the underlying disease process, and its potential to significantly change the lives of people living with this rare and vision-threatening disease underscores the compelling value it offers. In addition to the value TEPEZZA brings to patients who previously had no meaningful options other than multiple eye surgeries, the pricing decision also reflects the significant investment made to develop and make an approved treatment available to a rare disease patient population. Horizon engaged in meaningful conversations with payors, as well as key members of the Thyroid Eye Disease community regarding this value in relation to pricing.",,15000,1,1,,,,,,,,,,,,,,,,,,,, +"Horizon Therapeutics USA, Inc.",75987014514,"PROCYSBI (cysteamine bitartrate) delayed-release oral granules 300 MG, 120 Packets",2020-04-23,48633.6,"The PROCYSBI Delayed-Release Oral Granules in Packets product provides another administration option for patients, in addition to PROCYSBI capsules. The new tear-open packets offer a convenient option for cystinosis patients who may have difficulty swallowing, need to sprinkle the granules on certain foods or mix with select liquids, or administer medication through a gastrostomy tube (G-tube). Additionally, the ability to access PROCYSBI granules in tear-open packets may help reduce the burden families living with cystinosis often face with managing multiple medications every day. Price remains consistent between 75mg capsules and 75mg and 300mg packets at the mg level. Horizon’s approach will continue to focus on educating physicians about the disease state and PROCYSBI, providing education and support that simplifies the patient journey, and helping to facilitate access to PROCYSBI.",,15,,,,,,,"Acquisition fields left blank as Horizon did not acquire PROCYSBI Delayed-Release Oral Granules in Packets. Horizon expects there to be 60 patients on treatment this year across all four NDC’s, which is approximately 15 patients per NDC. MediSpan is showing market availability of 3/17/2020 as PROCYSBI was added to MediSpan earlier than the product was available for ordering. Actual market availability was 4/23/2020 as reflected in this report.",,,,,,,,,,,,,,, +"Horizon Therapeutics USA, Inc.",75987014513,"PROCYSBI (cysteamine bitartrate) delayed-release oral granules 300 MG, 60 Packets",2020-04-23,24316.8,"The PROCYSBI Delayed-Release Oral Granules in Packets product provides another administration option for patients, in addition to PROCYSBI capsules. The new tear-open packets offer a convenient option for cystinosis patients who may have difficulty swallowing, need to sprinkle the granules on certain foods or mix with select liquids, or administer medication through a gastrostomy tube (G-tube). Additionally, the ability to access PROCYSBI granules in tear-open packets may help reduce the burden families living with cystinosis often face with managing multiple medications every day. Price remains consistent between 75mg capsules and 75mg and 300mg packets at the mg level. Horizon’s approach will continue to focus on educating physicians about the disease state and PROCYSBI, providing education and support that simplifies the patient journey, and helping to facilitate access to PROCYSBI.",,15,,,,,,,"Acquisition fields left blank as Horizon did not acquire PROCYSBI Delayed-Release Oral Granules in Packets. Horizon expects there to be 60 patients on treatment this year across all four NDC’s, which is approximately 15 patients per NDC. MediSpan is showing market availability of 3/17/2020 as PROCYSBI was added to MediSpan earlier than the product was available for ordering. Actual market availability was 4/23/2020 as reflected in this report.",,,,,,,,,,,,,,, +"Horizon Therapeutics USA, Inc.",75987014014,"PROCYSBI (cysteamine bitartrate) delayed-release oral granules 75 MG, 120 Packets",2020-04-23,12158.4,"The PROCYSBI Delayed-Release Oral Granules in Packets product provides another administration option for patients, in addition to PROCYSBI capsules. The new tear-open packets offer a convenient option for cystinosis patients who may have difficulty swallowing, need to sprinkle the granules on certain foods or mix with select liquids, or administer medication through a gastrostomy tube (G-tube). Additionally, the ability to access PROCYSBI granules in tear-open packets may help reduce the burden families living with cystinosis often face with managing multiple medications every day. Price remains consistent between 75mg capsules and 75mg and 300mg packets at the mg level. Horizon’s approach will continue to focus on educating physicians about the disease state and PROCYSBI, providing education and support that simplifies the patient journey, and helping to facilitate access to PROCYSBI.",,15,,,,,,,"Acquisition fields left blank as Horizon did not acquire PROCYSBI Delayed-Release Oral Granules in Packets. Horizon expects there to be 60 patients on treatment this year across all four NDC’s, which is approximately 15 patients per NDC. MediSpan is showing market availability of 3/17/2020 as PROCYSBI was added to MediSpan earlier than the product was available for ordering. Actual market availability was 4/23/2020 as reflected in this report.",,,,,,,,,,,,,,, +"Horizon Therapeutics USA, Inc.",75987014013,"PROCYSBI (cysteamine bitartrate) delayed-release oral granules 75 MG, 60 Packets",2020-04-23,6079.2,"The PROCYSBI Delayed-Release Oral Granules in Packets product provides another administration option for patients, in addition to PROCYSBI capsules. The new tear-open packets offer a convenient option for cystinosis patients who may have difficulty swallowing, need to sprinkle the granules on certain foods or mix with select liquids, or administer medication through a gastrostomy tube (G-tube). Additionally, the ability to access PROCYSBI granules in tear-open packets may help reduce the burden families living with cystinosis often face with managing multiple medications every day. Price remains consistent between 75mg capsules and 75mg and 300mg packets at the mg level. Horizon’s approach will continue to focus on educating physicians about the disease state and PROCYSBI, providing education and support that simplifies the patient journey, and helping to facilitate access to PROCYSBI.",,15,,,,,,,"Acquisition fields left blank as Horizon did not acquire PROCYSBI Delayed-Release Oral Granules in Packets. Horizon expects there to be 60 patients on treatment this year across all four NDC’s, which is approximately 15 patients per NDC. MediSpan is showing market availability of 3/17/2020 as PROCYSBI was added to MediSpan earlier than the product was available for ordering. Actual market availability was 4/23/2020 as reflected in this report.",,,,,,,,,,,,,,, +"Immunomedics, Inc.",55135013201,TRODELVY (sacituzumab govitecan-hziy) 180 mg vial,2020-04-28,2012.5,,1,9000,1,1,,,,,"Specific to Introduced to Market Date (4/28/2020) TRODELVY was FDA approved on 4/22/2020, which is the date provided to Medispan. However, the date of product availability (or Product Launch Date) into the U.S. market was 4/28/2020. + + +Specific to Estimated Number of Patients Immunomedics is providing the following additional information that is publicly available: +Breast cancer is the most commonly diagnosed cancer in women in the US. +Source: Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019;69(1):7-34. +Based on data from the NCI’s SEER program, approximately 260,000 new cases of breast cancer were diagnosed in women in the US in 2019. +Source: National Cancer Institute. Cancer Stat Facts: Female Breast Cancer 2019; https://seer.cancer.gov/statfacts/html/breast.html. Accessed December 17, 2019 +Of all new cases of breast cancer, approximately 10-15% are diagnosed with TNBC. +Source: American Cancer Society. Triple-negative breast cancer. https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/types-of-breast-cancer/triple-negative.html +Approximately 6-10% of new breast cancer cases are initially Stage 4 or metastatic. This is sometimes called “de novo” metastatic disease, meaning from the beginning. +Source: Metastatic Breast Cancer Network. Incidence and incidence rates. http://mbcn.org/education/category/incidence-and-incidence-rates +Approximately 30-40% of new breast cancer cases (Stage 1, Stage 2, and Stage 3) will progress to Stage 4 or metastatic stage. +Source: Zeichner SB, et al. Breast Cancer Bas Clin Res. 2016;10:25-36 +Combining the two data points (de novo metastatic and those who progress to Stage 4) arrives at approximately 10,000 to 11,000 patients. Applying descending treatment rates sequentially from 1L to 2L to 3L you arrive at approximately 8,000 - 9,000 addressable patients. It is important to note that the initial indication for Trodelvy is for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Due to various external factors and dynamics, Immunomedics does not reasonably know how many patients will actually be prescribed TRODELVY. + +Immunomedics does not publicly disclose the Marketing/Pricing Plan of TRODELVY. Thus, consistent with 22 C.C.R. §96076(c), Immunomedics has left that field blank. + +Because this drug was not acquired, the fields ""acquisition date,"" ""acquisition price"" and ""acquisition price comment"" have been left blank.",,,,,,,,,,,,,,, +Incyte Corporation,50881002801,Pemazyre 13.5mg 14 count bottle,2020-04-20,17000,"To market PEMAZYRE, Incyte designed activities to increase awareness and understanding with healthcare providers about the first FDA-approved product for these patients. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers. There is a consumer-directed website to educate patients on the disease state and PEMAZYRE, and Incyte intends to limit other direct-to-consumer advertising activities given the limited patient population. +At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations. + +- Cholangiocarcinoma (CCA) is an orphan disease with limited treatment options. +- PEMAZYRE is the first treatment innovation for patients with cholangiocarcinoma since chemotherapy was approved 25 years ago +- It is a targeted treatment approved in the United States for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test.",,,1,1,,,,,"Comment regarding Field 7: +While Incyte's estimated volume of patients who may be prescribed PEMAZYRE is not available in the public domain, Cholangiocarcinoma (CCA) is a rare disease with a poor prognosis. Epidemiology studies suggest that the incidence rate of CCA ranges between 2.2 to 2.8 per 100,000 lives. CCA is a molecular target-rich disease with FGFR2 fusions and rearrangements representing 10-16% of intrahepatic CCA patients. FGFR2 fusions and rearrangements are rare in extrahepatic CCA. Patients with unresectable, previously treated iCCA with an FGFR2 fusion or rearrangement translate to ~1 per 1 million lives. + +Comment regarding Field 8: Acquisition date - n/a + +Comment regarding Field 9: Acquisition price - n/a + +General Comment: +In the event 2017 California Senate Bill 17 (“SB-17”) and the laws it implements, including Cal. Health & Safety Code § 127677, are found unconstitutional or otherwise unlawful, Incyte reserves all of its legal rights. In issuing this report in an attempt to comply with Cal. Health & Safety Code § 127677, Incyte does not waive any legal claims or legal rights related to SB-17. +Please note that portions of this report and its contents may be exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes Incyte’s proprietary commercial information and otherwise would not be in the public interest to disclose. We ask that you please contact the Incyte legal department at 1801 Augustine Cut-Off, Wilmington, DE 19803 if you receive any PRA requests so that we may take appropriate steps to work with you to protect such information.",,,,,,,,,,,,,,, +Incyte Corporation,50881002601,Pemazyre 4.5mg 14 count bottle,2020-04-20,17000,"To market PEMAZYRE, Incyte designed activities to increase awareness and understanding with healthcare providers about the first FDA-approved product for these patients. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers. There is a consumer-directed website to educate patients on the disease state and PEMAZYRE, and Incyte intends to limit other direct-to-consumer advertising activities given the limited patient population. +At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations. + +- Cholangiocarcinoma (CCA) is an orphan disease with limited treatment options. +- PEMAZYRE is the first treatment innovation for patients with cholangiocarcinoma since chemotherapy was approved 25 years ago +- It is a targeted treatment approved in the United States for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test.",,,1,1,,,,,"Comment regarding Field 7: +While Incyte's estimated volume of patients who may be prescribed PEMAZYRE is not available in the public domain, Cholangiocarcinoma (CCA) is a rare disease with a poor prognosis. Epidemiology studies suggest that the incidence rate of CCA ranges between 2.2 to 2.8 per 100,000 lives. CCA is a molecular target-rich disease with FGFR2 fusions and rearrangements representing 10-16% of intrahepatic CCA patients. FGFR2 fusions and rearrangements are rare in extrahepatic CCA. Patients with unresectable, previously treated iCCA with an FGFR2 fusion or rearrangement translate to ~1 per 1 million lives. + +Comment regarding Field 8: Acquisition date - n/a + +Comment regarding Field 9: Acquisition price - n/a + +General Comment: +In the event 2017 California Senate Bill 17 (“SB-17”) and the laws it implements, including Cal. Health & Safety Code § 127677, are found unconstitutional or otherwise unlawful, Incyte reserves all of its legal rights. In issuing this report in an attempt to comply with Cal. Health & Safety Code § 127677, Incyte does not waive any legal claims or legal rights related to SB-17. +Please note that portions of this report and its contents may be exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes Incyte’s proprietary commercial information and otherwise would not be in the public interest to disclose. We ask that you please contact the Incyte legal department at 1801 Augustine Cut-Off, Wilmington, DE 19803 if you receive any PRA requests so that we may take appropriate steps to work with you to protect such information.",,,,,,,,,,,,,,, +Incyte Corporation,50881002701,Pemazyre 9.0mg 14 count bottle,2020-04-20,17000,"To market PEMAZYRE, Incyte designed activities to increase awareness and understanding with healthcare providers about the first FDA-approved product for these patients. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers. There is a consumer-directed website to educate patients on the disease state and PEMAZYRE, and Incyte intends to limit other direct-to-consumer advertising activities given the limited patient population. +At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations. + +- Cholangiocarcinoma (CCA) is an orphan disease with limited treatment options. +- PEMAZYRE is the first treatment innovation for patients with cholangiocarcinoma since chemotherapy was approved 25 years ago +- It is a targeted treatment approved in the United States for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test.",,,1,1,,,,,"Comment regarding Field 7: +While Incyte's estimated volume of patients who may be prescribed PEMAZYRE is not available in the public domain, Cholangiocarcinoma (CCA) is a rare disease with a poor prognosis. Epidemiology studies suggest that the incidence rate of CCA ranges between 2.2 to 2.8 per 100,000 lives. CCA is a molecular target-rich disease with FGFR2 fusions and rearrangements representing 10-16% of intrahepatic CCA patients. FGFR2 fusions and rearrangements are rare in extrahepatic CCA. Patients with unresectable, previously treated iCCA with an FGFR2 fusion or rearrangement translate to ~1 per 1 million lives. + +Comment regarding Field 8: Acquisition date - n/a + +Comment regarding Field 9: Acquisition price - n/a + +General Comment: +In the event 2017 California Senate Bill 17 (“SB-17”) and the laws it implements, including Cal. Health & Safety Code § 127677, are found unconstitutional or otherwise unlawful, Incyte reserves all of its legal rights. In issuing this report in an attempt to comply with Cal. Health & Safety Code § 127677, Incyte does not waive any legal claims or legal rights related to SB-17. +Please note that portions of this report and its contents may be exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes Incyte’s proprietary commercial information and otherwise would not be in the public interest to disclose. We ask that you please contact the Incyte legal department at 1801 Augustine Cut-Off, Wilmington, DE 19803 if you receive any PRA requests so that we may take appropriate steps to work with you to protect such information.",,,,,,,,,,,,,,, +"Ingenus Pharmaceuticals, LLC",50742052005,Cyclophosphamide Injection 1gm/5ml,2020-07-31,732.5,"Ingenus prices their products based on the current market conditions along with a number of variables. All of these product specific variables are entered into a pricing model and pricing is determined. Some examples ( not all ) are cost of goods, profit share, freight costs, product volume, customer specific volumes, the COT/channels the specific product is sold in, rebates, chargebacks, contractual obligations. These factors vary product by product and aren’t all applicable in every case.",,218623,,,,,,,"As a manufacturer, Ingenus does not estimate the number of patients that may be prescribed our products. We manufacturer volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. Acquisition is not applicable. The total therapeutic WAC for this both SKUs of this product reaches the specified $670.00 amount",,,,,,,,,,,,,,, +"Ingenus Pharmaceuticals, LLC",50742051902,Cyclophosphamide Injection 500mg/2.5ml,2020-07-31,366.25,"Ingenus prices their products based on the current market conditions along with a number of variables. All of these product specific variables are entered into a pricing model and pricing is determined. Some examples ( not all ) are cost of goods, profit share, freight costs, product volume, customer specific volumes, the COT/channels the specific product is sold in, rebates, chargebacks, contractual obligations. These factors vary product by product and aren’t all applicable in every case.",,36174,,,,,,,"As a manufacturer, Ingenus does not estimate the number of patients that may be prescribed our products. We manufacturer volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. Acquisition is not applicable. The total therapeutic WAC for this both SKUs of this product reaches the specified $670.00 amount",,,,,,,,,,,,,,, +"Intra-Cellular Therapies, Inc.",72060014230,"Caplyta, 42 mg, capsule, 30 pack",2020-03-18,1320,,1,2400000,,,,,,,,,,,,,,,,,,,,,, +"Janssen Biotech, Inc.",57894050301,DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) Strength:1800mg / 15 mL Form:1 Single Vial,2020-05-04,7574,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with multiple myeloma. The pricing plan has WAC set for 1800mg / 15 mL subcutaneous injections at $7,574.00. The list price of DARZALEX FASPRO™ is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. DARZALEX FASPRO™ will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. On June 3, 2020, approval was received in the EU.",,,,,,,,,"The estimated number of patients in the United States with a condition for which DARZALEX FASPRO™ may be prescribed is not in the public domain or publicly available. DARZALEX FASPRO™ was developed by Janssen Biotech, Inc.",,,,,,,,,,,,,,, +"Jazz Pharmaceuticals, Inc.",68727071201,Zepzelca (lurbinectedin) 4mg lyophilized powder single dose vial,2020-07-07,6633,,1,8500,,1,2019-12-19,200000000,,"Lurbinectedin was licensed on December 19, 2019 through an exclusive license agreement between PharmaMar and Jazz Pharmaceuticals. Under the terms of the agreement, PharmaMar receives an upfront payment of $200 million with potential regulatory milestone payments of up to $250 million upon the achievement of accelerated and/or full regulatory approval of lurbinectedin by FDA within certain timelines. PharmaMar is also eligible to receive additional commercial milestone payments tied to future net sales of lurbinectedin.",,,,,,,,,,,,,,,, +"Jazz Pharmaceuticals, Inc.",68727015001,"Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution",2020-11-02,5110.12,,1,,,1,,,,,,,,,,,,,,,,,,,, +Karyopharm Therapeutics Inc.,72237010106,XPOVIO (selinexor) 40mg (16 Tablets),2020-06-22,22000,,1,9000,,1,,,,,,,,,,,,,,,,,,,, +Karyopharm Therapeutics Inc.,72237010107,XPOVIO (selinexor) 40mg (8 Tablets),2020-06-22,22000,,1,9000,,1,,,,,,,,,,,,,,,,,,,, +Karyopharm Therapeutics Inc.,72237010103,XPOVIO (selinexor) 60mg (24 Tablets),2020-06-22,22000,,1,9000,,1,,,,,,,,,,,,,,,,,,,, +"Kite Pharma, Inc.",71287021901,"TECARTUS™ (brexucabtagene autoleucel) 2 × 106CAR-positive viable T cells per kg of body weight, with a maximum of 2 × 108 CAR-positive viable T cells in approximately 68 mL of cell suspension for infusion",2020-07-30,373000,,1,,1,1,,,,,"The information provided in this report is subject to general limitations and assumptions Kite has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Kite believes is in the public domain or otherwise publicly available. + +Kite is not aware of publicly available information related to the estimated number of patients that may be treated with TECARTUS cell therapy. Consistent with Section 127681(c) of the California Health and Safety Code, Kite is unable to provide an estimated number of patients in its report. + +Kite has not provided a response to the drug acquisition related data fields for this drug product because Kite developed this drug product.",,,,,,,,,,,,,,, +Mayne Pharma Inc,51862029043,Triamcinolone Acetonide External Ointment 0.05% 430GM,2020-05-18,779.33,,1,13435,,,,,,,"Estimated number of patients is an annualized number based on IQVIA average last 8 weeks of weekly scripts. +Introduced to Market Date (when product is commercially available) is expected end of May 2020.",,,,,,,,,,,,,,, +Mayne Pharma Inc,51862033801,Chlorzoxazone 375mg Tabs 100,2020-07-28,744.29,,1,8694,,,,,,,,,,,,,,,,,,,,,, +Mayne Pharma Inc,51862034001,Chlorzoxazone 750mg Tabs 100,2020-07-28,832.25,,1,23769,,,,,,,,,,,,,,,,,,,,,, +Mayne Pharma Inc,51862057130,Doryx (Doxycycline Hyclate) Oral Tablet Delayed Release 80 MG,2020-10-12,950,,1,2000000,,,2015-02-25,50000000,,,Doxycyline Hyclate is used to treat a wide variety of infections. The estimated number of patients is purely a guess as Mayne Pharma has no visibility into the prescribing habits of HCPs sufficient to provide a reliable number. Please refer to https://www.cdc.gov/ for additional information.,,,,,,,,,,,,,,, +"Meitheal Pharmaceuticals, Inc.",71288055586,Fulvestrant Injection 250mg 5mL SD Syringe 1 Pk of 2 Syringes,2020-04-22,700,This is a generic product and is not marketed. *(See Comments),,239431,,,,,,,"Meitheal markets generic Fulvestrant as a therapeutic equivalent to the innovator (brand) drug. As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. Because its Fulvestrant product is a generic product and there are a number of alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed Fulvestrant. As such, given Fulvestrant's primary use for the treatment of breast cancer, Meitheal's best estimate regarding a patient population can be derived from the Centers for Disease Control and Prevention's (""CDC"") tracking of breast cancer diagnoses within the United States. According to the CDC's most recent data (in 2017), approximately 239,431 women over the age of 40 were diagnosed with breast cancer. (https://gis.cdc.gov/Cancer/USCS/DataViz.html).",,,,,,,,,,,,,,, +"Merck & Co., Inc.",6385602,"RECARBRIO™ 1.25 grams (imipenem 500mg, cilastatin 500mg, relebactam 250mg)/Vial, powder",2020-01-06,6687.5,"Marketing: At the time of introduction of RECARBRIO to the market, Merck will inform customers of its availability, accompanied by limited promotion to healthcare professionals. + +Pricing: Merck prices our products, including RECARBRIO, to support access for patients today while also funding the critical investments that will empower our team of more than 12,000 Merck researchers to invent the cures and treatments of tomorrow. Our Company has a long history of responsibly pricing our medicines based on various factors, including the value provided to patients and the health care system, unmet medical need, access and ability to pay, R&D sustainability, and the competitive environment. Merck does not maintain records that reflect how these factors are applied in the context of any particular product.",,,,1,,,,,"Estimated Patients: The estimated volume of patients who may be prescribed the drug. RECARBRIO is indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa. + +RECARBRIO is also indicated in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible Gram-negative microorganisms: Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Fusobacterium nucleatum, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Parabacteroides distasonis and Pseudomonas aeruginosa. + +Acquisition Date / Acquisition Price: Acquisition fields are not applicable as Merck has not acquired this product. + +Marketing/Pricing Plan (Non Public): Consistent with SB 17, Merck has limited its response to information publicly available or otherwise in the public domain. + +Drug Product Description: RECARBRIO is delivered by intravenous (IV) infusion over 30 minutes every 6 hours in patients 18 years of age and older.","https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=338, https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=339",,,,,,,,,,,,,, +"Merck & Co., Inc.",6503302,"ONTRUZANT® (trastuzumab-dttb) for injection, for intravenous use, 150 mg of lyophilized trastuzumab-dttb, 15 mL single-dose vial, Package of one 15 mL single-dose vial",2020-04-15,1324.66,"Marketing: Promotional activities for ONTRUZANT will primarily include detailing of the product by Merck sales representatives to health care professionals working in various care settings, including infusion centers and hospitals. ONTRUZANT will also be marketed in the US with limited print distribution and digital resources to health care professionals. However, there will be no direct-to-consumer marketing for ONTRUZANT such as TV, magazine or journal ads. + +Pricing: We believe that biosimilars provide a market-based solution to health care spending with significant promise to deliver cost savings. Increasing choice in treatment options and decreasing out-of-pocket costs for HER-2 positive breast cancer patients is a primary focus in our pricing strategy for ONTRUZANT. As such, the price of ONTRUZANT, a biosimilar to Herceptin, will be established in the U.S. at a list price (wholesaler acquisition cost) of $1,324.66 for the 150 mg single-dose vial and $3,709.04 for the 420 mg multiple-dose vial, representing a 15% discount to the current list price of Herceptin. Additionally, it’s important to note that the WAC does not include discounts that may be paid on this product to payers, providers, distributors and other purchasing organizations.",,88833,,,2013-02-18,,1,,"Marketing/Pricing Plan (Non Public): Consistent with SB 17, Merck has limited its response to information publicly available or otherwise in the public domain. + +Estimated Patients: Ontruzant has the same indications as Herceptin and is indicated for the treatment of HER2-overexpressing breast cancer and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction. According to the American Cancer Society, approximately 268,600 women are diagnosed with breast cancer and 27,510 diagnosed with gastric cancer yearly.  Of the 296,110 annual breast and gastric cancer diagnoses, collectively, approximately 15% - 30% of these patients are HER2 positive (sources:  American Cancer Society Breast Cancer Statistics, ESMO Her2+ Gastric Cancer).  Assuming the higher limit of the estimated range of 30%, the estimated annual patient population for ONTRUZANT is approximately 88,833.  However, it is important to note there are several other products on the market that are indicated to treat these disease states, including the originator and several other biosimilars that would likely be used to treat a portion of the 88,833 annual cases.  + +Breakthrough Therapy Indicator / Priority Review Indicator: ONTRUZANT was not granted breakthrough therapy designation or priority review. + +Acquisition Date / Acquisition Price: It is important to note that by completing the acquisition-related fields, Merck is not representing that Merck has acquired all rights and obligations associated with ONTRUZANT. Rather, in 2013, Merck entered into an agreement with Samsung Bioepis wherein Merck acquired responsibilities for commercialization of the product in the U.S. Samsung Bioepis, as the manufacturer of ONTRUZUANT and BLA holder, remains responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration. As part of this agreement with respect to ONTRUZANT, Merck has paid an upfront payment, pre-specified clinical and regulatory milestones and product supply payment. To the best of Merck’s knowledge, the amount of these payments has not been publicly disclosed.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=436,,,,,,,,,,,,,, +"Merck & Co., Inc.",6503402,"ONTRUZANT® (trastuzumab-dttb) for injection, for intravenous use, 420 mg of lyophilized trastuzumab-dttb, 40 mL multi-dose vial with diluent, Package of one 40 mL multi-dose vial with diluent",2020-04-15,3709.04,"Marketing: Promotional activities for ONTRUZANT will primarily include detailing of the product by Merck sales representatives to health care professionals working in various care settings, including infusion centers and hospitals. ONTRUZANT will also be marketed in the US with limited print distribution and digital resources to health care professionals. However, there will be no direct-to-consumer marketing for ONTRUZANT such as TV, magazine or journal ads. + +Pricing: We believe that biosimilars provide a market-based solution to health care spending with significant promise to deliver cost savings. Increasing choice in treatment options and decreasing out-of-pocket costs for HER-2 positive breast cancer patients is a primary focus in our pricing strategy for ONTRUZANT. As such, the price of ONTRUZANT, a biosimilar to Herceptin, will be established in the U.S. at a list price (wholesaler acquisition cost) of $1,324.66 for the 150 mg single-dose vial and $3,709.04 for the 420 mg multiple-dose vial, representing a 15% discount to the current list price of Herceptin. Additionally, it’s important to note that the WAC does not include discounts that may be paid on this product to payers, providers, distributors and other purchasing organizations.",,88833,,,2013-02-18,,1,,"Marketing/Pricing Plan (Non Public): Consistent with SB 17, Merck has limited its response to information publicly available or otherwise in the public domain. + +Estimated Patients: Ontruzant has the same indications as Herceptin and is indicated for the treatment of HER2-overexpressing breast cancer and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction. According to the American Cancer Society, approximately 268,600 women are diagnosed with breast cancer and 27,510 diagnosed with gastric cancer yearly.  Of the 296,110 annual breast and gastric cancer diagnoses, collectively, approximately 15% - 30% of these patients are HER2 positive (sources:  American Cancer Society Breast Cancer Statistics, ESMO Her2+ Gastric Cancer).  Assuming the higher limit of the estimated range of 30%, the estimated annual patient population for ONTRUZANT is approximately 88,833.  However, it is important to note there are several other products on the market that are indicated to treat these disease states, including the originator and several other biosimilars that would likely be used to treat a portion of the 88,833 annual cases.  + +Breakthrough Therapy Indicator / Priority Review Indicator: ONTRUZANT was not granted breakthrough therapy designation or priority review. + +Acquisition Date / Acquisition Price: It is important to note that by completing the acquisition-related fields, Merck is not representing that Merck has acquired all rights and obligations associated with ONTRUZANT. Rather, in 2013, Merck entered into an agreement with Samsung Bioepis wherein Merck acquired responsibilities for commercialization of the product in the U.S. Samsung Bioepis, as the manufacturer of ONTRUZUANT and BLA holder, remains responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration. As part of this agreement with respect to ONTRUZANT, Merck has paid an upfront payment, pre-specified clinical and regulatory milestones and product supply payment. To the best of Merck’s knowledge, the amount of these payments has not been publicly disclosed.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=437,,,,,,,,,,,,,, +MorphoSys,73535020801,Monjuvi (tatasitamab-cxix),2020-08-05,1200,"Tafasitamab-cxix is approved in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). Accordingly, MorphoSys and our co-promotion partner plan to engage in a marketing plan for tafasitamab-cxix directed to educate providers and patient groups about this potential treatment option for DLBCL. In general, we plan marketing initiatives for tafasitamab-cxix that include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), materials to be used by our oncology sales managers to share information on tafasitamab with prescribers, materials to be used by our access and policy team with payers and other coverage decision makers regarding medical policy inclusion for tafasitamab and materials to educate patients about relapsed or refractory diffuse large B-cell lymphoma in the United States. + +The list price of tafasitamab-cxix does not reflect discounts and rebates, which may be available through the Medicaid Drug Rebate Program (MDRP), Medicare, and/or the commercial insurance market. Tafasitamab-cxix also will be discounted, as required, under the 340B Drug Pricing Program, the Federal Supply Schedule (FSS), and any other applicable government programs. For these reasons, the actual cost of tafasitamab-cxix to individual patients, providers, and health insurers is expected to be lower than WAC, and, in the case of patients, the actual cost likely will vary from patient to patient based on individual insurance coverage. We have implemented pricing for tafasitamab-cxix considering appropriate access for patients, while taking into account costs undertaken in research, development, manufacturing, and marketing of the drug, as well as the companys' business operations and internal evaluations of the market for this new treatment. At MorphoSys, we strive to discover, develop, and deliver breakthrough cancer therapies to patients who need them. Society relies on research-driven companies like MorphoSys to provide new medicines to address unmet medical needs, and we take seriously the trust that patients, caregivers, and healthcare professionals (HCPs) place in us. We believe our commitment does not end until our treatments are accessible for the patients who are prescribed them. We thoughtfully price our drugs by balancing the value of the outcomes and innovation they bring to patients and the healthcare system, with market and societal expectations. More detailed marketing and pricing plans are not in the public domain or otherwise publicly available.",,10000,1,1,,,,,,,,,,,,,,,,,,,, +Mylan Institutional Inc,42292005505,Paliperidone ER 9mg UD20,2020-03-13,763.21,,1,4200000,,,,,,,"Paliperidone is indicated for (1) Schizophrenia: The efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults; (2) Schizoaffective Disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy. According to the National Alliance on Mental Illness (NAMI), it was estimated that Schizophrenia affects approximately 1% of the population (approximately 3.2M of the 328M US Population), and Schizoaffective Disorder is prevalent in approximately affects roughly 0.3% of the population (approximately 984,000 of the 328M US Population) (https://www.nami.org/learn-more/mental-health-conditions/schizoaffective-disorder). Therefore, an estimated 4.2M patients in the United States may be prescribed this product. + +The Product was not a result of an acquisition.",,,,,,,,,,,,,,, +Mylan Institutional Inc,42292005703,Abiraterone Acetate 250mg Tabs UD30,2020-06-08,425,,1,89482,,,,,,,"Abiraterone acetate tablets are indicated for the treatment of patients with metastatic castration-resistant prostate cancer. In 2020, an estimated 191,930 new cases of prostate cancer are expected to be diagnosed in men in the U.S. From them, 21,112 (11%) may have metastatic CRPC (mCRPC), plus 68,370 patients diagnosed in prior years (prevalence) and becoming mCRPC. In total, potentially 89,482 may require the use of abiraterone as part of their treatment during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378461501,"Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release Tablets, 10mg/10mg, 100s",2020-07-21,592.05,,1,2996432,,,,,,,"Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Based on the literature, up to 80% of women experienced nausea and vomiting during pregnancy (NVP) in the U.S. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3990370/) The provisional number of births for the United States in 2019 was 3,745,540. (https://www.cdc.gov/nchs/data/vsrr/vsrr-8-508.pdf). Therefore, an estimated (using available data) 2,996,432 patients in the United States could potentially use this product as part of their pregnancy during the current year. + +Please note that, although not all courses of treatment of the Product trigger the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program (the “threshold”), this notice is being submitted because the Product triggers the threshold only when taking into account the maximum recommended dose as listed in the Product Prescribing Information.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378039614,"Dimethyl Fumarate Delayed-Release Capsules, 120mg, 14 count",2020-08-18,1666.62,,1,776836,,1,,,,,"Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Based on the literature, approximately 85% of patients with MS are initially diagnosed with RRMS (https://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS) A 2017 study confirmed approximately 913,925 adult patients have MS in the United States. (https://www.nationalmssociety.org/About-the-Society/News/Landmark-Study-Estimates-Nearly%C2%A01-Million-in-the-U#:~:text=The%20estimated%20prevalence%20of%20MS,or%20913%2C925%20adults%20with%20MS). Therefore, an estimated (using available data) 776,836 patients in the United States could potentially use this product as part of their MS treatment during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378039991,"Dimethyl Fumarate Delayed-Release Capsules, 240mg, 60 count",2020-08-18,7142.43,,1,776836,,1,,,,,"Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Based on the literature, approximately 85% of patients with MS are initially diagnosed with RRMS (https://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS) A 2017 study confirmed approximately 913,925 adult patients have MS in the United States. (https://www.nationalmssociety.org/About-the-Society/News/Landmark-Study-Estimates-Nearly%C2%A01-Million-in-the-U#:~:text=The%20estimated%20prevalence%20of%20MS,or%20913%2C925%20adults%20with%20MS). Therefore, an estimated (using available data) 776,836 patients in the United States could potentially use this product as part of their MS treatment during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378309685,"Everolimus Tablets, 2.5mg, 28 count",2020-09-10,6419.43,,1,272125,,,,,,,"Everolimus Tablets (label and PI) are indicated for the treatment of hormone receptor-positive HER2-negative breast cancer, tuberous sclerosis complex-associated renal angiomyolipoma, and tuberous sclerosis complex-associated subependymal giant cell astrocytoma. Based on the literature in 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. (https://www.cancer.gov/types/breast/patient/breast-screening-pdq#section/all) According to the National Institute of Cancer the total percentage of breast cancer that is the subtype HR+/HER2- is 67%. (https://seer.cancer.gov/statfacts/html/breast-subtypes.html) Therefore, an estimated 222,125 (67% of 331,530) women in the United States may be prescribed the product for the first indication. +Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 80% of patients with TSC may develop renal angiomyolipomas (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4080684/). Therefore, an estimated 40,000 patients may be prescribed this product for the second indication. +Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 20% of patients with TSC general develop subependymal giant cell astrocytomas (SEGAs) during the first two decades of their life (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5707039/). Therefore, an estimated 10,000 patients in the United States may be prescribed this product for the third indication. +Therefore, considering all approved indications, a total of 272,125 patients in the United States may be prescribed the product.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378309785,"Everolimus Tablets, 5mg, 28 count",2020-09-10,6714.62,,1,272125,,,,,,,"Everolimus Tablets (label and PI) are indicated for the treatment of hormone receptor-positive HER2-negative breast cancer, tuberous sclerosis complex-associated renal angiomyolipoma, and tuberous sclerosis complex-associated subependymal giant cell astrocytoma. Based on the literature in 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. (https://www.cancer.gov/types/breast/patient/breast-screening-pdq#section/all) According to the National Institute of Cancer the total percentage of breast cancer that is the subtype HR+/HER2- is 67%. (https://seer.cancer.gov/statfacts/html/breast-subtypes.html) Therefore, an estimated 222,125 (67% of 331,530) women in the United States may be prescribed the product for the first indication. +Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 80% of patients with TSC may develop renal angiomyolipomas (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4080684/). Therefore, an estimated 40,000 patients may be prescribed this product for the second indication. +Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 20% of patients with TSC general develop subependymal giant cell astrocytomas (SEGAs) during the first two decades of their life (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5707039/). Therefore, an estimated 10,000 patients in the United States may be prescribed this product for the third indication. +Therefore, considering all approved indications, a total of 272,125 patients in the United States may be prescribed the product.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378309885,"Everolimus Tablets, 7.5mg, 28 count",2020-09-10,6714.62,,1,272125,,,,,,,"Everolimus Tablets (label and PI) are indicated for the treatment of hormone receptor-positive HER2-negative breast cancer, tuberous sclerosis complex-associated renal angiomyolipoma, and tuberous sclerosis complex-associated subependymal giant cell astrocytoma. Based on the literature in 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. (https://www.cancer.gov/types/breast/patient/breast-screening-pdq#section/all) According to the National Institute of Cancer the total percentage of breast cancer that is the subtype HR+/HER2- is 67%. (https://seer.cancer.gov/statfacts/html/breast-subtypes.html) Therefore, an estimated 222,125 (67% of 331,530) women in the United States may be prescribed the product for the first indication. +Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 80% of patients with TSC may develop renal angiomyolipomas (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4080684/). Therefore, an estimated 40,000 patients may be prescribed this product for the second indication. +Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 20% of patients with TSC general develop subependymal giant cell astrocytomas (SEGAs) during the first two decades of their life (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5707039/). Therefore, an estimated 10,000 patients in the United States may be prescribed this product for the third indication. +Therefore, considering all approved indications, a total of 272,125 patients in the United States may be prescribed the product.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378450093,"Budesonide ER Tablets, 9mg, 30 count",2020-10-20,1549.02,,1,907000,,1,,,,,"Budesonide extended-release tablets are indicated for the treatment of active, mild to moderate ulcerative colitis. Based on the literature, an estimated 907,000 Americans currently have ulcerative colitis. (https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf, page 10)",,,,,,,,,,,,,,, +"Novadoz Pharmaceuticals, LLC",72205004601,"Thiotepa for Injection 100mg, 1 per pack",2020-04-10,4250,,1,451,,,2020-03-04,0,1,This product was not acquired. MSN is the contract manufacturer for Novadoz. MSN owns the ANDA but the labeler code is owned by Novadoz.,,,,,,,,,,,,,,,, +"Novadoz Pharmaceuticals, LLC",72205004501,"Thiotepa for Injection 15mg, 1 per pack",2020-04-10,700,,1,3100,,,2020-03-04,0,1,This product was not acquired. MSN is the contract manufacturer for Novadoz. MSN owns the ANDA but the labeler code is owned by Novadoz.,,,,,,,,,,,,,,,, +"Novadoz Pharmaceuticals, LLC",72205005030,Toremifene Citrate Tablets 60mg,2020-10-19,1144.5,,1,6089,,,,,,,This product was not acquired. MSN is the contract manufacturer for Novadoz. MSN owns the ANDA but the labeler code is owned by Novadoz.,,,,,,,,,,,,,,, +Novartis,78070956,Tabrecta (Capmatinib) 56 tabs of 150mg,2020-05-06,8975,Novartis considered many factors in determining the price of Tabrecta. Tabrecta is the treatment specifically for patients with advanced or metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation with disease progression on or after platinum-based chemotherapy. We priced in parity to other treatments in this class and are focused on access to Tabrecta for this patient population.,,192200,1,1,,,,,"Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Novartis,78071656,Tabrecta (Capmatinib) 56 tabs of 200mg,2020-05-06,8975,Novartis considered many factors in determining the price of Tabrecta. Tabrecta is the treatment specifically for patients with advanced or metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation with disease progression on or after platinum-based chemotherapy. We priced in parity to other treatments in this class and are focused on access to Tabrecta for this patient population.,,192200,1,1,,,,,"Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Novartis,78100768,Kesimpta (Ofatumumab) 20mg/0.4mL (auto injector),2020-08-21,6916.67,"The marketing for Kesimpta includes education and promotion to physicians, direct to consumer promotions, other types of marketing (e.g., online platforms and education). KESIMPTA is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Kesimpta is the first B-cell therapy for patients with relapsing forms of multiple sclerosis or RMS that can be self-administered at home using an autoinjector pen. We priced in parity to other treatments in this class and are focused on access to Kesimpta for this patient population.",,500000,,1,,,,,"Novartis estimates there are 500,000 Multiple sclerosis patients in the United States. Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +"Noven Therapeutics, LLC",68968017203,Asenapine 3.8 mg/ 24 hours transdermal system,2020-03-02,1200,,1,2000,,,,,,,Product was not acquired,,,,,,,,,,,,,,, +"Noven Therapeutics, LLC",68968017303,Asenapine 5.7 mg/ 24 hours transdermal system,2020-03-02,1200,,1,2000,,,,,,,Product was not acquired,,,,,,,,,,,,,,, +"Noven Therapeutics, LLC",68968017403,Asenapine 7.6 mg/ 24 hours transdermal system,2020-03-02,1200,,1,2000,,,,,,,Product was not acquired,,,,,,,,,,,,,,, +Novo,169810001,Esperoct® 1000 IU,2020-02-03,2.23,,1,8000,,,,,,,"Regarding the reported wholesale acquisition cost (WAC), NNI reports the WAC of Esperoct® on a per International Unit (IU) basis, including in the primary public pricing databases (e.g., MediSpan Price Pro). Accordingly, the WAC for the Esperoct® NDC-11s at issue also will be publicly listed as $2.23. The amount of IUs prescribed is based on patient bodyweight. Based on dosages set forth in the FDA-approved labeling, we expect that, for all patients, a course of therapy will exceed the $670 threshold for a Medicare Part D Specialty Drug. The Prescribing Information for Esperoct®, which includes the FDA-approved dosages, is available here: https://www.novo-pi.com/esperoct.pdf. + +Regarding the reported patient estimate, Esperoct® is a coagulation Factor VIII concentrate indicated for use in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Per the Hemophilia Foundation of America, Hemophilia A affects nearly 20,000 people in the U.S. For the estimated patients requirement, market data indicates there are approximately 8,000 Hemophilia A patients on factor replacement therapy that could potentially use Esperoct® in the United States. It is not an estimate of prescriptions that might be written for Esperoct®. + +Esperoct® was developed by Novo Nordisk.",,,,,,,,,,,,,,, +Novo,169815001,Esperoct® 1500 IU,2020-02-03,2.23,,1,8000,,,,,,,"Regarding the reported wholesale acquisition cost (WAC), NNI reports the WAC of Esperoct® on a per International Unit (IU) basis, including in the primary public pricing databases (e.g., MediSpan Price Pro). Accordingly, the WAC for the Esperoct® NDC-11s at issue also will be publicly listed as $2.23. The amount of IUs prescribed is based on patient bodyweight. Based on dosages set forth in the FDA-approved labeling, we expect that, for all patients, a course of therapy will exceed the $670 threshold for a Medicare Part D Specialty Drug. The Prescribing Information for Esperoct®, which includes the FDA-approved dosages, is available here: https://www.novo-pi.com/esperoct.pdf. + +Regarding the reported patient estimate, Esperoct® is a coagulation Factor VIII concentrate indicated for use in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Per the Hemophilia Foundation of America, Hemophilia A affects nearly 20,000 people in the U.S. For the estimated patients requirement, market data indicates there are approximately 8,000 Hemophilia A patients on factor replacement therapy that could potentially use Esperoct® in the United States. It is not an estimate of prescriptions that might be written for Esperoct®. + +Esperoct® was developed by Novo Nordisk.",,,,,,,,,,,,,,, +Novo,169820001,Esperoct® 2000 IU,2020-02-03,2.23,,1,8000,,,,,,,"Regarding the reported wholesale acquisition cost (WAC), NNI reports the WAC of Esperoct® on a per International Unit (IU) basis, including in the primary public pricing databases (e.g., MediSpan Price Pro). Accordingly, the WAC for the Esperoct® NDC-11s at issue also will be publicly listed as $2.23. The amount of IUs prescribed is based on patient bodyweight. Based on dosages set forth in the FDA-approved labeling, we expect that, for all patients, a course of therapy will exceed the $670 threshold for a Medicare Part D Specialty Drug. The Prescribing Information for Esperoct®, which includes the FDA-approved dosages, is available here: https://www.novo-pi.com/esperoct.pdf. + +Regarding the reported patient estimate, Esperoct® is a coagulation Factor VIII concentrate indicated for use in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Per the Hemophilia Foundation of America, Hemophilia A affects nearly 20,000 people in the U.S. For the estimated patients requirement, market data indicates there are approximately 8,000 Hemophilia A patients on factor replacement therapy that could potentially use Esperoct® in the United States. It is not an estimate of prescriptions that might be written for Esperoct®. + +Esperoct® was developed by Novo Nordisk.",,,,,,,,,,,,,,, +Novo,169830001,Esperoct® 3000 IU,2020-02-03,2.23,,1,8000,,,,,,,"Regarding the reported wholesale acquisition cost (WAC), NNI reports the WAC of Esperoct® on a per International Unit (IU) basis, including in the primary public pricing databases (e.g., MediSpan Price Pro). Accordingly, the WAC for the Esperoct® NDC-11s at issue also will be publicly listed as $2.23. The amount of IUs prescribed is based on patient bodyweight. Based on dosages set forth in the FDA-approved labeling, we expect that, for all patients, a course of therapy will exceed the $670 threshold for a Medicare Part D Specialty Drug. The Prescribing Information for Esperoct®, which includes the FDA-approved dosages, is available here: https://www.novo-pi.com/esperoct.pdf. + +Regarding the reported patient estimate, Esperoct® is a coagulation Factor VIII concentrate indicated for use in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Per the Hemophilia Foundation of America, Hemophilia A affects nearly 20,000 people in the U.S. For the estimated patients requirement, market data indicates there are approximately 8,000 Hemophilia A patients on factor replacement therapy that could potentially use Esperoct® in the United States. It is not an estimate of prescriptions that might be written for Esperoct®. + +Esperoct® was developed by Novo Nordisk.",,,,,,,,,,,,,,, +Novo,169850001,Esperoct® 500 IU,2020-02-03,2.23,,1,8000,,,,,,,"Regarding the reported wholesale acquisition cost (WAC), NNI reports the WAC of Esperoct® on a per International Unit (IU) basis, including in the primary public pricing databases (e.g., MediSpan Price Pro). Accordingly, the WAC for the Esperoct® NDC-11s at issue also will be publicly listed as $2.23. The amount of IUs prescribed is based on patient bodyweight. Based on dosages set forth in the FDA-approved labeling, we expect that, for all patients, a course of therapy will exceed the $670 threshold for a Medicare Part D Specialty Drug. The Prescribing Information for Esperoct®, which includes the FDA-approved dosages, is available here: https://www.novo-pi.com/esperoct.pdf. + +Regarding the reported patient estimate, Esperoct® is a coagulation Factor VIII concentrate indicated for use in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Per the Hemophilia Foundation of America, Hemophilia A affects nearly 20,000 people in the U.S. For the estimated patients requirement, market data indicates there are approximately 8,000 Hemophilia A patients on factor replacement therapy that could potentially use Esperoct® in the United States. It is not an estimate of prescriptions that might be written for Esperoct®. + +Esperoct® was developed by Novo Nordisk.",,,,,,,,,,,,,,, +"NS Pharma, Inc.",73292001101,Viltepso,2020-08-21,1410,,1,328,,,2020-04-01,,1,"the “per vial” cost it is not a set dollar amount - the acquisition is set at 29,763 yen for this fiscal year (April 2020 – March 2021) and average exchange rate of the prior month of the shipment is used to calculate US$ amount. Thus the acquisition price fluctuates.","Duchenne Muscular Dystrophy (DMD), is an ultra-orphan disease with a very small patient population, estimates put the patient volume at an estimated 0.000001% of US population, or 328 patients nationally.",,,,,,,,,,,,,,, +Par Pharmaceutical ,49884014601,Penicillamine Capsules 250mg 100s,2020-01-02,20950.91,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is indicated for Wilson Disease, National Organization for Rare Disorders (“NORD”) indicates between 2,000 – 3,000 cases have been diagnosed in the United States. See https://rarediseases.org/rare-diseases/wilson-disease/. However, NORD indicates as many as 9,000 people in the United States may be actually affected by Wilson Disease. Further, NORD did not specify the number of patients diagnosed each month or year with Wilson Disease. Penicillamine is also indicated for excess cysteine excretion and severe rheumatoid arthritis unresponsive to other treatments. It is estimated that 1 in 10,000 people are affected by excess cysteine excretion in the United States. See https://ghr.nlm.nih.gov/condition/cystinuria#statistics. An estimated 1.3 million Americans suffer from rheumatoid arthritis. See https://www.rheumatoidarthritis.org/ra/facts-and-statistics/. +Because of the multiple indications of Penicillamine, and the absence of precise data about the various patient populations that have diseases for which Penicillamine is indicated, Par is unable to provide an estimate of the average number of patients who may be treated by this product. +Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that will be prescribed this product each month. +As a result, Par has left the “estimated number of patients” data field blank. +(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,254200001,Penicillamine Tablets 250mg 100s,2020-01-02,4652.92,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is indicated for Wilson Disease, National Organization for Rare Disorders (“NORD”) indicates between 2,000 – 3,000 cases have been diagnosed in the United States. See https://rarediseases.org/rare-diseases/wilson-disease/. However, NORD indicates as many as 9,000 people in the United States may be actually affected by Wilson Disease. Further, NORD did not specify the number of patients diagnosed each month or year with Wilson Disease. Penicillamine is also indicated for excess cysteine excretion and severe rheumatoid arthritis unresponsive to other treatments. It is estimated that 1 in 10,000 people are affected by excess cysteine excretion in the United States. See https://ghr.nlm.nih.gov/condition/cystinuria#statistics. An estimated 1.3 million Americans suffer from rheumatoid arthritis. See https://www.rheumatoidarthritis.org/ra/facts-and-statistics/. +Because of the multiple indications of Penicillamine, and the absence of precise data about the various patient populations that have diseases for which Penicillamine is indicated, Par is unable to provide an estimate of the average number of patients who may be treated by this product. +Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that will be prescribed this product each month. +As a result, Par has left the “estimated number of patients” data field blank. +(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,254101019,Diazoxide Oral Suspension 50mg/mL 30mL bottle,2020-08-04,275.52,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +(2) This product is indicated for management hypoglycemia due to hyperinsulinism associated with numerous different conditions. Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Because of the product’s widespread indications, and because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to provide an estimated number of patients who will be prescribed the products in the “estimated number of patients” data field. As a result, Par has left the estimated number of patients data field blank. +Because of the multiple indications of Diazoxide, and the absence of precise data about the various patient populations that have diseases for which Diazoxide is indicated, Par is unable to provide an estimate of the average number of patients who may be treated by this product. +Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that will be prescribed this product each month. +As a result, Par has left the “estimated number of patients” data field blank. +(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,42023016410,Vasostrict® 1 mL x 10 Single Dose Vials,2020-08-10,1975.6,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +(2) This product indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. +Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the number of patients who may be prescribed this product. +As a result, Par has left the “estimated number of patients” data field blank. +(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,49884094872,Sapropterin Dihydrochloride Powder for OS 100mg 30s,2020-08-28,967.2,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is a phenylalanine hydroxylase activator indicated to for hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). National Organization for Rare Disorders (“NORD”) indicates approximately 1 in 1,000,000 individuals may Tetrahydrobiopterin deficiencies in the general population. See https://rarediseases.org/rare-diseases/tetrahydrobiopterin-deficiency/. Further, NORD did not specify the number of patients diagnosed each month or year with Tetrahydrobiopterin deficiencies. + +Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that may be prescribed this product. +As a result, Par has left the “estimated number of patients” data field blank. +(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=448,,,,,,,,,,,,,, +Par Pharmaceutical ,49884087372,Sapropterin Dihydrochloride Powder for OS 500mg 30s,2020-08-28,4836,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is a phenylalanine hydroxylase activator indicated to for hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). National Organization for Rare Disorders (“NORD”) indicates approximately 1 in 1,000,000 individuals may Tetrahydrobiopterin deficiencies in the general population. See https://rarediseases.org/rare-diseases/tetrahydrobiopterin-deficiency/. Further, NORD did not specify the number of patients diagnosed each month or year with Tetrahydrobiopterin deficiencies. + +Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that may be prescribed this product. +As a result, Par has left the “estimated number of patients” data field blank. +(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=449,,,,,,,,,,,,,, +Par Pharmaceutical ,49884072008,Sapropterin Dihydrochloride Tablets 100mg 120s,2020-08-28,3868.8,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is a phenylalanine hydroxylase activator indicated to for hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). National Organization for Rare Disorders (“NORD”) indicates approximately 1 in 1,000,000 individuals may Tetrahydrobiopterin deficiencies in the general population. See https://rarediseases.org/rare-diseases/tetrahydrobiopterin-deficiency/. Further, NORD did not specify the number of patients diagnosed each month or year with Tetrahydrobiopterin deficiencies. + +Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that may be prescribed this product. +As a result, Par has left the “estimated number of patients” data field blank. +(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=447,,,,,,,,,,,,,, +Perrigo Pharmaceuticals,45802088918,Calcipotriene-Betamethasone Dipropionate Topical Susp 0.005%/0.064%,2020-10-09,1001.95,"We plan to market the product as a generic to the Brand reference drug primarily to regional and national wholesalers, warehousing retail chains, and hospital and LTC group purchasing organizations. +Product will be price to deliver value to the market as compared to the Brand reference drug.",,8000000,,,,,,,Drug Product was not acquired by Perrigo so blank fields in 10 and 11 are intentional.,,,,,,,,,,,,,,, +Pfizer,69023801,RUXIENCE 10mg/ml SSOL 1x10mLGVL US,2020-01-23,716.8,,1,204000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Based on our internal estimates of the size of the rituximab market based on Rituxan's usage across therapeutic areas, we estimate 240,000 patients currently being treated on Avastin. Note this includes Rheumatoid Arthritis; please note that Ruxience is not indicated for use in that patient population (15% of patients). Comment regarding Fields 10-13: Ruxience was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,69024901,RUXIENCE 10mg/ml SSOL 1x50mLGVL US,2020-01-23,3584,,1,204000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Based on our internal estimates of the size of the rituximab market based on Rituxan's usage across therapeutic areas, we estimate 240,000 patients currently being treated on Avastin. Note this includes Rheumatoid Arthritis; please note that Ruxience is not indicated for use in that patient population (15% of patients). Comment regarding Fields 10-13: Ruxience was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,69030501,TRAZIMERA 420mg/30ml SFDPO 1x1 GVL US,2020-02-18,3391.08,,1,64000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Based on our internal estimates of the size of the trastuzumab market based on Herceptin's usage across therapeutic areas, we estimate 64,000 patients currently being treated on Herceptin. Comment regarding Fields 10-13: Trazimera was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,69024810,PROPOFOL EDTA 10mg/ml INJ 10x100ml VL US,2020-09-17,213.8,,1,,,1,,,,,"Pfizer Inc. is the reporting manufacturer for this product launch based on the following information. Pfizer acquired InnoPharma in September 2014. The ANDA for Propofol EDTA was transferred to InnoPharma subsequent to the acquisition. There is no licensing agreement between InnoPharma and Pfizer Inc. for Propofol EDTA; Pfizer Inc. is the NDC holder. Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - The estimated number of patients who may be prescribed Propofol EDTA is unknown. Comment regarding Fields 10-13: Propofol EDTA was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,69020910,PROPOFOL EDTA 10mg/ml INJ 10x20ml VL US,2020-09-17,42.8,,1,,,1,,,,,"Pfizer Inc. is the reporting manufacturer for this product launch based on the following information. Pfizer acquired InnoPharma in September 2014. The ANDA for Propofol EDTA was transferred to InnoPharma subsequent to the acquisition. There is no licensing agreement between InnoPharma and Pfizer Inc. for Propofol EDTA; Pfizer Inc. is the NDC holder. Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - The estimated number of patients who may be prescribed Propofol EDTA is unknown. Comment regarding Fields 10-13: Propofol EDTA was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,69023420,PROPOFOL EDTA 10mg/ml INJ 20x50ml VL US,2020-09-17,213.8,,1,,,1,,,,,"Pfizer Inc. is the reporting manufacturer for this product launch based on the following information. Pfizer acquired InnoPharma in September 2014. The ANDA for Propofol EDTA was transferred to InnoPharma subsequent to the acquisition. There is no licensing agreement between InnoPharma and Pfizer Inc. for Propofol EDTA; Pfizer Inc. is the NDC holder. Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - The estimated number of patients who may be prescribed Propofol EDTA is unknown. Comment regarding Fields 10-13: Propofol EDTA was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,409351022,ERTAPENEM 1gm SPO 1x10 GVIAL US,2020-09-29,1170,,1,,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - The estimated number of patients who may be prescribed Ertapenem is unknown. Per 2020 IMS data, annual UoU is 3,584,259 (represents rolling 12 months). Comment regarding Fields 10-13: Ertapenem is licensed as part of a contract manufacturer relationship; Pfizer is not the ANDA holder. Because the product was not acquired, Fields 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +QBioMed Inc.,72928008901,"STRONTIUM CHLORIDE Sr-89 INJECTION, USP",2020-05-01,15000,,1,2000,,,2020-09-06,2252913,,Acquisition price includes global license and additional acquisition-related expenses.,,,,,,,,,,,,,,,, +Sanofi,24065601,SARCLISA (isatuximab-irfc),2020-03-09,3250,"Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by Healthcare Providers most likely to manage patients with relapsed and refractory multiple myeloma, materials to be used by sales representatives to share information on SARCLISA with prescribers, and materials to educate patients about relapsed and refractory multiple myeloma and SARCLISA.  Direct to Consumer (DTC) outreach for SARCLISA will include search, website, and online ad placements.  DTC initiatives are not expected to include any TV, radio or national magazine advertising. + +Sanofi’s commitment to pricing rests on three principles: a holistic assessment of value when setting launch prices, year-over-year price increases that are limited to National Health Expenditure projections, and disclosure of our aggregate gross and net prices changes to provide greater transparency about the pricing of our medicines. +These comprehensive principles were drafted to address questions around the price of medicines in the United States. Our goal is to make our medicines accessible and affordable to all patients. +We share concerns about the affordability of medicines, and we believe deeply in the important role we play in providing treatments for serious illnesses. We are determined to do our part in pricing our medicines with greater transparency and according to their value, while continuing to advance scientific knowledge and bringing life-saving treatments to patients worldwide.",,30000,,,,,,,"In the United States, it is estimated that there are 131,392 people living with multiple myeloma (MM).  In 2019, according to the American Cancer Society, MM was the third most common hematologic malignancy with 32,110 new cases. The national Surveillance Epidemiology and End Results (SEER), reported an annual age-standardized rate of 6.9 per 100,000 person for MM. MM remains an incurable disease with many patients relapsing multiple times throughout the course of the disease. It is estimated that 48%-66% of all treated patients are relapsed refractory multiple myeloma patients. Patients with relapsed refractory multiple myeloma who have received two prior therapies including lenalidomide and a proteasome inhibitor may be prescribed SARCLISA. Based upon the US prevalence of MM and the information above, sanofi-aventis US LLC reasonably estimates that the number of patients in the United States with a condition for which the new prescription drug may be prescribed is approximately 30,000. + +Regarding the request for acquisition data (items 10-13) there is No Data to Report - Not Acquired.",,,,,,,,,,,,,,, +"Seattle Genetics, Inc.",51144000212,TUKYSA (tucatinib) 150 mg x 120,2020-04-17,18500,"With regard to marketing plans, efforts to ensure that healthcare providers with appropriate patients are aware of TUKYSA™ include customary digital and print media campaigns, oncology account managers sharing information with healthcare providers, and engagement of healthcare providers at congresses. + +With regard to pricing plans, Seattle Genetics has a passion for helping patients, and that passion includes ensuring that we reach as many of the patients with cancers that our products treat as we can. Our pricing considerations are informed by that passion, and we incorporate diverse perspectives of stakeholders in the healthcare system. We also consistently seek to balance rewarding innovation while providing appropriate access for patients. Finally, we consider the clinical value our products deliver to patients, the severity of the cancers we treat, availability of alternative treatments, market dynamics, our continued ability to deliver new state-of-the-art innovations in response to other deadly cancers, and the meaningful impact we make on patient’s lives.",,,1,1,,,,,"Seattle Genetics does not believe the estimated number of patients in the United States with a condition for which this product may be prescribed is in the public domain. Thus, consistent with 22 C.C.R. §96076(c), Seattle Genetics has left that field blank. +Pursuant to discussions with OSHPD, cancer.net lists that an estimated 276,480 women in the United States will be diagnosed with invasive breast cancer. Additional, it lists that About 6% of women have metastatic cancer when they are first diagnosed with breast cancer. The issue with these two sources of data is that they do not reflect the actual pool of patients that are eligible to use TUKYSA. TUKYSA is indicated for use with HER2+ Metastatic Breast Cancer patients. The first statistic lists ALL breast cancer patients, and the second only relates to patients who are diagnosed as metastatic upon FIRST diagnosis with their doctor. Over time, more of the breast cancer population will develop mestases. As such, both of these numbers, even combined, do not represent the TUKYSA patient population. +Additionally, Seattle Genetics notes this product is indicated for metastatic HER2+ breast cancer after receiving one or more prior anti-HER2-based regimens in the metastatic setting, and we are able to provide the following additional publicly available information on breast cancer more generally. Specifically, in 2019, it is estimated that there will be 268,600 people diagnosed with breast cancer. However, this data does not include patients who progress to metastatic stage or recur. According to SEER statistics from 2009-2015, 6% of breast cancers were metastatic (distant). Please note that this data is out of date. According to a retrospective analysis of 159,334 breast cancer patients diagnosed between 2010 to 2013, 26% of metastatic breast cancers are HER2+. There is no public information Seattle Genetics is aware of regarding the number of HER2+ metastatic breast cancer patients receive anti-HER2-based regimens.",,,,,,,,,,,,,,, +"Seattle Genetics, Inc.",51144000260,TUKYSA (tucatinib) 150 mg x 60,2020-04-17,9250,"With regard to marketing plans, efforts to ensure that healthcare providers with appropriate patients are aware of TUKYSA™ include customary digital and print media campaigns, oncology account managers sharing information with healthcare providers, and engagement of healthcare providers at congresses. + +With regard to pricing plans, Seattle Genetics has a passion for helping patients, and that passion includes ensuring that we reach as many of the patients with cancers that our products treat as we can. Our pricing considerations are informed by that passion, and we incorporate diverse perspectives of stakeholders in the healthcare system. We also consistently seek to balance rewarding innovation while providing appropriate access for patients. Finally, we consider the clinical value our products deliver to patients, the severity of the cancers we treat, availability of alternative treatments, market dynamics, our continued ability to deliver new state-of-the-art innovations in response to other deadly cancers, and the meaningful impact we make on patient’s lives.",,,1,1,,,,,"Seattle Genetics does not believe the estimated number of patients in the United States with a condition for which this product may be prescribed is in the public domain. Thus, consistent with 22 C.C.R. §96076(c), Seattle Genetics has left that field blank. +Pursuant to discussions with OSHPD, cancer.net lists that an estimated 276,480 women in the United States will be diagnosed with invasive breast cancer. Additional, it lists that About 6% of women have metastatic cancer when they are first diagnosed with breast cancer. The issue with these two sources of data is that they do not reflect the actual pool of patients that are eligible to use TUKYSA. TUKYSA is indicated for use with HER2+ Metastatic Breast Cancer patients. The first statistic lists ALL breast cancer patients, and the second only relates to patients who are diagnosed as metastatic upon FIRST diagnosis with their doctor. Over time, more of the breast cancer population will develop mestases. As such, both of these numbers, even combined, do not represent the TUKYSA patient population. +Additionally, Seattle Genetics notes this product is indicated for metastatic HER2+ breast cancer after receiving one or more prior anti-HER2-based regimens in the metastatic setting, and we are able to provide the following additional publicly available information on breast cancer more generally. Specifically, in 2019, it is estimated that there will be 268,600 people diagnosed with breast cancer. However, this data does not include patients who progress to metastatic stage or recur. According to SEER statistics from 2009-2015, 6% of breast cancers were metastatic (distant). Please note that this data is out of date. According to a retrospective analysis of 159,334 breast cancer patients diagnosed between 2010 to 2013, 26% of metastatic breast cancers are HER2+. There is no public information Seattle Genetics is aware of regarding the number of HER2+ metastatic breast cancer patients receive anti-HER2-based regimens.",,,,,,,,,,,,,,, +"Seattle Genetics, Inc.",51144000160,TUKYSA (tucatinib) 50 mg x 60,2020-04-17,4600,"With regard to marketing plans, efforts to ensure that healthcare providers with appropriate patients are aware of TUKYSA™ include customary digital and print media campaigns, oncology account managers sharing information with healthcare providers, and engagement of healthcare providers at congresses. + +With regard to pricing plans, Seattle Genetics has a passion for helping patients, and that passion includes ensuring that we reach as many of the patients with cancers that our products treat as we can. Our pricing considerations are informed by that passion, and we incorporate diverse perspectives of stakeholders in the healthcare system. We also consistently seek to balance rewarding innovation while providing appropriate access for patients. Finally, we consider the clinical value our products deliver to patients, the severity of the cancers we treat, availability of alternative treatments, market dynamics, our continued ability to deliver new state-of-the-art innovations in response to other deadly cancers, and the meaningful impact we make on patient’s lives.",,,1,1,,,,,"Seattle Genetics does not believe the estimated number of patients in the United States with a condition for which this product may be prescribed is in the public domain. Thus, consistent with 22 C.C.R. §96076(c), Seattle Genetics has left that field blank. +Pursuant to discussions with OSHPD, cancer.net lists that an estimated 276,480 women in the United States will be diagnosed with invasive breast cancer. Additional, it lists that About 6% of women have metastatic cancer when they are first diagnosed with breast cancer. The issue with these two sources of data is that they do not reflect the actual pool of patients that are eligible to use TUKYSA. TUKYSA is indicated for use with HER2+ Metastatic Breast Cancer patients. The first statistic lists ALL breast cancer patients, and the second only relates to patients who are diagnosed as metastatic upon FIRST diagnosis with their doctor. Over time, more of the breast cancer population will develop mestases. As such, both of these numbers, even combined, do not represent the TUKYSA patient population. +Additionally, Seattle Genetics notes this product is indicated for metastatic HER2+ breast cancer after receiving one or more prior anti-HER2-based regimens in the metastatic setting, and we are able to provide the following additional publicly available information on breast cancer more generally. Specifically, in 2019, it is estimated that there will be 268,600 people diagnosed with breast cancer. However, this data does not include patients who progress to metastatic stage or recur. According to SEER statistics from 2009-2015, 6% of breast cancers were metastatic (distant). Please note that this data is out of date. According to a retrospective analysis of 159,334 breast cancer patients diagnosed between 2010 to 2013, 26% of metastatic breast cancers are HER2+. There is no public information Seattle Genetics is aware of regarding the number of HER2+ metastatic breast cancer patients receive anti-HER2-based regimens.",,,,,,,,,,,,,,, +Shionogi Inc.,59630026610,"FETROJA, for injection, 1 gram of cefiderocol, 2 grams of FETROJA for injection every 8 hours, 10 single-dose vials per pack",2020-02-24,1833.33,,1,142000,,1,,,,,"Pursuant to Cal. Health & Safety Code § 127681(c), the information provided in this report is limited to that which is otherwise in the public domain or publicly available. + +The marketing/pricing plan for Fetroja® is not in the public domain or publicly available. + +The estimated volume of patients who might be prescribed Fetroja® is not in the public domain or publicly available. + +Fetroja® was developed by Shionogi & Co., Ltd. and its affiliates; therefore, there is no acquisition price to report.",,,,,,,,,,,,,,, +"SK Life Science, Inc.",71699010030,XCOPRI® Cenobamate Tablets 100mg,2020-05-07,985,"While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US.",,1800000,,,,,,,"While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.”",,,,,,,,,,,,,,, +"SK Life Science, Inc.",71699020128,XCOPRI® Cenobamate Tablets 12.5mg(14)+25mg(14),2020-05-07,90,"While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US.",,1800000,,,,,,,"While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.”",,,,,,,,,,,,,,, +"SK Life Science, Inc.",71699015030,XCOPRI® Cenobamate Tablets 150mg,2020-05-07,985,"While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US.",,1800000,,,,,,,"While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.”",,,,,,,,,,,,,,, +"SK Life Science, Inc.",71699020328,XCOPRI® Cenobamate Tablets 150mg(14)+200mg(14),2020-05-07,985,"While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US.",,1800000,,,,,,,"While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.”",,,,,,,,,,,,,,, +"SK Life Science, Inc.",71699020030,XCOPRI® Cenobamate Tablets 200mg,2020-05-07,985,"While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US.",,1800000,,,,,,,"While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.”",,,,,,,,,,,,,,, +"SK Life Science, Inc.",71699010356,XCOPRI® Cenobamate Tablets 200mg(28)+150mg(28),2020-05-07,1970,"While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US.",,1800000,,,,,,,"While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.”",,,,,,,,,,,,,,, +"SK Life Science, Inc.",71699010256,XCOPRI® Cenobamate Tablets 200mg(28)+50mg(28),2020-05-07,985,"While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US.",,1800000,,,,,,,"While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.”",,,,,,,,,,,,,,, +"SK Life Science, Inc.",71699005030,XCOPRI® Cenobamate Tablets 50mg,2020-05-07,985,"While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US.",,1800000,,,,,,,"While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.”",,,,,,,,,,,,,,, +"SK Life Science, Inc.",71699020228,XCOPRI® Cenobamate Tablets 50mg(14)+100mg(14),2020-05-07,985,"While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US.",,1800000,,,,,,,"While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.”",,,,,,,,,,,,,,, +SpecGx,406222401,Levorphanol Tartrate Tablets 2mg,2020-01-10,4450,"This is a generic product, not marketed directly to consumers or healthcare professionals. WAC price is based upon an analysis of existing generic and brand WAC prices. The details of this analysis are considered proprietary information.",,19600000,,,,,,,"While the Centers for Disease Control and Prevention estimates that 19.6M individuals across the United States suffer from high-impact chronic pain, this product is appropriate for an extremely limited subset of patients with that condition. Physician guidance and the drug product labeling serve to identify the appropriate patient subset, which may result in approximately 1,000 prescriptions for this product per month across the United States. +This is a new product developed/manufactured by SpecGx and not acquired.",,,,,,,,,,,,,,, +"Strides Pharma, Inc.",42543096104,"Cinacalcet Tablets 30mg, 30 (Singapore)",2020-06-01,685.7,"Cinacalcet Tablets 30mg, 60mg, and 90mg are marketed in the generic multisource space, and therefore marketing of these product are not based on any aspects of the products themselves, but their prices and availability. For these reasons, Strides Pharma Inc.(""Strides"") does not interact with healthcare providers including physicians, hospital groups, group purchasing organizations, or other entities to promote Strides' products. The methodology that Strides uses to set the wholesale acquisition price(""WAC"") was to discount the reference drug price or match the lowest generic WACs available at the time of the product launch. Strides uses a subscription-based service, Medi-Span Price Rx, in obtaining this information to reflect a discount off of the Reference Drug listed by the FDA. Therefore, Cost-based, quality-adjusted, or value-based pricing were not used to establish WAC for this product.",,100000,,,,,,,The reason for leaving the acquisition-related fields blank was because Strides developed the drugs. The source for the estimated patients is National Organization for Rare Disorders.,,,,,,,,,,,,,,, +"Strides Pharma, Inc.",42543096204,"Cinacalcet Tablets 60mg, 30 (Singapore)",2020-06-01,1371.39,"Cinacalcet Tablets 30mg, 60mg, and 90mg are marketed in the generic multisource space, and therefore marketing of these product are not based on any aspects of the products themselves, but their prices and availability. For these reasons, Strides Pharma Inc.(""Strides"") does not interact with healthcare providers including physicians, hospital groups, group purchasing organizations, or other entities to promote Strides' products. The methodology that Strides uses to set the wholesale acquisition price(""WAC"") was to discount the reference drug price or match the lowest generic WACs available at the time of the product launch. Strides uses a subscription-based service, Medi-Span Price Rx, in obtaining this information to reflect a discount off of the Reference Drug listed by the FDA. Therefore, Cost-based, quality-adjusted, or value-based pricing were not used to establish WAC for this product.",,100000,,,,,,,The reason for leaving the acquisition-related fields blank was because Strides developed the drugs. The source for the estimated patients is National Organization for Rare Disorders.,,,,,,,,,,,,,,, +"Strides Pharma, Inc.",42543096304,"Cinacalcet Tablets 90mg, 30 (Singapore)",2020-06-01,2057.09,"Cinacalcet Tablets 30mg, 60mg, and 90mg are marketed in the generic multisource space, and therefore marketing of these product are not based on any aspects of the products themselves, but their prices and availability. For these reasons, Strides Pharma Inc.(""Strides"") does not interact with healthcare providers including physicians, hospital groups, group purchasing organizations, or other entities to promote Strides' products. The methodology that Strides uses to set the wholesale acquisition price(""WAC"") was to discount the reference drug price or match the lowest generic WACs available at the time of the product launch. Strides uses a subscription-based service, Medi-Span Price Rx, in obtaining this information to reflect a discount off of the Reference Drug listed by the FDA. Therefore, Cost-based, quality-adjusted, or value-based pricing were not used to establish WAC for this product.",,100000,,,,,,,The reason for leaving the acquisition-related fields blank was because Strides developed the drugs. The source for the estimated patients is National Organization for Rare Disorders.,,,,,,,,,,,,,,, +"Strides Pharma, Inc.",64380090190,"Triamcinolone Acetonide Ointment .05% 430G, 1",2020-06-08,779.3,"Triamcinolone Acetonide .05% 430G is marketed in the generic multisource space, and therefore marketing of the product is not based on any aspects of the product itself, but its price and availability. For these reasons, Strides Pharma Inc.(""Strides"")does not interact with healthcare providers including physicians, hospital groups, group purchasing organizations, or other entities to promote Strides' products. The methodology that Strides uses to set the wholesale acquisition price(""WAC"") was to discount the reference drug price or match the lowest generic WACs available at the time of the product launch. Strides uses a subscription-based service, Medi-Span Price Rx, in obtaining this information to reflect a discount off of the Reference Drug listed by the FDA. Therefore, Cost-based, quality-adjusted, or value-based pricing were not used to establish WAC for this product.",,39600000,,,,,,,The reason for leaving the acquisition-related fields blank was because Strides developed the drugs.The source for the estimated number of patients is the National Psoriasis Foundation and the National Eczema Association.,https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=442,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,10631000331,Absorica LD™ (isotretinoin) capsules 16mg,2020-01-27,1063.17,"• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable +• ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin.",,10000000,,,,,,,"1. This product was developed by Sun Pharmaceutical Industries, Ltd.(""Sun"") 2.The reason for leaving the acquisition-related fields blank was because Sun developed the drugs",,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,10631000531,Absorica LD™ (isotretinoin) capsules 24mg,2020-01-27,1143.91,"• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable +• ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin.",,10000000,,,,,,,"1. This product was developed by Sun Pharmaceutical Industries, Ltd.(""Sun"") 2.The reason for leaving the acquisition-related fields blank was because Sun developed the drugs",,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,10631000731,Absorica LD™ (isotretinoin) capsules 32mg,2020-01-27,1143.91,"• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable +• ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin.",,10000000,,,,,,,"1. This product was developed by Sun Pharmaceutical Industries, Ltd.(""Sun"") 2.The reason for leaving the acquisition-related fields blank was because Sun developed the drugs",,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,10631000231,Absorica LD™ (isotretinoin) capsules 8mg,2020-01-27,1063.17,"• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable +• ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin.",,10000000,,,,,,,"1. This product was developed by Sun Pharmaceutical Industries, Ltd.(""Sun"") 2.The reason for leaving the acquisition-related fields blank was because Sun developed the drugs",,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304072105,DILTIAZEM ER HCL 300MG 500 Capsules,2020-03-05,795.17,"This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers. This product also offers the convenience and economy of bulk packaging.",,10000000,,,,,,,"1. This product was developed by Sun Pharmaceutical Industries, Ltd.(""Sun"") 2.The reason for leaving the acquisition-related fields blank was because Sun developed the drugs 3. This product (ANDA approval) is being marketed in the generic, multisource space",,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,47335017149,Tobramycin Inhalation Solution 300mg/ 5ml,2020-04-21,1880.05,"This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Cost-based, quality-adjusted, or value-based pricings were not used to establish Wholesale Acquisition Cost for this product. This product is being marketed in the generic, multisource space. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,6000,,,,,,,"1) This product (ANDA approval) is being marketed in the generic, multisource space; 2) The reason for leaving the acquisition-related fields blank was because Sun developed the drugs",,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304058360,Fosamprenavir Oral Tablet 700mg,2020-06-05,999.89,"This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers. + +This product (ANDA approval) is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA.",,1200000,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,10631009510,HALOG SOLUTION USP 0.1% 5ML 120ML,2020-07-27,770.06,"This product is priced to reflect the clinical value of the drug and is priced on par with two other Halog formulations on the market - Halog Ointment and Halog Cream. The prevalence of corticosteroid-responsive dermatoses is unknown. However psoriasis and atopic dermatitis which fall within the category of corticosteroid-responsive dermatoses together represent a good proxy for the number of patients. in the United States, approximately 4.6% of +the population is affected with psoriasis1 and nearly 18 million people have AD2.",,18000000,,,2015-03-25,,1,Product was acquired by Sun Pharmaceuticals Ind. (SPIL) as part of the Ranbaxy acquisition estimated total acquisition of over $4 billion on 25th March 2015. There was no acquisition price directly associated with the Halog Solution product as the product was not launched at the time of company acquisition.,,,,,,,,,,,,,,,, +Sunovion Pharmaceuticals Inc.,63402001030,KYNMOBI 10 MG (Apomorphine Sublingual Film),2020-06-09,787.5,"""KYNMOBI™ (apomorphine hydrochloride) Sublingual Film was approved by the FDA in May 2020. It is the first and only sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD).  The WAC for a trade box of 30 films is slightly higher than the Medicare Part D Specialty Tier Threshold. KYNMOBI is available in 5 strengths (10mg, 15mg, 20mg, 25mg and 30mg). To market KYNMOBI™ (apomorphine hydrochloride) Sublingual Film, Sunovion designed activities to increase awareness and understanding with healthcare providers about this new product and its clinical efficacy, safety, and tolerability.  Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers (HCPs) in peer-to-peer forums.  There will be a Direct-to-Patient advertising campaign to educate patients about KYNMOBI and the treatment of OFF episodes. Sunovion will offer copayment assistance to commercially insured patients through a copay card program. Sunovion has also signed a national agreement with Walgreen’s retail pharmacies to provide easy access to a $0 titration kit and other support services.  +Pricing: +Sunovion is focused on the innovative application of science and medicine to help people living with serious psychiatric, neurological and respiratory conditions. Our philosophy around the pricing of our medications is grounded in three key pillars: providing value; facilitating broad and sustainable access; and supporting patients. +Sunovion’s scientific advancements and breakthrough medical innovations help drive improvement in individual patient care and outcomes and the overall healthcare system. Our treatment options provide significant clinical value for patients. We are committed to working with health care providers, policy makers, and public and private payers, to ensure patients have broad and sustainable access to our innovative therapies. We offer rebates, discounts and co-pay cards. We also maintain a prescription assistance program to help patients who require financial assistance. Eligible patients are able to access Sunovion’s life-changing therapies at no cost. +The price of Kynmobi was guided by our key pillars. We believe that Kynmobi’s strong safety and efficacy profile, as demonstrated in clinical trials, and unique route of administration exemplify scientific innovation and deliver significant benefits to patients living with Parkinson’s disease. We sought to balance the need to sustain current business operations and fuel future innovation with the interests of ensuring broad and open access for patients. We considered feedback from patients, physicians and payers, unmet medical needs, patient affordability, and the medication’s likely coverage and formulary placement. We also evaluated competitor products within the Parkinson’s disease space and strove to deliver the benefits of Kynmobi to patients, physicians and payers at a lower list price than its branded competitors. +Except as otherwise described, we did not use any cost-based pricing, quality-adjusted pricing, value-based pricing, or other specific pricing models or strategies in setting the price for Kynmobi.""",,558000,,,2016-10-21,635000000,,,patient estimate based on internal calculation using public data.,,,,,,,,,,,,,,, +Sunovion Pharmaceuticals Inc.,63402001530,KYNMOBI 15 MG (Apomorphine Sublingual Film),2020-06-09,787.5,"""KYNMOBI™ (apomorphine hydrochloride) Sublingual Film was approved by the FDA in May 2020. It is the first and only sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD).  The WAC for a trade box of 30 films is slightly higher than the Medicare Part D Specialty Tier Threshold. KYNMOBI is available in 5 strengths (10mg, 15mg, 20mg, 25mg and 30mg). To market KYNMOBI™ (apomorphine hydrochloride) Sublingual Film, Sunovion designed activities to increase awareness and understanding with healthcare providers about this new product and its clinical efficacy, safety, and tolerability.  Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers (HCPs) in peer-to-peer forums.  There will be a Direct-to-Patient advertising campaign to educate patients about KYNMOBI and the treatment of OFF episodes. Sunovion will offer copayment assistance to commercially insured patients through a copay card program. Sunovion has also signed a national agreement with Walgreen’s retail pharmacies to provide easy access to a $0 titration kit and other support services.  +Pricing: +Sunovion is focused on the innovative application of science and medicine to help people living with serious psychiatric, neurological and respiratory conditions. Our philosophy around the pricing of our medications is grounded in three key pillars: providing value; facilitating broad and sustainable access; and supporting patients. +Sunovion’s scientific advancements and breakthrough medical innovations help drive improvement in individual patient care and outcomes and the overall healthcare system. Our treatment options provide significant clinical value for patients. We are committed to working with health care providers, policy makers, and public and private payers, to ensure patients have broad and sustainable access to our innovative therapies. We offer rebates, discounts and co-pay cards. We also maintain a prescription assistance program to help patients who require financial assistance. Eligible patients are able to access Sunovion’s life-changing therapies at no cost. +The price of Kynmobi was guided by our key pillars. We believe that Kynmobi’s strong safety and efficacy profile, as demonstrated in clinical trials, and unique route of administration exemplify scientific innovation and deliver significant benefits to patients living with Parkinson’s disease. We sought to balance the need to sustain current business operations and fuel future innovation with the interests of ensuring broad and open access for patients. We considered feedback from patients, physicians and payers, unmet medical needs, patient affordability, and the medication’s likely coverage and formulary placement. We also evaluated competitor products within the Parkinson’s disease space and strove to deliver the benefits of Kynmobi to patients, physicians and payers at a lower list price than its branded competitors. +Except as otherwise described, we did not use any cost-based pricing, quality-adjusted pricing, value-based pricing, or other specific pricing models or strategies in setting the price for Kynmobi.""",,558000,,,2016-10-21,635000000,,,patient estimate based on internal calculation using public data.,,,,,,,,,,,,,,, +Sunovion Pharmaceuticals Inc.,63402002030,KYNMOBI 20 MG (Apomorphine Sublingual Film),2020-06-09,787.5,"""KYNMOBI™ (apomorphine hydrochloride) Sublingual Film was approved by the FDA in May 2020. It is the first and only sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD).  The WAC for a trade box of 30 films is slightly higher than the Medicare Part D Specialty Tier Threshold. KYNMOBI is available in 5 strengths (10mg, 15mg, 20mg, 25mg and 30mg). To market KYNMOBI™ (apomorphine hydrochloride) Sublingual Film, Sunovion designed activities to increase awareness and understanding with healthcare providers about this new product and its clinical efficacy, safety, and tolerability.  Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers (HCPs) in peer-to-peer forums.  There will be a Direct-to-Patient advertising campaign to educate patients about KYNMOBI and the treatment of OFF episodes. Sunovion will offer copayment assistance to commercially insured patients through a copay card program. Sunovion has also signed a national agreement with Walgreen’s retail pharmacies to provide easy access to a $0 titration kit and other support services.  +Pricing: +Sunovion is focused on the innovative application of science and medicine to help people living with serious psychiatric, neurological and respiratory conditions. Our philosophy around the pricing of our medications is grounded in three key pillars: providing value; facilitating broad and sustainable access; and supporting patients. +Sunovion’s scientific advancements and breakthrough medical innovations help drive improvement in individual patient care and outcomes and the overall healthcare system. Our treatment options provide significant clinical value for patients. We are committed to working with health care providers, policy makers, and public and private payers, to ensure patients have broad and sustainable access to our innovative therapies. We offer rebates, discounts and co-pay cards. We also maintain a prescription assistance program to help patients who require financial assistance. Eligible patients are able to access Sunovion’s life-changing therapies at no cost. +The price of Kynmobi was guided by our key pillars. We believe that Kynmobi’s strong safety and efficacy profile, as demonstrated in clinical trials, and unique route of administration exemplify scientific innovation and deliver significant benefits to patients living with Parkinson’s disease. We sought to balance the need to sustain current business operations and fuel future innovation with the interests of ensuring broad and open access for patients. We considered feedback from patients, physicians and payers, unmet medical needs, patient affordability, and the medication’s likely coverage and formulary placement. We also evaluated competitor products within the Parkinson’s disease space and strove to deliver the benefits of Kynmobi to patients, physicians and payers at a lower list price than its branded competitors. +Except as otherwise described, we did not use any cost-based pricing, quality-adjusted pricing, value-based pricing, or other specific pricing models or strategies in setting the price for Kynmobi.""",,558000,,,2016-10-21,635000000,,,patient estimate based on internal calculation using public data.,,,,,,,,,,,,,,, +Sunovion Pharmaceuticals Inc.,63402002530,KYNMOBI 25 MG (Apomorphine Sublingual Film),2020-06-09,787.5,"""KYNMOBI™ (apomorphine hydrochloride) Sublingual Film was approved by the FDA in May 2020. It is the first and only sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD).  The WAC for a trade box of 30 films is slightly higher than the Medicare Part D Specialty Tier Threshold. KYNMOBI is available in 5 strengths (10mg, 15mg, 20mg, 25mg and 30mg). To market KYNMOBI™ (apomorphine hydrochloride) Sublingual Film, Sunovion designed activities to increase awareness and understanding with healthcare providers about this new product and its clinical efficacy, safety, and tolerability.  Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers (HCPs) in peer-to-peer forums.  There will be a Direct-to-Patient advertising campaign to educate patients about KYNMOBI and the treatment of OFF episodes. Sunovion will offer copayment assistance to commercially insured patients through a copay card program. Sunovion has also signed a national agreement with Walgreen’s retail pharmacies to provide easy access to a $0 titration kit and other support services.  +Pricing: +Sunovion is focused on the innovative application of science and medicine to help people living with serious psychiatric, neurological and respiratory conditions. Our philosophy around the pricing of our medications is grounded in three key pillars: providing value; facilitating broad and sustainable access; and supporting patients. +Sunovion’s scientific advancements and breakthrough medical innovations help drive improvement in individual patient care and outcomes and the overall healthcare system. Our treatment options provide significant clinical value for patients. We are committed to working with health care providers, policy makers, and public and private payers, to ensure patients have broad and sustainable access to our innovative therapies. We offer rebates, discounts and co-pay cards. We also maintain a prescription assistance program to help patients who require financial assistance. Eligible patients are able to access Sunovion’s life-changing therapies at no cost. +The price of Kynmobi was guided by our key pillars. We believe that Kynmobi’s strong safety and efficacy profile, as demonstrated in clinical trials, and unique route of administration exemplify scientific innovation and deliver significant benefits to patients living with Parkinson’s disease. We sought to balance the need to sustain current business operations and fuel future innovation with the interests of ensuring broad and open access for patients. We considered feedback from patients, physicians and payers, unmet medical needs, patient affordability, and the medication’s likely coverage and formulary placement. We also evaluated competitor products within the Parkinson’s disease space and strove to deliver the benefits of Kynmobi to patients, physicians and payers at a lower list price than its branded competitors. +Except as otherwise described, we did not use any cost-based pricing, quality-adjusted pricing, value-based pricing, or other specific pricing models or strategies in setting the price for Kynmobi.""",,558000,,,2016-10-21,635000000,,,patient estimate based on internal calculation using public data.,,,,,,,,,,,,,,, +Sunovion Pharmaceuticals Inc.,63402003030,KYNMOBI 30 MG (Apomorphine Sublingual Film),2020-06-09,787.5,"""KYNMOBI™ (apomorphine hydrochloride) Sublingual Film was approved by the FDA in May 2020. It is the first and only sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD).  The WAC for a trade box of 30 films is slightly higher than the Medicare Part D Specialty Tier Threshold. KYNMOBI is available in 5 strengths (10mg, 15mg, 20mg, 25mg and 30mg). To market KYNMOBI™ (apomorphine hydrochloride) Sublingual Film, Sunovion designed activities to increase awareness and understanding with healthcare providers about this new product and its clinical efficacy, safety, and tolerability.  Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers (HCPs) in peer-to-peer forums.  There will be a Direct-to-Patient advertising campaign to educate patients about KYNMOBI and the treatment of OFF episodes. Sunovion will offer copayment assistance to commercially insured patients through a copay card program. Sunovion has also signed a national agreement with Walgreen’s retail pharmacies to provide easy access to a $0 titration kit and other support services.  +Pricing: +Sunovion is focused on the innovative application of science and medicine to help people living with serious psychiatric, neurological and respiratory conditions. Our philosophy around the pricing of our medications is grounded in three key pillars: providing value; facilitating broad and sustainable access; and supporting patients. +Sunovion’s scientific advancements and breakthrough medical innovations help drive improvement in individual patient care and outcomes and the overall healthcare system. Our treatment options provide significant clinical value for patients. We are committed to working with health care providers, policy makers, and public and private payers, to ensure patients have broad and sustainable access to our innovative therapies. We offer rebates, discounts and co-pay cards. We also maintain a prescription assistance program to help patients who require financial assistance. Eligible patients are able to access Sunovion’s life-changing therapies at no cost. +The price of Kynmobi was guided by our key pillars. We believe that Kynmobi’s strong safety and efficacy profile, as demonstrated in clinical trials, and unique route of administration exemplify scientific innovation and deliver significant benefits to patients living with Parkinson’s disease. We sought to balance the need to sustain current business operations and fuel future innovation with the interests of ensuring broad and open access for patients. We considered feedback from patients, physicians and payers, unmet medical needs, patient affordability, and the medication’s likely coverage and formulary placement. We also evaluated competitor products within the Parkinson’s disease space and strove to deliver the benefits of Kynmobi to patients, physicians and payers at a lower list price than its branded competitors. +Except as otherwise described, we did not use any cost-based pricing, quality-adjusted pricing, value-based pricing, or other specific pricing models or strategies in setting the price for Kynmobi.""",,558000,,,2016-10-21,635000000,,,patient estimate based on internal calculation using public data.,,,,,,,,,,,,,,, +Sunrise Pharmaceutical Inc.,11534019701,chlordiazePOXIDE-Clidinium Oral Capsule 5-2.5 MG 100 ct,2020-08-03,1395,"o Our plan is to offer this product for sale to wholesale, and retail customers",,5000000,,,,,,,,,,,,,,,,,,,,,, +"Taiho Oncology, Inc.",64842072709,"INQOVI Tablets, 35 mg. 5's",2020-08-31,7495,"The price is $7,495.00 per pack. Marketing plans will consist of print ads; journal ads, direct mail, and in-person calls to HCPs.",,10000,,1,,,,,,,,,,,,,,,,,,,, +TARO PHARMACEUTICALS,51672530708,Dapsone Topical Gel 7.5% Pump 90GM,2020-01-02,707.85,"This product (NDA Approval) is being marketed in the generic, multisource space. Dapsone 7.5% gel is considered to be an Authorized Generic (AG) . This product is priced in the market to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives who are responsible for generic sales do not promote the promote to health care providers.",,,,,,,,,"Taro Pharmaceutical USA . is a licensee for this Authorized Generic. This product is being marketed in the generic space. The product is priced to reflect a discount off of the Reference Drug listed by the FDA. +The estimated average of patients per month is unknown to Taro. +The product was not acquired.",,,,,,,,,,,,,,, +"Teva Parenteral Medicines, Inc. ",703400401,ROMIDEPSIN RTU INJ 27.5 MG/5.5ML 5.5ML,2020-04-14,8796.15,,1,20000,,,,,,,"Estimated average of up to 20,000 prescriptions per year, based on historic IQVIA data on sales of romidepsin vials. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,63459030343,HERZUMA® (trastuzumab-pkrb) 150 MG / 50 ML - 1 Vial,2020-03-16,1402.5,,1,135,,,2016-10-04,1,,"Teva acquired rights on October 4, 2016 from Celltrion to commercialize HERZUMA and another biosimilar product for $160M in up-front payments plus additional payments dependent on product sales. The acquisition price for the HERZUMA rights was incorporated into the broader deal's overall purchase price, and thus, there was no one particular price that Teva paid to acquire those rights. We were, nonetheless, required to enter a non-zero value in the ""Acquisition Cost"" field, and so we entered ""1.00.""","Average of approximately 250 patients per month anticipated (in total, across both NDC's).",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,63459030547,HERZUMA® (trastuzumab-pkrb) 420 MG / 10 ML - 1 Vial,2020-03-16,3927,,1,112,,,2016-10-04,1,,"Teva acquired rights on October 4, 2016 from Celltrion to commercialize HERZUMA and another biosimilar product for $160M in up-front payments plus additional payments dependent on product sales. The acquisition price for the HERZUMA rights was incorporated into the broader deal's overall purchase price, and thus, there was no one particular price that Teva paid to acquire those rights. We were, nonetheless, required to enter a non-zero value in the ""Acquisition Cost"" field, and so we entered ""1.00.""","Average of approximately 250 patients per month anticipated (in total, across both NDC's).",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93351656,DEFERASIROX 180MG TABLETS 30 (launched under ANDA 209223),2020-04-24,2189.07,,1,6770,,,,,,,"Average of approximately 6,770 prescriptions per year, based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591395550,VIGABATRIN 500MG POWDER FOR SOL 50,2020-05-14,1665.74,,1,23450,,,,,,,"Average of approximately 23,450 prescriptions per year, based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93776624,EVEROLIMUS TABLETS 2.5MG 28 (7X4),2020-06-10,6419.43,,1,2950,,,,,,,"Average of approximately 2,950 prescriptions per year, based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93776724,EVEROLIMUS TABLETS 5MG 28 (7X4),2020-06-10,6714.62,,1,12550,,,,,,,"Average of approximately 12,550 prescriptions per year, based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93776824,EVEROLIMUS TABLETS 7.5MG 28 (7X4),2020-06-10,6714.62,,1,4850,,,,,,,"Average of approximately 4,850 prescriptions per year, based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93313331,IMIQUIMOD CREAM 3.75 PUMP %/ MG 1,2020-07-29,1064.58,,1,1650,,,2016-08-02,33430000000,,"This product (the ""Product"") is an authorized generic version of Zyclara® Cream. Actavis Mid Atlantic LLC (“Actavis”) had certain rights to sell the Product, and on August 2, 2016, Teva acquired those rights, along with Actavis itself, as part of a broader deal involving other assets. The acquisition price for those rights was incorporated into that broader deal’s overall purchase price and, thus, there was no one particular price that Teva paid to acquire those rights. We were, nonetheless, required to enter a non-zero value in the ""Acquisition Price"" field, and so we entered $33,430,000,000, which is the total amount that Teva paid (along with roughly 100 million shares of Teva stock) in connection with the broader deal referenced above. Once again, and to be clear, this total is not representative of the amount that Teva paid for the rights to the Product in particular.","Estimated average of approximately 1,650 prescriptions per year, based on historic IQVIA data.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93537601,Clozapine ODT 150mg/100 count,2020-07-30,1726.32,,1,1800000,,,,,,,"Estimated average of approximately 25,400 prescriptions per year (across these three particular NDCs), based on historic IQVIA data, although research suggests that as many as 1.8 million Americans have been diagnosed with schizophrenia and/or schizoaffective disorder, the primary indications for this product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93537701,Clozapine ODT 200mg/100 count,2020-07-30,2301.77,,1,1800000,,,,,,,"Estimated average of approximately 25,400 prescriptions per year (across these three particular NDCs), based on historic IQVIA data, although research suggests that as many as 1.8 million Americans have been diagnosed with schizophrenia and/or schizoaffective disorder, the primary indications for this product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93537784,Clozapine ODT 200mg/48 count,2020-07-30,1104.83,,1,1800000,,,,,,,"Estimated average of approximately 25,400 prescriptions per year (across these three particular NDCs), based on historic IQVIA data, although research suggests that as many as 1.8 million Americans have been diagnosed with schizophrenia and/or schizoaffective disorder, the primary indications for this product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591405094,SILDENAFIL CITRATE 10MG/ML PWD ORSU 1,2020-08-17,984.97,,1,17000,,,,,,,"Estimated average of approximately 16,800 prescriptions per year, based on historic IQVIA data. Research similarly suggests that as many as 17,000 Americans have been diagnosed with pulmonary arterial hypertension, the primary indication for this product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93375028,TOBRAMYCIN SOL 300/4 MG/ML 28,2020-09-15,2672.21,,1,24000,,,,,,,"Estimated average of approximately 9,200 prescriptions per year (across these two particular NDCs), based on historic IQVIA data, although research suggests that as many as 24,000 Americans have been diagnosed with cystic fibrosis with Pseudomonas aeruginosa, the primary indication for this product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93375063,TOBRAMYCIN SOL 300/4 MG/ML 56,2020-09-15,5344.42,,1,24000,,,,,,,"Estimated average of approximately 9,200 prescriptions per year (across these two particular NDCs), based on historic IQVIA data, although research suggests that as many as 24,000 Americans have been diagnosed with cystic fibrosis with Pseudomonas aeruginosa, the primary indication for this product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93921906,DIMETHYL FUMARATE DR CAPSULES 240MG 60,2020-09-28,943.45,,1,728000,,,2020-08-25,,1,,"Estimated average of approximately 430,000 prescriptions per year, based on historic IQVIA data, although research suggests that as many as 728,000 Americans have been diagnosed with multiple sclerosis. + +The product is an authorized generic version of TECFIDERA®, manufactured by Biogen Swiss Manufacturing GmbH (“Biogen”). Teva sells the product as Biogen’s distributor in the US market, pursuant to an agreement between the parties dated August 25, 2020. The economic terms of that agreement, including any payments by Teva to acquire the rights to sell the product from Biogen, are confidential and non-public.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93523456,EFAVIRENZ/EMTRICITABINE/TENOFOVIR TAB 600MG/200MG/300MG 30,2020-09-30,2365.82,,1,1100000,,,,,,,"Estimated average of approximately 168,000 prescriptions per year, based on historic IQVIA data. Research suggests that as many 1.1 million Americans have been diagnosed with HIV. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93760756,EMTRICITABINE/TENOFOVIR TAB 200/300MG 30,2020-09-30,1455.4,,1,1100000,,,,,,,"Estimated average of approximately 1.4 million prescriptions per year, based on historic IQVIA data. Research suggests that as many 1.1 million Americans have been diagnosed with HIV. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +The PharmaNetwork LLC,53097056860,"Marinol 2.5 mg, 60 capsules in 1 bottle",2020-04-01,694.43,,1,804500,1,,,,,,"Marinol is indicated for anorexia associated with weight loss in patients with AIDS and for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. There are approximately 1.2 million people in the U.S. living with HIV and it is estimated that 20% to 34% of those patients will experince some degree of wasting or anorexia. There are approximately 650,000 people per year receiving chemotherapy treatments in the U.S. in outpatient settings and it is estimated that 45 to 61% of patients with cancer experience chemotherapy-induced nausea and vomiting. ThePharmaNetwork's estimated volume of patients who may be prescribed Marinol is not available in the public domain nor is the estimated number of patients for this drug known to ThePharmaNetwork. The estimated number of patients provided is a combination of 34% of 1.2 million HIV patients and 61% of 650,000 chemotherapy patients. + +ThePharmaNetwork did not acquire this product. Patheon Softgels Inc. is the supplier of this product and Alkem Laboratories Ltd. is the parent company of ThePharmaNetwork.",,,,,,,,,,,,,,, +Tolmar Inc,63646004012,"Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Topical Suspension, 2x60g",2020-06-01,1669.92,,1,8000000,,,,,,,"8,000,000 patients estimated based on the National Psoriasis Foundation. +While specific marketing and pricing plans are not available in the public domain, this is a generic drug that is not marketed. Tolmar has a long history of responsible pricing based on several factors including value provided to the patient and the healthcare system, unmet medical need, research and development sustainability, and the competitive environment.",,,,,,,,,,,,,,, +Tolmar Inc,63646004060,"Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Topical Suspension, 60g",2020-06-01,834.96,,1,8000000,,,,,,,"8,000,000 patients estimated based on the National Psoriasis Foundation. +While specific marketing and pricing plans are not available in the public domain, this is a generic drug that is not marketed. Tolmar has a long history of responsible pricing based on several factors including value provided to the patient and the healthcare system, unmet medical need, research and development sustainability, and the competitive environment.",,,,,,,,,,,,,,, +"Tolmar Pharmaceuticals, Inc.",62935015350,Fensolvi (leuprolide acetate),2020-06-05,22578,,1,13700,,,,,,,,,,,,,,,,,,,,,, +Ultragenyx Pharmaceuticals Inc.,69794005050,Dojolvi; 500mL; Bottle,2020-07-01,4875,"Ultragenyx does not have patented marketing information. Any marketing information related to this product is know only to Ultragenyx's Commercial team. Marketing information has potential commercial value and allowing this information to remain non-public and confidential, allows Ultragenyx to obtain a business advantage over its competitors who do not have or know Ultragenyx’s marketing information. Making the marketing information public would not serve the public interest and therefore disclosure is not required.",,1500,,,,,,,"The estimated prevalence of LC-FAOD is2,000-3,500 LC-FAOD in the US. However this is not the addressable population as many patients with different variants of LC-FAOD may not even know they have the disease. LC-FAOD is a general classification of many genetic mutations that vary in population size and severity. 1,500 patients is the estimation of patients that experience symptoms and seek medical attention due to LC-FAOD. + +Dojolvi was developed internally by Ultragenyx. Therefore there was no acquisition price.",,,,,,,,,,,,,,, +"UroGen Pharma, Inc.",72493010303,,2020-06-01,21376,"UroGen currently only sells Jelmyto in the U.S. UroGen's commercialization team has sales resources in the field detailing this product to healthcare providers. The drug (Jelmyto) is priced at WAC, with limited discounting.",,6500,1,1,,,,,We did not acquire the drug. This explains why the acquisition-related fields were left blank.,,,,,,,,,,,,,,, +"Viela Bio, Inc.",72677055101,"UPLIZNA™ (inebilizumab-cdon), Carton containing three 100 mg /10 mL single-dose vials",2020-07-13,131000,"Uplizna is the first and only B-cell depleter approved for the treatment adult patients with AQP4+ neuromyelitis optica spectrum disorder (NMOSD). Viela’s approach to marketing includes a focus on educating healthcare professionals, primarily neurologists, about the devastating effects of this rare disease and providing information about the efficacy, safety and dosing of Uplizna. Marketing includes dissemination of print materials, digital advertising, in-person presentations and virtual engagements. In addition to healthcare professionals, Viela also provides educational resources and support to the patient community in collaboration with advocacy organizations. + +Viela’s approach to pricing innovative therapies is driven by the value a drug brings to customers. Leading up to FDA approval, the company engaged with key stakeholders—including patients, payers and physicians—to better understand the value this medicine could bring to people affected by NMOSD, who despite recent innovation, have limited treatment options.",,10000,1,,,,,,,,,,,,,,,,,,,,, +ViiV Healthcare,49702025018,RUKOBIA (fostemsavir) 600mg extended-release tablets,2020-07-22,7650,,1,9300,1,1,,,,,"Regarding Marketing/Pricing Plan Description, ViiV has not released RUKOBIA's marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). + +RUKOBIA is a novel attachment inhibitor for the treatment of HIV-1 infection indicated for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection, failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The estimated HTE population who are unable to form a suppressive regimen and potentially eligible for treatment with RUKOBIA is approximately 9,300 for the US. This is based on the number of people living with HIV according to the Centers for Disease Control and Prevention (CDC) and a projection for the heavily treatment-experienced adult population who are unable to form a suppressive regimen. + +RUKOBIA was granted breakthrough therapy designation and priority review by the Food And Drug Administration. + +Note on Acquisition Fields: ViiV acquired fostemsavir as an investigational asset from Bristol Myers Squibb and completed development of the product. Accordingly, Rukobia was not an approved prescription drug at the time ViiV acquired it. Therefore the following fields related to drug acquisition have been left blank: ACQUISITION_DATE, ACQUISITION_PRICE, ACQUISITION_PRICE_NONPUBLIC, ACQUISITION_PRICE_COMMENT.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710151709,Fondaparinux Inj 10mg/0.8ml (2x0.8ml),2020-01-13,950.6,,1,,,,,,,,"Please note that the WAC represented is WAC for a 30 day course of treatment based on Zydus dosing assumption. Zydus dosing assumption is 10mg per day for 9 days. This is an AP rated generic product. Zydus is not the ANDA holder for this product but is the sales and marketing partner. Acquisition date and price are not applicable as the drug was not acquired. Additionally, as Zydus manufactures/sells generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710151406,Fondaparinux Inj 2.5mg/0.5ml (10x0.5ml),2020-01-13,705,,1,,,,,,,,"Please note that the WAC represented is WAC for a 30 day course of treatment based on Zydus dosing assumption. Zydus dosing assumption is 2.5mg per day for 32 days. This is an AP rated generic product. Zydus is not the ANDA holder for this product but is the sales and marketing partner. Acquisition date and price are not applicable as the drug was not acquired. Additionally, as Zydus manufactures/sells generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710151409,Fondaparinux Inj 2.5mg/0.5ml (2x0.5ml),2020-01-13,1211.7,,1,,,,,,,,"Please note that the WAC represented is WAC for a 30 day course of treatment based on Zydus dosing assumption. Zydus dosing assumption is 2.5mg per day for 32 days. This is an AP rated generic product. Zydus is not the ANDA holder for this product but is the sales and marketing partner. Acquisition date and price are not applicable as the drug was not acquired. Additionally, as Zydus manufactures/sells generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710151509,Fondaparinux Inj 5mg/0.4ml (2x0.4ml),2020-01-13,950.6,,1,,,,,,,,"Please note that the WAC represented is WAC for a 30 day course of treatment based on Zydus dosing assumption. Zydus dosing assumption is 5mg per day for 9 days. This is an AP rated generic product. Zydus is not the ANDA holder for this product but is the sales and marketing partner. Acquisition date and price are not applicable as the drug was not acquired. Additionally, as Zydus manufactures/sells generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710151609,Fondaparinux Inj 7.5mg/0.6ml (2x0.6ml),2020-01-13,950.6,,1,,,,,,,,"Please note that the WAC represented is WAC for a 30 day course of treatment based on Zydus dosing assumption. Zydus dosing assumption is 7.5mg per day for 9 days. This is an AP rated generic product. Zydus is not the ANDA holder for this product but is the sales and marketing partner. Acquisition date and price are not applicable as the drug was not acquired. Additionally, as Zydus manufactures/sells generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710113301,Chlorpromazine HCl 200mg Tab,2020-02-11,989.35,,1,,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Additionally, as Zydus manufactures generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We manufacture volume based on an estimated market share along with IQVIA EUTRx data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710153001,Doxorubicin Hydrochloride 20mg/10mL Liposomal Injection,2020-09-29,969,,1,,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Additionally, as Zydus manufactures/sells generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally, nor do we have access to any information which would indicate the number of patients in the United States with the condition(s) for which our products may be prescribed. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710153101,Doxorubicin Hydrochloride 50mg/25mL Liposomal Injection,2020-09-29,2422.55,,1,,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Additionally, as Zydus manufactures/sells generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients.",,,,,,,,,,,,,,, +AbbVie,74709530,QULIPTA (atogepant) is 10mg tablet taken orally once daily with or without food,2021-10-06,991,"QULIPTA is marketed for treatment of episodic migraine in adults. The Wholesale Acquisition Cost (WAC) of QULIPTA is $991.00 per a month supply for 10 mg (30 count), 30 mg (30 count), and 60 mg (30 count). To date AbbVie has not filed for regulatory approval of QULIPTA in jurisdictions outside the United States.",,14200000,,1,,,,,"Response on estimated volume of patients who may be prescribed the drug: + +QULIPTA is marketed for treatment of episodic migraine in adults. Based upon published analysis, episodic migraine affects approximately 14.2 million adults in the United States that are diagnosed and insured. See American Migraine Prevalence and Preventions studies (Lipton et al., 2007 & Buse et al., 2012), Chronic Migraine Epidemiology and Outcomes (CaMEO) study (Adams et al., 2015), Adelphi Migraine US DSP (Ford et al., 2017 & Mutebi, 2016), Diamond et al., 2007, US Census Bureau, 2017, and Current population survey (CPS), 2019. QULIPTA may be prescribed for that fraction of those patients for whom a physician and patient in consultation may consider this treatment appropriate.",,,,,,,,,,,,,,, +AbbVie,74709630,QULIPTA (atogepant) is 30mg tablet taken orally once daily with or without food,2021-10-06,991,"QULIPTA is marketed for treatment of episodic migraine in adults. The Wholesale Acquisition Cost (WAC) of QULIPTA is $991.00 per a month supply for 10 mg (30 count), 30 mg (30 count), and 60 mg (30 count). To date AbbVie has not filed for regulatory approval of QULIPTA in jurisdictions outside the United States.",,14200000,,1,,,,,"Response on estimated volume of patients who may be prescribed the drug (see Cal. Health & Saf. Code § 96076(b)(2): + +QULIPTA is marketed for treatment of episodic migraine in adults. Based upon published analysis, episodic migraine affects approximately 14.2 million adults in the United States that are diagnosed and insured. See American Migraine Prevalence and Preventions studies (Lipton et al., 2007 & Buse et al., 2012), Chronic Migraine Epidemiology and Outcomes (CaMEO) study (Adams et al., 2015), Adelphi Migraine US DSP (Ford et al., 2017 & Mutebi, 2016), Diamond et al., 2007, US Census Bureau, 2017, and Current population survey (CPS), 2019. QULIPTA may be prescribed for that fraction of those patients for whom a physician and patient in consultation may consider this treatment appropriate.",,,,,,,,,,,,,,, +AbbVie,74709430,QULIPTA (atogepant) is 60mg tablet taken orally once daily with or without food,2021-10-06,991,"QULIPTA is marketed for treatment of episodic migraine in adults. The Wholesale Acquisition Cost (WAC) of QULIPTA is $991.00 per a month supply for 10 mg (30 count), 30 mg (30 count), and 60 mg (30 count). To date AbbVie has not filed for regulatory approval of QULIPTA in jurisdictions outside the United States.",,14200000,,1,,,,,"Response on estimated volume of patients who may be prescribed the drug: + +QULIPTA is marketed for treatment of episodic migraine in adults. Based upon published analysis, episodic migraine affects approximately 14.2 million adults in the United States that are diagnosed and insured. See American Migraine Prevalence and Preventions studies (Lipton et al., 2007 & Buse et al., 2012), Chronic Migraine Epidemiology and Outcomes (CaMEO) study (Adams et al., 2015), Adelphi Migraine US DSP (Ford et al., 2017 & Mutebi, 2016), Diamond et al., 2007, US Census Bureau, 2017, and Current population survey (CPS), 2019. QULIPTA may be prescribed for that fraction of those patients for whom a physician and patient in consultation may consider this treatment appropriate.",,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729043630,Fulvestrant 50 mg/ml (PFS),2021-01-12,850,,1,0,,,,,,,"Accord did not acquire the NDC for Fulvestrant, the generic product was developed in house. +Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. + +Accord does not have internal methods or procedures to estimate a reasonable number of patients with a disease state and therefore, cannot answer this question with any level of accuracy that is needed in order to comply with the requirement.",,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729041759,Dimethyl Fumarate DR 240mg,2021-01-20,1050,,1,0,,,,,,,"Accord did not acquire the NDC for Dimethyl Fumarate, the generic product was developed in house. +Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. + +Accord does not have internal methods or procedures to estimate a reasonable number of patients with a disease state and therefore, cannot answer this question with any level of accuracy that is needed in order to comply with the requirement.",,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729043043,Argatroban in 0.9% Sodium Chloride,2021-10-07,1980,,1,0,,,,,,,"Accord did not acquire the NDC for Argatroban, the generic product was developed in house. + +Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. + +Accord does not have internal methods or procedures to estimate a reasonable number of patients with a disease state and therefore, cannot answer this question with any level of accuracy that is needed in order to comply with the requirement.",,,,,,,,,,,,,,, +"Actelion Pharmaceuticals US, Inc",66215071801,"UPTRAVI® (selexipag) IV, Strength: 1800mcg, Form: 1 Single Vial",2021-08-12,19200,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market UPTRAVI® IV in the US and promote to appropriate healthcare professionals who treat PAH patients who are hospitalized and are temporarily unable to take their UPTRAVI® Tablets. The pricing plan has WAC set for 1800mcg vial at $19,200.00 for a 30 day supply. The list price of UPTRAVI® IV is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. UPTRAVI® IV will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. International approvals are pending.",,,,,,,,,The estimated number of patients in the United States with a condition for which UPTRAVI® IV may be prescribed is not in the public domain or publicly available.,,,,,,,,,,,,,,, +ADC Therapeutics,79952011001,ZYNLONTA™ (loncastuximab tesirine-lpyl) 10mg per Vial,2021-05-01,23500,,1,1300,,,,,,,,,,,,,,,,,,,,,, +"Albireo Pharma, Inc.",74528012001,Bylvay/Odevixibat 1200mcg 30 capsules,2021-07-20,39600,"Albireo plans to engage in a range of marketing and sales activities to maximize patient benefit through BylvayTM awareness and education. +Marketing communications and sales activities in the U.S. include: market research, detailing, peer-to-peer speaker programs and symposia, congress sponsorships/exhibits/theaters, email and printed letter communications, websites, webinars, medical journal and website banner ads, social media announcements, and patient and physician announcement and educational materials. +Currently, Albireo does not plan to engage in free drug sampling, television or radio advertising, or direct-to-consumer promotional incentives. + +The company’s pricing plans for the product are not in the public domain or otherwise publicly available.",,150,,1,,,,,"BYLVAYTM (Odevixibat) is FDA-approved for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). There are no available registries or other sources of information that provide a definitive figure on the number of patients living with Progressive Familial Intrahepatic Cholestasis. Based on analysis of literature estimates of disease incidence and survival rates, we believe that there are approximately 3,500 patients in the United States living with some form of Progressive Familial Intrahepatic Cholestasis of which we expect approximately 600 will be eligible for treatment with Bylvay. We do not know how many of these potential patients might be prescribed Bylvay.",,,,,,,,,,,,,,, +"Albireo Pharma, Inc.",74528002001,Bylvay/Odevixibat 200mcg 30 capsules,2021-07-20,6600,"Albireo plans to engage in a range of marketing and sales activities to maximize patient benefit through BylvayTM awareness and education. +Marketing communications and sales activities in the U.S. include: market research, detailing, peer-to-peer speaker programs and symposia, congress sponsorships/exhibits/theaters, email and printed letter communications, websites, webinars, medical journal and website banner ads, social media announcements, and patient and physician announcement and educational materials. +Currently, Albireo does not plan to engage in free drug sampling, television or radio advertising, or direct-to-consumer promotional incentives. + +The company’s pricing plans for the product are not in the public domain or otherwise publicly available.",,150,,1,,,,,"BYLVAYTM (Odevixibat) is FDA-approved for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). There are no available registries or other sources of information that provide a definitive figure on the number of patients living with Progressive Familial Intrahepatic Cholestasis. Based on analysis of literature estimates of disease incidence and survival rates, we believe that there are approximately 3,500 patients in the United States living with some form of Progressive Familial Intrahepatic Cholestasis of which we expect approximately 600 will be eligible for treatment with Bylvay. We do not know how many of these potential patients might be prescribed Bylvay.",,,,,,,,,,,,,,, +"Albireo Pharma, Inc.",74528004001,Bylvay/Odevixibat 400mcg 30 capsules,2021-07-20,13200,"Albireo plans to engage in a range of marketing and sales activities to maximize patient benefit through BylvayTM awareness and education. +Marketing communications and sales activities in the U.S. include: market research, detailing, peer-to-peer speaker programs and symposia, congress sponsorships/exhibits/theaters, email and printed letter communications, websites, webinars, medical journal and website banner ads, social media announcements, and patient and physician announcement and educational materials. +Currently, Albireo does not plan to engage in free drug sampling, television or radio advertising, or direct-to-consumer promotional incentives. + +The company’s pricing plans for the product are not in the public domain or otherwise publicly available.",,150,,1,,,,,"BYLVAYTM (Odevixibat) is FDA-approved for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). There are no available registries or other sources of information that provide a definitive figure on the number of patients living with Progressive Familial Intrahepatic Cholestasis. Based on analysis of literature estimates of disease incidence and survival rates, we believe that there are approximately 3,500 patients in the United States living with some form of Progressive Familial Intrahepatic Cholestasis of which we expect approximately 600 will be eligible for treatment with Bylvay. We do not know how many of these potential patients might be prescribed Bylvay.",,,,,,,,,,,,,,, +"Albireo Pharma, Inc.",74528006001,Bylvay/Odevixibat 600mcg 30 capsules,2021-07-20,19800,"Albireo plans to engage in a range of marketing and sales activities to maximize patient benefit through BylvayTM awareness and education. +Marketing communications and sales activities in the U.S. include: market research, detailing, peer-to-peer speaker programs and symposia, congress sponsorships/exhibits/theaters, email and printed letter communications, websites, webinars, medical journal and website banner ads, social media announcements, and patient and physician announcement and educational materials. +Currently, Albireo does not plan to engage in free drug sampling, television or radio advertising, or direct-to-consumer promotional incentives. + +The company’s pricing plans for the product are not in the public domain or otherwise publicly available.",,150,,1,,,,,"BYLVAYTM (Odevixibat) is FDA-approved for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). There are no available registries or other sources of information that provide a definitive figure on the number of patients living with Progressive Familial Intrahepatic Cholestasis. Based on analysis of literature estimates of disease incidence and survival rates, we believe that there are approximately 3,500 patients in the United States living with some form of Progressive Familial Intrahepatic Cholestasis of which we expect approximately 600 will be eligible for treatment with Bylvay. We do not know how many of these potential patients might be prescribed Bylvay.",,,,,,,,,,,,,,, +"Alkermes, Inc",65757065242,"olanzapine and samidorphan tablets 10 mg/10 mg, 30 capsule count",2021-10-18,1390,"""The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors. +Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients. +Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals. +Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost.""",,6500000,,,,,,,The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired.,,,,,,,,,,,,,,, +"Alkermes, Inc",65757065244,"olanzapine and samidorphan tablets 10 mg/10 mg, 90 capsule count",2021-10-18,4170,"""The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors. +Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients. +Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals. +Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost.""",,6500000,,,,,,,The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired.,,,,,,,,,,,,,,, +"Alkermes, Inc",65757065342,"olanzapine and samidorphan tablets 15 mg/10 mg, 30 capsule count",2021-10-18,1390,"""The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors. +Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients. +Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals. +Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost.""",,6500000,,,,,,,The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired.,,,,,,,,,,,,,,, +"Alkermes, Inc",65757065344,"olanzapine and samidorphan tablets 15 mg/10 mg, 90 capsule count",2021-10-18,4170,"""The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors. +Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients. +Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals. +Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost.""",,6500000,,,,,,,The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired.,,,,,,,,,,,,,,, +"Alkermes, Inc",65757065442,"olanzapine and samidorphan tablets 20 mg/10 mg, 30 capsule count",2021-10-18,1390,"""The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors. +Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients. +Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals. +Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost.""",,6500000,,,,,,,The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired.,,,,,,,,,,,,,,, +"Alkermes, Inc",65757065444,"olanzapine and samidorphan tablets 20 mg/10 mg, 90 capsule count",2021-10-18,4170,"""The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors. +Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients. +Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals. +Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost.""",,6500000,,,,,,,The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired.,,,,,,,,,,,,,,, +"Alkermes, Inc",65757065142,"olanzapine and samidorphan tablets 5 mg/10 mg, 30 capsule count",2021-10-18,1390,"""The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors. +Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients. +Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals. +Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost.""",,6500000,,,,,,,The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired.,,,,,,,,,,,,,,, +"Alkermes, Inc",65757065144,"olanzapine and samidorphan tablets 5 mg/10 mg, 90 capsule count",2021-10-18,4170,"""The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors. +Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients. +Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals. +Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost.""",,6500000,,,,,,,The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired.,,,,,,,,,,,,,,, +Almirall LLC,16110039105,Klisyri 1% Ointment Packet,2021-02-08,990,"Marketing: Klisyri is FDA approved treatment for Actinic keratosis on the face or scalp which affects a number of patients in the US annually. Almirall's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment with Almirall products. + +Pricing: Based on meaningful market research, which looks at comparative products within the same clinical indication, therapeutic class and patient population, a cross functional team evaluates how the product differentiates from its competition in the market and, based +on the entirety of the data available, assesses a product baseline fair market value. + +Following interactions with payers, internal methodology is used to forecast a realistic cost of rebates and other instruments designed to facilitate patient access. + +Product price at launch reflects the sum of the data analysis in the light of all the principles outlined above, coupled with the Company’s assessment of its fair market value when compared with similar products already on the market. Full analysis of the clinical data, conducted to assess product differentiation from existing treatments available in that approved indication, represents an element of consideration in that regard.",,40000000,,,,,,,The American Academy of Dermatology has estimated that approximately 40 million Americans may be affected by AK. J. Am. Acad. Dermatol. 2018; 78:710.,,,,,,,,,,,,,,, +ALVOGEN,47781092501,"Pyrimethamine Tabs, 25mgs x 100 count",2021-12-01,29250,,1,,,,,,,,,,,,,,,,,,,,,,, +ALVOGEN,47781092530,"Pyrimethamine Tabs, 25mgs x 30 count",2021-12-01,8775,,1,,,,,,,,,,,,,,,,,,,,,,, +American Health Packaging,68084095001,Fluphenazine HCl Tablet 10mg 100UD,2021-02-16,1342.86,See Attached,,2600000,,,2021-01-26,385,,"As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC.  There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC.","1.ESTIMATED # PATIENTS: Patient Information - CANNOT BE DETERMINED: Fluphenazine, is a typical antipsychotic prescribed for treatment of schizophrenia, mania, bipolar disorder and dementia (reference: https://www.webmd.com/search/search_results/default.aspx?query=Fluphenazine+HCl+) and the estimated patient population for schizophrenia is 2.6 million (reference: https://www.treatmentadvocacycenter.org/evidence-and-research/learn-more-about/25-schizophrenia-fact-sheet#:~:text=Schizophrenia%20is%20a%20chronic%20and%20severe%20neurological%20brain%20disorder%20estimated,untreated%20in%20any%20given%20year). +2. Course of Therapy: Course of Therapy has been reviewed to determine submission.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=543,,,,,,,,,,,,,, +American Health Packaging,68084084601,Fluphenazine HCl Tablet 5mg 100UD,2021-02-16,1071.43,See Attached,,2600000,,,2021-01-26,305,,"As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC.  There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC.","1.ESTIMATED # PATIENTS: Patient Information - CANNOT BE DETERMINED: Fluphenazine, is a typical antipsychotic prescribed for treatment of schizophrenia, mania, bipolar disorder and dementia (reference: https://www.webmd.com/search/search_results/default.aspx?query=Fluphenazine+HCl+) and the estimated patient population for schizophrenia is 2.6 million (reference: https://www.treatmentadvocacycenter.org/evidence-and-research/learn-more-about/25-schizophrenia-fact-sheet#:~:text=Schizophrenia%20is%20a%20chronic%20and%20severe%20neurological%20brain%20disorder%20estimated,untreated%20in%20any%20given%20year). +2. Course of Therapy: Course of Therapy has been reviewed to determine submission.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=542,,,,,,,,,,,,,, +American Health Packaging,68001044432,Cyclophosphamide Inj 1mg/100ml vial,2021-03-12,1318.5,See Attached,,90000,,,2021-01-22,473,,"As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC.  There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC.","1.ESTIMATED # PATIENTS: Patient Information - CANNOT BE DETERMINED: Cyclophosphamide is used to treat various types of cancer including Hodgkins and Non-Hodgkins lymphoma. It is a chemotherapy drug that works by slowing or stopping cell growth (reference: http://chemocare.com/chemotherapy/drug-info/cyclophosphamide.aspx). The estimated patient population for Hodgkins/Non-Hodgkins is approximately 90,000 (reference www.cancer.net). +2. Course of Therapy: Course of Therapy has been reviewed to determine submission.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=545,,,,,,,,,,,,,, +American Health Packaging,68001047008,Metoprolol Succinate ER Tablet 100mg 1000 Bottle,2021-04-30,732.04,See Attached,,10800000,,,2021-04-26,178,,"As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC.  There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC.","1.ESTIMATED # PATIENTS: Metoprolol Succinate is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. (reference: https://www.webmd.com/drugs/2/search?type=drugs&query=Metoprolol%20Succinate%20ER) and the patient population is estimated at 108 million (reference: https://www.cdc.gov/bloodpressure/facts.htm#:~:text=Nearly%20half%20of%20adults%20in,are%20taking%20medication%20for%20hypertension.&text=Only%20about%201%20in%204,have%20their%20condition%20under%20control). +2. Course of Therapy: Course of Therapy has been reviewed to determine submission.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=544,,,,,,,,,,,,,, +American Health Packaging,68001049905,Venlafaxine ER Tablet 225mg,2021-04-30,774.68,Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice,,50000000,,,2021-10-01,25,,"As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC.  There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC.","1.ESTIMATED # PATIENTS: Patient Information - CANNOT BE DETERMINED: Venlafaxine is used for treatment of depression, anxiety, panic attacks, and social anxiety disorder (social phobia). (reference:the CDC estimates that in 2019, 8.1% of adults aged 18 and over had symptoms of anxiety disorder, 6.5% had symptoms of depressive disorder, and 10.8% had symptoms of anxiety disorder or depressive disorder). https://www.cdc.gov/nchs/covid19/pulse/mental-health.htm +2. Course Of Therapy: Course of Therapy has been reviewed to determine submission.",,,,,,,,,,,,,,, +American Health Packaging,60687059921,Flucytosine Capsule 250mg,2021-05-01,2455.86,Create collateral of new item; initiative AB stream serve; Email collateral to AHP customer base; utilize AHP & AB inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice,,9000000,,,2021-10-01,679,,"As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC.  There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC.","1.ESTIMATED # PATIENTS: Patient Information - CANNOT BE DETERMINED: Flucytosine is used for treatment of serious fungal infections, the CDC indicates that there were over 75,000 hospitalizations and nearly 9 million outpatient visits for fungal diseases in 2017. https://www.cdc.gov/fungal/cdc-and-fungal/burden.html +2. Course Of Therapy: Course of Therapy has been reviewed to determine submission.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=559,,,,,,,,,,,,,, +American Health Packaging,60687061021,Flucytosine Capsule 500mg,2021-05-02,4700.1,Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice,,9000000,,,2021-10-01,749,,"As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC.  There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC.","1.ESTIMATED # PATIENTS: Patient Information - CANNOT BE DETERMINED: Flucytosine is used for treatment of serious fungal infections, the CDC indicates that there were over 75,000 hospitalizations and nearly 9 million outpatient visits for fungal diseases in 2017. https://www.cdc.gov/fungal/cdc-and-fungal/burden.html +2. Course Of Therapy: Course of Therapy has been reviewed to determine submission.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=560,,,,,,,,,,,,,, +American Health Packaging,68001049236,Doxorubicin HCl Liposome Injection 20mg/10ml,2021-05-31,969,Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice,,147000,,,2021-10-01,349,,"As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC.  There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC.","1.ESTIMATED #PATIENTS: Patient Information - CANNOT BE DETERMINED: Doxorubicin HCl Liposome is used for treatment of anthracycline type of chemotherapy that is used to treat several different types of cancer. Doxorubicin works by slowing or stopping the growth of cancer cells.(reference: https://www.webmd.com/drugs/2/drug-7750/doxorubicin-intravenous/details)(https://clinicaltrials.gov/ct2/show/NCT04650984). +2. Course Of Therapy: Course of Therapy has been reviewed to determine submission.",,,,,,,,,,,,,,, +American Health Packaging,68001049326,Doxorubicin HCl Liposome Injection 50mg/25ml,2021-05-31,2422.55,Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice,,147000,,,2021-10-01,873,,"As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC.  There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC.","1.ESTIMATED #PATIENTS: Patient Information - CANNOT BE DETERMINED: Doxorubicin HCl Liposome is used for treatment of anthracycline type of chemotherapy that is used to treat several different types of cancer. Doxorubicin works by slowing or stopping the growth of cancer cells.(reference: https://www.webmd.com/drugs/2/drug-7750/doxorubicin-intravenous/details)(https://clinicaltrials.gov/ct2/show/NCT04650984). +2. Course Of Therapy: Course of Therapy has been reviewed to determine submission.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=561,,,,,,,,,,,,,, +Amgen,55513022401,RIABNI 10mg/mL Vial (10-pkg size),2021-01-04,716.8,"There will be no direct-to-consumer marketing for RIABNI such as TV ads or magazine ads. The only platforms directed to patients is patient education brochure and RIABNI.com website entitled “For Patients”. This content is designed to educate patients about the diseases aligned with the RIABNI indications and potential treatment with RIABNI, including important safety information. +Promotional activities to physicians will include professional detailing by Amgen sales representatives. Amgen is utilizing its existing oncology sales force to educate health care professionals about RIABNI, including the requirements for establishing biosimilarity to the reference product, Rituxan, and important safety information. Professional detailing entails resources such as a core visual aid and promotional leave-behind literature. There is no free drug or sample program. +RIABNI’s Wholesale Acquisition Cost (WAC, sometimes referred to as list price) will be lower than its reference product, Rituxan. The WAC of RIABNI in the U.S. is 23.7% lower than the reference product, Rituxan. RIABNI is being made available at a WAC of $716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial.",,,,,,,,,"Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Amgen,55513032601,RIABNI 10mg/mL Vial (50 pkg size),2021-01-04,3584,"There will be no direct-to-consumer marketing for RIABNI such as TV ads or magazine ads. The only platforms directed to patients is patient education brochure and RIABNI.com website entitled “For Patients”. This content is designed to educate patients about the diseases aligned with the RIABNI indications and potential treatment with RIABNI, including important safety information. +Promotional activities to physicians will include professional detailing by Amgen sales representatives. Amgen is utilizing its existing oncology sales force to educate health care professionals about RIABNI, including the requirements for establishing biosimilarity to the reference product, Rituxan, and important safety information. Professional detailing entails resources such as a core visual aid and promotional leave-behind literature. There is no free drug or sample program. +RIABNI’s Wholesale Acquisition Cost (WAC, sometimes referred to as list price) will be lower than its reference product, Rituxan. The WAC of RIABNI in the U.S. is 23.7% lower than the reference product, Rituxan. RIABNI is being made available at a WAC of $716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial.",,,,,,,,,"Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Amgen,55513048824,"Lumakras (30-day supply, 1 bottle of 240 120mg tablets)",2021-06-03,17900,"Pursuant to CA Health and Safety Code 127681, Amgen provides the following information: + +There is no direct-to-consumer marketing for Lumakras via TV or magazine ads. Promotional activities for patients are (1) patient website www.Lumakras.com, search and banner advertising (2) patient educational brochure and (3) pill caddy. The purpose of the website, drivers to website and brochure is to educate patients on testing for KRAS G12C and Lumakras aligned to the Lumakras USPI, including Important Safety Information. The pill caddy is available via Specialty Pharmacies and the Amgen Nurse Navigator program should a patient be prescribed Lumakras. + +Promotional activities to HCPs include sales representative detailing, speaker programs, congresses and non-personal promotion such as HCP website, www.Lumakrashcp.com, search, banner advertising, and other digital educational programming in line with the Lumakras USPI. The purpose of these tools is for education on testing for KRAS G12C and Lumakras. There are no direct-to-consumer promotional incentives such as free trial offers. There is no sample program. + +Amgen understands that the cost of prescription drugs is a concern for many people, and we are committed to the responsible pricing of our medicines. +Our approach to pricing across the globe is underpinned by two simple core principles: +I. Pricing our products according to the value they deliver +II. Employs flexible pricing approaches to ensure patient access + +LUMAKRAS is available at a WAC of $17,900 per 30-day supply. This price is in line with other targeted therapies in oncology.",,,1,1,,,,,"Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +"Amivas (US), LLC",73607000111,Artesunate for Injection - 2 pack,2021-03-30,9960,"Launch Plan Objectives: +Demonstrate early sales traction with stockpiling and pre-positioning sales within 1-3 months of NDA approval. Reinforce early sales traction through annual Infectious Disease conference attendance/booths in both Europe and US markets. + +Launch Strategy: +Website and social media presence that directs inquiries to the infectious disease community and distributors. Targeting hospitals with calls in historic malaria case regions/countries. Achieve through analysis of historical malaria rates but also ID physician hospital locations available through ID societies. Attend several ID conferences held during the year. Marketing has already been initiated as official organizations/literature have adopted Artesunate for Injection as first line therapy. This has been augmented by Amivas/USAMMDA cooperating in supplying Artesunate for Injection to the U.S. CDC for compassionate use under their treatment IND and this has been recognized by the American Society of Tropical Medicine and Hygiene (ASTMH). +Pricing Plan: +The cost per 110 mg vial of IV Artesunate provided by the manufacturer, Amivas (US), LLC is set at $4,980. Based on the studies conducted in the US, the average number of vials used per dose (2.4 mg/kg) resulting in an estimated cost per dose of roughly $35,403. Amivas conducted a base case cost-effectiveness analysis that had shown an indicative cost per life year saved of $62,232 and is calculated for treatment with Artesunate for Injection compared to using IV Quinine. Following annual 3% discounting of Life Years only as costs are all incurred in the first year, the Incremental cost-effectiveness ratio (ICER) = $110,469 per life year saved (discounted). Overall, the pricing and availability of a formulation of Artesunate for Injection in the US will provide substantive value in access for what is considered the international standard of care for an otherwise fatal disease.",,300,1,1,2017-02-13,10000,,none,,,,,,,,,,,,,,,, +"Amivas (US), LLC",73607000110,Artesunate for Injection - 4 pack,2021-03-30,19920,"Launch Plan Objectives: +Demonstrate early sales traction with stockpiling and pre-positioning sales within 1-3 months of NDA approval. Reinforce early sales traction through annual Infectious Disease conference attendance/booths in both Europe and US markets. + +Launch Strategy: +Website and social media presence that directs inquiries to the infectious disease community and distributors. Targeting hospitals with calls in historic malaria case regions/countries. Achieve through analysis of historical malaria rates but also ID physician hospital locations available through ID societies. Attend several ID conferences held during the year. Marketing has already been initiated as official organizations/literature have adopted Artesunate for Injection as first line therapy. This has been augmented by Amivas/USAMMDA cooperating in supplying Artesunate for Injection to the U.S. CDC for compassionate use under their treatment IND and this has been recognized by the American Society of Tropical Medicine and Hygiene (ASTMH). +Pricing Plan: +The cost per 110 mg vial of IV Artesunate provided by the manufacturer, Amivas (US), LLC is set at $4,980. Based on the studies conducted in the US, the average number of vials used per dose (2.4 mg/kg) resulting in an estimated cost per dose of roughly $35,403. Amivas conducted a base case cost-effectiveness analysis that had shown an indicative cost per life year saved of $62,232 and is calculated for treatment with Artesunate for Injection compared to using IV Quinine. Following annual 3% discounting of Life Years only as costs are all incurred in the first year, the Incremental cost-effectiveness ratio (ICER) = $110,469 per life year saved (discounted). Overall, the pricing and availability of a formulation of Artesunate for Injection in the US will provide substantive value in access for what is considered the international standard of care for an otherwise fatal disease.",,300,1,1,2017-02-13,10000,,none,,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238175406,Abiraterone Acetate Oral Tablet 500mg 60,2021-01-04,7446.72,This is a generic product that is not marketed.,,191930,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238209203,Emtricitabine - Tenofovir Disoproxil Fumarate Oral Tablet 100-150MG 30,2021-01-18,1411.74,This is a generic product that is not marketed.,,36400,,,,,,,This drug was not acquired,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238209303,Emtricitabine - Tenofovir Disoproxil Fumarate Oral Tablet 133-200MG 30,2021-01-18,1411.74,This is a generic product that is not marketed.,,36400,,,,,,,This drug was not acquired,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238209403,Emtricitabine - Tenofovir Disoproxil Fumarate Oral Tablet 167-250MG 30,2021-01-18,1411.74,This is a generic product that is not marketed.,,36400,,,,,,,This drug was not acquired,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238162103,Metyrosine Oral Capsule 250mg 30,2021-01-20,7500,This is a generic product that is not marketed,,41,,,,,,,This drug was developed in-house and was not acquired.,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238170303,Deferasirox Oral Granules 180mg 30,2021-02-19,2049.98,This is a generic product that is not marketed.,,41,,,,,,,This drug was developed in-house and was not acquired.,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238170403,Deferasirox Oral Granules 360mg 30,2021-02-19,4099.87,This is a generic product that is not marketed.,,41,,,,,,,,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,60219172107,Etravirine 100 MG,2021-06-14,1287.29,This is a generic product that is not marketed.,,100,,,,,,,This drug was developed in-house and was not acquired.,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,60219172206,Etravirine 200 MG,2021-06-14,1287.29,This is a generic product that is not marketed.,,100,,,,,,,This drug was developed in-house and was not acquired.,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,115214216,Colestipol Hydrochloride,2021-09-13,123.78,This is a generic product that is not marketed,,41,,,,,,,This is an existing product with an updated NDC,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121148307,arsenic Trioxide Injection 10mg/10ML (1 mg/1mL),2021-09-16,4266.11,This is a generic product that is not marketed,,41,,,,,,,,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121165801,arsenic Trioxide Injection 12mg/6ML (2 mg/1mL),2021-09-16,5119.33,This is a generic product that is not marketed,,41,,,,,,,,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,60219203601,Azathioprine 75mg,2021-11-22,1408.49,This is a generic product that is not marketed.,,1000000,,,,,,,This drug was developed in-house and was not acquired.,,,,,,,,,,,,,,, +ANIP,62559027705,Nebivolol Tablets 10mg 500ct,2021-10-01,1408.33,"ANI did some market research with customers to understand how many generic manufacturers would be coming to market on day 1. We realized that we would be most likely be the only TAA compliant product that would qualify to sell to the government. We were approached by a few companies that specialize in selling to the government to be our distribution and marketing partner and chose to go with Golden State. Through their expertise in selling new generic launches, they gave us guidance on an opening price point discounted off the branded prices. At this time, ANI is only focused on selling Nebivolol in the United States.",,12000,,,,,,,,,,,,,,,,,,,,,, +ANIP,62559027583,Nebivolol Tablets 2.5mg 2300ct,2021-10-01,6478.33,"ANI did some market research with customers to understand how many generic manufacturers would be coming to market on day 1. We realized that we would be most likely be the only TAA compliant product that would qualify to sell to the government. We were approached by a few companies that specialize in selling to the government to be our distribution and marketing partner and chose to go with Golden State. Through their expertise in selling new generic launches, they gave us guidance on an opening price point discounted off the branded prices. At this time, ANI is only focused on selling Nebivolol in the United States.",,12000,,,,,,,,,,,,,,,,,,,,,, +ANIP,62559027805,Nebivolol Tablets 20mg 500ct,2021-10-01,1408.33,"ANI did some market research with customers to understand how many generic manufacturers would be coming to market on day 1. We realized that we would be most likely be the only TAA compliant product that would qualify to sell to the government. We were approached by a few companies that specialize in selling to the government to be our distribution and marketing partner and chose to go with Golden State. Through their expertise in selling new generic launches, they gave us guidance on an opening price point discounted off the branded prices. At this time, ANI is only focused on selling Nebivolol in the United States.",,12000,,,,,,,,,,,,,,,,,,,,,, +ANIP,62559027671,Nebivolol Tablets 5mg 1100ct,2021-10-01,3098.33,"ANI did some market research with customers to understand how many generic manufacturers would be coming to market on day 1. We realized that we would be most likely be the only TAA compliant product that would qualify to sell to the government. We were approached by a few companies that specialize in selling to the government to be our distribution and marketing partner and chose to go with Golden State. Through their expertise in selling new generic launches, they gave us guidance on an opening price point discounted off the branded prices. At this time, ANI is only focused on selling Nebivolol in the United States.",,12000,,,,,,,,,,,,,,,,,,,,,, +ANIP,62559086015,Cortrophin Gel 400 USP units/5mL,2021-12-01,31851,"The Purified Cortrophin Gel marketing plan includes a small field-based sales force. Their efforts will focus on helping clinicians understand how to identify the appropriate chronic autoimmune disorder patients who could potentially benefit from treatment with Cortrophin Gel. Cortrophin Gel is generally reserved for use after first-line treatment or for acute treatment. Based on market research conducted by ANI, it’s estimated that there will be approximately 325 patients treated with Purified Cortrophin Gel in 2022. At this time, ANI is only focused on selling Purified Cortrophin Gel in the U.S. + +ANI will be launching Cortrophin Gel in the US Market in the first quarter of 2022. Cortrophin Gel is the first branded prescription alternative to Acthar Gel in the US Market. ANI has decided to launch Cortrophin Gel at a discount of twenty percent from Acthar Gel in order to bring a more affordable Corticotropin therapy to patients who need this therapy.",,325,,,,,,,,,,,,,,,,,,,,,, +Apellis Pharmaceuticals,73606001001,Empaveli 1080mg/20ml (54 mg/ml) in a single dose vial,2021-05-18,4403.84,"Marketing: EMPAVELITM is a FDA approved treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH). PNH often presents with persistently low hemoglobin, thrombosis and debilitating symptoms.   Apellis’s  approach will focus on educating healthcare providers and staff on how to diagnose PNH and provide information about treatment.  Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support to ensure rapid access to EMPAVELI. + +Pricing: EMPAVELITM has been developed for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).  EMPAVELI provides an option to deliver a safe, effective treatment that reduces the risk of persistently low hemoglobin and other debilitating symptoms in patients.  EMPAVELI is priced responsibly compared to similar agents. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage.  Apellis demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind.",,6000,,1,,,,,"Regarding the request for Acquisition Data (items 10-13), there is no data to report; not an Acquired Drug.",,,,,,,,,,,,,,, +Apotex Corp,60505612006,Micafungin PINJ 100mg,2021-02-12,1870,,1,2083,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505611905,Micafungin PINJ 50mg,2021-02-12,935,,1,2083,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505621401,Icatibant Acetate Inj,2021-04-15,2795.79,,1,6628,,,,,,,"Apotex’s trade secret information is very valuable to its competitors. Disclosure of Apotex Trade Secrets would permit Apotex’s competitors to understand Apotex’s potential pricing for Icatibant Acetate Inj and limitations on discounting, etc., such as by learning pricing methodology for Icatibant Acetate Inj. Such information would provide Apotex’s competitors an unfair advantage in competing for customers. The generic drug market is highly competitive in many therapeutic classes, making Apotex Trade Secrets very valuable to both Apotex and its competitors. +Because of the measures put in place by Apotex to protect the information, Apotex submits that it would be extremely difficult for anyone, including a competitor, to obtain a copy of Apotex Trade Secrets unless release as public information by the state of Oregon Department of Consumer and Business Services. Apotex is not aware of any Apotex Trade Secrets presently in any of its competitor’s hands. Competitors in the industry with one another should not share such trade secret information because it is competition sensitive. Indeed, competitors that share trade secret information, including pricing and production costs, with one another could be pursued by regulatory authorities for violating laws prohibiting collusive bidding and anti-competitive conduct. Apotex Trade Secrets cannot be properly or legally acquired by its competitors. +In conclusion, because Apotex Trade Secrets meet the definition of “trade secret” under the Federal Defend Trade Secrets Act of 2016, codified at 18 U.S.C. 1836, and the Price Transparency reporting for Icatibant Acetate Inj was marked to reflect such.",,,,,,,,,,,,,,, +Apotex Corp,60505476406,ABIRATERONE FCT 500MG 60 BTL,2021-07-14,4964.48,,1,20833,,,,,,,"Apotex’s trade secret information is very valuable to its competitors. Disclosure of Apotex Trade Secrets would permit Apotex’s competitors to understand Apotex’s potential pricing for Abiraterone and limitations on discounting, etc., such as by learning pricing methodology for Abiraterone. Such information would provide Apotex’s competitors an unfair advantage in competing for customers. The generic drug market is highly competitive in many therapeutic classes, making Apotex Trade Secrets very valuable to both Apotex and its competitors.",,,,,,,,,,,,,,, +"Arbor Pharmaceuticals, LLC",24338041024,Chlorpromazine Hydrocloride Oral Concentrate 100mg/mL 240mL Bottle,2021-08-09,2160,Chlorpromazine Hydrochloride Oral Concentrate is the only FDA approved oral concentrate of chlorpromazine which serves an unmet need for patients who need chlorpromazine but can’t or won’t swallow chlorpromazine tablets. It is priced on a comparative dose to dose cost similar to the existing brand tablet forms.,,2200000,,,,,,,,,,,,,,,,,,,,,, +argenx US Inc.,7347530415,VYVGART™ (efgartigimod alfa-fcab) 400 mg per 20 mL (20mg/mL) single use vial,2021-12-27,5950,,1,1,,,,,,,"The ""estimated patients"" quantity does not exist. We do not have information available that provides a reasonable basis to determine the estimated number of patients per month. Consistent with Cal. Health & Safety Code 127681(c), argenx is limiting its response to that which is otherwise in the public domain or publicly available. argenx’s estimated number of patients is argenx confidential and proprietary information and is not in the public domain or publicly available.",,,,,,,,,,,,,,, +"Ascend Laboratories, LLC",67877067362,Rufinamide Oral Suspension 40mg 460ML,2021-03-03,1202.38,,1,1,,,,,,,"Please note that an entry of ""1"" in the Estimated Average patients per month is essentially a place holder as the system does not allow a blank entry. The number of estimated patients is unknown to Ascend, and therefore cannot provide this information.",,,,,,,,,,,,,,, +"Ascend Laboratories, LLC",67877074801,SIROLIMUS 2MG TABLETS,2021-03-23,997.82,,1,1,,,,,,,"Please note that an entry of ""1"" in the Estimated Average patients per month is essentially a place holder as the system does not allow a blank entry. The number of estimated patients is unknown to Ascend, and therefore cannot provide this information.",,,,,,,,,,,,,,, +"Ascend Laboratories, LLC",67877073101,Chlordiazepoxide HCL 5/2.5mg 100 Caps,2021-04-01,840,,1,40000000,,,,,,,"Please note that an entry of ""1"" in the Estimated Average patients per month is essentially a place holder as the system does not allow a blank entry. The number of estimated patients is unknown to Ascend, and therefore cannot provide this information. + +Chlordiazepoxide is an FDA approved medication for adults with mild to moderate to severe anxiety, preoperative anxiety and alcohol withdrawal",,,,,,,,,,,,,,, +"Ascend Laboratories, LLC",67877063633,Tolvaptan 30mg 1X10 Tabs,2021-05-10,4805.25,,1,12000000,,,,,,,"Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease affecting over 12 million people worldwide. It's estimated that between 1 in every 400 to 2,500 people has the disease. It can affect women and men, across all ethnic groups.",,,,,,,,,,,,,,, +"Ascend Laboratories, LLC",67877072131,EVEROLIMUS 1MG TABLET 60 tabs,2021-11-30,2047.5,"Ascend does not have patented marketing information. Any marketing related to this product is only known to Ascend's commercial team. Marketing information has potential value and allowing this information to remain non-public and confidential, allows Ascend to obtain a business advantage over its competitors who do not know Ascend's marketing information. Making this public would not serve the public interest and therefore is not required. +Ascend does not have patented pricing methodology information. Any pricing methodology information related to this product is only known to Ascend's commercial team. Pricing methodology information has potential value and allowing this information to remain non-public and confidential, allows Ascend to obtain a business advantage over its competitors who do not know Ascend's pricing methodology information. Making this public would not serve the public interest and therefore is not required.",,1,,,,,,,The estimated number of patients is unknown to Ascend Laboratories. This is a generic product with more than one manufacturer.,,,,,,,,,,,,,,, +"Ascend Laboratories, LLC",67877072031,EVEROLIMUS 0.75MG TABLET 60 Tabs,2021-12-01,750,"Ascend does not have patented marketing information. Any marketing related to this product is only known to Ascend's commercial team. Marketing information has potential value and allowing this information to remain non-public and confidential, allows Ascend to obtain a business advantage over its competitors who do not know Ascend's marketing information. Making this public would not serve the public interest and therefore is not required. +Ascend does not have patented pricing methodology information. Any pricing methodology information related to this product is only known to Ascend's commercial team. Pricing methodology information has potential value and allowing this information to remain non-public and confidential, allows Ascend to obtain a business advantage over its competitors who do not know Ascend's pricing methodology information. Making this public would not serve the public interest and therefore is not required.",,0,,,,,,,The estimated total of patients is unknown as of this time.,,,,,,,,,,,,,,, +"Ascendis Pharma, Inc.",73362000601,"SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 20.8 mg/package.",2021-10-13,4544.8,,1,40000,,,,,,,"WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs. +Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential.",,,,,,,,,,,,,,, +"Ascendis Pharma, Inc.",73362000701,"SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 25.2 mg/package",2021-10-13,5506.2,,1,40000,,,,,,,"WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs. +Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential.",,,,,,,,,,,,,,, +"Ascendis Pharma, Inc.",73362000401,"SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 14.4 mg/package.",2021-10-13,3146.4,,1,40000,,,,,,,"WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs. +Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential.",,,,,,,,,,,,,,, +"Ascendis Pharma, Inc.",73362000501,"SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 17.2 mg/package.",2021-10-13,3758.2,,1,40000,,,,,,,"WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs. +Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential.",,,,,,,,,,,,,,, +"Ascendis Pharma, Inc.",73362000801,"SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 30.4 mg/package.",2021-10-13,6642.4,,1,40000,,,,,,,"WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs. +Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential.",,,,,,,,,,,,,,, +"Ascendis Pharma, Inc.",73362000901,"SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 36.4 mg/package.",2021-10-13,7953.4,,1,40000,,,,,,,"WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs. +Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential.",,,,,,,,,,,,,,, +"Ascendis Pharma, Inc.",73362001001,"SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 44 mg/package.",2021-10-13,9614,,1,40000,,,,,,,"WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs. +Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential.",,,,,,,,,,,,,,, +"Ascendis Pharma, Inc.",73362001101,"SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 53.2/package.",2021-10-13,11624.2,,1,40000,,,,,,,"WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs. +Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential.",,,,,,,,,,,,,,, +"Ascendis Pharma, Inc.",73362000301,"SKYTROFA? is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 12 mg/package.",2021-10-13,2622,,1,40000,,,,,,,"WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs. +Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential.",,,,,,,,,,,,,,, +"Astellas Pharma US, Inc.",469062599,Xtandi® (enzalutamide) 40 mg Tablets,2021-03-01,12275.7,,1,,,,,,,,"Astellas has not released the information requested in column 7 (estimated volume of patients that may be prescribed the drug) in the public domain. Further, Astellas does not currently believe this information is in the public domain or publicly available. As a result, Astellas is limiting its response to this reporting requirement pursuant to Cal. Health & Safety Code Section 127681(c). Xtandi Tablets was not acquired; therefore, columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +"Astellas Pharma US, Inc.",469072560,Xtandi® (enzalutamide) 80 mg Tablets,2021-03-01,12275.7,,1,,,,,,,,"Astellas has not released the information requested in column 7 (estimated volume of patients that may be prescribed the drug) in the public domain. Further, Astellas does not currently believe this information is in the public domain or publicly available. As a result, Astellas is limiting its response to this reporting requirement pursuant to Cal. Health & Safety Code Section 127681(c). Xtandi Tablets was not acquired; therefore, columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +AstraZeneca ,310061028,Name- Koselugo (selumetinib) Dosage- 25mg/m2 Form- Capsules: 10mg 28 count bottle,2021-05-20,2117.08,"AstraZeneca will engage 2 sales representatives to cover the state of California. Patient brochures as well as therapy management guides, may be left behind in offices for informational purposes. AstraZeneca provides online resources via KOSELUGO™ US healthcare professionals and patient websites. Patients may register for the KOSELUGO™ support program via the website which will enroll them in a digital relationship marketing program to receive materials such as welcome letters, patient brochures, etc. The KOSELUGO™ patient savings program for eligible commercially insured patients will be available for patients in California and can be found via AstraZeneca’s Product website. The KOSELUGO™ is currently only marketed in the United States. When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers.",,1556,1,1,2003-12-18,,1,"KOSELUGO™ is an orally available, inhibitor of mitogen-activated protein kinases 1 and 2 (MEK1/2) and is indicated for the treatment of pediatric patients 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).",,,,,,,,,,,,,,,, +AstraZeneca ,310062528,Name- Koselugo (selumetinib) Dosage- 25mg/m2 Form- Capsules: 25mg 28 count bottle,2021-05-20,5292.56,"AstraZeneca will engage 2 sales representatives to cover the state of California. Patient brochures as well as therapy management guides, may be left behind in offices for informational purposes. AstraZeneca provides online resources via KOSELUGO™ US healthcare professionals and patient websites. Patients may register for the KOSELUGO™ support program via the website which will enroll them in a digital relationship marketing program to receive materials such as welcome letters, patient brochures, etc. The KOSELUGO™ patient savings program for eligible commercially insured patients will be available for patients in California and can be found via AstraZeneca’s Product website. The KOSELUGO™ is currently only marketed in the United States. When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers.",,1556,1,1,2003-12-18,,1,"KOSELUGO™ is an orally available, inhibitor of mitogen-activated protein kinases 1 and 2 (MEK1/2) and is indicated for the treatment of pediatric patients 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).",,,,,,,,,,,,,,,, +AstraZeneca ,310304000,SAPHNELO (anifrolumab-fnia): LIQUID 300mg/2mL 300mg VIAL,2021-08-02,4600.54,"AstraZeneca will engage 2 sales representative to cover the state of California. Patient brochures as well as therapy management guides, may be left behind in offices for informational purposes. +AstraZeneca provides online resources via SAPHNELO™ US healthcare professionals and patient websites. Patients may register for the SAPHNELO™ support program via the website which will enroll them in a digital relationship marketing program to receive materials such as welcome letters, patient brochures, etc. The SAPHNELO™ patient savings program for eligible commercially insured patients will be available for patients in New Hampshire and can be found via AstraZeneca’s Product website. +The SAPHNELO™ is currently only marketed in the United States. When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. +Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers.",,300000,,,,,,,"SAPHNELO (anifrolumab-fnia) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.",,,,,,,,,,,,,,, +"Aurinia Pharma U.S., Inc.",75626000101,LUPKYNIS (voclosporin),2021-01-22,3950,"Specific marketing and pricing plans are not available in the public domain or publicly available. To market LUPKYNIS, Aurinia engages in activities with healthcare providers and appropriate patients to increase awareness and understanding of lupus nephritis and this drug product which is the first oral treatment specifically approved for adult patients with active lupus nephritis.  When determining the price of LUPKYNIS, we considered the value that this innovative product offers to patients and the US healthcare system as a whole in the context of the lupus nephritis disease burden. Our objectives when setting the price for LUPKYNIS were to ensure that: Patients and clinicians have access to this new valuable treatment option; the healthcare system benefits from reduced economic disease burden from Lupus Nephritis; the value of LUPKYNIS relative to other treatment options is reflected; Aurinia can continue to invest in patient support and future innovation.",,100000,,1,,,,,"It is estimated that between 200-300K patients have systemic lupus erythematosus (SLE) in the US. Approximately 40-50% of those patients will develop lupus nephritis over their lifetime. There are no available population estimates that quantify the number of lupus nephritis patients with active disease. We expect that a subset of these lupus nephritis patients with active disease may be prescribed LUPKYNIS. + +The product was not acquired",,,,,,,,,,,,,,, +"Aurobindo Pharma USA, Inc.",59651037790,Droxidopa Capsules USP 300 mg 90/Bottle,2021-02-18,688.05,,1,5000,,,,,,,,https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=563,,,,,,,,,,,,,, +AuroMedics Pharma LLC,55150029710,"Dexmedetomidine HCl Injection, Single Dose Bag 400mcg/100mL - 10s",2021-02-10,800,we plan to market the drug to hospital customers,,100000,,,2020-12-07,,1,acquisition price is proprietary,"this is a generic drug, with several other manufacturers in the market. number of patients is an estimate",,,,,,,,,,,,,,, +AuroMedics Pharma LLC,55150027101,"Cyclophosphamide Injection, SDV 1g/5mL - 1s",2021-10-12,730,"We plan to market the drug to oncology physicians, clinics and hospitals",,65000,,,,,,,"This is a 505b2 drug, with other manufacturers and drug presentations in the market. Number of patients is an estimate.",,,,,,,,,,,,,,, +AuroMedics Pharma LLC,55150031625,"Isoproterenol Hydrochloride Injection USP, 0.2mg/1mL Ampules - 25s",2021-12-31,11250,We plan to market the drug to hospital customers,,5000,,,,,,,"This is a generic drug, with other manufacturers and drug presentations in the market. Number of patients is an estimate",,,,,,,,,,,,,,, +AuroMedics Pharma LLC,55150031710,"Isoproterenol Hydrochloride Injection USP, 1mg/5mL Ampules - 10s",2021-12-31,5450,We plan to market the drug to hospital customers,,5000,,,,,,,"This is a generic drug, with other manufacturers and drug presentations in the market. Number of patients is an estimate.",,,,,,,,,,,,,,, +"AVEO Pharmaceuticals, Inc.",45629008901,Fotivada Oral Capsule .89mg/cap,2021-03-24,24150,"Marketing: Fotivada is a treatment for relapsed or refractory advanced renal cell carcinoma (RCC) in adult patients. Aveo's marketing approach will focus on educating health care providers on how to diagnose and treat patients efficiently to relieve symptoms for patients. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support for Fotivada to ensure rapid access to therapy. + +Pricing: Fotivada has been developed for the treatment of relapsed or refractory advanced renal cell carcinoma (RCC). Fotivada provides an option to deliver a safe, effective treatment that reduces the symptoms in patients. Fotivada is priced responsibly compared to similar oncology agents with significant clinical benefit and disease modification. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage. Aveo demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind.",,48000,,,,,,,,,,,,,,,,,,,,,, +"AVEO Pharmaceuticals, Inc.",45629013401,Fotivada Oral Capsule 1.34mg/cap,2021-03-24,24150,"Marketing: Fotivada is a treatment for relapsed or refractory advanced renal cell carcinoma (RCC) in adult patients. Aveo's marketing approach will focus on educating health care providers on how to diagnose and treat patients efficiently to relieve symptoms for patients. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support for Fotivada to ensure rapid access to therapy. + +Pricing: Fotivada has been developed for the treatment of relapsed or refractory advanced renal cell carcinoma (RCC). Fotivada provides an option to deliver a safe, effective treatment that reduces the symptoms in patients. Fotivada is priced responsibly compared to similar oncology agents with significant clinical benefit and disease modification. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage. Aveo demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind.",,48000,,,,,,,,,,,,,,,,,,,,,, +AvKare,42291020516,PHENobarbital-Belladonna Alk Oral Elixir 16.2 MG/5ML,2021-03-16,1297.83,,1,3400000,,,,,,,This drug was not acquired,,,,,,,,,,,,,,, +AvKare,42291043930,Emtricitabine-Tenofovir DF Oral Tablet 200-300 MG,2021-04-12,861.36,,1,1200000,,,,,,,Drug was not acquired,,,,,,,,,,,,,,, +AvKare,50268033112,Flucytosine Oral Capsule 250 MG,2021-05-10,1631.77,,1,220000,,,,,,,,,,,,,,,,,,,,,, +AvKare,50268033212,Flucytosine Oral Capsule 500 MG,2021-05-10,3082.94,,1,220000,,,,,,,,,,,,,,,,,,,,,, +AvKare,42291007360,Abiraterone Acetate 500mg Tablet 60ct,2021-07-12,6339.58,,1,248530,,,,,,,Drug was not acquired,,,,,,,,,,,,,,, +B. Braun Medical Inc.,264440054,1 g of Magnesium Sulfate in 100 mL 5% Dextrose Injection,2021-09-09,153.12,"WAC pricing is based on B. Braun's assessment of costs to develop and produce the drug as well as an assessment of market pricing for similar products. At the time of entering the commercial market, the marketing plan for this drug was still in development and not available at the time of this notification. Marketing of this drug is expected to begin in October 2021.",,400000,,,,,,,"There was a question regarding the Course of Therapy and we were unable to calculate to cost until we resolved the question causing the delay in reporting. + + +The Prices noted herein are B. Braun's distributor in-to-stock prices for its authorized distributors, as published by third party database companies, such as Red Book, First Databank, Medi-Span and Gold Standard. B. Braun's in-to-stock prices may not represent actual transaction prices, and do not include prompt pay or other discounts, rebates, chargebacks, or other reductions in price. By providing a distributor in-to-stock price, B. Braun does not make any representation or suggestion concerning the amount for which any healthcare provider should be or should seek to be reimbursed or the likelihood of coverage or reimbursement for any referenced product. These prices should not be considered a reflection of the actual selling prices for products purchased from B. Braun or B. Braun's view of the actual prices at which B. Braun's products may be resold by wholesalers or other customers.",,,,,,,,,,,,,,, +B. Braun Medical Inc.,264420452,2 g of Magnesium Sulfate in 50 mL Water for Injection,2021-10-04,301.92,WAC pricing is based on B. Braun's assessment of costs to develop and produce the drug as well as an assessment of market pricing for similar products. Marketing for this drug will begin in early November through online display ads and email marketing.,,400000,,,,,,,""" +The Prices noted herein are B. Braun's distributor in-to-stock prices for its authorized distributors, as published by third party database companies, such as Red Book, First Databank, Medi-Span and Gold Standard. B. Braun's in-to-stock prices may not represent actual transaction prices, and do not include prompt pay or other discounts, rebates, chargebacks, or other reductions in price. By providing a distributor in-to-stock price, B. Braun does not make any representation or suggestion concerning the amount for which any healthcare provider should be or should seek to be reimbursed or the likelihood of coverage or reimbursement for any referenced product. These prices should not be considered a reflection of the actual selling prices for products purchased from B. Braun or B. Braun's view of the actual prices at which B. Braun's products may be resold by wholesalers or other customers. """,,,,,,,,,,,,,,, +"Bausch + Lomb, Inc.",71565004001,XIPERE (triamcinolone acetonide injectable suspension) 40mg/mL,2021-11-29,1650,,1,60000,,,,,,,"The product was not acquired. There are an estimated 60,000 patients that suffer from uveitic macular edema. We do not know how many patients will be prescribed XIPERE™.",,,,,,,,,,,,,,, +Baxter Healthcare Corporation,10019098201,Cyclo 25MG USP 100 TABLETS,2021-05-03,294.6,Oral Cyclophosphamide is a generic medication that has been on market for several years. Baxter intends to provide the product at competitive price based off the current market landscape today.,,5410,,,,,,,"Estimated Number of Patients: +This drug is used to treat various forms of cancer. It is difficult to estimate the number of patients based on calculations we estimate per month divided by the 2020 units sold per IQVIA. + +General Comment: Cyclophosphamide Tablet is prescribed based on diagnosis and weight of the patient. While there are instances in which the monthly supply of the drug could exceed the Medicare Specialty tier of $670.00 threshold based on the above stated factors triggering State Transparency Reporting per your State’s legislation. However, Baxter Healthcare Corporation does not believe the threshold will be exceeded often.",,,,,,,,,,,,,,, +Baxter Healthcare Corporation,10019098401,Cyclo 50MG USP 100 TABLETS,2021-05-03,420.99,Oral Cyclophosphamide is a generic medication that has been on market for several years. Baxter intends to provide the product at competitive price based off the current market landscape today.,,37139,,,,,,,"Estimated Number of Patients: +This drug is used to treat various forms of cancer. It is difficult to estimate the number of patients based on calculations we estimate per month divided by the 2020 units sold per IQVIA. + +General Comment: Cyclophosphamide Tablet is prescribed based on diagnosis and weight of the patient. While there are instances in which the monthly supply of the drug could exceed the Medicare Specialty tier of $670.00 threshold based on the above stated factors triggering State Transparency Reporting per your State’s legislation. However, Baxter Healthcare Corporation does not believe the threshold will be exceeded often.",,,,,,,,,,,,,,, +Biocon Limited,70377001322,Everolimus Tablets 10mg 28ct,2021-10-01,3141,"Launch of a generic pharmaceutical. Pricing and supply offers made to large GPOs with purchasing decision authority for retail, wholesale, and specialty outlets. GPOs include Red Oak Sourcing, Walgreens Boots Alliance Development, ClarusONE Sourcing Services, and Econdisc. Biocon will offer an eVoucherRx program to lower patient co-pays at the point of sale.",,13000,,,,,,,,,,,,,,,,,,,,,, +Biocon Limited,70377001022,Everolimus Tablets 2.5mg 28ct,2021-10-01,3141,"Launch of a generic pharmaceutical. Pricing and supply offers made to large GPOs with purchasing decision authority for retail, wholesale, and specialty outlets. GPOs include Red Oak Sourcing, Walgreens Boots Alliance Development, ClarusONE Sourcing Services, and Econdisc. Biocon will offer an eVoucherRx program to lower patient co-pays at the point of sale.",,13000,,,,,,,,,,,,,,,,,,,,,, +Biocon Limited,70377001122,Everolimus Tablets 5mg 28ct,2021-10-01,3141,"Launch of a generic pharmaceutical. Pricing and supply offers made to large GPOs with purchasing decision authority for retail, wholesale, and specialty outlets. GPOs include Red Oak Sourcing, Walgreens Boots Alliance Development, ClarusONE Sourcing Services, and Econdisc. Biocon will offer an eVoucherRx program to lower patient co-pays at the point of sale.",,13000,,,,,,,,,,,,,,,,,,,,,, +Biocon Limited,70377001222,Everolimus Tablets 7.5mg 28ct,2021-10-01,3141,"Launch of a generic pharmaceutical. Pricing and supply offers made to large GPOs with purchasing decision authority for retail, wholesale, and specialty outlets. GPOs include Red Oak Sourcing, Walgreens Boots Alliance Development, ClarusONE Sourcing Services, and Econdisc. Biocon will offer an eVoucherRx program to lower patient co-pays at the point of sale.",,13000,,,,,,,,,,,,,,,,,,,,,, +Biogen,64406001701,PLEGRIDY (peginterferon beta-1a) injection for intramuscular use is available in a carton (NDC: 64406-0017-01) containing two-125 mcg/0.5 mL single-dose prefilled syringes of PLEGRIDY,2021-03-01,7205.54,"Plegridy Intramuscular will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences for use in patients with Relapsing forms of Multiple Sclerosis. Biogen has a set of Pricing Principles that inform pricing decisions for its products. Those principles are: 1. Value to Patients 2. Present and Future Benefit to Society 3. Fullfilling our commitment to Innovation 4. Evolution toward Value Based Care and 5. Affordability & Sustainability. Further information can found at: https://www.biogen.com/content/dam/corporate/en_us/pdfs/BIOGEN_PricingPrinciplesInfographic_4-26-19.pdf",,504000,,,,,,,"PLEGRIDY (peginterferon beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. The estimated number of patients is based on 2021 prevalence estimates resulting from analyses of several data sources and publications.",,,,,,,,,,,,,,, +Biogen,64406010101,Aduhelm 170 mg/1.7 mL (100 mg/mL) single-dose vial,2021-06-15,952,"ADUHELM will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. +[Biogen has] engaged extensively with health economists, public health experts, and payers about ADUHELM – and we have examined other recent biologic drug innovations. Consistent with our pricing principles, we have established a price for ADUHELM that reflects the overall value this treatment brings to patients, caregivers and society – and one that will enable continuous innovation. We have determined the launch price of ADUHELM based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials. Biogen has established the price of ADUHELM based on the overall value this treatment is expected to bring to patients, caregivers, and society, while reflecting key principles such as innovation, access and sustainability. The wholesale acquisition cost (WAC) of ADUHELM, which is an infusion once every four weeks, is $4,312 per infusion for a patient of 74 kg–the average weight of a U.S. patient with mild cognitive impairment (MCI) or mild dementia. The yearly cost at the maintenance dose (10 mg/kg) would be $56,000. The cost during the first year of treatment will be lower due to the titration period. WAC is a list price and not the net price or the price paid by patients with insurance. +Biogen has a set of Pricing Principles that inform pricing decisions for its products. Those principles are: 1. Value to Patients, 2. Present and Future Benefit to Society, 3. Fulfilling our commitment to Innovation, 4. Evolution toward Value Based Care, and 5. Affordability & Sustainability. +Further information can be found at: +https://www.biogen.com/content/dam/corporate/en_us/pdfs/BIOGEN_PricingPrinciplesInfographic_4-26-19.pdf",,2000000,,1,,,,,"With regards to the ""ESTIMATED_PATIENTS"", based on the entry criteria of the clinical trials conducted with ADUHELM, we estimate the appropriate patient population for ADUHELM to be approximately 1-2 million. These are patients who have been clinically diagnosed with mild cognitive impairment or mild dementia suspected to be due to Alzheimer’s disease who would have confirmed amyloid beta pathology, if tested.It is important to note that we do not expect all of these patients will be treated with ADUHELM, for a variety of reasons, including appropriate patient selection criteria, a complex diagnostic and care pathway and limited capacity of specialists, who we believe will be the primary prescribers of ADUHELM. As a result of these factors, we anticipate that patient uptake will be gradual over a number of years.",,,,,,,,,,,,,,, +Biogen,64406010202,Aduhelm 300 mg/3 mL (100 mg/mL) single-dose vial,2021-06-15,1680,"ADUHELM will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. +[Biogen has] engaged extensively with health economists, public health experts, and payers about ADUHELM – and we have examined other recent biologic drug innovations. Consistent with our pricing principles, we have established a price for ADUHELM that reflects the overall value this treatment brings to patients, caregivers and society – and one that will enable continuous innovation. We have determined the launch price of ADUHELM based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials. Biogen has established the price of ADUHELM based on the overall value this treatment is expected to bring to patients, caregivers, and society, while reflecting key principles such as innovation, access and sustainability. The wholesale acquisition cost (WAC) of ADUHELM, which is an infusion once every four weeks, is $4,312 per infusion for a patient of 74 kg–the average weight of a U.S. patient with mild cognitive impairment (MCI) or mild dementia. The yearly cost at the maintenance dose (10 mg/kg) would be $56,000. The cost during the first year of treatment will be lower due to the titration period. WAC is a list price and not the net price or the price paid by patients with insurance. +Biogen has a set of Pricing Principles that inform pricing decisions for its products. Those principles are: 1. Value to Patients, 2. Present and Future Benefit to Society, 3. Fulfilling our commitment to Innovation, 4. Evolution toward Value Based Care, and 5. Affordability & Sustainability. +Further information can be found at: +https://www.biogen.com/content/dam/corporate/en_us/pdfs/BIOGEN_PricingPrinciplesInfographic_4-26-19.pdf",,2000000,,1,,,,,"With regards to the ""ESTIMATED_PATIENTS"", based on the entry criteria of the clinical trials conducted with ADUHELM, we estimate the appropriate patient population for ADUHELM to be approximately 1-2 million. These are patients who have been clinically diagnosed with mild cognitive impairment or mild dementia suspected to be due to Alzheimer’s disease who would have confirmed amyloid beta pathology, if tested.It is important to note that we do not expect all of these patients will be treated with ADUHELM, for a variety of reasons, including appropriate patient selection criteria, a complex diagnostic and care pathway and limited capacity of specialists, who we believe will be the primary prescribers of ADUHELM. As a result of these factors, we anticipate that patient uptake will be gradual over a number of years.",,,,,,,,,,,,,,, +Bristol Myers Squibb,73153090001,"Breyanzi packed in a carton containing up to 4 vials, depending upon the concentration of the cryopreserved drug product CAR-positive viable T cells",2021-02-08,410300,"We consider multiple factors when setting a list price for a medicine, including: +• The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. +• Market and business considerations, including: +• Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world; +• Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply +To market Breyanzi, Bristol-Myers Squibb has, to date, engaged in the following activities: • Direct-To-Consumer Marketing: Developing digital, web-based and print advertisements that are distributed through mobile applications and websites. + +• Healthcare Professional Marketing Practices: Developing web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, and magazines; developing a peer-to-peer speaker program; hosting promotional booths at conferences attended by healthcare professionals",,130,1,1,2019-11-20,74000000000,,BMS obtained rights for BREYANZI as part of Celgene acquisition. This acquisition did not consist of costs for individual assets,"Based on 2020 Q1-Q2 earnings reports, CAR T commercially infused patients have been estimated to be around 140 patients per month (roughly 800 patients in the first 2 QTRs). BMS is unable to provide an estimate of the number of patients who will be prescribed BREYANZI each month",,,,,,,,,,,,,,, +Bristol Myers Squibb,59572051502,ABECMA® 250 mL infusion bag and metal cassette,2021-03-26,419500,"We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply",,1680,1,1,2019-11-20,74000000000,,BMS obtained rights for ABECMA as part of Celgene acquisition. This acquisition did not consist of costs for individual assets,"Comment regarding Field 7: Based on 2020 Q1-Q2 earnings reports, CAR T commercially infused patients have been estimated to be around 140 patients per month (roughly 800 patients in the first 2 QTRs). BMS is unable to provide exact number of patients who will be prescribed ABECMA each month",,,,,,,,,,,,,,, +Bristol Myers Squibb,59572051501,ABECMA® 50 mL infusion bag and metal cassette,2021-03-26,419500,"We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply",,1680,1,1,2019-11-20,74000000000,,BMS obtained rights for ABECMA as part of Celgene acquisition. This acquisition did not consist of costs for individual assets,"Comment regarding Field 7: Based on 2020 Q1-Q2 earnings reports, CAR T commercially infused patients have been estimated to be around 140 patients per month (roughly 800 patients in the first 2 QTRs). BMS is unable to provide exact number of patients who will be prescribed ABECMA each month",,,,,,,,,,,,,,, +Bristol Myers Squibb,59572051503,ABECMA® 500 mL infusion bag and metal cassette,2021-03-26,419500,"We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply",,1680,1,1,2019-11-20,74000000000,,BMS obtained rights for ABECMA as part of Celgene acquisition. This acquisition did not consist of costs for individual assets,"Comment regarding Field 7: Based on 2020 Q1-Q2 earnings reports, CAR T commercially infused patients have been estimated to be around 140 patients per month (roughly 800 patients in the first 2 QTRs). BMS is unable to provide exact number of patients who will be prescribed ABECMA each month",,,,,,,,,,,,,,, +"ChemoCentryx, Inc.",73556016801,"TAVNEOS (avacopan) 10 mg capsules, 1 x 180",2021-10-18,14450,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat adults diagnosed with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)), in line with the TAVNEOS?? Prescribing Information. Promotional activities to HCPs include sales representative detailing with appropriate supporting materials, journal ads, speaker programs, congress participation and non-personal promotion such as an HCP website, www.tavneos.com, search, banner advertising, and other digital educational programming. There is no sample program and no free trial offers for consumers. +Direct-to-consumer activities may include a patient website (with accompanying digital promotion), patient brochures, and additional resources such as a peer program or welcome kit. The purpose of the website, drivers to website, and brochure is to educate patients on the availability of new treatment options aligned to the TAVNEOS Prescribing Information and Medication Guide, including Important Safety Information. There is no direct-to-consumer marketing for TAVNEOS via TV. + +ChemoCentryx considers multiple factors when setting a list price for a medicine, such as the following: 1. Value of the drug to patients; 2. The clinical and economic value of the drug; 3. Overall research and development costs; 4. Commitment to R&D and Innovation; 5. Cost of comprehensive patient support programs to ensure patient access.",,1000,,,,,,,,,,,,,,,,,,,,,, +"ChemoCentryx, Inc.",73556016802,"TAVNEOS (avacopan) 10 mg capsules, 1 x 30",2021-10-18,2408,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat adults diagnosed with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)), in line with the TAVNEOS?? Prescribing Information. Promotional activities to HCPs include sales representative detailing with appropriate supporting materials, journal ads, speaker programs, congress participation and non-personal promotion such as an HCP website, www.tavneos.com, search, banner advertising, and other digital educational programming. There is no sample program and no free trial offers for consumers. +Direct-to-consumer activities may include a patient website (with accompanying digital promotion), patient brochures, and additional resources such as a peer program or welcome kit. The purpose of the website, drivers to website, and brochure is to educate patients on the availability of new treatment options aligned to the TAVNEOS Prescribing Information and Medication Guide, including Important Safety Information. There is no direct-to-consumer marketing for TAVNEOS via TV. + +ChemoCentryx considers multiple factors when setting a list price for a medicine, such as the following: 1. Value of the drug to patients; 2. The clinical and economic value of the drug; 3. Overall research and development costs; 4. Commitment to R&D and Innovation; 5. Cost of comprehensive patient support programs to ensure patient access.",,1000,,,,,,,,,,,,,,,,,,,,,, +Chiesi USA,10122021256,Bronchitol 4-Week Carton (56ct carton),2021-03-03,3482,"Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by Healthcare Providers (HCPs) most likely to manage patients with cystic fibrosis, materials to be used by sales representatives to share information on Bronchitol with HCPs who treat patients with cystic fibrosis or prescribe Bronchitol to such patients, and materials to educate patients about cystic fibrosis and Bronchitol.  Sustainability has always been important for Chiesi, but today it is part of our strategic plan. This means that we are committed to improving the quality of life of patients, to protect the planet and its inhabitants, to put ourselves at the service of the community, to encourage the growth of our people, and to guarantee the maximum transparency of our work.",,622,,,,,,,Acquired while in development; Approved while owned by Chiesi USA.,,,,,,,,,,,,,,, +Chiesi USA,10122021214,Bronchitol 7-Day Carton (14ct carton),2021-03-03,870.5,"Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by Healthcare Providers (HCPs) most likely to manage patients with cystic fibrosis, materials to be used by sales representatives to share information on Bronchitol with HCPs who treat patients with cystic fibrosis or prescribe Bronchitol to such patients, and materials to educate patients about cystic fibrosis and Bronchitol.  Sustainability has always been important for Chiesi, but today it is part of our strategic plan. This means that we are committed to improving the quality of life of patients, to protect the planet and its inhabitants, to put ourselves at the service of the community, to encourage the growth of our people, and to guarantee the maximum transparency of our work.",,622,,,,,,,Acquired while in development; Approved while owned by Chiesi USA.,,,,,,,,,,,,,,, +Chiesi USA,10122010305,FERRIPROX 1000mg (TID) FILM COATED TABLETS,2021-09-25,7215.73,"Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by Healthcare Providers (HCPs) most likely to manage patients with thalassemia, sickle cell disease, and other anemias.  Sustainability has always been important for Chiesi, but today it is part of our strategic plan.  This means that we are committed to improving the quality of life of patients, to protect the planet and its inhabitants, to put ourselves at the service of the community, to encourage the growth of our people, and to guarantee the maximum transparency of our work.",,650,,,,,,,New NDC reflecting manufacturer's labeler code.,,,,,,,,,,,,,,, +Chiesi USA,10122010010,FERRIPROX 500mg FILM COATED TABLETS,2021-11-01,7215.73,"Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by Healthcare Providers (HCPs) most likely to manage patients with thalassemia, sickle cell disease, and other anemias.  Sustainability has always been important for Chiesi, but today it is part of our strategic plan.  This means that we are committed to improving the quality of life of patients, to protect the planet and its inhabitants, to put ourselves at the service of the community, to encourage the growth of our people, and to guarantee the maximum transparency of our work.",,730,,,,,,,New NDC reflecting manufacturer's labeler code.,,,,,,,,,,,,,,, +Cintex Services LLC,24470092360,Chlorzoxazone Tablets USP 250 mg,2021-09-23,1194,,1,12000,,,,,,,"ANDA 215158 for this product was approved on 07/29/21. The approval owner was Senores Pharma. Cintex subsequently obtained marketing rights from Senores for this product, which will be sold under the Cintex label, NDC number 24470-0923-60. The begin marketing date/entry to marker for this NDC is 09/23/21.",,,,,,,,,,,,,,, +"Civica, Inc",72572003510,Bivalirudin Trifluoroacetate IV 250 mg 10 pack,2021-01-01,1094.7,,1,427081,,,2020-12-21,,1,"Civica is selling under a product supply agreement under the manufacturer. There was no licensing fee, or acquisition price, only a fee per unit purchased from the manufacturer",,,,,,,,,,,,,,,, +"Dash Pharmaceuticals, LLC",69339013012,Zileuton ER Tablets,2021-01-04,3222.04,This product will only be marketed in the US. DASH plans to sell this product to major wholesale distributors at a price that is competitive with the other AB Rated Zileuton generic products currently in the marketplace.,,6829,,,2021-01-04,,1,"DASH is selling under a licensing agreement from the manufacturer. There was no licensing fee, just a profit split in the marketing arrangement.",,,,,,,,,,,,,,,, +"Dash Pharmaceuticals, LLC",69339014819,Sucralfate Oral Suspension,2021-02-25,899.7,Product will be priced competitively with other equivalent generics currently in the marketplace.,,134,,,,,,,,,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598065101,Vigabatrin Tablets USP 500mg US 100s,2021-02-01,10511.89,,1,400000,,1,,,,,"Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Vigabatrin Tablet 500MG product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) Vigabatrin tablets dosing regimen depends on the indication, age group, weight, and dosage form (tablets or powder for oral solution). Because of the risk of vision loss, Vigabatrin should be withdrawn from patients with refractory complex partial seizures who fail to show substantial clinical benefit within 3 months of initiation and within 2 to 4 weeks of initiation for patients with infantile spasms, or sooner if treatment failure becomes obvious.(iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. In any event, roughly 400,000 people living in the United States are likely to have refractory epilepsy.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598047730,"Sapropterin Dihydrochloride Sachets, 100 mg, 30 ct",2021-04-06,870.48,,1,19000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Organization for Rare Disorders, the reported incidence of Phenylketonuria (PKU) from newborn screening programs ranges from one in 13,500 to 19,000 newborns in the United States However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Sapropterin dihydrochloride sachets 100mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598045202,Albendazole Tabs USP 200mg US 2s,2021-04-28,80,,1,1300,,,,,,,"1) Though the WAC is only $80 per package, the drug exceeds the threshold based on monthly usage. 2) Dr. Reddy’s did not acquire the product",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598090158,"Ertapenem for Injection 1g per vial,10s",2021-05-10,1000,,1,250000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. However, we listed the number of cases of pyelonephritis in the US, which is one of the conditions this product treats, for reference. 2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from Gland Pharma Ltd.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598062857,"Carmustine for Injection, USP 100mg/vial",2021-10-14,750,,1,700000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with other generics available. The patient size provided is the number of Americans with brain tumor, which this chemotherapy drug is used to treat. 2) Dr. Reddy’s did not acquire the product as this product is a DRL-owned ANDA.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598047611,"Daptomycin for Injection, 350mg/vial",2021-10-14,40,,1,165000,,,,,,,"1. Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with other generics available. The estimate provided is based on the incidence rate of staphylococcus aureus bacteremia in the US, which this drug is used to treat. 2. Dr. Reddy’s did not acquire the product as this product is a DRL-owned ANDA.3. Although the WAC per package is only $40, the monthly course of therapy exceeds the threshold of $670.",,,,,,,,,,,,,,, +"Eiger BioPharmaceuticals, Inc.",73079005030,Zokinvy Oral Capsule 50 MG 30 pack,2021-01-25,21510,"ZOKINVY is the first and only FDA approved treatment for Progeria (Hutchinson-Gilford Progeria Syndrome, or HGPS) and Processing Deficient Progeroid Laminopathies, very rare genetic diseases causing children to age rapidly resulting in a median survival rate of 14.5 years for patients that are not treated with ZOKINVY. As a general matter, Eiger's activities supporting the launch are designed to educate providers about the approved indication, efficacy and safety data contained within the FDA approved label. + +If requested, educational materials will be provided to patients and families to support drug access and affordability for ZOKINVY to ensure rapid access to this critical therapy. Eiger is committed in ensuring availability of its products to those patients in need. Eiger considered its price determination with comparisons to similar ultra-orphan agents with significant clinical benefit and disease modification as well as development costs, complexity of manufacturing, distribution, access, education, and storage.",,15,1,1,,,,,,,,,,,,,,,,,,,, +"Eiger BioPharmaceuticals, Inc.",73079007530,Zokinvy Oral Capsule 75 MG 30 pack,2021-01-25,32265,"ZOKINVY is the first and only FDA approved treatment for Progeria (Hutchinson-Gilford Progeria Syndrome, or HGPS) and Processing Deficient Progeroid Laminopathies, very rare genetic diseases causing children to age rapidly resulting in a median survival rate of 14.5 years for patients that are not treated with ZOKINVY. As a general matter, Eiger's activities supporting the launch are designed to educate providers about the approved indication, efficacy and safety data contained within the FDA approved label. + +If requested, educational materials will be provided to patients and families to support drug access and affordability for ZOKINVY to ensure rapid access to this critical therapy. Eiger is committed in ensuring availability of its products to those patients in need. Eiger considered its price determination with comparisons to similar ultra-orphan agents with significant clinical benefit and disease modification as well as development costs, complexity of manufacturing, distribution, access, education, and storage.",,15,1,1,,,,,,,,,,,,,,,,,,,, +Eli Lilly and Company,2121001,TAUVID™ injection for intravenous use 10 mCi 1 syringe,2021-01-11,3500,,1,910000,,1,,,,,"TAUVID™, a radioactive diagnostic agent, was approved by the FDA in May 2020 for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD). + +Based on Alzheimer's Disease Facts and Figures, [https://www.alz.org/media/Documents/alzheimers-facts-and-figures.pdf], the incidence of Alzheimer's in the United States is 910,000 per year (an average of 75,833/month). Patients with Alzheimer's may or may not be prescribed TAUVID for use in diagnostic imaging. + +In 2013, Lilly announced that it had acquired two investigational positron emission tomography (PET) tracers from Siemens Molecular Imaging, Inc. One of the acquired tracers was flortaucipir F 18. Pursuant to California SB 17, Lilly is limiting its response to what is in the public domain or otherwise publicly available. Lilly does not believe the acquisition date or cost is in the public domain. [https://investor.lilly.com/news-releases/news-release-details/lilly-acquires-novel-tau-tangle-diagnostic-program-bolster] + +All information is provided by Eli Lilly and Company (""Lilly"") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=464,,,,,,,,,,,,,, +Epic Pharma,42806056201,Chlordiazepoxide Hcl Cap 10mg 100ct,2021-06-17,1686,,1,1940,,,,,,,,,,,,,,,,,,,,,, +Epic Pharma,42806056301,Chlordiazepoxide Hcl Cap 25mg 100ct,2021-06-17,1786,,1,2825,,,,,,,,,,,,,,,,,,,,,, +Estreno Pharma,72763020110,"Tavaborole Topical Solution, 5%",2021-02-11,1284.2,Generic launch- priced with competitive market.,,45000000,,,,,,,"ANDA approved 2/3/2021 + +ANDA approval was in the name of Flatwing Pharmaceuticals, the ANDA was just transferred to IdentiRx of which Estreno Pharmaceuticals is the distributor for IdentiRx. Estreno controls the WAC.",,,,,,,,,,,,,,, +"Eton Pharmaceuticals, Inc.",71863011460,Carglumic acid tablet for oral suspension 200mg,2021-12-20,10921.8,"""To market CARGLUMIC ACID, Eton designed activities to increase awareness and understanding with healthcare providers about CARGLUMIC ACID. Marketing activities will include education and training provided by our sales force and by contracted speakers to health care providers. Consumer-directed communications to educate patients on the disease state and CARGLUMIC ACID are planned. At Eton, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations. + +The product is launching at a price 18% lower than the branded product to provide broader access to the drug at a lower cost for patients. Eton's pricing plan is set for CARGLUMIC ACID prices at approximately cost plus a margin to cover Eton's overhead and research and development expenses. """,,10,,,2021-10-28,3250000,,,,,,,,,,,,,,,,,, +"Exelan Pharmaceuticals, Inc.",76282067830,Efavirenz-Emtricitab-Tenofovir Oral Tablet 600-200-300 MG,2021-04-27,1599.9,,1,1200000,,,,,,,Product not acquired,,,,,,,,,,,,,,, +"Exelan Pharmaceuticals, Inc.",76282067730,EMTRICITABINE AND TENOFOVIR DF TAB 200mg/300mg,2021-05-07,852.53,,1,1200000,,,,,,,Product not acquired,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219019030,VORICONAZOLE (voriconazole) 200mg Each,2021-02-02,60,,1,2000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,63323087550,FOSCARNET 6000 mg per 250 mL,2021-02-11,472.77,,1,1000,,,,,,,FOSCARNET is not an acquired product.,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219020005,TEMSIROLIMUS (temsirolimus) 25mg/ml,2021-05-03,1180,,1,2186,,,,,,,,,,,,,,,,,,,,,, +"G1 Therapeutics, Inc.",73462010101,"COSELA (trilaciclib) for injection, 300mg",2021-03-01,1417,,1,21000,1,1,,,,,,,,,,,,,,,,,,,, +Genentech USA,50242007855,"Susvimo, 10mg/0.1ml Vial with Initial Fill Needle",2021-11-29,8000,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. + +We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,288,,,,,,,"Estimated number of patients per year. + +Susvimo Fill Needle was not acquired from a 3rd party.",,,,,,,,,,,,,,, +Genentech USA,50242007812,"Susvimo, 10mg/0.1ml Vial, Refill Needle",2021-11-29,8000,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. + +We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,84,,,,,,,"Estimated number of patients for Susvimo refill needle is per year. + +Susvimo was not acquired from a 3rd party.",,,,,,,,,,,,,,, +"Gilead Sciences, Inc.",61958220501,"EPCLUSA® (sofosbuvir 150mg/velpatasvir 37.5mg) oral pellets, 28 packets",2021-10-18,24920,,1,,,1,,,,,"The information provided in this report is subject to general limitations and assumptions Gilead has shared with HCAI (previously known as OSHPD). The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Gilead believes is in the public domain or otherwise publicly available. + +EPCLUSA oral pellets were granted orphan drug status by the FDA since it is estimated that, for the product, less than 200,000 patients in the U.S. are affected by a condition that it may be used to treat. However, Gilead is not aware of publicly available information related to the estimated number of patients that may be treated with EPCLUSA oral pellets. Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is unable to provide an estimated number of patients in its report. + +Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product.",,,,,,,,,,,,,,, +"Gilead Sciences, Inc.",61958220401,"EPCLUSA® (sofosbuvir 200mg/velpatasvir 50mg) oral pellets, 28 packets",2021-10-18,24920,,1,,,1,,,,,"The information provided in this report is subject to general limitations and assumptions Gilead has shared with HCAI (previously known as OSHPD). The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Gilead believes is in the public domain or otherwise publicly available. + +EPCLUSA oral pellets were granted orphan drug status by the FDA since it is estimated that, for the product, less than 200,000 patients in the U.S. are affected by a condition that it may be used to treat. However, Gilead is not aware of publicly available information related to the estimated number of patients that may be treated with EPCLUSA oral pellets. Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is unable to provide an estimated number of patients in its report. + +Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product.",,,,,,,,,,,,,,, +GlaxoSmithKline,173089803,JEMPERLI INJ 500MG/10ML,2021-04-23,10369.38,,1,2663,1,1,,,,,"Endometrial cancer is a main type of uterine cancer that forms in the inner lining of the uterus, known as the endometrium. Endometrial cancer can be classified as mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or mismatch repair-proficient/microsatellite stable. There are limited treatment options for women whose disease progresses on or after first-line therapy.? Nearly 60,000 new cases of endometrial cancer are expected in the US in 2021, making endometrial cancer the most common gynaecologic malignancy in the US. Approximately 25% of women with endometrial cancer will be diagnosed with advanced disease or will experience a recurrence. Of these, approximately 25% will be mismatch repair deficient with 71% or approximately 2,663 patients having progressed on prior platinum-based chemotherapy and therefore eligible for JEMPERLI. Diagnosed patients may or may not be prescribed JEMPERLI (NDC: 00173089803) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with JEMPERLI (NDC: 00173089803). +GSK has not released JEMPERLI's (NDC: 00173089803) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462037130,"Topiramate Extended-Release Capsules USP, 200 mg",2021-02-05,730.38,,1,152914,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending December 2020 is 152,914 total prescriptions. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462071308,RUFINAMIDE TABS 200MG 120,2021-06-01,901.14,,1,82125,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending April 2021 is 82,125 total prescriptions. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462071408,RUFINAMIDE TABS 400MG 120,2021-06-01,1802.27,,1,82125,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending April 2021 is 82,125 total prescriptions. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462068401,Sirolimus Tablets 2 mg,2021-06-03,2777.54,,1,209827,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending April 2021 is 209,827 prescriptions. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462083365,Arformoterol Tartrate Inhalation Solution 15 mcg/2ml 60X2ml,2021-06-23,1026.54,,1,279013,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending May 2021 is 279,013 total prescriptions. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010049709,"Metformin Hydrochloride Extended-Release Tablets, USP 1000MG",2021-02-12,2625,,1,1000,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Granules Pharmaceuticals Inc.,70010049601,"Metformin Hydrochloride Extended-Release Tablets, USP 500MG",2021-02-12,1615,,1,1000,,,,,,,The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission.,,,,,,,,,,,,,,, +Heritage Pharmacueticals Inc. D/B/A Avet Pharmacueticals Inc,23155054025,Doxercalciferol Capsules 2.5 mg 50 ct,2021-02-24,695,,1,250,,,,,,,,,,,,,,,,,,,,,, +Heritage Pharmacueticals Inc. D/B/A Avet Pharmacueticals Inc,23155074841,Pentamidine Isethionate for Injection 300mg 10 pack,2021-05-25,977,,1,3500,,,,,,,,,,,,,,,,,,,,,, +Heritage Pharmacueticals Inc. D/B/A Avet Pharmacueticals Inc,23155079041,Carmustine for Injection 100 mg i Vial Private Label,2021-07-06,1226,,1,700,,,2012-11-28,,1,,,,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54048013,"Everolimus Tablets 2.5mg, Bottle of 30",2021-02-10,12012.98,,1,76080,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma is replacing previously launched NDC #00054-0480-14 (blister pack of 28 tablets) with a new package configuration of 30 tablets per bottle. + +Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2021 approximately76,080 people will be diagnosed with advanced renal cell carcinoma.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54363063,"Naproxen Oral Suspension, USP, 125mg per 5mL, 500mL Bottle",2021-02-22,896.44,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,29000000,,,2015-07-28,2650000000,,"The ANDA for Naproxen OS was acquired along with all of the assets of Roxane Laboratories, Inc. in a transaction which closed February 29, 2016. Total acquisition price was 2,650,000,000.00 including the Naproxen ANDA.","Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. + +Hikma has not evaluated the volume of patients in the USA. Naproxen oral suspension is a non-steroidal anti-inflammatory drug indicated for the relief of the signs and symptoms of: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, tendonitis, bursitis, acute gout; and the management of: pain and primary dysmenorrhea. According to sciencedaily.com, about 29 million Americans use over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs) to treat pain.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54057625,"Deferiprone Tablets, 500mg, 1 bottle of 100",2021-05-29,6148.08,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,1000,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Deferiprone is indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. According to the Boston Children's Hospital, in the United States, there are only about 1,000 people with thalassemia major",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54042623,"Rufinamide Tablets, 400mg, 1 bottle of 120",2021-05-30,737.04,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,86060,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Rufinamide is indicated as adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (""LGS"") in pediatric patients 1 year of age and older and in adults. The incidence of LGS is estimated at approximately 26 per 100,000 people. Therefore, there are approximately 86,060 patients in the United States.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54048113,"Everolimus Tablets, 5mg, bottle of 30",2021-06-07,12565.37,This is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,76080,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma is replacing previously launched NDC #00054-0481-14 (blister pack of 28 tablets) with a new package configuration of 30 tablets per bottle. + +Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2021 approximately 76,080 people will be diagnosed with advanced renal cell carcinoma.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,143929910,"Ganciclovir for Injection, 500mg, 20mL",2021-06-14,684,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,10000000,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Ganciclovir is indicated for the treament of CMV retinitis in immunocompromised adult patients; or prevention of CMV disease in adult transplant recipients. According to the Medline Plus, approximately 50% and 80% of adults in the US have had a CMV infection by age 40.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,143939810,"Ertapenem for Injection, 1GM, vial size 20mL, 10 vial package",2021-08-16,900,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,13100,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. + +Hikma has not evaluated the volume of patients in the USA. Ertapenem Injection is a penem antibacterial indicated for the treatment of moderate to severe infections caused by susceptible bacteria. According to the CDC.gov, in 2017 CRE (""carbapenem-resistant Enterobacterales"") caused an estimated 13,100 infections in the United States.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54049713,"Everolimus Tablets, 7.5mg, bottle of 30",2021-08-23,12565.37,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,76080,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma is replacing previously launched NDC #00054-0497-14 (blister pack of 28 tablets) with a new package configuration of 30 tablets per bottle. + +Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2021 approximately 76,080 people will be diagnosed with advanced renal cell carcinoma.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54060421,"Everolimus Tablets, 1mg, Bottle of 60",2021-11-19,1902.85,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,106859,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. + +Hikma has not evaluated the volume of patients in the USA. Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: kidney and liver transplant. According to organdonor.gov, there are approximately 106,859 people on the national transplant waiting list.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54048213,"Everolimus Tablets, 10mg, Bottle of 30",2021-11-23,6714.62,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,70080,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. + +Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2021 approximately 76,080 people will be diagnosed with advanced renal cell carcinoma.",,,,,,,,,,,,,,, +"Impel NeuroPharma, Inc.",77530072504,"TRUDHESA™, DHE Nasal Spray, 1.45mg, 4 single-dose units",2021-09-17,850,,1,67000,,,,,,,"1= Proprietary, non public information",,,,,,,,,,,,,,, +Incyte Corporation,50881000705,Opzelura (ruxolitinib) cream 1.5% 60gm tube,2021-10-04,1950,"""To market OPZELURA, Incyte designed activities to increase awareness and understanding with healthcare providers about OPZELURA. Marketing activities will include education and training provided by our sales force and by contracted speakers to health care providers. Consumer-directed communications to educate patients on the disease state and OPZELURA are planned. At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations. + +OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.""",,5500000,,1,,,,,"Comment regarding Field 7: Provide source of population data (e.g. IQVIA) or explanation ""Incyte's estimated volume of patients who may be prescribed OPZELURA is not available in the public domain. Estimated population is derived from the following publically available information . . ."" Comment regarding Fields 8 and 9: Acquisition fields left blank as drug was developed by Incyte. General Comment: In the event 2017 California Senate Bill 17 (“SB-17”) and the laws it implements, including Cal. Health & Safety Code § 127677, are found unconstitutional or otherwise unlawful, Incyte reserves all of its legal rights. In issuing this report in an attempt to comply with Cal. Health & Safety Code § 127677, Incyte does not waive any legal claims or legal rights related to SB-17. Please note that portions of this report and its contents may be exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes Incyte’s proprietary commercial information and otherwise would not be in the public interest to disclose. We ask that you please contact the Incyte legal department at 1801 Augustine Cut-Off, Wilmington, DE 19803 if you receive any PRA requests so that we may take appropriate steps to work with you to protect such information.",,,,,,,,,,,,,,, +"Ingenus Pharmaceuticals, LLC",50742052110,Cyclophosphamide 200mg 10ml Injection,2021-12-17,1465,"Ingenus prices their products based on the current market conditions along with a number of variables. All of these product specific variables are entered into a pricing model and pricing is determined. Some examples ( not all ) are cost of goods, profit share, freight costs, product volume, customer specific volumes, the COT/channels the specific product is sold in, rebates, chargebacks, contractual obligations. These factors vary product by product and aren’t all applicable in every case.",,30000,,,,,,,"As a manufacturer, Ingenus does not estimate the number of patients that may be prescribed our products. We manufacturer volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. Acquisition is not applicable.",,,,,,,,,,,,,,, +"Janssen Biotech, Inc.",57894050101,"RYBREVANT™ (amivantamab-vmjw), Strength: 350mg/7mL, Form: 1 Single Vial",2021-05-24,2986.43,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion. The pricing plan has WAC set for 350 mg / 7 mL vial at $2,986.43. The list price of RYBREVANT™ is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. RYBREVANT™ will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. International approvals are pending.",,,1,1,,,,,The estimated number of patients in the United States with a condition for which RYBREVANT™ may be prescribed is not in the public domain or publicly available.,,,,,,,,,,,,,,, +"Janssen Pharmaceuticals, Inc. ",50458070714,PONVORY™ (ponesimod) Starter Pack Strength:10MG Form:Tablet,2021-03-24,3772.3,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with Relapsing forms of Multiple Sclerosis (RMS). The pricing plan has WAC set for the Multiple Strength, Titration Pack 14 set at $3,772.30. The list price of PONVORY is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. PONVORY will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. International approvals are pending.",,,,,,,,,Janssen's estimated volume of patients who may be prescribed PONVORY is not available in the public domain. This was not an acquisition.,,,,,,,,,,,,,,, +"Janssen Pharmaceuticals, Inc. ",50458072030,PONVORY™ (ponesimod) Strength:20MG Form:Tablet,2021-03-24,8083.5,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with Relapsing forms of Multiple Sclerosis (RMS). The pricing plan has WAC set for a 30 day supply of the 20 mg maintenance dose at $8,083.50. The list price of PONVORY is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. PONVORY will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. International approvals are pending.",,,,,,,,,Janssen's estimated volume of patients who may be prescribed PONVORY is not available in the public domain. This was not an acquisition.,,,,,,,,,,,,,,, +"Janssen Pharmaceuticals, Inc. ",50458057501,"XARELTO® for Oral Suspension Strength: 1 mg/mL, Form: Suspension, Reconstituted, Oral",2021-12-28,492.5,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market XARELTO® for Oral Suspension in the US through non-personal channels to appropriate healthcare professionals who treat pediatric patients that fall within approved indications. The pricing plan has WAC set for 155mg at $492.50 for a 30-day maintenance dose. . The list price of XARELTO® for Oral Suspension is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. XARELTO® for Oral Suspension will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs.",,1560,,,,,,,"The 1,560 estimated number of patients reflects the CDC.gov estimate of the annual incidence of Venous Thromboembolism (VTE) in children of up to 2.1 per 100,000, applied to the US child population of 74.3 million (from childstats.gov.)",,,,,,,,,,,,,,, +"Jazz Pharmaceuticals, Inc.",68727090003,"Rylaze, one carton containing 3 single dose vials, each single dose vial contains 10 mg/0.5 mL solution of asparaginase erwinia chrysanthemi (recombinant)-rywn",2021-07-15,13170,,1,6000,,,,,,,,,,,,,,,,,,,,,, +"Kadmon Pharmaceuticals, LLC",79802020030,REZUROCK™ (belumosudil) tablets,2021-08-15,15500,"Kadmon announced the product’s approval and also made available, through healthcare professionals, patient savings and support programs, which includes co-pay savings for eligible commercial patients. Marketing initiatives include print and digital media, engagement at scientific meetings and speaker events attended by HCPs most likely to manage patients with chronic graft-versus-host disease (cGVHD), materials to be used by sales representatives to share information on REZUROCKTM with prescribers, and materials to educate patients about cGVHD. Pricing methodology is based on cost (including development and manufacturing costs) and the market (including the current number of branded and generic competitors and the number of competitors expected to enter the market). Kadmon established its WAC price at $15,500 for a 30-count bottle of REZUROCKTM (belumosudil) tablets based on, amongst other factors, its unique clinical value and the pricing of other branded products for the same disease. At the same time, Kadmon set its WAC at a level it hopes will enable it, among other things, to i) recoup the significant costs it incurred in evaluating the economic and intellectual property landscape surrounding a prospective product, sponsoring the clinical trials, sourcing the active pharmaceutical ingredient (API), sourcing excipients, conducting R&D to achieve the acceptable formulation of the product, conducting biostudies, conducting stability studies, developing analytical methods, paying facility fees, submitting the NDA and responding to FDA inquiries; ii) cover its manufacturing costs; iii) cover distribution costs; iv) provide discounts and fund chargebacks as required by partners in the supply chain, including the cost for copay assistance and free drug programs for patients; and v) earn a reasonable return on investment for its shareholders.",,5000,1,1,,,,,"The monthly prevalence of cGVHD patients is believed to be approximately 5,000 patients. The expectation is for our product to be prescribed to a portion of these patients. Reference: Source Healthcare Analytics - PrescriberSource APLD 2019",,,,,,,,,,,,,,, +"KMM Pharmaceuticals, LLC",52187054548,Iodoquinol 1% - Hydrocortisone Acetate 2% - Aloe Polysaccharides 1% Gel48gm,2021-02-18,2000,,1,480,,,,,,,"This is an unapproved DESI/Grandfathered drug not considered a ""New Prescription Drug"" under Chapter 9.5, Art. 1, 96060 (f)",,,,,,,,,,,,,,, +"Lannett Company, Inc.",527323737,LEVORPHANOL TARTRATE 3 mg Tablet 100 ct,2021-01-21,6675,"Levorphanol Tartrate is a FDA approved treatment which Lannett’s approach will focus on educating healthcare professional staff on how to diagnose within the critical time window, and provide information about treatment with Levorphanol Tartrate. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support to ensure rapid access to therapy. + +Levorphanol Tartrate has been developed for the treatment of patients and provides treatment options to delivers a safe, effective treatment. Levorphanol Tartrate is priced responsibly compared to similar agents with significant clinical benefit. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage of product. Lannett demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind.",,96327,,,,,,,Lannett does not actively track estimated patients therefore the answer submitted is an estimate formulated by determining the estimated patient volumes for each indication and applying a market share factor to arrive at a final estimate for the product.,,,,,,,,,,,,,,, +"Lannett Company, Inc.",527296443,CHLORPROMAZINE HCL 100 mg Tablet 1000 ct,2021-02-02,5295.86,"Chlorpromazine is a FDA approved treatment which Lannett’s approach will focus on educating healthcare professional staff on how to diagnose within the critical time window, and provide information about treatment with Chlorpromazine. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support to ensure rapid access to therapy. + +Chlorpromazine has been developed for the treatment of patients and provides treatment options to delivers a safe, effective treatment. Chlorpromazine is priced responsibly compared to similar agents with significant clinical benefit. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage of product. Lannett demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind.",,59486,,,,,,,Lannett does not actively track estimated patients therefore the answer submitted is an estimate formulated by determining the estimated patient volumes for each indication and applying a market share factor to arrive at a final estimate for the product.,,,,,,,,,,,,,,, +"Lannett Company, Inc.",527296543,CHLORPROMAZINE HCL 200 mg Tablet 1000 ct,2021-02-02,7553.15,"Chlorpromazine is a FDA approved treatment which Lannett’s approach will focus on educating healthcare professional staff on how to diagnose within the critical time window, and provide information about treatment with Chlorpromazine. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support to ensure rapid access to therapy. + +Chlorpromazine has been developed for the treatment of patients and provides treatment options to delivers a safe, effective treatment. Chlorpromazine is priced responsibly compared to similar agents with significant clinical benefit. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage of product. Lannett demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind.",,59486,,,,,,,Lannett does not actively track estimated patients therefore the answer submitted is an estimate formulated by determining the estimated patient volumes for each indication and applying a market share factor to arrive at a final estimate for the product.,,,,,,,,,,,,,,, +"Lannett Company, Inc.",527296243,CHLORPROMAZINE HCL 25 mg Tablet 1000 ct,2021-02-02,2669.55,"Chlorpromazine is a FDA approved treatment which Lannett’s approach will focus on educating healthcare professional staff on how to diagnose within the critical time window, and provide information about treatment with Chlorpromazine. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support to ensure rapid access to therapy. + +Chlorpromazine has been developed for the treatment of patients and provides treatment options to delivers a safe, effective treatment. Chlorpromazine is priced responsibly compared to similar agents with significant clinical benefit. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage of product. Lannett demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind.",,59486,,,,,,,Lannett does not actively track estimated patients therefore the answer submitted is an estimate formulated by determining the estimated patient volumes for each indication and applying a market share factor to arrive at a final estimate for the product.,,,,,,,,,,,,,,, +"Lannett Company, Inc.",527296343,CHLORPROMAZINE HCL 50 mg Tablet 1000 ct,2021-02-02,3765.05,"Chlorpromazine is a FDA approved treatment which Lannett’s approach will focus on educating healthcare professional staff on how to diagnose within the critical time window, and provide information about treatment with Chlorpromazine. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support to ensure rapid access to therapy. + +Chlorpromazine has been developed for the treatment of patients and provides treatment options to delivers a safe, effective treatment. Chlorpromazine is priced responsibly compared to similar agents with significant clinical benefit. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage of product. Lannett demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind.",,59486,,,,,,,Lannett does not actively track estimated patients therefore the answer submitted is an estimate formulated by determining the estimated patient volumes for each indication and applying a market share factor to arrive at a final estimate for the product.,,,,,,,,,,,,,,, +"LEADING PHARMA, LLC",69315023203,Aminocaproic Acid Tabs 1000mg,2021-03-16,713.46,Generic product no pricing or marketing plan,,33000,,,2016-04-16,,1,,"This is an AB rated generic product that was developed by Carnegie Pharmaceuticals. Acquisition date was 4/16/2016 and price is not applicable. Additionally, as Leading Pharma sells generic products to wholesalers and retail pharmacies, we do not estimate the number of patients that may be prescribed our products neither by state or nationally, nor do we have access to any information which would indicate the number of patients in the United States with the condition(s) for which our products may be prescribed. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Leading Pharma subscribes to. Leading Pharma feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients.",,,,,,,,,,,,,,, +Lupin Pharmaceuticals,70748025807,Posaconazole DR Tablets 100mg x 60,2021-02-16,3289.44,"This is a partner product that we do not manufacture, but just help market and distribute. Price was determined by original owner, AET.",,10000,,,,,,,"This is a marketing agreement with the original manufacturer. We did not acquire the product, we just assist in marketing and distribution with a royalty sharing agreement in place.",,,,,,,,,,,,,,, +Lupin Pharmaceuticals,70748015301,PENICILLAMINE TAB 250mg x 100,2021-03-01,4652.92,Product has generic competition so pricing was determined to be competitive with current market contenders.,,500,,,,,,,This product was internally developed by Lupin R&D. No acquisition to report.,,,,,,,,,,,,,,, +Lupin Pharmaceuticals,43386040512,Nitazoxanide Tablets 500mg x 12,2021-03-03,1561.1,WAC pricing was established at approximately a 14% discount to the Brand product. Contract pricing was negotiated at a customer specific level across our customer base.,,3000,,,,,,,We did not acquire this drug. It is an AG of our own product in house.,,,,,,,,,,,,,,, +Lupin Pharmaceuticals,43386040503,Nitazoxanide Tablets 500mg x 30,2021-03-05,3625.81,WAC pricing was established at approximately a 14% discount to the Brand product. Contract pricing was negotiated at a customer specific level across our customer base.,,3000,,,,,,,We did not acquire this drug. It is an AG of our own product in house.,,,,,,,,,,,,,,, +"Macrogenics, Inc.",74527002202,MARGENZA™ (margetuximab-cmkb) 25mg/mL per Vial {1 Vial per Pack},2021-03-04,2077,,1,7000,,,,,,,"Confidential Trade Secret Information of MacroGenics, not for public disclosure: We estimate that there are approximately 7,000 patients in the U.S. with metastatic HER2 positive breast cancer that are in the third or later line of therapy for their metastatic disease. + +Confidential Trade Secret Information of MacroGenics, not for public disclosure: The marketing plans for the launch of MARGENZA include a product website, creation of various physical and electronic marketing brochures, and web advertising for the product. In addition, commercial personnel will have virtual and in-person meetings with potential MARGENZA customers including healthcare professionals, hospital and healthcare systems, and payors to discuss the product. The pricing plan for the launch of MARGENZA includes listing the WAC price for the product in major pricing compendia. MacroGenics will also provide appropriate product discounts off of the WAC price to contracted customers, and to contracted GPO members. MARGENZA is only approved at this time in the United States, and it is not at this time anticipated MARGENZA will be approved outside the United States in 2021, and therefore it is not anticipated there will be sales of MARGENZA in 2021 outside of the United States.t.",,,,,,,,,,,,,,, +"Macrogenics, Inc.",74527002203,MARGENZA™ (margetuximab-cmkb) 25mg/mL per Vial {4 Vials per Pack},2021-03-10,8308,,1,7000,,,,,,,"Confidential Trade Secret Information of MacroGenics, not for public disclosure: The marketing plans for the launch of MARGENZA include a product website, creation of various physical and electronic marketing brochures, and web advertising for the product. In addition, commercial personnel will have virtual and in-person meetings with potential MARGENZA customers including healthcare professionals, hospital and healthcare systems, and payors to discuss the product. The pricing plan for the launch of MARGENZA includes listing the WAC price for the product in major pricing compendia. MacroGenics will also provide appropriate product discounts off of the WAC price to contracted customers, and to contracted GPO members. MARGENZA is only approved at this time in the United States, and it is not at this time anticipated MARGENZA will be approved outside the United States in 2021, and therefore it is not anticipated there will be sales of MARGENZA in 2021 outside of the United States.t. + +Confidential Trade Secret Information of MacroGenics, not for public disclosure: We estimate that there are approximately 7,000 patients in the U.S. with metastatic HER2 positive breast cancer that are in the third or later line of therapy for their metastatic disease.",,,,,,,,,,,,,,, +Mayne Pharma Inc,51862069010,Tavaborole Topical Solution 5% 10mL (Mayne Label),2021-02-15,1284.22,NDC change from previous listed Encube ND (21922002012).,,53356,,,2020-12-08,204000,,,"Estimated number of patients is based off IMS MAT TRx script data. +NDC change from 21922002012. No WAC change.",,,,,,,,,,,,,,, +Mayne Pharma Inc,51862051260,Calcipotriene Foam 0.005%,2021-04-29,765.1,,1,3693,,,,,,,The estimated number of patients is purely an estimate based on the Sorilux brand (51862037660) IMS TRx data. Mayne Pharma has no visibility into the prescribing habits of HCPs sufficient to provide a reliable number. Please refer to https://www.cdc.gov/ for additional information.,,,,,,,,,,,,,,, +Mayne Pharma Inc,68308057530,ISOtretinoin Oral Capsule 40 MG 30 count,2021-09-03,1036.6,,1,173179,,,,,,,Estimated number of patients based on IMS weekly Rx data.,,,,,,,,,,,,,,, +Mayne Pharma Inc,68308057030,ISOtretinoin Oral Capsule 10 MG 30 count,2021-09-24,963.44,,1,7975,,,,,,,Estimated number of patients based on IMS weekly Rx data.,,,,,,,,,,,,,,, +Mayne Pharma Inc,68308057130,ISOtretinoin Oral Capsule 20 MG 30 count,2021-09-24,963.44,,1,43797,,,,,,,Estimated number of patients based on IMS weekly Rx data.,,,,,,,,,,,,,,, +Mayne Pharma Inc,68308057330,ISOtretinoin Oral Capsule 30 MG 30 count,2021-09-24,1036.6,,1,220707,,,,,,,Estimated number of patients based on IMS weekly Rx data.,,,,,,,,,,,,,,, +"Meitheal Pharmaceuticals, Inc.",71288012820,Clofarabine Injection 20mg 20 mL (1mg/mL) SDV,2021-03-24,800,"Meitheal markets generic clofarabine as a therapeutic equivalent to the innovator (brand) drug. As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product.",,3000,,,,,,,"Because its clofarabine product is a generic product and there are a number of alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed clofarabine. As such, given clofarabine's primary use for the treatment of acute lymphoblastic leukemia (ALL) in pediatric patients under the age of 21, Meitheal's best estimate regarding a patient population can be derived from the Centers for Disease Control and Prevention's (""CDC"") tracking of ALL diagnoses within the United States. According to the CDC's most recent data (in 2017), the number of new cases of ALL in pediatric patients is 3,000 or more. (https://www.cdc.gov/mmwr/volumes/66/wr/mm6636a3.htm).",,,,,,,,,,,,,,, +"Meitheal Pharmaceuticals, Inc.",71288012902,"Dactinomycin for Injection, USP 500mcg (0.5mg) 2mL SDV",2021-04-20,1400,"Meitheal markets generic dactinomycin as a therapeutic equivalent to the innovator (brand) drug. As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product.",,200000,,,,,,,"Because its dactinomycin product is a generic product and there are a number of alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed dactinomycin. In addition, there are several indications where the use of dactinomycin is approved to treat a number of conditions. Meitheal reasonably estimates, based on information publicly available on cancer.org via the American Cancer Society, that there is potential for approximately 200,000 prescriptions of dactinomycin annually for treatment for a number of diseases.",,,,,,,,,,,,,,, +"Meitheal Pharmaceuticals, Inc.",71288080506,Isosulfan Blue Injection 1% 50mg 5mL (10mg/mL) SD Vial,2021-11-03,800,"Meitheal markets generic isosulfan blue 1% as a therapeutic equivalent to the innovator (brand) drug. As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Meitheal primarily markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. The target users for isosulfan blue are large cancer centers, teaching hospitals and cancer clinics.",,80000,,,,,,,"IIsosulfan blue injection 1% is a diagnostic product and is not a therapeutic used to treat a specific condition. It is used as an aid (or adjunct)in a procedure called lymphography (medical imaging procedure) to test how well the lymphatic system is working in certain parts of the body. It is used to find: lymphedema, chyluria, chylous ascites, chylothorax, and cancer of the lymph nodes. Isosulfan blue is a dye made in the laboratory that helps identify the sentinel lymph node (the first lymph node that cancer spreads to from a primary tumor). Based on IMS (IQVIA) prescription data, Meitheal estimates that there are 80,000 units sold in the US each year. Meitheal also estimates that there are 80,000 patients prescribed this product annually.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=562,,,,,,,,,,,,,, +"Melinta Therapeutics, LLC",70842022501,"KIMYRSA is supplied as sterile, lyophilized powder containing 1,200 mg of oritavancin (as oritavancin diphosphate) in a single-dose clear glass vial, which must be reconstituted and further diluted prior to intravenous administration. One vial is packaged",2021-07-07,4884,,1,705600,,,,,,,"This drug was not acquired. In regard to the estimated number of patients, KIMYRSA™ (oritavancin) for Injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and methicillin-resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only). Available literature on disease incidence generally focuses on skin and skin structure infections (SSTIs), which are acute or chronic infections of the skin and underlying tissue without a minimum lesion size requirement. SSTIs covers a broader array of skin infections and includes, for example, ABSSSIs, necrotizing fasciitis, and infections caused by gram-negative and anaerobic pathogens. The estimated annual incidence of patients who receive intravenous antibiotics for SSTI is 705,600 (8.4M annual patient visits for purulent SSTI, with 8.4% receiving an intravenous antibiotic). (Reference: Fritz SA, Shapiro DJ, Hersh AL. National Trends in Incidence of Purulent Skin and Soft Tissue Infections in Patients Presenting to Ambulatory and Emergency Department Settings, 2000-2015. Clin Infect Dis. 2020 Jun 10;70(12):2715-2718. doi: 10.1093/cid/ciz977. PMID: 31605485.)",,,,,,,,,,,,,,, +"Merck & Co., Inc.",6533101,"belzutifan, tablet, 90, 40 mg",2021-08-30,26400,"Marketing Description: Promotional activities for WELIREG will primarily include detailing of the product by Merck sales representatives to health care professionals including physicians, pharmacists, payers, and other healthcare providers. WELIREG will also be marketed in the US with print distribution and digital resources to health care professionals and patients. + +Pricing Plan Description: Merck considers several factors in determining the price of our medications. These factors are listed below and are largely based on the value of the product, as well as the competitive landscape, and market for the medication. +•Value provided to patients: To what extent does a new medicine or vaccine establish a new standard of care that has the potential to significantly extend and improve patient lives? +•Value provided to healthcare systems: To what extent does a new medicine or vaccine reduce the costs associated with hospitalization and other costly complications of disease if not appropriately (or optimally) treated? +•Unmet need: Does a new medicine or vaccine address a critical unmet medical need for large numbers of people, + where few or no treatments exist? +•Access and Affordability: How can we assure that various customers-including national, regional or local institutional payers, physicians, employers and patients-can afford to pay for our products? +•R&D sustainability: Given the long-term risk and cost of capital, are we appropriately compensating our investors to ensure that we can continue the risky and capital-intensive biopharmaceutical research and development that will bring forward medically-important breakthroughs? +•Competition: What are the costs of other treatments and interventions currently on the market relative to the value provided by Merck's products?",,6000,1,1,2019-07-11,1200000000,,"•This drug was acquired in development stage from clinical-stage biopharmaceutical company. +•Merck made an upfront payment of $1.2 billion for the asset acquisition of Peloton. +•Research and development expenses recorded at acquisition were $993 million.","Marketing/Pricing Plan (Non Public): +Consistent with SB 17, Merck has limited its response to information publicly available or otherwise in the public domain. + +Estimated Patients: +WELIREG is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Von Hippel-Lindau (VHL) disease is a rare hereditary tumor syndrome affecting an estimated 1/36,000 live births globally [NORD. Accessed January 28, 2021. https://rarediseases.org/rare-diseases/von-hippel-lindau-disease/ ]. It is estimated that 2020 US prevalence of VHL disease is 10,000 patients. At any given time, renal cell carcinoma (RCC) may affect up to 30% of VHL patients in the US [Chittiboina P, Lonser RR. Handb Clin Neurol. 2015;132:139–156.]. For patients with tumors that reach greater than 3cm in size, a partial nephrectomy may be performed to reduce the risk of metastasis while maintaining kidney function[Varshney N et al. J Kidney Cancer VHL. 2017;4:20–29.]. Additionally, it is estimated Central nervous system (CNS) hemangioblastomas affecting 60% to 80% of all patients [Varshney N, Kebede AA, Owusu-Dapaah H, et al. A review of von Hippel-Lindau syndrome. J Kidney Cancer VHL. 2017;4(3):20–29.] Finally, pancreatic neuroendocrine tumors (pNET) affect approximately 15% of VHL patients [Michael Charlesworth, Caroline S Verbeke, Gavin A Falk, et al. Pancreatic lesions in von Hippel-Lindau disease? A systematic review and meta-synthesis of the literature. J Gastrointest Surg. 2012 Jul;16(7):1422-8. doi: 10.1007/s11605-012-1847-0. Epub 2012 Feb 28.] However, we do not expect all of these patients would be eligible for therapy and not all of these patients will receive WELIREG.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=553,,,,,,,,,,,,,, +"Micro Labs USA, Inc.",72485011310,"Isoproterenol HCl Injection, USP 1 mg/5 mL (0.2 mg/mL) 10 Ampules Pack",2021-09-09,8495,Marketing partner - Armas intends to engage with purchasing organizations and bring savings to convert customers to Armas product,,8810,,,,,,,Estimated Number of Patients is based on the past 12 month`s IMS data. Column 10 to 13 intentionally left blank as its not applicable.,,,,,,,,,,,,,,, +Mirum Pharmaceuticals,79378011001,Product Name – Maralixibat oral solution Dosage Strength – 9.5mg/mL Package Size – 30mL Bottle Dosage Form – Oral,2021-09-29,46500,,1,2500,1,1,,,,,,,,,,,,,,,,,,,, +"Mitsubishi Tanabe Pharma America, Inc.",70510220102,Exservan (riluzole) oral film,2021-05-12,3143,,1,400,,,2021-01-21,,1,,,,,,,,,,,,,,,,, +Mylan Institutional Inc,67457038681,Mycophenolate Mofetil 500mg LYO 4PK,2021-01-26,290,,1,35381,,,,,,,"Please note that, although not all courses of treatment of the Product trigger the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program (the “threshold”), this notice is being submitted because the Product triggers the threshold only when taking into account the maximum recommended dose as listed in the Product Prescribing Information. + +Mycophenolate mofetil for injection is indicated for prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immunosuppressants. Based on the literature, in 2020, 22,817 had kidney transplants, 3,658 had heart transplants, and 8,906 had liver transplants (https://unos.org/data/transplant-trends/). Therefore, an estimated (using available data) 35,381 patients in the United States could potentially use this product during the current year. + +The product was not a result of an acquisition.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378233078,"Rufinamide Tablets USP, 200 mg",2021-06-01,1367.06,,1,48000,,,,,,,"Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults (see US Prescribing Information). Based on the literature, approximately 48,000 children and adults in the United States suffer from LGS. (https://www.lgsfoundation.org/epidemiology). Therefore, an estimated (using available data) 48,000 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378233178,"Rufinamide Tablets USP, 400 mg",2021-06-01,2734.11,,1,48000,,,,,,,"Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults (see US Prescribing Information). Based on the literature, approximately 48,000 children and adults in the United States suffer from LGS. (https://www.lgsfoundation.org/epidemiology). Therefore, an estimated (using available data) 48,000 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378163193,"Formoterol Fumarate 20mcg/2mL, Nebulizer Solution, 30 ct.",2021-06-22,481.26,,1,16400000,,,,,,,"Formoterol Fumarate 20mcg/2mL, Nebulizer Solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Based on the literature, in 2018, 16.4 million people reported a diagnosis of any type of COPD (chronic bronchitis, emphysema, or COPD). (https://www.cdc.gov/copd/index.html). Therefore, an estimated (using available data) 16.4 million patients in the United States could potentially use this product during the current year. + +Mylan reserves the right to reassess reporting requirements under the definition of a ""new prescription drug"" in any future submissions. This authorized generic Product is marketed under an NDA that was previously approved in 2007 and did not receive an initial approval under an original NDA.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378163191,"Formoterol Fumarate 20mcg/2mL, Nebulizer Solution, 60 ct.",2021-06-22,962.47,,1,16400000,,,,,,,"Formoterol Fumarate 20mcg/2mL, Nebulizer Solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Based on the literature, in 2018, 16.4 million people reported a diagnosis of any type of COPD (chronic bronchitis, emphysema, or COPD). (https://www.cdc.gov/copd/index.html). Therefore, an estimated (using available data) 16.4 million patients in the United States could potentially use this product during the current year. + +Mylan reserves the right to reassess reporting requirements under the definition of a ""new prescription drug"" in any future submissions. This authorized generic Product is marketed under an NDA that was previously approved in 2007 and did not receive an initial approval under an original NDA.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378000585,"Everolimus Dispersible Tablets, 2mg",2021-10-01,12894.98,,1,50000,,1,,,,,"Everolimus Tabs is indicated for oral suspension for adult and pediatric patients with Tuberous Sclerosis Complex. Based on the literature, approximately 50,000 patients in the United States have Tuberous Sclerosis Complex (https://www.tscalliance.org/about-tsc/what-is-tsc/). Therefore, an estimated (using available data) 50,000 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378000685,"Everolimus Dispersible Tablets, 3mg",2021-10-01,13024.14,,1,50000,,1,,,,,"Everolimus Tabs is indicated for oral suspension for adult and pediatric patients with Tuberous Sclerosis Complex. Based on the literature, approximately 50,000 patients in the United States have Tuberous Sclerosis Complex (https://www.tscalliance.org/about-tsc/what-is-tsc/). Therefore, an estimated (using available data) 50,000 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378000785,"Everolimus Dispersible Tablets, 5mg",2021-10-01,13555.52,,1,50000,,1,,,,,"Everolimus Tabs is indicated for oral suspension for adult and pediatric patients with Tuberous Sclerosis Complex. Based on the literature, approximately 50,000 patients in the United States have Tuberous Sclerosis Complex (https://www.tscalliance.org/about-tsc/what-is-tsc/). Therefore, an estimated (using available data) 50,000 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378438591,Naproxen and Esomeprazole Magnesium DR Tablets 375mg/20mg,2021-11-22,1613.43,,1,3354920,,1,,,,,"Naproxen component of Naproxen and Esomeprazole is indicated for relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults, and juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component is indicated to decrease the risk of developing naproxen-associated gastric ulcers. Based on the literature, the occurrence of rheumatoid arthritis and ankylosing spondylitis in the general population has a frequency between 0.3% and 1.5% (https://www.ncbi.nlm.nih.gov/books/NBK532288/). With the available United States population data of 333,880,005, that is an average of 3,004,920 patients (https://www.worldometers.info/world-population/us-population/). In the United States, about 350,000 new cases of peptic ulcers are diagnosed each year (https://pubmed.ncbi.nlm.nih.gov/6378441/). Therefore, an estimated (using available data) 3,354,920 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378438691,Naproxen and Esomeprazole Magnesium DR Tablets 500mg/20mg,2021-11-22,1613.43,,1,3354920,,1,,,,,"Naproxen component of Naproxen and Esomeprazole is indicated for relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults, and juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component is indicated to decrease the risk of developing naproxen-associated gastric ulcers. Based on the literature, the occurrence of rheumatoid arthritis and ankylosing spondylitis in the general population has a frequency between 0.3% and 1.5% (https://www.ncbi.nlm.nih.gov/books/NBK532288/). With the available United States population data of 333,880,005, that is an average of 3,004,920 patients (https://www.worldometers.info/world-population/us-population/). In the United States, about 350,000 new cases of peptic ulcers are diagnosed each year (https://pubmed.ncbi.nlm.nih.gov/6378441/). Therefore, an estimated (using available data) 3,354,920 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Specialty LP,49502025080,Semglee® (insulin glargine-yfgn) 1000IU/10mL 1PK Vial,2021-11-15,269.38,,1,34200000,,,,,,,"*Please note that, although not all courses of treatment of the Products trigger the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program (the “threshold”), this notice is being submitted because the Products may trigger the threshold depending on the units a patient may use in a 30-day period. + +Semglee is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Based on the literature and assuming all type 1 and type 2 patients will be insulin dependent, approximately 34.2 million people of all ages had diagnosed diabetes in the United State (https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf). However, not all type 2 diabetes patients are in need of insulin. All 1.6 million patients with type 1 diabetes will need insulin (https://www.diabetes.org/resources/statistics/statistics-about-diabetes). Therefore, an estimated (using available data) 34.2 million patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Specialty LP,49502025175,Semglee® (insulin glargine-yfgn) 300IU/3ML 5PK Pen,2021-11-15,404.04,,1,34200000,,,,,,,"*Please note that, although not all courses of treatment of the Products trigger the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program (the “threshold”), this notice is being submitted because the Products may trigger the threshold depending on the units a patient may use in a 30-day period. + +Semglee is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Based on the literature and assuming all type 1 and type 2 patients will be insulin dependent, approximately 34.2 million people of all ages had diagnosed diabetes in the United State (https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf). However, not all type 2 diabetes patients are in need of insulin. All 1.6 million patients with type 1 diabetes will need insulin (https://www.diabetes.org/resources/statistics/statistics-about-diabetes). Therefore, an estimated (using available data) 34.2 million patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Myovant Sciences Inc.,72974041501,"MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) 28 tablets",2021-06-17,974.54,,1,5000000,,,,,,,"MYFEMBREE is a combination of relugolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin, indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.",,,,,,,,,,,,,,, +"Nabriva Therapeutics US, Inc.",72000011010,Xenleta 600 mg tablets blister pack 10,2021-11-10,1375,"Nabriva pricing decisions regarding the WAC price of a medication are determined after consideration of many factors, including clinical and economic value of the particular therapy, therapeutic category, market dynamics, competitor pricing, discounts provided to customers in both the commercial and government channels, patient support to ensure patient access to life-saving and life-changing medications, overall research and development costs.",,28,,,,,,,,,,,,,,,,,,,,,, +"Neurocrine Biosciences, Inc.",70370106001,INGREZZA 60 MG CAPSULES,2021-06-01,7043,"We determine the price of our medicines based on their value and impact to patients, families, care partners, providers, insurers and society. In so doing, we adhere to the highest ethical and compliance standards and are guided by the following principles: +• Improving the lives and well-being of patients +• Maximizing access and reducing out-of-pocket costs for eligible patients +• Striving to reduce obstacles for patients to fill a prescription or undergo treatment +• Fueling the discovery and development of life-changing medicines",,500000,1,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Neurocrine Biosciences, Inc. is limiting its response to that which is otherwise in the public domain or publicly available. Marketing Plans are not in the public domain or publicly available. This drug was developed in-house and was not acquired. Tardive Dyskinesia affects an estimated 500,000 people in the U.S.",,,,,,,,,,,,,,, +"Nostrum Laboratories, Inc.",29033021401,Carisoprodol 100ct 350mg Tablets in 1 Bottle,2021-01-25,808.85,,1,5000,,,,,,,This product is drug listed but has not yet been sold/entered the market. Nostrum Labs expects to begin selling this product/launch the product in the next two months.,,,,,,,,,,,,,,, +Novartis,78109120,"SCEMBLIX 20 mg, 60 tablets",2021-10-29,17900,"The marketing for SCEMBLIX includes education and promotion to physicians, direct to consumer promotions, other types of marketing (e.g., online platforms and education). Novartis considered many factors in determining the price of SCEMBLIX. SCEMBLIX is the first FDA-approved CML treatment that works by binding to the ABL myristoyl pocket, and represents an important development for patients who experience resistance and/or intolerance to currently available TKI therapies1-3. We priced in parity to other branded treatments in this therapeutic area and are focused on access to SCEMBLIX i for this patient population.",,61700,1,1,,,,,"Novartis estimates there are 61700 patients with Chronic Myeloid Leukemia in the United States. Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Novartis,78109820,"SCEMBLIX 40 mg, 60 tablets",2021-10-29,17900,"The marketing for SCEMBLIX includes education and promotion to physicians, direct to consumer promotions, other types of marketing (e.g., online platforms and education). Novartis considered many factors in determining the price of SCEMBLIX. SCEMBLIX is the first FDA-approved CML treatment that works by binding to the ABL myristoyl pocket, and represents an important development for patients who experience resistance and/or intolerance to currently available TKI therapies1-3. We priced in parity to other branded treatments in this therapeutic area and are focused on access to SCEMBLIX i for this patient population.",,61700,1,1,,,,,"Novartis estimates there are 61700 patients with Chronic Myeloid Leukemia in the United States. Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Novartis,78100060,LEQVIO (Inclisiran 284mg subcutaneous injection),2021-12-22,3250,"Novartis considered many factors in determining the price of LEQVIO. LEQVIO is a first-in-class siRNA and is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C). We priced in parity to other branded treatments in this therapeutic area and are focused on access to LEQVIO for this patient population.",,30000000,,,,,,,"Novartis estimates there are 30,000,000 diagnosed prevalent patients with ASCVD in the United States. + +In January 2020, Novartis acquired The Medicines Company for $9.7 billion which included the global rights to develop, manufacture, and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals. During the acquisition and integration of the company, The Medicines Company submitted the New Drug Application for inclisiran in December 2019. + +Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Novo,169452514,Wegovy™ 0.25 mg/0.5 mL in 1 pre-filled pen; 4 pens in 1 carton,2021-06-15,1349.02,,1,2600000,,1,,,,,"Wegovy™ is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). The Prescribing Information for Wegovy™, is available at: https://www.novo-pi.com/wegovy.pdf. +Regarding the reported patient estimate, per IQVIA’s Longitudinal Access and Adjudication Database, citing 2020 year data, there are currently 2.6 million patients on pharmacotherapy medication for anti-obesity in the US. For the estimated patients requirement, Novo Nordisk utilizes this number of estimated patients on pharmacotherapy, however, we note that the total number of patients diagnosed with obesity is roughly 30 million, the majority of those patients will not go onto an anti-obesity pharmacotherapy treatment. Please note, this is not an estimate of prescriptions that might be written for Wegovy™ or each available dose of Wegovy™. Wegovy™ will represent a portion of the broader market for anti-obesity therapies. +Wegovy™ was developed by Novo Nordisk.",,,,,,,,,,,,,,, +Novo,169450514,Wegovy™ 0.5 mg/0.5 mL in 1 pre-filled pen; 4 pens in 1 carton,2021-06-15,1349.02,,1,2600000,,1,,,,,"Wegovy™ is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). The Prescribing Information for Wegovy™, is available at: https://www.novo-pi.com/wegovy.pdf. +Regarding the reported patient estimate, per IQVIA’s Longitudinal Access and Adjudication Database, citing 2020 year data, there are currently 2.6 million patients on pharmacotherapy medication for anti-obesity in the US. For the estimated patients requirement, Novo Nordisk utilizes this number of estimated patients on pharmacotherapy, however, we note that the total number of patients diagnosed with obesity is roughly 30 million, the majority of those patients will not go onto an anti-obesity pharmacotherapy treatment. Please note, this is not an estimate of prescriptions that might be written for Wegovy™ or each available dose of Wegovy™. Wegovy™ will represent a portion of the broader market for anti-obesity therapies. +Wegovy™ was developed by Novo Nordisk.",,,,,,,,,,,,,,, +Novo,169450114,Wegovy™ 1 mg/ 0.5 mL in 1 pre-filled pen; 4 pens in 1 carton,2021-06-15,1349.02,,1,2600000,,1,,,,,"Wegovy™ is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). The Prescribing Information for Wegovy™, is available at: https://www.novo-pi.com/wegovy.pdf. +Regarding the reported patient estimate, per IQVIA’s Longitudinal Access and Adjudication Database, citing 2020 year data, there are currently 2.6 million patients on pharmacotherapy medication for anti-obesity in the US. For the estimated patients requirement, Novo Nordisk utilizes this number of estimated patients on pharmacotherapy, however, we note that the total number of patients diagnosed with obesity is roughly 30 million, the majority of those patients will not go onto an anti-obesity pharmacotherapy treatment. Please note, this is not an estimate of prescriptions that might be written for Wegovy™ or each available dose of Wegovy™. Wegovy™ will represent a portion of the broader market for anti-obesity therapies. +Wegovy™ was developed by Novo Nordisk.",,,,,,,,,,,,,,, +Novo,169451714,Wegovy™ 1.7 mg/0.75 mL in 1 pre-filled pen; 4 pens in 1 carton,2021-06-15,1349.02,,1,2600000,,1,,,,,"Wegovy™ is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). The Prescribing Information for Wegovy™, is available at: https://www.novo-pi.com/wegovy.pdf. +Regarding the reported patient estimate, per IQVIA’s Longitudinal Access and Adjudication Database, citing 2020 year data, there are currently 2.6 million patients on pharmacotherapy medication for anti-obesity in the US. For the estimated patients requirement, Novo Nordisk utilizes this number of estimated patients on pharmacotherapy, however, we note that the total number of patients diagnosed with obesity is roughly 30 million, the majority of those patients will not go onto an anti-obesity pharmacotherapy treatment. Please note, this is not an estimate of prescriptions that might be written for Wegovy™ or each available dose of Wegovy™. Wegovy™ will represent a portion of the broader market for anti-obesity therapies. +Wegovy™ was developed by Novo Nordisk.",,,,,,,,,,,,,,, +Novo,169452414,Wegovy™ 2.4 mg/0.75 mL in 1 pre-filled pen; 4 pens in 1 carton,2021-06-15,1349.02,,1,2600000,,1,,,,,"Wegovy™ is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). The Prescribing Information for Wegovy™, is available at: https://www.novo-pi.com/wegovy.pdf. +Regarding the reported patient estimate, per IQVIA’s Longitudinal Access and Adjudication Database, citing 2020 year data, there are currently 2.6 million patients on pharmacotherapy medication for anti-obesity in the US. For the estimated patients requirement, Novo Nordisk utilizes this number of estimated patients on pharmacotherapy, however, we note that the total number of patients diagnosed with obesity is roughly 30 million, the majority of those patients will not go onto an anti-obesity pharmacotherapy treatment. Please note, this is not an estimate of prescriptions that might be written for Wegovy™ or each available dose of Wegovy™. Wegovy™ will represent a portion of the broader market for anti-obesity therapies. +Wegovy™ was developed by Novo Nordisk.",,,,,,,,,,,,,,, +"Oncopeptides, Inc.",73657002001,Pepaxto (melphalan flufenamide) for intravenous use,2021-03-01,9500,,1,500,,1,,,,,Estimated number of patients represent number who might potentially receive this drug in the US,,,,,,,,,,,,,,, +Organon,78206017202,SINGULAIR 10 mg tablet 90 count,2021-07-19,684.9,"Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product. + +Pricing: Organon is inheriting the pricing for Singulair from Merck, Organon is not adjusting WAC prices at time of launch.",,14288,,,2021-07-19,,1,"Organon is the resulting organization from the divesture of Merck's women's health division, biosimilars, and select legacy products for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label.","Total 2018 patients for Moktelukast (generic Singulair) was 7,017,347 - assuming an average yearly patient population growth rate of .6% (annual average in US) and a market share rate of 1% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 14,288.",,,,,,,,,,,,,,, +Organon,78206017402,VYTORIN 10; 10 mg/1; mg/1 Tablet 90 count,2021-07-19,1025.1,"Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product. + +Pricing: Organon is inheriting the pricing for Vytorin from Merck, Organon is not adjusting WAC prices at time of launch.",,60937,,,2021-07-19,,1,"Organon is the resulting organization from the divesture of Merck's women's health division, biosimilars, and select legacy products for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label.","Total 2021 patients for Ezetimibe (generic Vytorin) was 65,000,000 - assuming a market share rate of .75% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 60,937.",,,,,,,,,,,,,,, +Organon,78206017502,VYTORIN 10; 20 mg/1; mg/1 Tablet 90 count,2021-07-19,1025.1,"Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product. + +Pricing: Organon is inheriting the pricing for Vytorin from Merck, Organon is not adjusting WAC prices at time of launch.",,60937,,,2021-07-19,,1,"Organon is the resulting organization from the divesture of Merck's women's health division, biosimilars, and select legacy products for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label.","Total 2021 patients for Ezetimibe (generic Vytorin) was 65,000,000 - assuming a market share rate of .75% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 60,937.",,,,,,,,,,,,,,, +Organon,78206017602,VYTORIN 10; 40 mg/1; mg/1 Tablet 90 count,2021-07-19,1025.1,"Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product. + +Pricing: Organon is inheriting the pricing for Vytorin from Merck, Organon is not adjusting WAC prices at time of launch.",,60937,,,2021-07-19,,1,"Organon is the resulting organization from the divesture of Merck's women's health division, biosimilars, and select legacy products for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label.","Total 2021 patients for Ezetimibe (generic Vytorin) was 65,000,000 - assuming a market share rate of .75% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 60,937.",,,,,,,,,,,,,,, +Organon,78206017702,VYTORIN 10; 80 mg/1; mg/1 Tablet 90 count,2021-07-19,1025.1,"Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product. + +Pricing: Organon is inheriting the pricing for Vytorin from Merck, Organon is not adjusting WAC prices at time of launch.",,60937,,,2021-07-19,,1,"Organon is the resulting organization from the divesture of Merck's women's health division, biosimilars, and select legacy products for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label.","Total 2021 patients for Ezetimibe (generic Vytorin) was 65,000,000 - assuming a market share rate of .75% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 60,937.",,,,,,,,,,,,,,, +Organon,78206018102,ZOCOR 20 mg/1 Tablet 90 count,2021-07-19,725.4,"Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product. + +Pricing: Organon is inheriting the pricing for Zocor from Merck, Organon is not adjusting WAC prices at time of launch.",,17660,,,2021-07-19,,1,"Organon is the resulting organization from the divesture of Merck's women's health division, for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label.","Total 2018 patients for Simvastatin (generic Zocor) was 10,407,988 - assuming an average yearly patient population growth rate of .6% (annual average in US) and a market share rate of 1% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 17,660.",,,,,,,,,,,,,,, +Organon,78206018202,ZOCOR 40 mg/1 Tablet 90 count,2021-07-19,725.4,"Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product. + +Pricing: Organon is inheriting the pricing for Zocor from Merck, Organon is not adjusting WAC prices at time of launch.",,17660,,,2021-07-19,,1,"Organon is the resulting organization from the divesture of Merck's women's health division, for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label.","Total 2018 patients for Simvastatin (generic Zocor) was 10,407,988 - assuming an average yearly patient population growth rate of .6% (annual average in US) and a market share rate of 1% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 17,660.",,,,,,,,,,,,,,, +Organon,78206017902,ZOCOR 80 mg/1 Tablet 90 count,2021-07-19,725.4,"Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product. + +Pricing: Organon is inheriting the pricing for Zocor from Merck, Organon is not adjusting WAC prices at time of launch.",,17660,,,2021-07-19,,1,"Organon is the resulting organization from the divesture of Merck's women's health division, for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label.","Total 2018 patients for Simvastatin (generic Zocor) was 10,407,988 - assuming an average yearly patient population growth rate of .6% (annual average in US) and a market share rate of 1% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 17,660.",,,,,,,,,,,,,,, +Organon,78206011901,Clarinex 5 mg Tablet 100 ct,2021-08-16,730,"Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product. + +Pricing: Organon is inheriting the pricing for Clarinex from Merck, Organon is not adjusting WAC prices at time of launch.",,162500,,,2021-08-16,,1,"Organon is the resulting organization from the divesture of Merck's women's health division, biosimilars, and select legacy products for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label.","Total 2021 patients for Desloratadine (generic Clarinex) was 32,500,000 - assuming a market share rate of 1% and patients receiving one dosage do not also receive another dosage strength in the same year the total patient volume in 2021 is 162,500.",,,,,,,,,,,,,,, +Organon,78206014501,Nexplanon 68 mg Implant 1 ct,2021-08-16,1030.64,"Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product. + +Pricing: Organon is inheriting the pricing for Nexplanon from Merck, Organon is not adjusting WAC prices at time of launch.",,904000,,,2021-08-16,,1,"Organon is the resulting organization from the divesture of Merck's women's health division, biosimilars, and select legacy products for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label.","To account for the impact of COVID the estimated number of patients in 2019 and 2020 have been averaged resulting in an estimated 904,000 patients annually in the US.",,,,,,,,,,,,,,, +Organon,78206014701,Ontruzant 150 mg 1 vial injection,2021-10-01,1324.66,"""Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product. + +Pricing: Organon is inheriting the pricing from Merck, Organon is not adjusting WAC prices at time of launch.""",,639,,,2021-10-01,,1,"Organon is the resulting organization from the divesture of Merck's women's health division, for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label.",,,,,,,,,,,,,,,, +Organon,78206014801,Ontruzant 420 mg 1 vial injection,2021-10-01,3709.04,"""Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product. + +Pricing: Organon is inheriting the pricing from Merck, Organon is not adjusting WAC prices at time of launch.""",,639,,,2021-10-01,,1,"Organon is the resulting organization from the divesture of Merck's women's health division, for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label.",,,,,,,,,,,,,,,, +Organon,78206016201,Renflexis 100 mg solution 1 vial,2021-10-01,753.39,"""Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product. + +Pricing: Organon is inheriting the pricing from Merck, Organon is not adjusting WAC prices at time of launch.""",,24299,,,2021-10-01,,1,"Organon is the resulting organization from the divesture of Merck's women's health division, for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label.",,,,,,,,,,,,,,,, +Origin Biosciences Inc. ,73129000101,Nulibry (fosdenopterin hydrobromide) for injection 9.5mg/vial,2021-02-26,1369.86,"Nulibry is the first and only FDA approved treatment for MoCD Type A, a rare and rapidly progressing, fatal, inborn error of metabolism that often presents with intractable seizures shortly after birth. Origin’s approach will focus on educating pediatric neurologists, neonatologists, geneticists, and all NICU/PICU staff on how to diagnose MoCD Type A within the critical time window, and provide information about treatment with Nulibry. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support for Nulibry to ensure rapid access to life saving therapy",,20,1,1,,,,,The product was not acquired and as such no information is to be disclosed,,,,,,,,,,,,,,, +Padagis US LLC,574093125,Doxorubicin Hydrochloride Liposome Injection 50 mg/25 mL (2mg/mL) 25mL,2021-10-25,1515.6,Product is be priced to deliver value to the market as compared to the Brand referenced drug.,,39976,,,,,,,"As a generic manufacturer, Padagis does not have information available to accurately determinate the number of patients that could potentially have a condition for which the drug may be prescribed. Padagis neither collects nor uses estimated patient information and does not believe there is publicly available data that accurately represents the number of patients for all indications. +Based on NSP data available to Padagis, Padagis estimates that approximately 39,976 Total Units were sold for this drug in the past 12 months, but number of units sold should not be misinterpreted as an accurate estimate of the number of patients with a condition for which the new drug may be prescribed, as dosage and therapy may vary across individual patients.",,,,,,,,,,,,,,, +Par Pharmaceutical ,254205301,Chlorzoxazone Tablets 375mg 100s,2021-06-10,370,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. + +(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Par notes that this product is indicated adjunct to other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The World Health Organization (“WHO”) indicates approximately 1,710,000,000 people have musculoskeletal conditions world-wide (see https://www.who.int/news-room/fact-sheets/detail/musculoskeletal-conditions#:~:text=%20Musculoskeletal%20conditions%20include%20conditions%20that%20affect%3A%20,body%20areas%20or%20systems%2C%20such%20as...%20More%20 ). + +However, WHO does not specify the number of patients diagnosed each month or year with musculoskeletal conditions. Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s Chlorzoxazone Tablets because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: “Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. +(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,49884015576,Varenicline Tablets .5mg 56s,2021-09-16,364.52,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Par notes that this product is indicated as an aid to smoking cessation treatment. The Centers for Disease Control and Prevention (“CDC”) indicates that in 2015 22.7 million adult smokers in the United States wanted to quit smoking. https://www.cdc.gov/tobacco/data_statistics/fact_sheets/cessation/smoking-cessation-fast-facts/index.html + +However, CDC does not specify the number of smokers intending to quit each month or year. Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s Varenicline Tablets because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: “Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. +(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,49884055601,"Isosorbide Dinitrate Tablets, USP 40mg 100s",2021-12-13,1335.37,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product is a generic, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data. + +Par notes that this product is indicated for the prevention of angina pectoris due to coronary artery disease. The Centers for Disease Control and Prevention (“CDC”) estimates that 18.2 million adults in the United States have coronary artery disease and the Mayo Clinic notes that angina is a common symptom of coronary artery disease. ( https://www.cdc.gov/heartdisease/facts.htm, https://www.mayoclinic.org/diseases-conditions/angina/symptoms-causes/syc-20369373 ) + +The CDC did not indicate how many cases of coronary artery disease occur each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s Isosorbide because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. +(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Pfizer,69102902,XELJANZ 1MG/ML ORSOL 1X240ML PBTL US,2021-02-08,3944.39,,1,3000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 3,000 patients across the United States, could potentially receive the Oral Solution formulation. Comment regarding Fields 10-13: Xeljanz Oral Solution was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,409012001,Daptomycin for Injection 350mg per Vial (1’s),2021-10-04,50,,1,393466,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Approximately 393,466 patients are estimated to receive Daptomycin annually. Comment regarding Fields 10-13: Daptomycin was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,409012201,Daptomycin for Injection 500mg per Vial (1’s),2021-10-04,79,,1,393466,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Approximately 393,466 patients are estimated to receive Daptomycin annually. Comment regarding Fields 10-13: Daptomycin was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +PharmaEssentia USA Corporation,73536050001,BESREMi (Ropeginterferon alfa-2b-njft) 500 mcg/ml single use vial,2021-12-03,6988,,1,161110,,1,,,,,,,,,,,,,,,,,,,, +Piramal Critical Care,66794023444,"Dexmedetomidine Hydrochloride Injection, USP 200 mcg/50mL (4 mcg/mL)",2021-08-15,720,Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Piramal Critical Care’s Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is priced responsibly and in line with current market conditions.,,750315,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Piramal is limiting its response to that which is otherwise in the public domain or publicly available. The Estimated Patient amount is based on the number of eaches sold in the last 12 month period from July 2020 through June 2021. This number does not account for multiple vials dosed to a single patient as this information is not readily available. This product was not acquired; however, Piramal's marketing rights were in-licensed. Piramal does not believe this information is publicly available and has not released this information in the public domain.",,,,,,,,,,,,,,, +Piramal Critical Care,66794023541,"Dexmedetomidine Hydrochloride Injection, USP 400 mcg/100mL (4 mcg/mL)",2021-08-15,720,Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Piramal Critical Care’s Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is priced responsibly and in line with current market conditions.,,3237152,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Piramal is limiting its response to that which is otherwise in the public domain or publicly available. The Estimated Patient amount is based on the number of eaches sold in the last 12 month period from July 2020 through June 2021. This number does not account for multiple vials dosed to a single patient as this information is not readily available. This product was not acquired; however, Piramal's marketing rights were in-licensed. Piramal does not believe this information is publicly available and has not released this information in the public domain.",,,,,,,,,,,,,,, +Primus Pharmaceuticals Inc,68040071428,Sernivo® Spray; Betamethasone dipropionate 0.05%,2021-08-02,997.5,,1,45000,,,2021-03-11,,1,,,"https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=554, https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=555",,,,,,,,,,,,,, +"Progenics Pharmaceuticals, Inc.",71258002200,PYLARIFY® (piflufolastat F 18) Injection,2021-05-26,4600,"Product will be marketed in the US and the pricing model will be consistant with our WAC Pricing through December 31, 2021",,250000,,1,,,,,"Brand New Product to Market, we do not have estimate of usage yet.",,,,,,,,,,,,,,, +"Puma Biotechnology, Inc.",70437024033,Nerlynx (neratinib) 40mg 133 count bottle,2021-06-21,12940,,1,3350,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088077200,"Sumansetron, sumatriptan tablets USP 50mg (9ct) + Ondansetron tablets USP 4mg (30ct)",2021-01-01,3352.8,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,0,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088017554,"Probitrol, capsules, 31 billion, 30ct",2021-01-04,1744,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,0,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088017457,"Promerol, capsules, 31 billion, 30ct",2021-01-04,3136,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,0,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088017354,"Vitranol Fe, caplets, multivitamin + iron, 30ct",2021-01-04,1800,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,0,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088017754,"Venexa Fe, multivitamin + iron (30CT)",2021-01-29,1930,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,150000,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088017654,"Venexa, caplets, multivitamin, 30ct",2021-01-29,1544,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,0,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088017854,"Pretrate, prenatal/postnatal multivitamin, (30ct) caplets",2021-02-01,1460,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,2000000,,,,,,,0,,,,,,,,,,,,,,, +PureTek Corporation,59088017954,"Lacterol (30ct), probiotic (30ct)",2021-02-10,1962,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,100000,,,,,,,Dispensed by prescription,,,,,,,,,,,,,,, +PureTek Corporation,59088018158,"Foltin-Z, multivitamin (60ct)",2021-02-11,1740,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,150000,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088018258,"Ribotin- E, multivitamin (60ct) caplets",2021-02-11,1740,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,150000,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088018058,"Zintrexyl-C, multivitamin (60ct)",2021-02-11,1740,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,150000,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088018354,"Probitran, probiotic (30ct)",2021-05-03,1962,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,100000,,,,,,,dispensed by prescription,,,,,,,,,,,,,,, +PureTek Corporation,59088018454,"Purefoltin, Folic acid 1mg + Vitamin D3 5,000 IU (30ct)",2021-05-03,2200,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,300000,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088018654,"Ventrixyl, multivitamin (30ct)",2021-06-04,1800,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,150000,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088046607,"Lidogel, Lidocaine HCI 2.8% Gel, (100g)",2021-07-21,1516,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,250000,,,,,,,0,,,,,,,,,,,,,,, +PureTek Corporation,59088018754,"Ventrixyl Fe, Multivitamin (30ct) tablets",2021-08-11,1800,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,150000,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088019454,"Probinate, probiotic, (30ct) capsules",2021-08-20,1480,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,100000,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088019354,"Vitramyn, multivitamin (30ct) caplets",2021-08-20,1800,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,150000,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088018554,"Folditam, Folic Acid 1mg + Vit D3 10,000IU, tablets (30ct)",2021-09-02,1704,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,2000000,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088043207,"Radiaura Skin Recovery Cream, Lidocaine HCI 3%_ Hydrocotisone Acetate 0.5%, cream (85g)",2021-09-02,1123.81,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,500000,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088048058,"Foliflex Multivitamin, 30ct caplets",2021-10-14,1392,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,350000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088047507,"Lidorex. Lidocaie HCI 2.8% Gel, 3.5oz (100g)",2021-10-14,1516,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,275000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088020054,"Foltamin, Folic Acid 1mg + Vitamin D3 5000IU, tablets (30ct)",2021-11-29,1760,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,300000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088071500,"Lidotor, Lidocaine 2.5%/Prilocaine 2.5% cream USP 30gm + Occlusive Dressing (5ct)",2021-11-29,1820,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,150000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088019954,"Probisol, 2 Strain AcidoBifido 31 Billion, capsules (30ct)",2021-11-29,1569.6,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,250000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +"QED Therapeutics, Inc. ",72730011101,Truseltiq 100mg capsules 1 blister pack,2021-06-16,21500,"Truseltiq (infigratinib) is a new option for 2L+ FGFR2 fusion CCA who are in need of therapeutic options after frontline therapy. QED’s approach will focus on educating physicians about CCA, NGS testing, Truseltiq and important information about treatment with targeted therapies like FGFR inhibitors. Educational materials will be provided across the patient journey, to HCPs and to consumers, and provide information about access support for Truseltiq.",,250,,,,,,,"Maximum potential of 250 patients (Total annual patient population in intrahepatic cholangiocarcinoma of 3,000 per year/ 12 months) + +Source: https://rarediseases.org/rare-diseases/cholangiocarcinoma/#:~:text=Affected%20Populations&text=The%20incidence%20of%20intrahepatic%20cholangiocarcinoma,States%20is%20increasing%20%5B7%5D",,,,,,,,,,,,,,, +"QED Therapeutics, Inc. ",72730010101,Truseltiq 125mg capsules 1 blister pack,2021-06-16,21500,"Truseltiq (infigratinib) is a new option for 2L+ FGFR2 fusion CCA who are in need of therapeutic options after frontline therapy. QED’s approach will focus on educating physicians about CCA, NGS testing, Truseltiq and important information about treatment with targeted therapies like FGFR inhibitors. Educational materials will be provided across the patient journey, to HCPs and to consumers, and provide information about access support for Truseltiq.",,250,,,,,,,"Maximum potential of 250 patients (Total annual patient population in intrahepatic cholangiocarcinoma of 3,000 per year/ 12 months) + +Source: https://rarediseases.org/rare-diseases/cholangiocarcinoma/#:~:text=Affected%20Populations&text=The%20incidence%20of%20intrahepatic%20cholangiocarcinoma,States%20is%20increasing%20%5B7%5D",,,,,,,,,,,,,,, +"QED Therapeutics, Inc. ",72730050601,Truseltiq 50mg capsules 1 blister pack,2021-06-16,21500,"Truseltiq (infigratinib) is a new option for 2L+ FGFR2 fusion CCA who are in need of therapeutic options after frontline therapy. QED’s approach will focus on educating physicians about CCA, NGS testing, Truseltiq and important information about treatment with targeted therapies like FGFR inhibitors. Educational materials will be provided across the patient journey, to HCPs and to consumers, and provide information about access support for Truseltiq.",,250,,,,,,,"Maximum potential of 250 patients (Total annual patient population in intrahepatic cholangiocarcinoma of 3,000 per year/ 12 months) + +Source: https://rarediseases.org/rare-diseases/cholangiocarcinoma/#:~:text=Affected%20Populations&text=The%20incidence%20of%20intrahepatic%20cholangiocarcinoma,States%20is%20increasing%20%5B7%5D",,,,,,,,,,,,,,, +"QED Therapeutics, Inc. ",72730020201,Truseltiq 75mg capsules 1 carton pack (2 blister packs),2021-06-16,21500,"Truseltiq (infigratinib) is a new option for 2L+ FGFR2 fusion CCA who are in need of therapeutic options after frontline therapy. QED’s approach will focus on educating physicians about CCA, NGS testing, Truseltiq and important information about treatment with targeted therapies like FGFR inhibitors. Educational materials will be provided across the patient journey, to HCPs and to consumers, and provide information about access support for Truseltiq.",,250,,,,,,,"Maximum potential of 250 patients (Total annual patient population in intrahepatic cholangiocarcinoma of 3,000 per year/ 12 months) + +Source: https://rarediseases.org/rare-diseases/cholangiocarcinoma/#:~:text=Affected%20Populations&text=The%20incidence%20of%20intrahepatic%20cholangiocarcinoma,States%20is%20increasing%20%5B7%5D",,,,,,,,,,,,,,, +"Regeneron Pharmaceuticals, Inc.",61755001001,EVKEEZA (evinacumab-dgnb) 1200 mg/8 mL (150mg/ mL),2021-02-16,37500,"Marketing + +Planned marketing activities that will support the approval of EVKEEZA™ (evinacumab-dgnb) include raising awareness about homozygous familial hypercholesterolemia (HoFH) and EVKEEZA among healthcare professionals through physician-focused product and disease education websites, other digital media, print media, and use of sales representatives to promote the FDA-approved indication. Anticipated direct-to-consumer marketing activities include a consumer-focused product website and other digital media. + +Pricing + +Regeneron approaches pricing with fairness, affordability and access at the forefront. Our pricing philosophy is guided by several principles. + +First, medicines should be priced fairly. We take a value-based pricing approach that reflects their benefit to patients, society and the healthcare system. We consider the long-term investment and risk inherent in science and technology innovation, which is required to bring novel medicines to patients. + +Second, medicines are only useful if patients in need can access and afford them. We are committed to supporting patients’ access by providing financial assistance for eligible patients. + +Third, our growth is driven by scientific innovation, not pricing. Any price changes Regeneron makes is designed to keep pace with the medicine’s value and our costs, and in careful consideration of commercial competitiveness. + +Regeneron also seeks to work collaboratively with other stakeholders in the healthcare system and welcome their input on fair and cost-effective pricing. These principles taken together help to ensure advancing our goal of setting fair, value-based prices for our medicines and breaking down barriers to patient access.",,1300,1,1,,,,,"All information submitted by Regeneron Pharmaceuticals, Inc. to the California Office of Statewide Health Planning and Development under Cal. Code. Regs. Tit. 22, § 96076, including all information contained in this submission, is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act. Regeneron requests that the confidentiality of this submission and of all Regeneron’s related information herein be maintained to the maximum extent permitted by law. To the extent that any of this designated information is requested, whether under the California Public Records Act or otherwise, Regeneron requests that it be notified of the request and afforded an opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +"Regeneron Pharmaceuticals, Inc.",61755001301,EVKEEZA (evinacumab-dgnb) 345 mg/2.3 mL (150mg/mL),2021-02-16,10781.25,"Marketing + +Planned marketing activities that will support the approval of EVKEEZA™ (evinacumab-dgnb) include raising awareness about homozygous familial hypercholesterolemia (HoFH) and EVKEEZA among healthcare professionals through physician-focused product and disease education websites, other digital media, print media, and use of sales representatives to promote the FDA-approved indication. Anticipated direct-to-consumer marketing activities include a consumer-focused product website and other digital media. + +Pricing + +Regeneron approaches pricing with fairness, affordability and access at the forefront. Our pricing philosophy is guided by several principles. + +First, medicines should be priced fairly. We take a value-based pricing approach that reflects their benefit to patients, society and the healthcare system. We consider the long-term investment and risk inherent in science and technology innovation, which is required to bring novel medicines to patients. + +Second, medicines are only useful if patients in need can access and afford them. We are committed to supporting patients’ access by providing financial assistance for eligible patients. + +Third, our growth is driven by scientific innovation, not pricing. Any price changes Regeneron makes is designed to keep pace with the medicine’s value and our costs, and in careful consideration of commercial competitiveness. + +Regeneron also seeks to work collaboratively with other stakeholders in the healthcare system and welcome their input on fair and cost-effective pricing. These principles taken together help to ensure advancing our goal of setting fair, value-based prices for our medicines and breaking down barriers to patient access.",,1300,1,1,,,,,"All information submitted by Regeneron Pharmaceuticals, Inc. to the California Office of Statewide Health Planning and Development under Cal. Code. Regs. Tit. 22, § 96076, including all information contained in this submission, is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act. Regeneron requests that the confidentiality of this submission and of all Regeneron’s related information herein be maintained to the maximum extent permitted by law. To the extent that any of this designated information is requested, whether under the California Public Records Act or otherwise, Regeneron requests that it be notified of the request and afforded an opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Rhythm Pharmaceuticals Inc.,72829001001,Imcivree Injection 10 mg/ml,2021-03-05,3300,"Marketing: Imcivree is the first and only FDA approved treatment for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. Rhythm's approach will focus on educating health care providors on how to diagnose and treat patients efficently to relieve symptoms for patients. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support for Imcivree to ensure rapid access to life saving therapy + +Pricing: Imcivree (Setmelanotide injection) has been developed for the treatment of obesity due to POMC, PCSK1 or LEPR deficiency are ultra-rare diseases caused by variants in POMC, PCSK1 or LEPR genes that impair the melanocortin-4 (MC4) receptor pathway. Imcivree provides an option where there is none currently and delivers a safe, effective treatment that reduces the symptoms in patients. Imcivree is priced responsibly compared to similar orphan agents with significant clinical benefit and disease modification. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage. Rhythm demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind.",,200,1,1,,,,,,,,,,,,,,,,,,,, +Sagent Pharmaceuticals,25021018984,"Foscarnet Sodium Injection (24mg/ml, 250ml, 10x250ml)",2021-07-01,4727.7,Target vial users to convert to generic bags. No increases expected price competitive to tyye vials,,1000,,,,,,,New Gx Entry,,,,,,,,,,,,,,, +Sandoz Inc.,781347432,CARMUSTINE 100MG/VL 1LYVI,2021-06-17,1714.3,This launch is specific to the U.S. Sandoz Inc. is contracting within the oncology and hospital space. Resources are available for hospital buyers. The WAC is priced lower than the WAC of the reference product.,,169626,,,,,,,"Carmustine for Injection, USP is indicated as palliative therapy as a single agent or in established combination therapy in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. Multiple myeloma in combination with prednisone. Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs. Based on 2020 Kantar Health data, the prevalence of brain tumors and multiple myeloma (the two most common indications for this product) in the U.S. is approximately 169,626 individuals. + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. + +Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,781315401,FERUMOXYTOL INJ 510MG/17ML 1LIVI,2021-07-15,869.14,This launch is specific to the U.S. Sandoz Inc. is contracting within the oncology and hospital space. Resources are available for hospital buyers. The WAC is priced lower than the WAC of the reference product.,,3000000,,,,,,,"According to the National Heart, Lung, and Blood Institute, an estimated 3 million individuals suffer from anemia in the U.S. Increasing prevalence of target diseases, such as rheumatoid arthritis, autoimmune diseases, kidney conditions, cancer, liver disorders, thyroid diseases, and inflammatory bowel diseases, is a major factor facilitating the growth of the market for intravenous iron drugs. Some of the most common forms of anemia are iron and vitamin deficiency, a plastic, hemolytic, and sickle cell. Some of the common causes of anemia are iron, vitamin A and B12, and folate deficiencies. Source: https://www.grandviewresearch.com/industry-analysis/intravenous-iron-drugs-market + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. + +Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sanofi,58468042601,NEXVIAZYME™ (avalglucosidase alfa-ngpt),2021-08-17,1714.9,"Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Pompe disease, materials to be used by sales representatives to share information on NEXVIAZYME with prescribers, and materials to educate patients about Pompe and NEXVIAZYME.  Direct to Consumer (DTC) outreach for NEXVIAZYME will include search, website, and online ad placements.  DTC initiatives are not expected to include any TV, radio, or national magazine advertising. + +Sanofi’s commitment to pricing rests on three principles: a holistic assessment of value when setting launch prices, year-over-year price increases that are limited to National Health Expenditure projections, and disclosure of our aggregate gross and net prices changes to provide greater transparency about the pricing of our medicines. These comprehensive principles were drafted to address questions around the price of medicines in the United States. Our goal is to make our medicines accessible and affordable to all patients. We share concerns about the affordability of medicines, and we believe deeply in the important role we play in providing treatments for serious illnesses. We are determined to do our part in pricing our medicines with greater transparency and according to their value, while continuing to advance scientific knowledge and bringing life-saving treatments to patients worldwide. As part of our commitment to ensure treatment access and affordability for innovative therapies, Sanofi has decided to price NEXVIAZYME the same as alglucosidase alfa, the only other FDA-approved therapy for the treatment of Pompe disease and the comparator arm in the pivotal study.",,3500,1,1,,,,,"Pompe disease is a rare, degenerative muscle disorder that can impact an individual’s ability to move and breathe. It affects an estimated 3,500 people in the United States (US) and can manifest at any age from infancy to late adulthood.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=552,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923022702,AMONDYS45 Casimersen 100MG/2mL injection vial in carton,2021-02-25,1600,"Consistent with Section 127681(c) of the California Health and Safety Code, Sarepta is limiting its response to that which is otherwise in the public domain or publicly available. Sarepta’s marketing and pricing plans for AMONDYS 45 are neither in the public domain nor publicly available.",,,,1,,,,,"Response to ""Estimated Number of Patients"": AMONDYS 45 is an antisense oligonucleotide from Sarepta’s phosphorodiamidate morpholino oligomer platform, indicated for the treatment of Duchenne muscular dystrophy in patients with a confirmed mutation amenable to exon 45 skipping. Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.)",,,,,,,,,,,,,,, +"Seattle Genetics, Inc.",51144000301,"TIVDAK™ (Tisotumab vedotin - tftv ) For injection, for intravenous use. 40mg vial",2021-09-20,5885,"With regard to marketing plans, efforts to ensure that healthcare providers with appropriate patients are aware of Tivdak™ include customary digital and print media campaigns, oncology account managers sharing information with healthcare providers, and engagement of healthcare providers at congresses. + +With regard to pricing plans, Seagen Inc has a passion for helping patients, and that passion includes ensuring that we reach as many of the patients with cancers that our products treat as we can. Our pricing considerations are informed by that passion, and we incorporate diverse perspectives of stakeholders in the healthcare system. We also consistently seek to balance rewarding innovation while providing appropriate access for patients. Finally, we consider the clinical value our products deliver to patients, the severity of the cancers we treat, availability of alternative treatments, market dynamics, our continued ability to deliver new state-of-the-art innovations in response to other deadly cancers, and the meaningful impact we make on patient’s lives.",,0,1,1,,,,,"Seagen Inc does not believe the estimated number of patients in the United States with a condition for which this product may be prescribed is in the public domain. Thus, consistent with 22 C.C.R. §96076(c), Seagen Inc has inserted zero in order to ensure report submission. Seagen Inc notes this product is indicated for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, and we are able to provide the following publicly available information on cervical cancer more generally. Specifically, in 2020, there were 13,800 people diagnosed with cervical cancer in the United States. According to SEER statistics and published literature, 5,237 (out of the 13,800 incident CC patients in 2020) became eligible for 1L r/mCC treatment, among whom 2,619 (50% of 5,237) became eligible for 2L treatment.",,,,,,,,,,,,,,, +"SK Life Science, Inc.",71699010456,XCOPRI® Cenobamate Tablets 100mg(28)+150mg(28),2021-05-03,1029.33,"While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US.",,1800000,,,,,,,"While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.”",,,,,,,,,,,,,,, +Sobi Inc,66658050101,Gamifant10 mg/2 mL (5 mg/mL)SINGLE DOSE VIAL,2021-01-01,6679.8,continuing to perform same approach as we do for the NDC Label code it is replacing 72171 501-01,,12,1,1,,,,,1 vial 10mg-  this is not commercial active yet as we are awaiting for NDC 72171-501-01 to be exhausted out of market place that will be circa May 2021 onwards.  This is part of original BLA 761107. This NDC is replacing NDC 72171-501-01. There is no price difference of these same products different NDCs,https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=467,,,,,,,,,,,,,, +Sobi Inc,66658050501,Gamifant50 mg/10 mL (5 mg/mL) SINGLE DOSE VIAL,2021-01-01,16885.05,continuing to perform same approach as we do for the NDC Label code it is replacing 72171 505-01,,10,1,1,,,,,1 vial 50mg-  this is not commercial active yet as we are awaiting for NDC 72171-505-01 to be exhausted out of market place that will be circa February 2021 onwards.  This is part of original BLA 761107. this new NDC is replacing NDC 72171-505-01. There is no price difference of these same products different NDCs,https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=468,,,,,,,,,,,,,, +Sobi Inc,66658051001,Gamifant100 mg/20 mL (5 mg/mL)SINGLE DOSE VIAL,2021-01-11,33770.1,continuing to perform same approach as we do for the Gamifant Label that has and is currently approved. this is just a new strength drug to the product,,6,1,1,,,,,1 vial 10mg-  this is new NDC to part of original BLA 761107 Supplemental approval letter (BLA 761107/S-004),https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=469,,,,,,,,,,,,,, +Solaris Pharma Corporation,73473030275,Clindamycin Phosphate External Gel 1 %™ (clindamycin phosphate) 75mL per Bottle,2021-09-17,888.63,,1,45000000,,,,,,,,,,,,,,,,,,,,,, +Stratatech Corporation,73612020001,StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen - dsat),2021-10-22,4000,"In accordance with Mallinckrodt’s drug pricing pledge, we price our innovative drugs to reflect the value to patients, providers, and the healthcare system as a whole. StrataGraft is a highly specialized product used in the hospital setting for the treatment of deep partial thickness burns. The product will only be directly marketed to healthcare practitioners, including surgeons, operating in approximately 115 burn centers across the US.",,10000,,1,,,,,"According to the American Burn Association Fact Sheet (https://ameriburn.org/who-we-are/media/burn-incidence-fact-sheet/) on Burn Incidence, there are approximately 486,000 burn injuries that receive medical treatment on an annual basis. Of those, approximately 40,000 patients are hospitalized for their burns on an annual basis and approximately 25 percent of  these patients receive an autograft during their stay and could potentially be eligible to receive Stratagraft. Stratagraft is only indicated for deep partial thickness burn treatment, and only a limited subset of patients would be eligible for treatment with this product.",,,,,,,,,,,,,,, +"Strides Pharma, Inc.",42543088904,Efavirenz Tablets 600mg,2021-03-26,894.32,"This product is marketed in the generic multisource space, and therefore marketing of the product is not based on any aspects of the product itself, but its price and availability. For these reasons, Strides Pharma Inc.(""Strides"")does not interact with healthcare providers including physicians, hospital groups, group purchasing organizations, or other entities to promote Strides' products. +The methodology that Strides uses to set the wholesale acquisition price(""WAC"") was to discount the reference drug price or match the lowest generic WACs available at the time of the product launch. Strides uses a subscription-based service, Medi-Span Price Rx, in obtaining this information to reflect a discount off of the Reference Drug listed by the FDA. Therefore, Cost-based, quality-adjusted, or value-based pricing were not used to establish WAC for this product.",,1200000,,,,,,,"The reason for leaving the acquisition-related fields blank was because Strides developed the drug. The source for the estimated patients is Hiv.gov, an official US government website managed by the US Department of Health & Human Services.",,,,,,,,,,,,,,, +"Strides Pharma, Inc.",42543071904,Emtricitabine & Tenofovir Disoproxil Fumarate Tablets 200/300mg,2021-03-26,1455.4,"This product is marketed in the generic multisource space, and therefore marketing of the product is not based on any aspects of the product itself, but its price and availability. For these reasons, Strides Pharma Inc.(""Strides"")does not interact with healthcare providers including physicians, hospital groups, group purchasing organizations, or other entities to promote Strides' products. +The methodology that Strides uses to set the wholesale acquisition price(""WAC"") was to discount the reference drug price or match the lowest generic WACs available at the time of the product launch. Strides uses a subscription-based service, Medi-Span Price Rx, in obtaining this information to reflect a discount off of the Reference Drug listed by the FDA. Therefore, Cost-based, quality-adjusted, or value-based pricing were not used to establish WAC for this product.",,1200000,,,,,,,"The reason for leaving the acquisition-related fields blank was because Strides developed the drug. The source for the estimated patients is Hiv.gov, an official US government website managed by the US Department of Health & Human Services.",,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304008690,Droxidopa Caps 100mg 90ct,2021-02-19,740,"This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,0,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304010490,Droxidopa Caps 200mg 90ct,2021-02-19,1080,"This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,0,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304011290,Droxidopa Caps 300mg 90ct,2021-02-19,1440,"This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.",,0,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,57664002597,Isotretinoin Capsules 40mg 3 x 10 Packs,2021-04-27,915.13,"• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable • ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin.",,10000000,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,57664002097,Isotretinoin Capsules 10mg 3 x 10 Packs,2021-04-29,850.54,"• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable • ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin.",,10000000,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,57664002197,Isotretinoin Capsules 20mg 3 x 10 Packs,2021-04-29,850.54,"• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable • ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin.",,10000000,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,57664002297,Isotretinoin Capsules 25mg 3 x 10 Packs,2021-04-29,915.13,"• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable • ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin.",,10000000,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,57664002397,Isotretinoin Capsules 30mg 3 x 10 Packs,2021-04-29,915.13,"• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable • ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin.",,10000000,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,57664002497,Isotretinoin Capsules 35mg 3 x 10 Packs,2021-04-29,915.13,"• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable • ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin.",,10000000,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304009127,Sunitinib Malate Capsules 12.5mg 28ct,2021-08-16,5092.79,"This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers. This product (ANDA approval) is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA.",,4999,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304009227,Sunitinib Malate Capsules 25mg 28ct,2021-08-16,10185.59,"This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers. This product (ANDA approval) is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA.",,4999,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304009327,Sunitinib Malate Capsules 37.5mg 28ct,2021-08-16,15278.39,"This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers. This product (ANDA approval) is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA.",,4999,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304009427,Sunitinib Malate Capsules 50mg 28ct,2021-08-16,17731.67,"This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers. This product (ANDA approval) is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA.",,4999,,,,,,,,,,,,,,,,,,,,,, +"Takeda Pharmaceuticals America, Inc.",63020004012,EXKIVITY™ (mobocertinib) capsules,2021-09-20,25000,"While specific marketing and pricing plans are not available in the public domain, generally we do plan to market Exkivity in the US through print and digital media materials created to be used by sales representatives to share information on Exkivity with prescribers and through the use of print and digital materials made available to educate patients about Exkivity. We will also promote Exkivity to appropriate healthcare professionals, who treat individuals diagnosed with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion, a rare condition, through engagement at scientific meetings and conferences. Takeda considers a number of factors when deciding the price at which to set its prescription drugs, including, but not limited to: (i) the value medicine brings to patients and society; (ii) access to medicines; and (iii) providing a thoughtful approach that allows us to continue to deliver innovative medicines. Patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ non-small cell lung cancer (NSCLC) make up approximately 1-2% of patients with NSCLC. This disease carries a worse prognosis than other EGFR mutations and has been historically underserved. Exkivity is a first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations. In establishing WAC, Takeda also evaluated the access landscape for EGFR Exon20 insertion+ NSCLC patients, including the current treatment landscape and associated costs, likelihood of payor coverage, and options for patients without coverage. In addition, Takeda considered its ability to continue to fund the discovery of future oncology innovations and the resources needed to bring new therapies to market.",,4000,1,1,,,,,"The estimated number of patients in any given state in the United States (U.S.) with a condition for which EXKIVITY may be prescribed each month is not known but EGFR exon 20 disease makes up 1% to 2% of all NSCLC cases, or about 2,000 to 4,000 patients per year in the U.S.",,,,,,,,,,,,,,, +TARO PHARMACEUTICALS,51672417406,Imiquimod Cream,2021-02-09,1040.93,"This product (ANDA approval) is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA.",,2408,,,,,,,,,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,51759020222,AJOVY® (fremanezumab-vfrm) Injection Autoinjector Triple Pack,2021-01-19,1900.08,,1,19000000,,,,,,,"Estimated average of approximately 80,000 prescriptions per year, based on historic sales data, although research suggests that as many as 19 million Americans suffer from migraines, which this product is indicated to prevent. +Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591243315,ISOTRETINOIN CAPSULE 10MG 30,2021-04-30,763.57,,1,7000000,,1,,,,,"Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591243415,ISOTRETINOIN CAPSULE 20MG 30,2021-04-30,763.57,,1,7000000,,1,,,,,"Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591245115,ISOTRETINOIN CAPSULE 25MG 30,2021-04-30,821.56,,1,7000000,,1,,,,,"Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591243515,ISOTRETINOIN CAPSULE 30MG 30,2021-04-30,821.56,,1,7000000,,1,,,,,"Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591250115,ISOTRETINOIN CAPSULE 35MG 30,2021-04-30,821.56,,1,7000000,,1,,,,,"Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591243615,ISOTRETINOIN CAPSULE 40MG 30,2021-04-30,821.56,,1,7000000,,1,,,,,"Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93557201,ERYTHROMYCIN TABLETS 500MG 100,2021-05-04,997.1,,1,66000000,,1,,,,,"Estimated average of approximately 140,000 prescriptions per year, based on historic IQVIA data, although research suggests that approximately 66,000,000 patients per year are prescribed outpatient pharmacy antibiotics, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93790901,TIOPRONIN ORAL TABLETS 100MG 100CT,2021-05-17,2437.27,,1,13200,,1,,,,,"Research suggests that approximately 13,200 patients in the US suffer from severe homozygous cystinuria, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93406106,FORMOTEROL FUMARATE INH SOL 10MCG/ML 60,2021-06-22,963.79,,1,26500000,,,,,,,"Estimated average of approximately 195,300 prescriptions per year, based on historic IQVIA data, although research suggests that approximately 26,500,000 US adults suffer from chronic obstructive pulmonary disease, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,591283201,BEXAROTENE 75MG SGL CAPSULES 100,2021-11-11,2835.7,,1,1100,,,,,,,"Estimated average of 700 prescriptions per month, based on historic IQVIA data. Research similarly suggests that there are approximately 1,100 patients in the US who suffer from cutaneous T-cell lymphoma and are being treated with bexarotene. + +Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93766256,ERLOTINIB HCL TABLETS EQ 25MG 30,2021-12-08,1673.68,,1,32000,,,,,,,"Estimated average of up to 119 prescriptions per month, based on historic IQVIA data, although research suggests that there are as many as 32,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480372001,PYRIMETHAMINE TABLETS 25MG 100,2021-12-15,25650,,1,2000,,1,,,,,"Estimated average of roughly 100 prescriptions per month, based on historic IQVIA data, although research suggests that as many as 2,000 Americans take the product annually. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480372056,PYRIMETHAMINE TABLETS 25MG 30,2021-12-15,7695,,1,2000,,1,,,,,"Estimated average of roughly 100 prescriptions per month, based on historic IQVIA data, although research suggests that as many as 2,000 Americans take the product annually. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93819928,SUNITINIB MALATE CAPSULES 12.5MG 28,2021-12-22,4889.07,,1,2800,,1,,,,,"Estimated average of up to 1,057 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that as many as 2,800 Americans take the product annually. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93822428,SUNITINIB MALATE CAPSULES 25MG 28,2021-12-22,9778.16,,1,2800,,1,,,,,"Estimated average of up to 1,057 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that as many as 2,800 Americans take the product annually. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93822928,SUNITINIB MALATE CAPSULES 37.5MG 28,2021-12-22,14667.25,,1,2800,,1,,,,,"Estimated average of up to 1,057 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that as many as 2,800 Americans take the product annually. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,93823128,SUNITINIB MALATE CAPSULES 50MG 28,2021-12-22,17022.4,,1,2800,,1,,,,,"Estimated average of up to 1,057 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that as many as 2,800 Americans take the product annually. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +"TG Therapeutics, Inc.",73150020012,"UKONIQ (umbralisib) 200 mg tablets, 120 count bottle",2021-02-05,15900,"Marketing Plan: + +UKONIQ™ was approved on 2/5/2021 as a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. TG has designed marketing activities to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indications, efficacy and safety data contained within UKONIQ’s FDA approved label. + + • UKONIQ will not have any DTC advertisements on any platforms at launch. We will, however, have a patient-facing website that provides information about UKONIQ, the diseases it is approved to treat, and the TG Patient Support Program. + + • At launch TG will not offer coupons or free trials. However, at launch TG will offer copayment assistance to commercially insured patients through the TG Patient Support Program. Information about the TG Patient Support Program, including the commercial co-pay program, will be provided to healthcare providers (“HCPs”) by our sales representatives and via an HCP website, and to patients via a patient-facing website. + +Pricing Plan: + +TG Therapeutics was founded with one broad mission: to develop novel and valuable treatment options for patients with B-cell diseases. Our commitment to patients, however, goes beyond science. We believe that access is essential in ensuring advances are available to patients who are in need of treatment options. Ahead of our first commercial launch, we created a unique approach to our decision-making around access and pricing anchored on the clinical value of our products and guided by three core pillars: fiercely focused on patients, access and solutions. These guiding principles are inspired by our mission, shaped our pricing decision for UKONIQ and will continue to shine through in our commitment to patients. Further information about our commitment to patient access can be found here: https://www.tgtherapeutics.com/wp-content/uploads/2021/02/Our-Commitment-to-Patient-Access.pdf",,10000,1,1,2012-08-16,,1,"The price TG Therapeutics paid for acquisition of the rights to develop and commercialize UKONIQ™ is not shared publicly, and TG Therapeutics has taken reasonable measures to keep this information confidential. Access to the information is limited to certain individuals within the company’s management team and finance functions. The information is subject to non-disclosure requirements in employment agreements. Accordingly, TG Therapeutics is limiting its response to this item pursuant to California Health & Safety Code § 127681(c).","Comment regarding number of Estimated Patients field: Each year there are approximately 18,000-20,000 patients in the US who are in need of a new treatment for their relapsed disease in both Marginal zone lymphoma (MZL) and Follicular lymphoma (FL). Although difficult to estimate precisely, we believe there are ~8,000-10,000 patients within our FDA labelled indications.",,,,,,,,,,,,,,, +"Upsher-Smith Laboratories, LLC",245057501,Isotretinoin Capsules 40 mg,2021-06-25,821.56,"Isotretinoin is a generic medication. Upsher-Smith Laboratories, LLC intends to provide the product at a competitive price based off the current market landscape today.",,1800000,,,,,,,,,,,,,,,,,,,,,, +"Upsher-Smith Laboratories, LLC",245057001,Isotretinoin Capsules 10 mg,2021-09-22,763.57,"Isotretinoin is a generic medication. Upsher-Smith Laboratories, LLC intends to provide the product at a competitive price based off the current market landscape today.",,1800000,,,,,,,,,,,,,,,,,,,,,, +"Upsher-Smith Laboratories, LLC",245057101,Isotretinoin Capsules 20 mg,2021-09-22,763.57,"Isotretinoin is a generic medication. Upsher-Smith Laboratories, LLC intends to provide the product at a competitive price based off the current market landscape today.",,1800000,,,,,,,,,,,,,,,,,,,,,, +Vanda Pharmaceuticals Inc.,43068030406,Hetlioz LQ 158 mL 4mg/ mL,2021-03-08,21205.59,,1,15000,,1,,,,,"SMS is estimated to affect 1/15,000-25,000 births in the U.S. (https://www.orpha.net/consor/cgi-bin/OC_Exp.php?Lng=GB&Expert=819)",,,,,,,,,,,,,,, +Vanda Pharmaceuticals Inc.,43068030402,Hetlioz LQ 48 mL 4mg/ mL,2021-03-08,6442.2,,1,15000,,1,,,,,"SMS is estimated to affect 1/15,000-25,000 births in the U.S. (https://www.orpha.net/consor/cgi-bin/OC_Exp.php?Lng=GB&Expert=819)",,,,,,,,,,,,,,, +Vgyaan Pharmaceuticals LLC,72664061128,"LEUPROLIDE ACETATE, 1MG/0.2ML, 2.8ML Vial",2021-12-01,712.8,,1,100000,,1,,,,,,,,,,,,,,,,,,,, +ViiV Healthcare,49702025315,CABENUVA (cabotegravir 400 mg/2mL; rilpivirine 600 mg/2mL),2021-02-01,3960,,1,609000,,1,,,,,"Regarding Marketing/Pricing Plan Description, ViiV has not released CABENUVA's marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). +The 609,000 patient figure does not reflect the number of patients that are estimated to be treated with Cabenuva; rather, it represents the estimated number of virologically- suppressed adults (18+) in the US living with diagnosed HIV-1 infection, based on the CDC Selected National HIV Prevention and Care Outcomes, July 2019. To be eligible for Cabenuva according to the indication, in addition to being virologically suppressed, the patient must be on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to cabotegravir or rilpivirine, however since there are no known estimates for these parameters, the estimated number of patients provided does not reflect any assumptions regarding these clinical requirements, nor does it take into consideration a projection for the number of patients willing to switch to an injectable formulation. CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. CABENUVA consists of long-acting cabotegravir, an integrase strand transfer inhibitor (INSTI), and long-acting rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which allows for 2 separate once-monthly provider administered injections. This is the first FDA-approved long-acting complete regimen for HIV-infected adults administered by providers once a month. +CABENUVA was granted priority review by the Food And Drug Administration. +Note on Acquisition Fields: CABENUVA was developed by ViiV Healthcare, therefore the following fields related to drug acquisition have been left blank: ACQUISITION_DATE, ACQUISITION_PRICE, ACQUISITION_PRICE_NONPUBLIC, ACQUISITION_PRICE_COMMENT.",,,,,,,,,,,,,,, +ViiV Healthcare,49702024015,CABENUVA (cabotegravir 600 mg/3mL; rilpivirine 900 mg/3mL),2021-02-01,5940,,1,609000,,1,,,,,"Regarding Marketing/Pricing Plan Description, ViiV has not released CABENUVA's marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). +The 609,000 patient figure does not reflect the number of patients that are estimated to be treated with Cabenuva; rather, it represents the estimated number of virologically- suppressed adults (18+) in the US living with diagnosed HIV-1 infection, based on the CDC Selected National HIV Prevention and Care Outcomes, July 2019. To be eligible for Cabenuva according to the indication, in addition to being virologically suppressed, the patient must be on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to cabotegravir or rilpivirine, however since there are no known estimates for these parameters, the estimated number of patients provided does not reflect any assumptions regarding these clinical requirements, nor does it take into consideration a projection for the number of patients willing to switch to an injectable formulation. CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. CABENUVA consists of long-acting cabotegravir, an integrase strand transfer inhibitor (INSTI), and long-acting rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which allows for 2 separate once-monthly provider administered injections. This is the first FDA-approved long-acting complete regimen for HIV-infected adults administered by providers once a month. +CABENUVA was granted priority review by the Food And Drug Administration. +Note on Acquisition Fields: CABENUVA was developed by ViiV Healthcare, therefore the following fields related to drug acquisition have been left blank: ACQUISITION_DATE, ACQUISITION_PRICE, ACQUISITION_PRICE_NONPUBLIC, ACQUISITION_PRICE_COMMENT.",,,,,,,,,,,,,,, +VistaPharm Inc,66689011010,Lacosamide Oral Solution 20mL x 10 UDC,2021-11-15,740,,1,18000,,,,,,,This drug was not acquired from the approval owner. UCB is still the owner of the approval.,,,,,,,,,,,,,,, +Woodward Pharma Services LLC,69784024010,Carboprost Tromethamine Intramuscular Solution 250 MCG/ML,2021-06-01,3189.9,,1,5000,,,,,,,Product was not acquired therefore product acquisition cost is not N/A,,,,,,,,,,,,,,, +Woodward Pharma Services LLC,69784081001,"Sodium Phenylacetate and Sodium Benzoate Injection 10%/10%, 50mL, 1 ct",2021-06-18,5000,,1,3000,,,,,,,Product was not acquired therefore product acquisition cost is not N/A,,,,,,,,,,,,,,, +Y-mAbs Therapeutics Inc. ,73042020101,"Danyelza Injection, 40mg/10mg, single use vial",2021-02-01,20368,"Y-mAbs' pricing decisions regarding the introductory WAC was determined after very thoughtful and careful consideration of a number of interdependent factors. + +These factors include but are not limited to the following: + +1. The clinical and economic value of the drug; +2. Market dynamics and competitive pricing and total cost of care within the drug's therapeutic category; +3. Discounts provided to customers for commercial and government channels; +4. Cost of comprehensive patient support programs to ensure patient access; and +5. Overall research and development costs & reinvestment into future R&D + +Y-mAbs will use (digital and print) promotion that focuses on raising awareness of Danyelza as well as the deployment of a national sales force.",,700,1,1,,,,,"Y-mAbs has left the fields regarding acquisition blank because Danyelza was not acquired, but was developed by Y-mAbs.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710153406,Cisatracurium Besylate 200mg/20mL Solution for Injection,2021-01-15,2670,,1,1,,,,,,,"This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “1” in the “Estimated Number of Patients” column for the following reasons: +• Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. +• We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. +• Cisatracurium Besylate Injection has multiple indications as listed in the Indications and Usage section in our Prescribing Information (as of January 22, 2021). Zydus neither collects nor uses estimated patient information in our normal course of business. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710139009,Droxidopa 200mg Capsules (90 Count),2021-02-19,1226.05,,1,1,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “1” in the “Estimated Number of Patients” column for the following reasons: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710139109,Droxidopa 300mg Capsules (90 Count),2021-02-19,1839.08,,1,1,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “1” in the “Estimated Number of Patients” column for the following reasons: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,68382012001,Azathioprine 100mg Tablets (100),2021-10-14,738.76,,1,1,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “1” in the “Estimated Number of Patients” column for the following reasons: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,68382011901,Azathioprine 75mg Tablets (100),2021-10-14,1657.05,,1,1,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “1” in the “Estimated Number of Patients” column for the following reasons: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710149105,Fluphenazine HCl 10mg Tablets (500),2021-10-26,1826.8,,1,1,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “1” in the “Estimated Number of Patients” column for the following reasons: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710149005,Fluphenazine HCl 5mg Tablets (500),2021-10-26,1448.9,,1,1,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “1” in the “Estimated Number of Patients” column for the following reasons: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710172608,Nelarabine Inj 250mg/50mL (6X5mL),2021-11-19,3966,,1,186400,,,,,,,"This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “186400” in the “Estimated Number of Patients” column. Approximately 1,519,907 people in the United States are living with or in remission from leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS) or myeloproliferative neoplasms (MPNs) and it is estimated that 186,400 people in the US will be diagnosed with leukemia, lymphoma or myeloma in 2021. *Information is from the Leukemia and Lymphoma Society website (https://www.lls.org/facts-and-statistics/facts-and-statistics-overview as of 11/30/2021 +Zydus does not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. Zydus neither collects nor uses estimated patient information in our normal course of business.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710101403,Phytonadione (Vitamin K) 5mg Tablet 30 Count,2021-12-13,1125.37,,1,334,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “334” in the “Estimated Number of Patients” column for the following reasons: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Phytonadione is indicated for the treatment of adults with coagulation disorders (hypoprothrombinemia). As per the Medscape article dated June 16, 2021, both acquired and inherited hypoprothrombinemia are exceedingly rare in the United States. Hypoprothrombinemia due to vitamin K deficiency is rarely seen since vitamin K injections are routinely given in the neonatal period. Per the Pubmed.gov (https://pubmed.ncbi.nlm.nih.gov/19141155/) online article dated November 14, 2008, Prothrombin (factor II) deficiency is a rare autosomal recessive coagulation disorder that occurs in approximately 1 in 1-2 million people. Zydus took this information by the estimated number of people in the USA as of December 20, 2021 (per https://www.worldometers.info/world-population/us-population/) and came up with our estimated patients number.",,,,,,,,,,,,,,, +"Aadi Bioscience, Inc.",80803015350,FYARRO™ (sirolimus protein-bound particles for injectable suspension) (albumin-bound) 100 MG per Vial {1 Vial per Pack},2022-02-22,6785,,1,300,1,1,,,,,"""Aadi has listed Fyarro with a WAC price effective date of 11/22/2021 within the pricing compendiums (i.e., Medispan); however, the product was not made available for purchase in California until February 21, 2022. + +Specific to Estimated Number of Patients: It is estimated there are 100-300 new patients per year in the US with advanced / malignant PEComa. (Note: There is no formal published epidemiology information; Aadi analysis based on multiple sources including Aadi internal data and external research) + +Specific to the Acquisition Fields: Aadi owns the FDA regulatory approval for FYARRO and the drug is and has always been sold under an Aadi labeler code. The FDA-approved drug was not “acquired” and Aadi was extensively involved in the research and development of the drug, including conducting clinical trials and submitting the application for FDA approval. We note that Aadi licensed from Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation, now Bristol-Myers Squibb Company the exclusive rights for certain patents and a non-exclusive license for certain technology and know-how pertaining to ABI-009 (which ultimately became FYARRO). Those license rights enabled Aadi to pursue the clinical trials and related development work necessary to seek and obtain FDA approval of the product. + +""",,,,,,,,,,,,,,, +AbbVie,74231030,RINVOQ (upadacitinib) 30MG 30 Day Bottle,2022-01-24,5671.26,"RINVOQ is marketed for the treatment of refractory, moderate to severe Atopic Dermatitis in adults and pediatrics 12 and above. The Wholesale Acquisition Cost (WAC) of RINVOQ is $5,671.26 for a month supply of 30 mg (30 count). To date, RINVOQ has been approved in >50 jurisdictions outside the United States.",,12000,1,1,,,,,"Response on estimated volume of patients: RINVOQ is marketed for the treatment of refractory, moderate to severe atopic dermatitis in adults and children 12 years and older. Based upon published analysis, atopic dermatitis affects approximately 16.5 million adults and 9.6 million children under the age of 18 in the United States. See Shaw TE, Currie GP, Koudelka CW, Simpson EL. Eczema prevalence in the United States: data from the 2003 National Survey of Children’s Health. J Invest Dermatol. 2011;131(1):67-73, Silverberg JI, Simpson EL. Association between severe eczema in children and multiple comorbid conditions and increased healthcare utilization. Pediatr Allergy Immunol. 2013;24(5):476-486, Silverberg JI, Simpson EL. Associations of childhood eczema severity: a US population-based study. Dermatitis. 2014;25(3):107-114, Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J Invest Dermatol. 2019;139(3):583-590. RINVOQ may be prescribed for a fraction of those patients for whom a physician and patient in consultation may consider this treatment appropriate.",,,,,,,,,,,,,,, +AbbVie,74104328,RINVOQ (upadacitinib) 45MG 30 Day Bottle,2022-03-23,10586.24,"RINVOQ is marketed to treat adults with moderately to severely active ulcerative colitis (UC) . The Wholesale Acquisition Cost (WAC) of RINVOQ 45mg tablets is $10,586.35 per bottle of 28 tablets. To date, RINVOQ has been approved in jurisdictions outside the United States.",,7200,,1,,,,,,,,,,,,,,,,,,,, +AbbVie,74501501,RISA 600mg / 10mL VIAL,2022-06-28,9136.4,"SKYRIZI is marketed for the treatment of moderately to severely active Crohn's disease in adults. The Wholesale Acquisition Cost (WAC) of SKYRIZI is $9,136.40. To date, SKYRIZI has been approved in >50 jurisdictions outside the United States.",,1000,,1,,,,,"Response on estimated volume of patients (1,000 per month): Inflammatory bowel disease (IBD) is a family of chronic inflammatory diseases that affect different regions of the GI tract and includes both ulcerative colitis (UC and Crohn’s disease (CD). In the United State, nearly 1.5 million Americans are affected by this chronic disease. + +CD is a chronic inflammatory disease characterized by discontinuous areas of transmural inflammation (skip lesions) that occur anywhere along the GI tract, from the mouth to the anus. CD is an unpredictable, progressive disease that impacts patients’ daily lives and when inadequately controlled, CD can lead to irreversible damage to the intestines. + +In North America, the incidence of CD ranges from 3.1 to 14.6 cases per 100,000 person-years, with a prevalence of 26 to 199 cases per 100,000 person-years. CD affects males slightly more than females. The peak age at onset for IBD is between 15 and 30 years, with a second peak occurring between 60 and 80 years.",,,,,,,,,,,,,,, +AbbVie,74107001,SKYRIZI (risankizumab-rzaa),2022-08-23,18272.79,"SKYRIZI is marketed for the treatment of moderately to severely active Crohn's disease in adults. The Wholesale Acquisition Cost (WAC) of SKYRIZI is $18,272.79",,1000,,1,,,,,"Response on estimated volume of patients (1,000 per month) - Inflammatory bowel disease (IBD) is a family of chronic inflammatory diseases that affect different regions of the GI tract and includes both ulcerative colitis (UC and Crohn’s disease (CD). In the United State, nearly 1.5 million Americans are affected by this chronic disease. + +CD is a chronic inflammatory disease characterized by discontinuous areas of transmural inflammation (skip lesions) that occur anywhere along the GI tract, from the mouth to the anus. CD is an unpredictable, progressive disease that impacts patients’ daily lives and when inadequately controlled, CD can lead to irreversible damage to the intestines. + +In North America, the incidence of CD ranges from 3.1 to 14.6 cases per 100,000 person-years, with a prevalence of 26 to 199 cases per 100,000 person-years. CD affects males slightly more than females. The peak age at onset for IBD is between 15 and 30 years, with a second peak occurring between 60 and 80 years.",,,,,,,,,,,,,,, +AbbVie,74106501,risankizumab-rzaa 180mg/1.2ml OBI,2022-12-28,18272.79,"SKYRIZI is marketed for the treatment of moderately to severely active Crohn's disease in adults. The Wholesale Acquisition Cost (WAC) of SKYRIZI is $18,272.79. To date, SKYRIZI has been approved in >50 jurisdictions outside the United States.",,1000,,1,,,,,"Response on estimated volume of patients (1,000 per month): Inflammatory bowel disease (IBD) is a family of chronic inflammatory diseases that affect different regions of the GI tract and includes both ulcerative colitis (UC and Crohn’s disease (CD). In the United State, nearly 1.5 million Americans are affected by this chronic disease. + +CD is a chronic inflammatory disease characterized by discontinuous areas of transmural inflammation (skip lesions) that occur anywhere along the GI tract, from the mouth to the anus. CD is an unpredictable, progressive disease that impacts patients’ daily lives and when inadequately controlled, CD can lead to irreversible damage to the intestines. + +In North America, the incidence of CD ranges from 3.1 to 14.6 cases per 100,000 person-years, with a prevalence of 26 to 199 cases per 100,000 person-years. CD affects males slightly more than females. The peak age at onset for IBD is between 15 and 30 years, with a second peak occurring between 60 and 80 years.",,,,,,,,,,,,,,, +"Accord BioPharma, Inc.",69448001463,1 SYRINGE in 1 CARTON (69448-014-63) > .37 g in 1 SYRINGE,2022-04-05,3900,,1,74000,,,2022-01-28,,1,,,,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729024438,Pemetrexed Disodium Intravaneous Sol Reconstituted 1000MG 1 pack,2022-05-25,1044.5,,1,0,,,,,,,"Accord did not acquire the NDC for Pemetrexed, the generic product was developed in house. + +Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. + +Accord does not have internal methods or procedures to estimate a reasonable number of patients with a disease state and therefore, cannot answer this question with any level of accuracy that is needed in order to comply with the requirement.",,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729046785,Pirfenidone 267 mg tablet 3 pack,2022-05-27,7147.41,,1,0,,,,,,,"""Accord did not acquire the NDC for Pemetrexed, the generic product was developed in house. + +Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. + +Accord does not have internal methods or procedures to estimate a reasonable number of patients with a disease state and therefore, cannot answer this question with any level of accuracy that is needed in order to comply with the requirement.""",,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729046815,Pirfenidone 801 mg tablet 1 pack,2022-05-27,7147.41,,1,0,,,,,,,"""Accord did not acquire the NDC for Pemetrexed, the generic product was developed in house. + +Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. + +Accord does not have internal methods or procedures to estimate a reasonable number of patients with a disease state and therefore, cannot answer this question with any level of accuracy that is needed in order to comply with the requirement.""",,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729052235,Pemetrexed Injection 1000mg/40mL (25mg/mL) SDV,2022-09-08,1044.5,,1,28500,,,,,,,,,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729034210,Fingolimod 0.5mg Caps 30 Pack,2022-10-18,4870.56,,1,1,,,,,,,,,,,,,,,,,,,,,, +"Accord Healthcare, Inc.",16729025105,"Bendamustine HCl for Injection, USP 100mg/vial",2022-12-07,1600,,1,1240,,,,,,,"Accord Healthcare is a generic drug manufacturer, and this drug is a generic product with many other generics products available within this therapeutic class. Bendamustine Hydrochloride for Injection is an alkylating drug indicated for treatment of patients with Chronic lymphocytic leukemia and Indolent B-cell non-Hodgkin lymphoma.",,,,,,,,,,,,,,, +Advagen Pharma Limited,72888008630,Diclofenac Potassium Tablet 25mg 30ct,2022-07-07,861.29,,1,24000,,,,,,,This is a new presentation to be added in the next few weeks. Advagen already markets 2 other presentations in 50mg tablet from. This product was not acquired. Marketing right were granted to Advagen by the approval owner.,,,,,,,,,,,,,,, +Advanced Accelerator Applications,66948001061,"PLUVICTO (Single dose vial, 7.5 ml to 12.5 ml)",2022-03-23,42500,"The marketing for PLUVICTO (Lutetium Lu 177 vipivotide tetraxetan) includes education and promotion to physicians, direct to consumer promotions, other types of marketing (e.g., online platforms and education).",,1300,1,1,,,,,"Advanced Accelerator Applications considered many factors in determining the price of PLUVICTO and the financial and non-financial factors are considered as a whole when establishing the WAC price. We priced in parity to other branded treatments in this therapeutic area. Factors in our pricing methodology included consideration of value delivered to the patient, healthcare system, and society, as well as existing market dynamics, and aggregate company-wide costs for research and development; manufacturing and distribution; to undertake quality measures; and ensure safety and effectiveness with ongoing pharmacovigilance for patients.",,,,,,,,,,,,,,, +Agios Pharmaceuticals,71334021020,PYRUKYND 20mg Monthly Pack (20mg 14ct blister card x 4),2022-02-25,25760,,1,13,,1,,,,,The exact prevalence of Pyruvate Kinase Deficiency is unknown. Diagnosed prevalence is estimated at 3.2 to 8.5 per one million people. Secrest MH et al. Eur J Haematol. 2020;105:173-184. doi:10.1111/ejh.13424,,,,,,,,,,,,,,, +Agios Pharmaceuticals,71334022512,PYRUKYND 20mg/5mg Taper Pack,2022-02-25,6440,,1,13,,1,,,,,The exact prevalence of Pyruvate Kinase Deficiency is unknown. Diagnosed prevalence is estimated at 3.2 to 8.5 per one million people. Secrest MH et al. Eur J Haematol. 2020;105:173-184. doi:10.1111/ejh.13424,,,,,,,,,,,,,,, +Agios Pharmaceuticals,71334021550,PYRUKYND 50mg Monthly Pack (50mg 14ct blister card x 4),2022-02-25,25760,,1,13,,1,,,,,The exact prevalence of Pyruvate Kinase Deficiency is unknown. Diagnosed prevalence is estimated at 3.2 to 8.5 per one million people. Secrest MH et al. Eur J Haematol. 2020;105:173-184. doi:10.1111/ejh.13424,,,,,,,,,,,,,,, +Agios Pharmaceuticals,71334023013,PYRUKYND 50mg/20mg Taper Pack,2022-02-25,6440,,1,13,,1,,,,,The exact prevalence of Pyruvate Kinase Deficiency is unknown. Diagnosed prevalence is estimated at 3.2 to 8.5 per one million people. Secrest MH et al. Eur J Haematol. 2020;105:173-184. doi:10.1111/ejh.13424,,,,,,,,,,,,,,, +Agios Pharmaceuticals,71334020505,PYRUKYND 5mg Monthly Pack (5mg 14ct blister card x 4),2022-02-25,25760,,1,13,,1,,,,,The exact prevalence of Pyruvate Kinase Deficiency is unknown. Diagnosed prevalence is estimated at 3.2 to 8.5 per one million people. Secrest MH et al. Eur J Haematol. 2020;105:173-184. doi:10.1111/ejh.13424,,,,,,,,,,,,,,, +Agios Pharmaceuticals,71334022011,PYRUKYND 5mg Taper Pack (5mg 7ct blister card x 1),2022-02-25,3220,,1,13,,1,,,,,The exact prevalence of Pyruvate Kinase Deficiency is unknown. Diagnosed prevalence is estimated at 3.2 to 8.5 per one million people. Secrest MH et al. Eur J Haematol. 2020;105:173-184. doi:10.1111/ejh.13424,,,,,,,,,,,,,,, +Akorn Inc ,17478079312,Cetrorelix Acetate for Injection 0.25mg,2022-10-24,187.15,,1,40000,,,,,,,,,,,,,,,,,,,,,, +"Alembic Pharmaceuticals, Inc.",62332065530,"Formoterol Fumarate Inhalation Solution, 20mcg, 30mL",2022-04-06,481.89,We plan to launch the product as a generic drug and compete on price with other manufacturers.,,32000,,,,,,,,,,,,,,,,,,,,,, +"Alembic Pharmaceuticals, Inc.",62332065560,"Formoterol Fumarate Inhalation Solution, 20mcg, 60mL",2022-04-06,963.78,We plan to launch the product as a generic drug and compete on price with other manufacturers.,,32000,,,,,,,,https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=659,,,,,,,,,,,,,, +"Alembic Pharmaceuticals, Inc.",62332047964,"Pirfenidone Tablet, 267mg",2022-06-30,5360.55,,1,100000,,,,,,,,,,,,,,,,,,,,,, +"Alembic Pharmaceuticals, Inc.",62332048090,"Pirfenidone Tablet, 801mg",2022-06-30,5360.55,,1,100000,,,,,,,,,,,,,,,,,,,,,, +American Regent ,517102025,Vasopressin 20unit/mL 1mL Vial,2022-02-03,3951,"We do not intend to engage in, nor have we engaged in to date, any substantial marketing activities relating to the Vasopressin Product in the U.S. or internationally. Our marketing efforts to promote the new drug are generally limited to marketing on our website as well as digital announcements (including those at professional society events) to announce the availability of the new Vasopressin Product. Our pricing plans are not in the public domain.",,1000,,,,,,,"We provide the following comment regarding the patient estimate: Vasopressin is approved by the FDA to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. It is estimated that 3.8MM vials are used annually. If we then assume that an estimated 3.8 vials per patient are used on average by each patient then this total is 1,000,000 unique patients annually or 83,333 per month for the entire market. We do not know how many of those potential patients may take this product. + +We provide the following comment regarding the acquisition fields: This product was not acquired and the acquisition fields are not applicable. + +We provide the following general comment: We have limited the information included in this submission to that which is otherwise in the public domain or publicly available, as the California requirements permit.",,,,,,,,,,,,,,, +American Regent ,517038105,"PROVAYBLUE ® (methylene blue) injection USP, 0.5% 50 mg/10 mL (5 mg/mL)",2022-05-09,1823,"We do intend to engage in domestic only marketing activities relating to the ProvayBlue launch to create market awareness of this new vial presentation. Our marketing efforts to promote the new drug are generally through digital media, American Regent website, ProvayBlue website and eblasts. Printed marketing materials are only for the use of the sales force and are used to facilitate a conversation. Our pricing plans are not in the public domain.",,,,,,,,,"We provide the following comment regarding the patient estimate: ProvayBlue (Methylene Blue) is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. This product is also an orphan drug, which is a drug that is used for rare diseases. The number of patients that use ProvayBlue (Methylene Blue) on label is unknown. However, we do know that ProvayBlue (Methylene Blue) is used off label as a marker dye. American Regent sells 439,060 number of units a year in a 10ml ampule and now it is available in a 10ml vial. The number of patients of it being used as a marker dye is unknown. + +We provide the following comment regarding the Priority Review Field: This product did not receive a priority review; however, it did receive an accelerated approval. + +We provide the following comment regarding the acquisition fields: ProvayBlue is not an acquired product. The partner from whom we license the drug, (which is not affiliated with American Regent) is the NDA holder of this NDC. + +We provide the following general comment: We have limited the information included in this submission to that which is otherwise in the public domain or publicly available, as the California requirements permit.",,,,,,,,,,,,,,, +American Regent ,517060201,INJECTAFER 100 mg/2 mL (50 mg/mL),2022-08-03,166.05,"We do intend to engage in domestic only marketing activities relating to the Injectafer launch to create market awareness of this new presentation. Our marketing efforts to promote the new drug are generally through digital media, Daiichi Sankyo website, Injectafer websites and eblasts. Printed marketing materials are only for the use of the sales force and are used to facilitate a conversation. Our pricing plans are not in the public domain.",,,,,,,,,"We provide the following comment regarding the patient estimate: Injectafer (Ferric Carboxymaltose) is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in adults and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron and adult patients who have non-dialysis dependent chronic kidney disease. The total number of patients that use Injectafer annually is unknown, however over a twelve-month period ending June 2022 [*IMS MAT June 2022], the total number of Injectafer milligrams that were reported to be sold to the market was 511,516,500, thus based on a 1500mg regiment of 750mg for each infusion, the minimum number of patients is about 341,000. + +*IMS SMART-US EDITION NSP DATABASE + +We provide the following comment regarding the acquisition fields: Injectafer is not an acquired product. The licensor has granted American Regent the right to develop, manufacture, distribute and sell the product in the United States. American Regent is the NDA holder of this NDC but markets the drug through our parent company, Daiichi Sankyo, Inc. + +We provide the following general comment: We have limited the information included in this submission to that which is otherwise in the public domain or publicly available, as the California requirements permit.",,,,,,,,,,,,,,, +Amgen,55513011201,"TEZSPIRE (210 mg/1.91 mL (110 mg/mL) prefilled syringe, 1 pk)",2022-01-07,3633,"There is a direct-to-consumer marketing plan for Tezspire. Efforts in the public domain currently consist of: (1) patient website www.tezspire.com, search and banner advertising (2) patient educational brochure and (3) social media. The purpose of the website is to educate patients about the definition of severe asthma and Tezspire aligned to the Tezspire USPI, including Important Safety Information. It also provides information about the Tezspire Together hub for access services. + +Promotional activities to HCPs include the HCP website, www.tezspirehcp.com, search, banner advertising, and other digital educational programs in line with the Tezspire USPI. The purpose of these tools is for education that Tezspire is the first and only biologic approved for severe asthma without phenotypic or biomarker limitations. Tezspire offers multiple free goods program in the form of a bridge program called FastStart for commercially insured eligible patients and a sample program. + +Amgen understands that the cost of prescription drugs is a concern for many people, and we are committed to the responsible pricing of our medicines. +Our approach to pricing across the globe is underpinned by two simple core principles: +I. Pricing our products according to the value they deliver +II. Employs flexible pricing approaches to ensure patient access + +TEZSPIRE is available at a WAC of $3,633.00 per 30-day supply.",,,1,1,,,,,"Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121168007,"Carboprost Tromethamine Injection, USP 250 mcg/mL",2022-02-08,3189.9,This is a generic product that is not marketed.,,27383,,,,,,,"Estimated average of patients per month is unknown to Amneal Pharmaceuticals LLC.  This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121156807,Releuko (filgrastim-ayow) 300 mcg/0.5 mL Injection 10 Single-dose Prefilled Syringes,2022-02-28,2280,This is a generic product that is not marketed.,,2867,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121156907,Releuko (filgrastim-ayow) 300 mcg/mL Injection 10 x 1 mL Single-dose Vials,2022-02-28,2280,This is a generic product that is not marketed.,,8667,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121157007,Releuko (filgrastim-ayow) 480 mcg/0.8 mL Injection 10 Single-dose Prefilled Syringes,2022-02-28,3648,This is a generic product that is not marketed.,,3641,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121157107,Releuko (filgrastim-ayow) 480 mcg/1.6 mL (300 mcg/mL) Injection 10 x 1.6mL Single-dose Vials,2022-02-28,3648,This is a generic product that is not marketed.,,29560,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238229801,Oxycodone ER 40mg Tablet 100,2022-04-01,1284.25,This is a generic product that is not marketed.,,1574,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238230001,Oxycodone ER 80mg Tablet 100,2022-04-01,2240.96,This is a generic product that is not marketed.,,893,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70257041687,"Lyvispah (Baclofen) Oral Granules 20mg, 90ct",2022-05-16,1650,"When pricing our medicines, Amneal considers not only the market dynamics that may impact access for patients, but also looks at overall benefits to help maintain continuous supply to patients, sponsorship of patient assistance programs, and reinvestment into Amneal to support new therapies, supply chain, and R&D to bring drugs to market and help improve the value our therapies bring to the healthcare system.",,50,,,2022-02-09,83000500,,"Under the terms of the transaction, Amneal will pay approximately $83.5 million of cash at close, and certain royalties (low double-digits) based on annual net sales for certain acquired products. The transaction will be financed with cash on hand and is expected to close in the first quarter of 2022, subject to the satisfaction of customary closing conditions, including clearance under the Hart-Scott Rodino Antitrust Improvements Act.",Lyvispah was part of a larger acquisition involving multiple products and as such an acquisition cost specific to Lyvispah is not available,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238208806,Bexarotene 1% Topical Gel 60g,2022-05-23,23268.93,This is a generic product that is not marketed.,,66,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,60219164008,Pirfenidone 267mg,2022-05-25,5360.56,This is a generic product that is not marketed.,,193906,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,60219164109,Pirfenidone 801mg,2022-05-25,5360.56,This is a generic product that is not marketed.,,58746,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121175407,Alymsys (bevacizumab-maly) Injection 100mg/4ml,2022-05-26,7186,This is a generic product that is not marketed.,,24950,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121175501,Alymsys (bevacizumab-maly) Injection 400mg/16ml,2022-05-26,2874.4,This is a generic product that is not marketed.,,25050,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121175507,Alymsys (bevacizumab-maly) Injection 400mg/16ml 10 x 16mL single-dose vial,2022-05-26,28744,This is a generic product that is not marketed.,,25050,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238142401,Vigabatrin Tabs 500mg,2022-06-30,10511.89,This is a generic product that is not marketed.,,1602,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121164205,"Vasopressin Injection, 20 Units/mL x 25 SDV",2022-08-10,2627.63,This is a generic product that is not marketed.,,4466,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121164207,"Vasopressin Injection, 20 Units/mL x 10 SDV",2022-09-02,1051.05,This is a generic product that is not marketed.,,3020,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,65162068312,Diclofenac Sodium 2% Topical Solution,2022-11-15,1616.82,This is a generic product that is not marketed.,,448815,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +"Amylyx Pharmaceuticals, Inc.",73063003503,Relyvrio- Sodium phenylbutyrate 3g and taurursodiol 1g - 56ct,2022-10-06,12504.24,,1,29000,,1,,,,,"For column 7 ""Estimated Number of Patients"" 29,000 adults living with ALS in the United States.",,,,,,,,,,,,,,, +"Amylyx Pharmaceuticals, Inc.",73063003504,Relyvrio- Sodium phenylbutyrate 3g and taurursodiol 1g - 7ct,2022-10-06,1563.03,,1,29000,,1,,,,,"For column 7 ""Estimated Number of Patients"" 29,000 adults living with ALS in the United States.",,,,,,,,,,,,,,, +Analog Pharma,70505021060,"NITISINONE capsules, for oral use 10 mg.",2022-07-07,21797,"Orphan drug, extremely rare disease with less than 300 patients and 25% less than the brand.",,300,,,,,,,,,,,,,,,,,,,,,, +Analog Pharma,70505020260,"NITISINONE capsules, for oral use 2 mg.",2022-07-07,4360,"Orphan drug, extremely rare disease with less than 300 patients and 25% less than the brand.",,300,,,,,,,,,,,,,,,,,,,,,, +Analog Pharma,70505020560,"NITISINONE capsules, for oral use 5 mg.",2022-07-07,10899,"Orphan drug, extremely rare disease with less than 300 patients and 25% less than the brand.",,300,,,,,,,,,,,,,,,,,,,,,, +ANIP,70954025510,"Methyltestosterone Capsules, USP 10mg 100ct",2022-04-25,6213.88,"Novitium did some market research with customers to understand the generic pricing. At this time, Novitium is focused on selling Methyltestosterone in the United States.",,15,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505623004,Paclitaxel Injection,2022-04-12,1441.01,,1,62000,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505605004,Bortezomib for Injection,2022-05-02,913.71,,1,34940,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505040603,Diclofenac Sodium Solution,2022-05-09,1616.82,,1,3000000,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505431800,TOLVAPTAN,2022-05-20,4687.19,,1,2985,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505606700,Pemetrexed for Injection 1000 mg,2022-05-25,4280.78,,1,198862,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505606600,Pemetrexed for Injection 500 mg,2022-05-25,2140.39,,1,198862,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505606800,Pemetrexed for Injection 750 mg,2022-05-25,3210.59,,1,198862,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505455303,Ambrisentan Tabs 10mg,2022-07-13,5533.61,,1,1000,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505455203,Ambrisentan Tabs 5mg,2022-07-13,5533.61,,1,1000,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505453402,Lenalidomide Capsules 10mg,2022-09-06,20157.36,,1,11065,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505453502,Lenalidomide Capsules 15mg,2022-09-06,15118.04,,1,11065,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505453702,Lenalidomide Capsules 25mg,2022-09-06,15118.04,,1,11065,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505453302,Lenalidomide Capsules 5mg,2022-09-06,20157.36,,1,11065,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505431700,TOLVAPTAN 15MG,2022-09-06,3671.1,,1,2985,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505433203,Fingolimod Capsules 0.5mg,2022-10-18,4870.56,,1,15000,,,,,,,,,,,,,,,,,,,,,, +"Ardelyx, Inc.",73154005060,IBSRELA 50 mg,2022-03-18,1500,"""• Marketing messaging will emphasize the unique, first-in-class mechanism of action of IBSRELA (tenapanor), and the clinical data that demonstrates significant improvement in abdominal pain, bloating and constipation with a quick onset of action and sustained efficacy. +• IBSRELA will be positioned as a first-in-class NHE3 inhibitor that provides a new therapeutic option for adults with IBS-C. +• This positioning and messaging focus will establish IBSRELA, with its new mechanistic approach, and triple-acting effect, as a meaningful new medicine in the treatment toolkit for HCPs who treat adult patients with IBS-C. Sales force focus is on the HCPs who treat patients with IBS-C. + +Ardelyx is a biopharmaceutical company founded with a mission to discover, develop, and commercialize innovative first in class medicines that meet significant unmet medical needs. Pricing for IBSRELA (tenapanor) was determined based on a consideration of therapeutic area dynamics and the clinical value proposition of IBSRELA. Therapeutic area dynamics include the multifactorial pathophysiology of IBS-C, the limited number of therapies available, and the unmet medical needs of adult patients. Considerations of the clinical value proposition of IBSRELA include its first-in-class, novel mechanism of action and demonstrated safety and efficacy profile from the Phase 3 clinical trial program. The WAC price of IBSRELA of $1500 for a 30-day supply of treatment is within the range of currently marketed IBS therapies.""",,11000000,,,,,,,,,,,,,,,,,,,,,, +"Ascend Laboratories, LLC",67877063502,TOLVAPTAN 15MG TABLETS Size 10,2022-09-07,4630.1,,1,1,,,,,,,"The ""1"" is a place holder as the estimated number of patients is unknown to Ascend Laboratories. Ascend is a generic manufacturer, and the drug is used for Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease affecting over 12 million people worldwide. It's estimated that between 1 in every 400 to 2,500 people has the disease. It can affect women and men, across all ethnic groups.",,,,,,,,,,,,,,, +"Ascend Laboratories, LLC",67877063533,TOLVAPTAN 15MG TABLETS Size 1X10,2022-09-07,4630.1,,1,1,,,,,,,"The ""1"" is a place holder as the estimated number of patients is unknown to Ascend Laboratories. Ascend is a generic manufacturer, and the drug is used for Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease affecting over 12 million people worldwide. It's estimated that between 1 in every 400 to 2,500 people has the disease. It can affect women and men, across all ethnic groups.",,,,,,,,,,,,,,, +"Ascend Laboratories, LLC",67877047630,FINGOLIMOD 0.5MG CAPSULE,2022-09-26,8279.94,,1,1,,,,,,,"Fingolimod capsule is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older. As Ascend's product is a generic, it is unknown how many patients will take it.",,,,,,,,,,,,,,, +AstraZeneca ,310351260,CALQUENCE® (acalabrutinib),2022-08-16,14485.92,"""AstraZeneca will engage 9 sales representatives to cover the state of California. Patient brochures as well as therapy management guides, may be left behind in offices for informational purposes. AstraZeneca provides online resources via CALQUENCE US healthcare professionals and patient websites. Patients may register for the CALQUENCE support program via the website which will enroll them in a digital relationship marketing program to receive materials such as welcome letters, patient brochures, etc. The CALQUENCE patient savings program for eligible commercially insured patients will be available for patients in California and can be found via AstraZeneca’s Product website. + +When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s +pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers.""",,11500,,,,,,,"CALQUENCE is a targeted alternative to traditional chemotherapy. CALQUENCE is a kinase inhibitor that affects the growth of MCL cancer cells. Kinases are part of the chemical pathways within cells, some of which can start the growth of new cells. Kinase inhibitors help stop growth signals and reduce the number of new cancer cells being made. CALQUENCE works by blocking a protein called Bruton tyrosine kinase (BROO-tuhn TY-ruh-seen KY-nays), or BTK, in B cells.",,,,,,,,,,,,,,, +AstraZeneca ,310450525,IMJUDO LQD 25MG VI 1X1.25ML US,2022-11-17,3250,"When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers.",,10000,,1,,,,,"Imjudo is indicated in combination with durvalumab, for treatment of adult patients with unresectable hepatocellular carcinoma.",,,,,,,,,,,,,,, +AstraZeneca ,310453530,IMJUDO LQD 300MG VI 1X15ML US,2022-11-17,39000,"When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers.",,10000,,1,,,,,"Imjudo is indicated in combination with durvalumab, for treatment of adult patients with unresectable hepatocellular carcinoma.",,,,,,,,,,,,,,, +AstraZeneca ,310621039,FARXIGA TAB 10MG HUD BL 3X10 EA US,2022-12-02,548.83,"When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers.",,,,,,,,,This is the HUD (or Hospital Unit Dose) of Farxiga.,,,,,,,,,,,,,,, +"Aurobindo Pharma USA, Inc.",59651043601,Digoxin Tablets USP 62.5 mcg (0.0625mg) - 100/Bottle,2022-02-15,1152,,1,60,,,,,,,,,,,,,,,,,,,,,, +"Aurobindo Pharma USA, Inc.",59651035308,Diclofenac Potassium Capsules 25 mg - 120/Bottle,2022-03-24,1054.5,,1,60,,,,,,,,,,,,,,,,,,,,,, +AuroMedics Pharma LLC,55150036610,"Arsenic Trioxide Injection, 12mg/6ml SDV - 10s",2022-04-04,5253.5,We plan to market the drug to clinics and hospitals,,1000,,,,,,,,,,,,,,,,,,,,,, +AuroMedics Pharma LLC,55150038301,"Pemetrexed for injection, USP SDV, 1000mg/vial - 1s",2022-05-27,1000,We plan to market the drug to clinics and hospitals,,1000,,,,,,,,,,,,,,,,,,,,,, +AuroMedics Pharma LLC,55150037125,"Vasopressin Injection USP, SDV 20 units/1mL - 25s",2022-06-30,3753.64,we plan to market the drug to clinics and hospitals,,10000,,,,,,,,,,,,,,,,,,,,,, +AuroMedics Pharma LLC,55150042110,Esmolol Hydrochloride in Sodium Chloride Injection SD Bags 2000mg/100mL - 10's,2022-08-10,1595,We plan to market the drug to clinics and hospitals,,10000,,,,,,,,,,,,,,,,,,,,,, +AuroMedics Pharma LLC,55150042010,Esmolol Hydrochloride in Sodium Chloride Injection SD Bags 2500mg/250mL - 10's,2022-08-10,1398,We plan to market the drug to clinics and hospitals,,10000,,,,,,,,,,,,,,,,,,,,,, +AuroMedics Pharma LLC,55150032925,"Medroxyprogesterone Acetate Injectable Suspension USP, SDV 150mg/mL - 25s",2022-12-31,915.92,"We plan to market the drug to clinics, pharmacies and hospitals",,10000,,,,,,,,,,,,,,,,,,,,,, +AvKare,42291087001,Tretinoin 10mg Cap - 100ct,2022-06-15,2523.35,,1,1000,,,,,,,"Drug has been previously submitted to compendia, but not previously launched or marketed by the manufacturer",,,,,,,,,,,,,,, +AvKare,50268068312,POSACONAZOLE DR TAB 100MG 2X10 CT,2022-08-07,850,,1,29000,,,,,,,Drug not acquired,,,,,,,,,,,,,,, +AvKare,42291047312,Etravirine 100mg 120ct,2022-12-07,929.36,,1,1200000,,,,,,,,,,,,,,,,,,,,,, +AvKare,42291047460,Etravirine 200mg 60ct,2022-12-07,929.36,,1,1200000,,,,,,,,,,,,,,,,,,,,,, +"Axsome Therapeutics, Inc.",81968004530,Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) 105MG; 45MG 30 Tablets,2022-10-17,524,,1,6217,1,,,,,,"Axsome Therapeutics, Inc. considers the process of assessing and developing a marketing and pricing plan to be a trade secret using confidential information and cannot release this data into the public domain.",,,,,,,,,,,,,,, +Azurity Pharmaceuticals,52652600102,Fleqsuvy 300ml 25mg per 5ml,2022-03-18,1650,"Azurity Institutional Sales Force promoting Fleqsuvy to in- and out-patient pharmacies in the hospital setting.  The sales force provided with marketing materials highlighting the profile and benefits of Fleqsuvy, including its oral suspension liquid nature, concentrated formulation and advantages as compared to Ozobax. After in-depth research, recommendation was to Price Fleqsuvy less vs Ozobax to gain favorable payer coverage relative to Ozobax",,250,,,,,,,,,,,,,,,,,,,,,, +Biocon Limited,70377010411,Aminocaproic Acid Oral Solution,2022-10-24,1100,"Launch of a generic pharmaceutical. Pricing and supply offers made to large GPOs with purchasing decision authority for retail, wholesale, and specialty outlets. GPOs include Red Oak Sourcing, Walgreens Boots Alliance Development, ClarusONE Sourcing Services, and Econdisc. This product is priced at a discount of ~60% off the brand WAC.",,69000,,,,,,,,,,,,,,,,,,,,,, +Biocon Limited,70377010311,Aminocaproic Acid Tablets,2022-10-24,1008.11,"Launch of a generic pharmaceutical. Pricing and supply offers made to large GPOs with purchasing decision authority for retail, wholesale, and specialty outlets. GPOs include Red Oak Sourcing, Walgreens Boots Alliance Development, ClarusONE Sourcing Services, and Econdisc. This product is priced at a discount of ~20% off the brand WAC.",,20000,,,,,,,,,,,,,,,,,,,,,, +Biogen,64406001901,Byooviz 0.5 mg (0.05 mL of 10 mg/mL solution),2022-07-01,1130,"BYOOVIZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. + +Further information can be found at: +https://www.biogen.com/content/dam/corporate/en_us/pdfs/BIOGEN_PricingPrinciplesInfographic_4-26-19.pdf",,1000000,,,,,,,"BYOOVIZ™ (ranibizumab-nuna), a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Myopic Choroidal Neovascularization (mCNV). The estimated number of patients provided in this report is based on 2021 prevalence estimates resulting from analyses of several data sources and publications.",,,,,,,,,,,,,,, +"BioXcel Therapeutics, Inc.",81092112001,Igalmi Sublingual Film 120 MCG 10,2022-07-01,1050,"BioXcel Therapeutics, Inc.consider multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). Igalmi is an FDA approved treatment for Schizophrenia or bipolar I or II disorder in adults. which affects a number of patients in the US annually. BioXcel Therapeutics, Inc. approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment with BioXcel Therapeutics, Inc. products.",,20625,1,,,,,,,,,,,,,,,,,,,,, +"BioXcel Therapeutics, Inc.",81092118001,Igalmi Sublingual Film 180 MCG 10,2022-07-01,1050,"BioXcel Therapeutics, Inc.consider multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). Igalmi is an FDA approved treatment for Schizophrenia or bipolar I or II disorder in adults. which affects a number of patients in the US annually. BioXcel Therapeutics, Inc. approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment with BioXcel Therapeutics, Inc. products.",,8839,1,,,,,,,,,,,,,,,,,,,,, +"bluebird bio, Inc.",73554311101,ZYNTEGLO (betibeglogene autotemcel),2022-10-01,2800000,,1,1500,1,1,,,,,,,,,,,,,,,,,,,, +"bluebird bio, Inc.",73554211101,"SKYSONA is a cell suspension for intravenous infusion; a single dose of SKYSONA contains a minimum of 5.0 × 10^6 CD34+ cells/kg of body weight, suspended in a solution containing 5% dimethyl sulfoxide (DMSO)",2022-12-01,3000000,"SKYSONA is an autologous hematopoietic stem cell-based gene therapy indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD). CALD is a rare, progressive, neurodegenerative disease that primarily affects young boys and causes irreversible, devastating neurologic decline, including major functional disabilities such as loss of communication, cortical blindness, requirement for tube feeding, total incontinence, wheelchair dependence, or complete loss of voluntary movement. Nearly half of patients who do not receive treatment die within five years of symptom onset. bluebird took this profound impact into consideration when pricing the therapy—weighing the therapy’s robust and sustained clinical benefit, quality of life improvements for patients and their families, cost savings to the system, and the overall impact on society. We are focused on timely access to this therapy for this patient population.",,40,1,1,,,,,,,,,,,,,,,,,,,, +Boehringer Ingelheim,597003510,SPEVIGO Vial 450mg/7.5mL (60mg/mL) 2ct,2022-09-01,51133,"Specific Marketing and Pricing Plans for Spevigo® are not in the public domain or publicly available. Boehringer Ingelheim considers several factors in determining the price of our medicines. These factors include: the value of innovative medicines; cost effectiveness (meaning the economic value to patients given the effectiveness of the drug, compared to other drugs in the same class); investments made (including in research and development), manufacturing and other costs and the risks undertaken. Boehringer Ingelheim invests 20% of its net sales into research and development.",,22816,1,1,,,,,"Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available. + +Note to Estimated Number of Patients: SPEVIGO® is the first approved treatment option for generalized pustular psoriasis (GPP) flares in adults. It is estimated that 1 out of every 10,000 people have GPP. In the US, 22,816 patients are diagnosed with GPP, a fraction of which experience a GPP flare in a given year.",,,,,,,,,,,,,,, +Bristol Myers Squibb,3712511,OPDUALAG™ (240 mg and 80 mg/20 mL (12 mg and 4 mg/mL) Injection,2022-03-18,13694.27,"We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply.",,180,,1,,,,,"Comment regarding ""Estimated Number of Patients"" : 180 patients per month (forecast)",,,,,,,,,,,,,,, +Bristol Myers Squibb,73625011311,"Camzyos 10mg capsule, bottle of 30",2022-04-28,7356.16,"We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 25% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply.",,200,1,,2020-11-17,1310000000,,Mavacamten is a heritage Myokardia investigational medication that BMS acquired in 2020 for $13.1 billion. Acquisition price of the individual drug is not publicly available,"Comment regarding ""Estimated Number of Patients"" : This is a first in class medication and the expectation is about 200 per month, subject to change.",,,,,,,,,,,,,,, +Bristol Myers Squibb,73625011411,"Camzyos 15mg capsule, bottle of 30",2022-04-28,7356.16,"We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 25% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply.",,200,1,,2020-11-17,1310000000,,Mavacamten is a heritage Myokardia investigational medication that BMS acquired in 2020 for $13.1 billion. Acquisition price of the individual drug is not publicly available,"Comment regarding ""Estimated Number of Patients"" : This is a first in class medication and the expectation is about 200 per month, subject to change.",,,,,,,,,,,,,,, +Bristol Myers Squibb,73625011111,"Camzyos 2.5mg capsule, bottle of 30",2022-04-28,7356.16,"We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 25% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply.",,200,1,,2020-11-17,1310000000,,Mavacamten is a heritage Myokardia investigational medication that BMS acquired in 2020 for $13.1 billion. Acquisition price of the individual drug is not publicly available,"Comment regarding ""Estimated Number of Patients"" : This is a first in class medication and the expectation is about 200 per month, subject to change.",,,,,,,,,,,,,,, +Bristol Myers Squibb,73625011211,"Camzyos 5mg capsule, bottle of 30",2022-04-28,7356.16,"We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 25% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply.",,200,1,,2020-11-17,1310000000,,Mavacamten is a heritage Myokardia investigational medication that BMS acquired in 2020 for $13.1 billion. Acquisition price of the individual drug is not publicly available,"Comment regarding ""Estimated Number of Patients"" : This is a first in class medication and the expectation is about 200 per month, subject to change.",,,,,,,,,,,,,,, +Bristol Myers Squibb,3089511,"SOTYKTU™ (deucravacitinib) for oral use, 6mg tablets; pink, round, biconvex, laser printed with “BMS 895” and “6 mg” on one side with no content on the other side",2022-09-12,6164.38,"We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 25% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply.",,900,,,,,,,"Comment regarding ""Estimated Number of Patients"" : Estimated 900 patients per month (forecast). However, BMS is unable to provide an exact number of patients who will be prescribed Sotyktu each month.",,,,,,,,,,,,,,, +Calliditas Therapeutics US Inc.,81749000401,TARPEYO™ (budesonide) delayed release capsules,2022-01-27,14160,,1,4000,,1,,,,,Estimated Number of Patients: There is no ICD-10 code for IgA Nephropathy and no IgA Nephropathy patient registry in the state. The estimated IgAN incidence in the US based on native biopsy is 4000 - 4500 IgAN patients.,,,,,,,,,,,,,,, +"Camber Pharmaceuticals, Inc.",31722057960,Maraviroc 150mg 60ct,2022-02-07,1410.82,,1,1200000,,,,,,,,,,,,,,,,,,,,,, +"Camber Pharmaceuticals, Inc.",31722058060,Maraviroc 300mg 60ct,2022-02-07,1410.82,,1,1200000,,,,,,,,,,,,,,,,,,,,,, +"Camber Pharmaceuticals, Inc.",31722087227,Pirfenidone 267mg 270ct,2022-10-01,1800,,1,100000,,,,,,,,,,,,,,,,,,,,,, +"Camber Pharmaceuticals, Inc.",31722087390,Pirfenidone 801mg 90ct,2022-10-01,1800,,1,100000,,,,,,,,,,,,,,,,,,,,,, +"Camber Pharmaceuticals, Inc.",31722088930,Fingolimod 0.5mg 30ct,2022-10-17,3681.73,,1,1000000,,,,,,,,,,,,,,,,,,,,,, +"Celltrion USA, Inc.",72606057301,Abiraterone Acetate 500mg,2022-01-21,4219.54,"This product is a generic equivalent of an existing innovator product. Celltrion USA, Inc. does not engage in direct-to-consumer marketing and paid advertising to consumers, physicians, or other healthcare professionals for its generic products.",,4500,,,,,,,,,,,,,,,,,,,,,, +"Cerona Therapeutics, Inc.",81643927001,"Floxuridine; for injection; sterile,nonpyrogenic, lyophilized powder for reconstitution; Each vial (packaged individually) contains 500 mg of floxuridine to be reconstituted with 5 mL of sterile water for injection",2022-06-27,3350,,1,1000,,,,,,,,,,,,,,,,,,,,,, +Chiesi USA,10122050201,Revcovi® (elapegademase-IvIr 1.6mg/ml) Injection,2022-04-18,11245.59,,1,47,,1,2020-11-24,,1,Private company deal. Price not released.,New NDC reflecting manufacturer's labeler code.,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097087067,Lanreotide Injection 120mg/0.5ml Syringe 1ct,2022-01-31,8892.66,,1,175000,,,,,,,Product was not acquired,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097093698,Lanthanum Carbonate Chew Tabs 1000mg 90's,2022-02-25,971.48,,1,558060,,1,,,,,"Pricing for this product was submitted to data compendia on 2/2/2022, however the product was not commercially available until 2/25/2022. This product was not acquired.",,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097093498,Lanthanum Carbonate Chew Tabs 500 mg 90's,2022-02-25,971.48,,1,558060,,1,,,,,"Pricing for this product was submitted to data compendia on 2/2/2022, however the product was not commercially available until 2/25/2022. This product was not acquired.",,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097093598,Lanthanum Carbonate Chew Tabs 750mg 90's,2022-02-25,971.48,,1,558060,,1,,,,,"Pricing for this product was submitted to data compendia on 2/2/2022, however the product was not commercially available until 2/25/2022. This product was not acquired.",,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097098793,Pirfenidone Tabs 267mg 270ct,2022-08-16,1800,,1,100000,1,,2022-05-11,,1,"Drug is licensed from another manufacturer, acquisition price represents licensing cost",,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097098805,Pirfenidone Tabs 801mg 90ct,2022-08-16,1800,,1,100000,1,,2022-05-11,,1,"Drug is licensed from another manufacturer, acquisition price represents licensing cost",,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097038273,Lenalidomide Capsules 10mg 28 count,2022-09-08,20157.36,,1,34000,1,,,,,,,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097038381,Lenalidomide Capsules 15 mg 21 count,2022-09-08,15118.04,,1,34000,1,,,,,,,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097038581,Lenalidomide Capsules 25mg 21 count,2022-09-08,15118.04,,1,34000,1,,,,,,,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097038173,Lenalidomide Capsules 5mg 28’s,2022-09-08,20157.36,,1,34000,1,,,,,,,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097090950,Leuprolide acetate suspension 22.5mg/2ml syringe,2022-11-22,1355.07,,1,270000,,,,,,,drug not acquired,,,,,,,,,,,,,,, +CMP Pharma,46287004515,"Tadalafil oral suspension, 20mg.5 mL, 150 mL bottle",2022-10-12,1895,,1,1000,,,,,,,,,,,,,,,,,,,,,, +"Coherus BioSciences, Inc.",70114044001,"Each CIMERLI 0.3 mg carton contains a single-dose, 2-mL glass vial with a WHITE CAP designed to deliver 0.05 mL of 6 mg/mL ranibizumab-eqrn solution",2022-10-03,816,,1,1621598,,,,,,,,,,,,,,,,,,,,,, +"Coherus BioSciences, Inc.",70114044101,"Each CIMERLI 0.5 mg carton contains a single-dose, 2-mL glass vial with a BLUE CAP designed to deliver 0.05 mL of 10 mg/mL ranibizumab-eqrn solution.",2022-10-03,1360,,1,1621598,,,,,,,,,,,,,,,,,,,,,, +CTI BioPharma Corp.,72482010012,"VONJO 100 mg capsule, 120 capsules",2022-03-10,19500,"VONJO will be promoted by our commercial field team to healthcare professionals to educate them on our product. We will use various means of promotion including in-office visits, virtual meetings, ad campaigns, and digital marketing. Pricing was established by CTI BioPharma Corp. after conducting extensive market research and analysis, which included the research and development investment made, forecasted operational costs, and the overall competitive landscape to reach our determination of launch WAC price. Our launch WAC price is intended to reflect the drug’s specific value to patients within our indicated population and the healthcare providers who treat them.",,7000,,1,,,,,,,,,,,,,,,,,,,, +"Dash Pharmaceuticals, LLC",69339015917,Itraconazole Oral Solution 100mg/10mL 1x40 10mL Unit Dose Cups,2022-04-29,979.3,Pricing is consistent with WAC pricing for generic 150mL bottle with a premium added for the unit dose packaging components,,1260,,,,,,,,,,,,,,,,,,,,,, +"Dermavant Sciences, Inc.",81672505101,"VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Each gram of VTAMA cream contains 10 mg of tapinarof in a white to off-white cream.",2022-05-26,1325,"Dermavant Sciences, Inc. (“Dermavant”) will market VTAMA (tapinarof) cream, 1% in the United States through national and regional wholesalers/distributors as well as independent retail pharmacies. Dermavant has a national sales force in place to inform and educate healthcare professionals (HCPs) about VTAMA cream and it will also engage in non-personal promotion through print and online medical/general media. A website www.VTAMA.com provides further information about VTAMA cream. HCPs and Patients can call 1-8-DERMAVANT / 1-833-762-8268 for assistance. The list price for VTAMA cream in the United States is $1,325. VTAMA cream is not marketed by Dermavant in any other country outside the United States.",,460000,,,,,,,,,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598008525,"Vasopressin Injection, USP 20u/mL 1mL SDV 25s",2022-02-08,3951.2,,1,230000,,,,,,,"1) Dr. Reddy's Laboratories, Inc. does not estimate the number of patients for this drug. Number provided is the number of cases of septic shock in the US each year; 2) Dr. Reddy’s did not acquire the product; 3) Product is an authorized generic of Vasostrict®",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598013074,"Methylprednisolone Sodium Succinate Injection 1 gm, 1 vial",2022-04-04,32.5,,1,6600000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number indicated is the number of adults reporting moderate-to-severe symptoms of atopic dermatitis which is one of the drug's indications. 2) Dr. Reddy's did not acquire the product; 3) The WAC price, when accounting for a 30-day supply, exceeds the reporting threshold.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598047060,Posaconazole DR Tabs 100mg US 60s,2022-04-19,970,,1,23000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is the number instances of invasive fungal candidiasis infections in the US per year. 2) Dr. Reddy's did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598038662,"Pemetrexed for Injection 100mg, 1 Vial",2022-05-25,159,,1,541000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with lung cancer in the US. 2) Dr. Reddy’s did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598038711,"Pemetrexed for Injection 500mg, 1 Vial",2022-05-25,793,,1,541000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with lung cancer in the US. 2) Dr. Reddy’s did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598045804,Sorafenib Tablets 200mg 120s HDPE US,2022-06-13,15534.96,,1,70000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimated number of patients is the number of diagnosed patients of kidney and renal pelvic cancers in the US. 2) Dr. Reddy’s did not acquire the product",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598014362,Azacitidine for Injection 100mg/vial,2022-07-07,100,,1,20000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number of patients provided is based on the incidence of myelodysplastic syndrome per year in the US. 2) Dr. Reddy's did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598042660,Bortezomib 3.5mg IV/SC Inj 1's USA,2022-07-26,250,,1,35000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate of 35000 is the number of patients with multiple myeloma in the US. +2) Dr. Reddy's did not acquire the product. 3) Although WAC is only $250.00, it exceeds the threshold for a 30-day supply.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598016001,Potassium Chloride Solution 10% 40MEQ/30ML 100CT,2022-08-16,1260,,1,44000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of patients with severe hypokalemia in the US. 2) Dr. Reddy's did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598051263,"Lenalidomide Capsules 10 mg, 28 ct",2022-09-07,20157.36,,1,200000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of patients with mantle cell lymphoma in the US. 2) Dr. Reddy's did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598051321,"Lenalidomide Capsules 15 mg, 21 ct",2022-09-07,15118.04,,1,200000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of patients with mantle cell lymphoma in the US. 2) Dr. Reddy's did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598051663,"Lenalidomide Capsules 2.5 mg, 28 ct",2022-09-07,20157.36,,1,200000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of patients with mantle cell lymphoma in the US. 2) Dr. Reddy's did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598051421,"Lenalidomide Capsules 20 mg, 21 ct",2022-09-07,15118.04,,1,200000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of patients with mantle cell lymphoma in the US. 2) Dr. Reddy's did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598051521,"Lenalidomide Capsules 25 mg, 21 ct",2022-09-07,15118.04,,1,200000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of patients with mantle cell lymphoma in the US. 2) Dr. Reddy's did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598051163,"Lenalidomide Capsules 5 mg, 28 ct",2022-09-07,20157.36,,1,200000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of patients with mantle cell lymphoma in the US. 2) Dr. Reddy's did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598009730,"Sapropterin Dihydrochloride Sachet 100mg (Javygtor), 30s",2022-09-19,1260,,1,19000,,,,,,,"1) Dr. Reddy’s did not acquire the product 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Organization for Rare Disorders, the reported incidence of Phenylketonuria (PKU) from newborn screening programs ranges from one in 13,500 to 19,000 newborns in the United States However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Sapropterin dihydrochloride sachets 100mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598037074,Pemetrexed for Injection 1000mg/Vial USA 1's,2022-09-26,1586,,1,541000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with lung cancer in the US. 2) Dr. Reddy’s did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598005311,"Desmopressin 4mcg/ml Soln for Inj(MDV), 10ml",2022-10-03,525,,1,60600,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with other generics available.  Notwithstanding, the total patient population for: Hemophilia A is approximately 33,000; Von Willebrand Disease is approximately 14,600; Diabetes Insipidus is approximately 13,000.  However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed Dr. Reddy’s Desmopressin Acetate Injection given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient. 2) Dr. Reddy's did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598009604,"Sapropterin DiHCL Tablets (Javygtor) 100 mg, 120s",2022-10-04,5040,,1,19000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Organization for Rare Disorders, the reported incidence of Phenylketonuria (PKU) from newborn screening programs ranges from one in 13,500 to 19,000 newborns in the United States However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Sapropterin dihydrochloride tablets 100mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Penicillamine in rheumatoid arthritis patients should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. 2) This is currently being marketing by Cycle Pharma. 3) 2) Dr. Reddy's did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598028530,Fingolimod 0.5mg 30s capsules,2022-10-20,4140,,1,1000000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with MS in the US. 2) Dr. Reddy’s did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598017111,"Thiotepa for injection, 100mg/Vial, 1 vial",2022-10-27,2995,,1,300000,,,,,,,"1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with breast and ovarian cancer in the US. 2) Dr. Reddy’s did not acquire the product.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598016230,"Sapropterin Dihydrochloride Sachets, 500 mg (Javygtor), 30s",2022-12-22,6300,,1,19000,,,,,,,"1) Dr. Reddy’s did not acquire the product 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Organization for Rare Disorders, the reported incidence of Phenylketonuria (PKU) from newborn screening programs ranges from one in 13,500 to 19,000 newborns in the United States However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Sapropterin dihydrochloride sachets 500mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598004763,Sunitinib Malate Caps 37.5mg 28s,2022-12-27,12453.31,,1,6000,,,,,,,"1) Dr. Reddy’s did not acquire the product. 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with gastrointestinal stromal tumors (GIST) per year.",,,,,,,,,,,,,,, +"Eckson Labs, LLC",44118070010,"Plexion Cleanser Strength: Sodium Sulfacetimide, sulfer 9.8%, 4.8% 285g Tube",2022-04-01,693,,1,12000,,,,,,,"This product has an anticipated launch of April 1, 2022.",,,,,,,,,,,,,,, +"Eckson Labs, LLC",44118070260,"Plexion Cloths Sodium Sulfacetamide, Sulfur 9.8%4.8% 60ct 4g per packet in 1 carton",2022-05-03,752,,1,6000,,,,,,,,,,,,,,,,,,,,,, +"Eckson Labs, LLC",44118070302,Plexion Lotion Sulfur and Sulfacetamide Sodium 48mg98mg/g 57g in 1 bottle,2022-05-03,699,,1,9000,,,,,,,,,,,,,,,,,,,,,, +"Eckson Labs, LLC",44118070430,Vytone Cream Hydrocortizone Acetate and Iodoquinol 19mg10mg/g 30ct 2gm packets in 1 carton,2022-05-03,854,,1,6000,,,,,,,,,,,,,,,,,,,,,, +"Edenbridge Pharmaceuticals, LLC",42799095001,Vigabatrin Tablets USP 500mg 100CT,2022-12-12,10511.89,,1,12,,,,,,,The first shipments of this presentation of Vigabatrin are scheduled to ship on or around 12/22/22. This product was not acquired. Edenbridge is not the ANDA holder.,,,,,,,,,,,,,,, +Eli Lilly and Company,2147180,MOUNJARO 10 mg/0.5 mL 4 single-dose pens,2022-06-02,974.33,,1,34500000,,1,,,,,"MOUNJAROTM (tirzepatide) injection is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MOUNJARO was approved by the FDA in May 2022. +Based on diabetes prevalence data from CDC’s diabetes statistics report [https://www.cdc.gov/diabetes/data/statistics-report/index.html], approximately 33.6 to 35.4 million people have type 2 diabetes. The average of that range (34.5 million) is reflected in the Estimated Patients field. People with type 2 diabetes may or may not use MOUNJARO to manage their diabetes. +All information is provided by Eli Lilly and Company (""Lilly"") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and.",,,,,,,,,,,,,,, +Eli Lilly and Company,2146080,MOUNJARO 12.5 mg/0.5 mL 4 single-dose pens,2022-06-02,974.33,,1,34500000,,1,,,,,"MOUNJAROTM (tirzepatide) injection is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MOUNJARO was approved by the FDA in May 2022. +Based on diabetes prevalence data from CDC’s diabetes statistics report [https://www.cdc.gov/diabetes/data/statistics-report/index.html], approximately 33.6 to 35.4 million people have type 2 diabetes. The average of that range (34.5 million) is reflected in the Estimated Patients field. People with type 2 diabetes may or may not use MOUNJARO to manage their diabetes. +All information is provided by Eli Lilly and Company (""Lilly"") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and.",,,,,,,,,,,,,,, +Eli Lilly and Company,2145780,MOUNJARO 15 mg/0.5 mL 4 single-dose pens,2022-06-02,974.33,,1,34500000,,1,,,,,"MOUNJAROTM (tirzepatide) injection is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MOUNJARO was approved by the FDA in May 2022. +Based on diabetes prevalence data from CDC’s diabetes statistics report [https://www.cdc.gov/diabetes/data/statistics-report/index.html], approximately 33.6 to 35.4 million people have type 2 diabetes. The average of that range (34.5 million) is reflected in the Estimated Patients field. People with type 2 diabetes may or may not use MOUNJARO to manage their diabetes. +All information is provided by Eli Lilly and Company (""Lilly"") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and.",,,,,,,,,,,,,,, +Eli Lilly and Company,2150680,MOUNJARO 2.5 mg/0.5 mL 4 single-dose pens,2022-06-02,974.33,,1,34500000,,1,,,,,"MOUNJAROTM (tirzepatide) injection is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MOUNJARO was approved by the FDA in May 2022. +Based on diabetes prevalence data from CDC’s diabetes statistics report [https://www.cdc.gov/diabetes/data/statistics-report/index.html], approximately 33.6 to 35.4 million people have type 2 diabetes. The average of that range (34.5 million) is reflected in the Estimated Patients field. People with type 2 diabetes may or may not use MOUNJARO to manage their diabetes. +All information is provided by Eli Lilly and Company (""Lilly"") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and.",,,,,,,,,,,,,,, +Eli Lilly and Company,2149580,MOUNJARO 5 mg/0.5 mL 4 single-dose pens,2022-06-02,974.33,,1,34500000,,1,,,,,"MOUNJAROTM (tirzepatide) injection is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MOUNJARO was approved by the FDA in May 2022. +Based on diabetes prevalence data from CDC’s diabetes statistics report [https://www.cdc.gov/diabetes/data/statistics-report/index.html], approximately 33.6 to 35.4 million people have type 2 diabetes. The average of that range (34.5 million) is reflected in the Estimated Patients field. People with type 2 diabetes may or may not use MOUNJARO to manage their diabetes. +All information is provided by Eli Lilly and Company (""Lilly"") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and.",,,,,,,,,,,,,,, +Eli Lilly and Company,2148480,MOUNJARO 7.5 mg/0.5 mL 4 single-dose pens,2022-06-02,974.33,,1,34500000,,1,,,,,"MOUNJAROTM (tirzepatide) injection is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MOUNJARO was approved by the FDA in May 2022. +Based on diabetes prevalence data from CDC’s diabetes statistics report [https://www.cdc.gov/diabetes/data/statistics-report/index.html], approximately 33.6 to 35.4 million people have type 2 diabetes. The average of that range (34.5 million) is reflected in the Estimated Patients field. People with type 2 diabetes may or may not use MOUNJARO to manage their diabetes. +All information is provided by Eli Lilly and Company (""Lilly"") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and.",,,,,,,,,,,,,,, +"Exelan Pharmaceuticals, Inc.",76282071727,Pirfenidone Tablets 267mg 270ct,2022-08-02,6292.7,,1,100000,,,,,,,product not acquired,,,,,,,,,,,,,,, +"Exelan Pharmaceuticals, Inc.",76282071690,Pirfenidone Tablets 801mg 90ct,2022-08-02,6281.05,,1,100000,,,,,,,product not acquired,,,,,,,,,,,,,,, +"Fennec Pharmaceuticals, Inc.",73077001001,"PEDMARK (sodium thiosulfate injection), 12.5 g/100 mL, 100 mL vial",2022-10-11,11417.09,,1,3480,1,1,,,,,"PEDMARK was not aquired. Comment regarding to patient estimate - Cisplatin carries the highest risk of ototoxicity among all FDA-approved platinum compounds1. About 5000 children (=18 years) are diagnosed with a solid tumor and treated with platinum-based chemotherapy every year in the United States.2,3 About 70% of these patients (~3500) are diagnosed with localized, non-metastatic disease.4 (1. Langer T et al. Trends Pharmacol Sci. 2013;34(8):458-469. 2. Ward E et al. CA Cancer J Clin. 2014;64(2):83-103. 3. National Cancer Institute. Standard populations – 19 age groups. Accessed June 10, 2022. https://seer.cancer.gov/stdpopulations/stdpop.19ages.html 4. Perkins SM et al. PLoS One. 2014;9(7):e100396. 5. Camet ML et al. Front Oncol. 2021;11:673080. FDA, US Food and Drug Administration). We estimate approximately 290 patients on a monthly based in the United States.",,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,63323092688,romiDEPsin Intravenous Solution Reconstituted 10 MG,2022-02-07,3168.65,,1,216,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219038030,Allopurinol Sodium Intravenous Solution Reconstituted 500 MG,2022-05-17,2900,,1,2000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,63323013410,PEMEtrexed Disodium Intravenous Solution Reconstituted 100 MG,2022-05-24,125,,1,788000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,63323045050,PEMEtrexed Disodium Intravenous Solution Reconstituted 500 MG,2022-05-24,625,,1,788000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219038110,"Iodixanol Inj 270 MG/ML (Iodine Equivalent), 100 ML, Unit-Dose, Bottle Qty 10",2022-07-15,1021.3,,1,479000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219038150,"Iodixanol Inj 270 MG/ML (Iodine Equivalent), 150 ML, Unit-Dose, Bottle Qty 10",2022-07-15,1489.6,,1,479000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219038310,"Iodixanol Inj 320 MG/ML (Iodine Equivalent), 100 ML, Unit-Dose, Bottle Qty 10",2022-07-15,1134.9,,1,479000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219038350,"Iodixanol Inj 320 MG/ML (Iodine Equivalent), 150 ML, Unit-Dose, Bottle Qty 10",2022-07-15,1566.7,,1,479000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219038370,"Iodixanol Inj 320 MG/ML (Iodine Equivalent), 200 ML, Unit-Dose, Bottle Qty 10",2022-07-15,1930,,1,479000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219002920,"Thiotepa For Inj 100 MG, 1 Each, Unit-Dose, Vial",2022-07-20,3000,,1,415000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219008850,Gadoterate Meglumine Intravenous Solution 50 MMOL/100ML,2022-10-27,1084.98,,1,4165,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219055001,PRALAtrexate Intravenous Solution 20 MG/ML,2022-11-29,4981.97,,1,1420,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219055202,PRALAtrexate Intravenous Solution 40 MG/2ML,2022-11-29,9963.94,,1,713,,,,,,,,,,,,,,,,,,,,,, +Genentech USA,50242009601,Vabysmo 6mg/0.05ml Vial,2022-02-08,2190,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. + +We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,80000,,,,,,,Estimated number of patients for Vabysmo is per year. Vabysmoo was not acquired from a 3rd party,,,,,,,,,,,,,,, +GlaxoSmithKline,173090442,"NUCALA, Injection, 40 mg/0.4mL, 1 Syringe in 1 Carton",2022-06-22,1330.14,,1,300000,,,,,,,"NUCALA (NDC: 001730090442) is a 40 mg prefilled syringe approved for appropriate children aged 6 to 11 years old who have severe eosinophilic asthma (SEA). Asthma is the most common chronic disease in children. It is estimated that 6 million children in the US are living with asthma. Approximately 2.5-5% (150,000-300,000) of these cases are characterized as severe. Diagnosed patients may or may not be prescribed NUCALA (NDC: 00173090442) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with NUCALA (NDC: 00173090442). +GSK has not released NUCALA's (NDC: 00173090442) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).",,,,,,,,,,,,,,, +GlaxoSmithKline,58160082415,"PRIORIX, Single dose vial, 0.5mL, package size: 10",2022-08-02,873.14,,1,,,,,,,,"GSK has not released PRIORIX's (NDC: 58160-0824-15) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). +GSK is limiting its response to information that which is otherwise in the public domain or publicly available per California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). We are unable to identify specific and accurate information in the public domain regarding the estimated volume of patients who may be prescribed Priorix (NDC:58160082415) for Measles, Mumps, Rubella. According to the CDC, roughly 90% of children under 24 months are vaccinated against mumps, measles, rubella (MMR), and there are roughly 3.6 million births per year. PRIORIX is approved for administration at 12 through 15 months of age for the first dose and at 4 through 6 years of age for the second dose. +https://www.cdc.gov/nchs/data/vsrr/vsrr012-508.pdf +https://www.cdc.gov/nchs/fastats/measles.htm",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462088260,"Abiraterone Acetate oral tablets 500 mg, 120 count",2022-06-22,4219.54,,1,45309,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, however IQVIA MAT data for the 12 months ending May 2022 is 45,309 prescriptions for 500 mg. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462016630,"Fingolimod Capsules 0.5 mg, 30",2022-10-31,1000,,1,182150,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, however IQVIA MAT data for the 12 months ending September 2022 is 182,150 prescriptions. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462085320,"Sodium Phenylbutyrate Tablets 500mg, 250",2022-11-22,3000,,1,1760,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, however IQVIA MAT data for the 12 months ending September 2022 is 1,760 prescriptions. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +"Global Blood Therapeutics, Inc.",72786011102,Oxbryta 300mg Tablets for Oral Suspension 60-Count Bottle,2022-01-10,10417,"(a)Description of the marketing used in the introduction of the new prescription drug: +Marketing efforts used by Global Blood Therapeutics, Inc. (GBT) in the introduction of OXBRYTA currently include direct-to-consumer advertising through print materials, web-based mediums, in-person patient ambassador programs and radio. In addition, GBT participates in patient-focused conferences and events. GBT does not currently plan to conduct direct-to-consumer advertising of OXBRYTA through television. +GBT will offer a free drug program for qualifying patients. Aside from such program, GBT does not plan to provide direct-to-consumer promotional incentives that are different from GBT’s “patient assistance programs” +GBT will educate health care providers about OXBRYTA through in-office visits by GBT representatives, direct mailings, educational speaker programs, promotion at large conferences and conventions as well as web-based mediums. GBT will distribute educational materials to health care providers regarding OXBRYTA, including medical journal articles about the drug. +GBT does not plan to offer product samples for OXBRYTA, and will not provide any “gifts” to health care providers. (b) Methodology used to establish the price of the new prescription drug: +Global Blood Therapeutics, Inc. (GBT) does not conceptualize its pricing decisions by considering a specific set of financial and/or non-financial factors. A range of considerations impacted its decision to set the wholesale acquisition cost for OXBRYTA. The following list of financial and nonfinancial factors reflects its good faith effort to articulate the considerations that impacted its pricing decision: +• The direct and indirect cost and burden of sickle cell disease in the patient population for which OXBRYTA is indicated and the prevalence of the disease. +• The value and impact of OXBRYTA for patients, their families and society, including its clinical benefit relative to existing treatments for sickle cell disease, and the anticipated cost savings GBT’s believes OXBRYTA will bring to the health care system. +• The impact on net revenues, and the need to fund operations, which includes production, supply, and other operational and administrative costs. +• GBT’s commitment to and investment in developing medicines for sickle cell disease, including costs associated with developing OXBRYTA, as well as anticipated future investments in research and development. +• The results of GBT’s extensive research with patients, physicians and payers, including regarding stakeholder perceptions and potential government and commercial payer coverage for OXBRYTA. +• The price of OXBRYTA as compared to treatments for other orphan drugs, which require a significant investment for a smaller eligible patient population.",,16000,,,,,,,,,,,,,,,,,,,,,, +"Global Blood Therapeutics, Inc.",72786011103,Oxbryta 300mg Tablets for Oral Suspension 90-Count Bottle,2022-01-10,10417,"(a)Description of the marketing used in the introduction of the new prescription drug: +Marketing efforts used by Global Blood Therapeutics, Inc. (GBT) in the introduction of OXBRYTA currently include direct-to-consumer advertising through print materials, web-based mediums, in-person patient ambassador programs and radio. In addition, GBT participates in patient-focused conferences and events. GBT does not currently plan to conduct direct-to-consumer advertising of OXBRYTA through television. +GBT will offer a free drug program for qualifying patients. Aside from such program, GBT does not plan to provide direct-to-consumer promotional incentives that are different from GBT’s “patient assistance programs”. +GBT will educate health care providers about OXBRYTA through in-office visits by GBT representatives, direct mailings, educational speaker programs, promotion at large conferences and conventions as well as web-based mediums. GBT will distribute educational materials to health care providers regarding OXBRYTA, including medical journal articles about the drug. +GBT does not plan to offer product samples for OXBRYTA, and will not provide any “gifts” to health care providers. (b) Methodology used to establish the price of the new prescription drug: +Global Blood Therapeutics, Inc. (GBT) does not conceptualize its pricing decisions by considering a specific set of financial and/or non-financial factors. A range of considerations impacted its decision to set the wholesale acquisition cost for OXBRYTA. The following list of financial and nonfinancial factors reflects its good faith effort to articulate the considerations that impacted its pricing decision: +• The direct and indirect cost and burden of sickle cell disease in the patient population for which OXBRYTA is indicated and the prevalence of the disease. +• The value and impact of OXBRYTA for patients, their families and society, including its clinical benefit relative to existing treatments for sickle cell disease, and the anticipated cost savings GBT’s believes OXBRYTA will bring to the health care system. +• The impact on net revenues, and the need to fund operations, which includes production, supply, and other operational and administrative costs. +• GBT’s commitment to and investment in developing medicines for sickle cell disease, including costs associated with developing OXBRYTA, as well as anticipated future investments in research and development. +• The results of GBT’s extensive research with patients, physicians and payers, including regarding stakeholder perceptions and potential government and commercial payer coverage for OXBRYTA. +• The price of OXBRYTA as compared to treatments for other orphan drugs, which require a significant investment for a smaller eligible patient population.",,16000,,,,,,,,,,,,,,,,,,,,,, +Heritage Pharmacueticals Inc. D/B/A Avet Pharmacueticals Inc,23155084012,DICLOFENAC POTASSIUM 25MG 120CT CAPSULES,2022-12-19,1609.11,,1,10000,,,,,,,10000 patients on an annual basis. Estimate based on customer volumes.,,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,143939210,"Remifentanil HCl for Injection, 2mg/5mL",2022-01-04,1225,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,36241815,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. + +Hikma has not evaluated the volume of patients in the USA. Remifentanil Hydrochloride for injection is an opioid agonist indicated for intravenous administration: (1) as an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. According to the American Hospital Association, there were approximately 36,241,815 admissions to U.S. Hospitals.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54071119,"Deferiprone Tablets, 1000mg, bottle of 50",2022-02-11,6975.58,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,125000,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. +Deferiprone is indicated for the treatment of patients with trans-fusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate, as well as sickle cell anemia disorders.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,143939310,"Remifentanil HCl for Injection, 5mg, 10 vials",2022-06-02,2600,"This drug is a generic product, therefore no marketing and pricing plans are available. This product is sold in the United States only.",,36241815,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. + +Hikma has not evaluated the volume of patients in the USA. Remifentanil Hydrochloride for injection is an opioid agonist indicated for intravenous administration: (1) as an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. According to the American Hospital Association, there were approximately 36,241,815 admissions to U.S. Hospitals.",,,,,,,,,,,,,,, +"Horizon Therapeutics USA, Inc.",75987015003,Injection 100 MG/10 ML,2022-05-30,131000,"Uplizna is the first and only B-cell depleter approved for the treatment adult patients with AQP4+ neuromyelitis optica spectrum disorder (NMOSD). Horizon’s approach to marketing includes a focus on educating healthcare professionals, primarily neurologists, about the devastating effects of this rare disease and providing information about the efficacy, safety and dosing of Uplizna. Marketing includes dissemination of print materials, digital advertising, in-person presentations and virtual engagements. In addition to healthcare professionals, Horizon also provides educational resources and support to the patient community in collaboration with advocacy organizations. + +Horizon’s approach to pricing innovative therapies is driven by the value a drug brings to customers. Leading up to FDA approval, the company engaged with key stakeholders—including patients, payers and physicians—to better understand the value this medicine could bring to people affected by NMOSD, who despite recent innovation, have limited treatment options.",,10000,1,,2021-03-15,3000000000,,"In March 2021, Horizon completed the acquisition of Viela, in which Horizon acquired all of the issued and outstanding shares of Viela’s common stock for $53.00 per share in cash. The total consideration for the acquisition was approximately $3.0 billion, including cash acquired of $342.3 million.",,,,,,,,,,,,,,,, +Immunocore Commercial LLC,80446040101,Injection: 100 mcg/0.5 mL solution in a single-dose vial,2022-02-11,18760,"KIMMTRAK will be promoted by our commercial field teams to healthcare professionals and payers to educate them on our product. We will use various means of promotion including in-office visits, virtual meetings, ad campaigns, and digital marketing. Pricing was established by a comprehensive analysis to reflect the drug’s value to patients within our indicated population and the healthcare providers who treat them.",,400,1,1,,,,,There are roughly 800-1000 metastatic uveal melanoma patients diagnosed and living in the U.S.  Approximately half of these patient are HLA-A-0201 positive making them eligible for KIMMTRAK,,,,,,,,,,,,,,, +"ImmunoGen, Inc.",72903085301,ELAHERE 100 mg/20 mL,2022-11-28,6220,,1,5200,,1,,,,,,,,,,,,,,,,,,,, +"Ingenus Pharmaceuticals, LLC",50742048401,Bortezomib Injection 3.5mg/vial,2022-05-02,800,"Ingenus prices their products based on the current market conditions along with a number of variables. All of these product specific variables are entered into a pricing model and pricing is determined. Some examples ( not all ) are cost of goods, profit share, freight costs, product volume, customer specific volumes, the COT/channels the specific product is sold in, rebates, chargebacks, contractual obligations. These factors vary product by product and aren’t all applicable in every case.",,32500,,,,,,,"As a manufacturer, Ingenus does not estimate the number of patients that may be prescribed our products. We manufacturer volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. Acquisition is not applicable.",,,,,,,,,,,,,,, +"Ingenus Pharmaceuticals, LLC",50742034001,Pemetrexed 100mg Injection,2022-05-25,160,"Ingenus does not plan to promote Pemetrexed Injection to physicians or other health professionals. The product will be sold to wholesalers and specialty distributors. +Ingenus prices their products based on the current market conditions along with a number of variables. All of these product specific variables are entered into a pricing model and pricing is determined. Some examples ( not all ) are cost of goods, profit share, freight costs, product volume, customer specific volumes, the COT/channels the specific product is sold in, rebates, chargebacks, contractual obligations. These factors vary product by product and aren’t all applicable in every case.",,25000,,,,,,,"As a manufacturer, Ingenus does not estimate the number of patients that may be prescribed our products. We manufacturer volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. The patient number provided is a based on the number of patients covered by the drug indication. Acquisition is not applicable. The WAC per vial price is below the threshold, however when course of therapy is considered, the total WAC would be above the threshold.",,,,,,,,,,,,,,, +"Ingenus Pharmaceuticals, LLC",50742034101,Pemetrexed 500mg Injection,2022-05-25,800,"Ingenus does not plan to promote Pemetrexed Injection to physicians or other health professionals. The product will be sold to wholesalers and specialty distributors. +Ingenus prices their products based on the current market conditions along with a number of variables. All of these product specific variables are entered into a pricing model and pricing is determined. Some examples ( not all ) are cost of goods, profit share, freight costs, product volume, customer specific volumes, the COT/channels the specific product is sold in, rebates, chargebacks, contractual obligations. These factors vary product by product and aren’t all applicable in every case.",,25000,,,,,,,"As a manufacturer, Ingenus does not estimate the number of patients that may be prescribed our products. We manufacturer volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. The patient number provided is a based on the number of patients covered by the drug indication. Acquisition is not applicable.",,,,,,,,,,,,,,, +"Janssen Biotech, Inc.",57894011102,"CARVYKTI™ Strength: 0.5-1.0×10^6 CAR+ viable T-cells per kg of body wt, with a ma dose of 1×10^8 CAR+ viable T-cells, 5% DMSO, Form: Suspension for intravenous infusion, ,Package Size 30mL",2022-03-03,465000,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with relapsed/refractory multiple myeloma who have received a proteosome inhibitor, immunomodulatory agent and anti-CD 38 therapy. The WAC is set at $465,000. The list price of CARVYKTI™ does not include discounts which may be available through Medicaid, Medicare, and commercial insurance. CARVYKTI™ will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. International approvals are pending.",,34920,1,1,,,,,"There are 34,920 newly diagnosed patients with multiple myeloma each year. CARVYKTI™ is indicated for patients with relapsed refractory disease. Exact information for the CARVYKTI™ indicated patient population is not available in the public domain.",,,,,,,,,,,,,,, +"Janssen Biotech, Inc.",57894011101,"CARVYKTI™ Strength: 0.5-1.0×10^6 CAR+ viable T-cells per kg of body wt, with a ma dose of 1×10^8 CAR+ viable T-cells, 5% DMSO, Form: Suspension for intravenous infusion, Package Size 70mL,",2022-03-03,465000,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with relapsed/refractory multiple myeloma who have received a proteosome inhibitor, immunomodulatory agent and anti-CD 38 therapy. The WAC is set at $465,000. The list price of CARVYKTI™ does not include discounts which may be available through Medicaid, Medicare, and commercial insurance. CARVYKTI™ will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. International approvals are pending.",,34920,1,1,,,,,"There are 34,920 newly diagnosed patients with multiple myeloma each year. CARVYKTI™ is indicated for patients with relapsed refractory disease. Exact information for the CARVYKTI™ indicated patient population is not available in the public domain.",,,,,,,,,,,,,,, +"Janssen Biotech, Inc.",57894045001,TECVAYLI™ (teclistamab) Strength: 153 mg Form: 1 single vial Package Size: 1,2022-10-26,9027,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with relapsed/refractory multiple myeloma who have received a proteosome inhibitor, immunomodulatory agent, and CD-38 therapy. The pricing plan has WAC set for the 153 mg/1.7 mL vial at $9,027.00. The list price of TECVAYLI will also be discounted as required under the 340 B program, Federal Supply Schedule, and other government programs. In August 2022, the European Commission (EC) granted conditional marketing authorisation (CMA) of TECVAYLI® (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. European approval allows Janssen to market TECVAYLI in all member states of the European Union and the European Economic Area. International pricing plans are based on ensuring compliance with local laws and processes. Member states pricing and reimbursement negotiations are ongoing and are based upon local funding choices.",,34920,1,1,,,,,"There are 34,920 newly diagnosed patients with multiple myeloma each year. TECVAYLI is indicated for patients with relapsed refractory disease. Exact information for the TECVAYLI indicated population is not available in the public domain.",,,,,,,,,,,,,,, +"Janssen Biotech, Inc.",57894044901,TECVAYLI™ (teclistamab) Strength: 30 mg Form: 1 single vial Package Size: 1,2022-10-26,1770,"While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with relapsed/refractory multiple myeloma who have received a proteosome inhibitor, immunomodulatory agent, and CD-38 therapy. The pricing plan has WAC set for the 30 mg/3 mL vial at $1,770.00. The list price of TECVAYLI will also be discounted as required under the 340 B program, Federal Supply Schedule, and other government programs. In August 2022, the European Commission (EC) granted conditional marketing authorisation (CMA) of TECVAYLI® (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. European approval allows Janssen to market TECVAYLI in all member states of the European Union and the European Economic Area. International pricing plans are based on ensuring compliance with local laws and processes. Member states pricing and reimbursement negotiations are ongoing and are based upon local funding choices.",,34920,1,1,,,,,"There are 34,920 newly diagnosed patients with multiple myeloma each year. TECVAYLI is indicated for patients with relapsed refractory disease. Exact information for the TECVAYLI indicated population is not available in the public domain.",,,,,,,,,,,,,,, +Kedrion Biopharma Inc.,70573009902,Ryplazim 68.8 mg vial /1 vial per box,2022-01-19,2064,"The manifestations of cPLGD in patients are very variable resulting in widely varying treatment regimen. Real world data with 12 patients on Expanded Access showed that except for 1 patient all other patients are treated with the PI recommended dosage of 6.6 mg/kg BW. In contrast, the frequency of treatment is handled more flexible and most patients are on an extended regimen outside of the PI recommended frequency of 2,3 or 4 days. The majority of patients is on a 7 day treatment regimen. Based on the real world data of these 12 patients, the mean weekly treatment costs are $15,410.54. The treatment is a long-term replacement therapy that reduces or eliminates the number/size of the lesions in a patient. In the clinical trial 78% of external and 75% of internal lesions were resolved at the end of week 48. No recurrent or new lesions developed during the 48 weeks.",,500,1,1,2021-10-20,1,,Acquisition part of a package for the purchase of the company Prometic; price for product cannot be singled out.,,,,,,,,,,,,,,,, +"KMM Pharmaceuticals, LLC",52187055510,"Ergotamine Tartrate and Caffeine Tablets, USP",2022-03-21,1110.22,,1,6000,,,,,,,"This drug is drug listed with the FDA and has also been listed with such data reporting services as MediSpan, but is yet to go into production and be launched.",,,,,,,,,,,,,,, +Laurus Generics Inc.,42385093412,Lopinavir and Ritonavir Tablets 200mg/50mg 120ct,2022-12-09,884.76,,1,25000,,,,,,,This product was not acquired. Product shipments to begin in the next two weeks. Estimated number of patients may change as the FDA is reviewing the efficacy of this drug for treatment in covid patients.,,,,,,,,,,,,,,, +Laurus Generics Inc.,42385092499,"Pirfenidone Tablets, 267mg (3) 90ct bottles in one carton",2022-12-24,2680.28,,1,5000,,,,,,,This product was not acquired. Laurus is the ANDA approval owner. The number of patients to be served is unknown at this time and is estimated.,,,,,,,,,,,,,,, +Laurus Generics Inc.,42385092590,"Pirfenidone Tablets, 534mg 90CT",2022-12-24,2680.28,,1,5000,,,,,,,This product was not acquired. Laurus is the ANDA approval owner. The number of patients to be served is unknown at this time and is estimated.,,,,,,,,,,,,,,, +Laurus Generics Inc.,42385092690,"Pirfenidone Tablets, 801mg 90CT",2022-12-24,2680.28,,1,5000,,,,,,,This product was not acquired. Laurus is the ANDA approval owner. The number of patients to be served is unknown at this time and is estimated.,,,,,,,,,,,,,,, +LEO Pharma Inc.,50222034602,Adbry (tralokinumab-ldrm); 150 mg/mL solution injection in a single-dose prefilled syringe with needle guard; one carton containing 2 prefilled syringes,2022-02-01,1674.4,"Adbry (tralokinumab-ldrm) will be marketed to appropriate healthcare professionals (HCPs) and adult patients in the U.S.* with moderate-to-severe atopic dermatitis who are candidates for the treatment. Generally, marketing activities that support the launch of a new treatment are designed to raise awareness and understanding among HCPs and patients about the approved indication, efficacy, and safety data contained within the treatment’s FDA-approved label. + +Specific marketing materials and activities used in the launch of the drug in the U.S. include: marketing materials, sales materials, digital advertisements through mobile and web-based platforms, digital patient brochures, third-party media channels and paid search, product-specific websites (www.AdbryHCP.com and www.Adbry.com), social media ads, banner ads, videos and video banners, professional congresses (including exhibit booths), and product speaker programs. + +LEO Pharma does not expect to launch any direct-to-consumer marketing advertisements on television in 2022. + +Consistent with industry practice relating to biologics and other specialty medicines, LEO Pharma also offers (including through third party service providers) patient support programs that are intended to facilitate a patient’s access to his/her/their medication as prescribed by the patient’s doctor. LEO Pharma does not consider those programs to be marketing or promotional activities. + +*Adbry is only marketed by LEO Pharma in the U.S.; however the drug is marketed and sold by affiliates of LEO Pharma in countries outside the U.S. under a different brand name in accordance with the laws and regulations of the corresponding jurisdiction. + +With respect to pricing plans, LEO Pharma is guided by a commitment to help advance the standard of care for people with skin diseases. Pricing decisions are intended to balance the need to continue to innovate and help patients who may be facing limited treatment options, while facilitating access to products for eligible patients. When establishing the wholesale acquisition cost of Adbry, LEO Pharma considered a range of financial and non-financial factors. These factors included, without limitation, the unique clinical value that Adbry offers as the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms[1], [2], [3]; the safety and efficacy profile of the drug; availability and accessibility of alternative therapies for the approved indication; patient access considerations, including the introduction of the Adbry Advocate Program to support U.S. patients at diagnosis and throughout treatment with Adbry; preclinical and ongoing clinical trials for the drug; anticipated rebates, discounts and other fees to be negotiated with supply chain partners, including wholesalers, distributors, and payers; manufacturing and marketing costs; available and resourced competitive market data, including market pricing and sales data; past and ongoing investments in R&D (including resources, infrastructure and organization) to support and build on the existing product portfolio while developing new and innovative therapies via a robust product pipeline; and licensing fees and royalty payments to its licensor. + +[1] LEO Pharma Inc. (2022). Adbry (tralokinumab-ldrm): Prescribing Information. Retrieved from: https://www.leo-pharma.us/Files/Billeder/US%20Website%20Product%20PIs/AdbryPI.pdf +[2] Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62. +[3] Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Ra1 and IL-13Ra2. J Mol Biol. 2017; 429:208–19.",,1,,,2016-06-30,115000000,,"LEO Pharma A/S, an affiliate of LEO Pharma Inc., entered into a license agreement with AstraZeneca on June 30, 2016 for the exclusive, global rights to tralokinumab in atopic dermatitis and any future dermatology indications. Per the terms of the agreement, the company was required to pay AstraZeneca an upfront payment of $115 million, plus up to $1 billion in commercially-related milestones and tiered percentage royalties on product sales.","With respect to column 7 (Estimated Number of Patients), Adbry (tralokinumab-ldrm) is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. [1] According to the National Eczema Association, approximately 16.5 million adults in the United States have AD, with nearly 6.6 million adults, or approximately 40%, affected by moderate or severe disease. [2], [3] LEO Pharma Inc. (LEO Pharma) does not know the specific number of patients who might meet the anticipated prescribing criteria for Adbry, or the volume of relevant patients who might be prescribed the product. + +[1] LEO Pharma Inc. (2022). Adbry (tralokinumab-ldrm): Prescribing Information. Retrieved from: https://www.leo-pharma.us/Files/Billeder/US%20Website%20Product%20PIs/AdbryPI.pdf +[2] National Eczema Association. (2022, March 1). Eczema Stats. https://nationaleczema.org/research/eczema-facts/ +[3] Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J Invest Dermatol. 2019;139(3):583-590. + +The wholesale acquisition cost (WAC) reflects the undiscounted list price to wholesalers without regard to prompt pay or other discounts, rebates, or other price reductions. The WAC may not represent actual costs to patients, payers and health systems and should not be considered a reflection of the actual transaction prices. The price paid by patients is often different than the WAC price, and most patients will not pay the WAC price. How much a patient will pay will depend on several factors, including the patient’s insurance coverage and any discount or other programs that the patient may be eligible to participate in. + +LEO Pharma provides this report consistent with its good faith understanding and interpretation of Cal. Health & Safety Code § 127681. In providing this report, LEO Pharma does not waive, but expressly reserves, any and all rights, claims or legal challenges with respect to Cal. Health & Safety Code § 127681, and related legislation, and any implementing regulations thereto, LEO Pharma’s interpretation thereof and/or the application thereof to LEO Pharma and/or any other entity affiliated with LEO Pharma.",,,,,,,,,,,,,,, +LEO Pharma Inc.,50222034604,Adbry (tralokinumab-ldrm); 150 mg/mL solution injection in a single-dose prefilled syringe with needle guard; two cartons (multipack) containing 4 prefilled syringes,2022-02-01,3348.8,"Adbry (tralokinumab-ldrm) will be marketed to appropriate healthcare professionals (HCPs) and adult patients in the U.S.* with moderate-to-severe atopic dermatitis who are candidates for the treatment. Generally, marketing activities that support the launch of a new treatment are designed to raise awareness and understanding among HCPs and patients about the approved indication, efficacy, and safety data contained within the treatment’s FDA-approved label. + +Specific marketing materials and activities used in the launch of the drug in the U.S. include: marketing materials, sales materials, digital advertisements through mobile and web-based platforms, digital patient brochures, third-party media channels and paid search, product-specific websites (www.AdbryHCP.com and www.Adbry.com), social media ads, banner ads, videos and video banners, professional congresses (including exhibit booths), and product speaker programs. + +LEO Pharma does not expect to launch any direct-to-consumer marketing advertisements on television in 2022. + +Consistent with industry practice relating to biologics and other specialty medicines, LEO Pharma also offers (including through third party service providers) patient support programs that are intended to facilitate a patient’s access to his/her/their medication as prescribed by the patient’s doctor. LEO Pharma does not consider those programs to be marketing or promotional activities. + +*Adbry is only marketed by LEO Pharma in the U.S.; however the drug is marketed and sold by affiliates of LEO Pharma in countries outside the U.S. under a different brand name in accordance with the laws and regulations of the corresponding jurisdiction. + +With respect to pricing plans, LEO Pharma is guided by a commitment to help advance the standard of care for people with skin diseases. Pricing decisions are intended to balance the need to continue to innovate and help patients who may be facing limited treatment options, while facilitating access to products for eligible patients. When establishing the wholesale acquisition cost of Adbry, LEO Pharma considered a range of financial and non-financial factors. These factors included, without limitation, the unique clinical value that Adbry offers as the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms[1], [2], [3]; the safety and efficacy profile of the drug; availability and accessibility of alternative therapies for the approved indication; patient access considerations, including the introduction of the Adbry Advocate Program to support U.S. patients at diagnosis and throughout treatment with Adbry; preclinical and ongoing clinical trials for the drug; anticipated rebates, discounts and other fees to be negotiated with supply chain partners, including wholesalers, distributors, and payers; manufacturing and marketing costs; available and resourced competitive market data, including market pricing and sales data; past and ongoing investments in R&D (including resources, infrastructure and organization) to support and build on the existing product portfolio while developing new and innovative therapies via a robust product pipeline; and licensing fees and royalty payments to its licensor. + +[1] LEO Pharma Inc. (2022). Adbry (tralokinumab-ldrm): Prescribing Information. Retrieved from: https://www.leo-pharma.us/Files/Billeder/US%20Website%20Product%20PIs/AdbryPI.pdf +[2] Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62. +[3] Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Ra1 and IL-13Ra2. J Mol Biol. 2017; 429:208–19.",,1,,,2016-06-30,115000000,,"LEO Pharma A/S, an affiliate of LEO Pharma Inc., entered into a license agreement with AstraZeneca on June 30, 2016 for the exclusive, global rights to tralokinumab in atopic dermatitis and any future dermatology indications. Per the terms of the agreement, the company was required to pay AstraZeneca an upfront payment of $115 million, plus up to $1 billion in commercially-related milestones and tiered percentage royalties on product sales.","With respect to column 7 (Estimated Number of Patients), Adbry (tralokinumab-ldrm) is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. [1] According to the National Eczema Association, approximately 16.5 million adults in the United States have AD, with nearly 6.6 million adults, or approximately 40%, affected by moderate or severe disease. [2], [3] LEO Pharma Inc. (LEO Pharma) does not know the specific number of patients who might meet the anticipated prescribing criteria for Adbry, or the volume of relevant patients who might be prescribed the product. + +[1] LEO Pharma Inc. (2022). Adbry (tralokinumab-ldrm): Prescribing Information. Retrieved from: https://www.leo-pharma.us/Files/Billeder/US%20Website%20Product%20PIs/AdbryPI.pdf +[2] National Eczema Association. (2022, March 1). Eczema Stats. https://nationaleczema.org/research/eczema-facts/ +[3] Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J Invest Dermatol. 2019;139(3):583-590. + +The wholesale acquisition cost (WAC) reflects the undiscounted list price to wholesalers without regard to prompt pay or other discounts, rebates, or other price reductions. The WAC may not represent actual costs to patients, payers and health systems and should not be considered a reflection of the actual transaction prices. The price paid by patients is often different than the WAC price, and most patients will not pay the WAC price. How much a patient will pay will depend on several factors, including the patient’s insurance coverage and any discount or other programs that the patient may be eligible to participate in. + +LEO Pharma provides this report consistent with its good faith understanding and interpretation of Cal. Health & Safety Code § 127681. In providing this report, LEO Pharma does not waive, but expressly reserves, any and all rights, claims or legal challenges with respect to Cal. Health & Safety Code § 127681, and related legislation, and any implementing regulations thereto, LEO Pharma’s interpretation thereof and/or the application thereof to LEO Pharma and/or any other entity affiliated with LEO Pharma.",,,,,,,,,,,,,,, +Lifestar Pharma LLC,70756061756,"Tobramycin Inhalation Solution, USP 300mg/4ml",2022-09-22,2350,,1,40000,,,,,,,Not Acquired,,,,,,,,,,,,,,, +Mallinckrodt Hospital Products Inc.,43825020001,Terlivaz; For injection: 0.85 mg terlipressin as a white to off-white lyophilized powder in a single-dose vial for reconstitution,2022-10-13,950,"TERLIVAZ is a vasopressin receptor agonist indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Hepatorenal syndrome is an acute and rare disease, occurring in a small patient population. Treatment is delivered by a highly specialized team of providers (typically hepatology, nephrology, critical care, or transplant specialty) in the hospital inpatient care setting. TERLIVAZ is marketed only to physicians and hospitals and not directly to patients. Mallinckrodt is committed to pricing our innovative products responsibly based on the value they represent to patients and the healthcare system while providing broad patient access. In so doing, we continue to invest in innovation that brings value to patients, providers, and the U.S. healthcare system through research and development, quality manufacturing, as well as through patient education and disease awareness.",,35000,,,,,,,,,,,,,,,,,,,,,, +"Marinus Pharmaceuticals, Inc.",81583010005,ZTALMY® (ganaxolone) oral suspension (50 mg/mL). Cherry flavored white to off white suspension in a 4 fl. oz (135 mL) round natural high density polyethylene bottle with a propylene child resistant cap containing 110 mL of ZTALMY. Carton with 5 bottles.,2022-08-22,12125,Marinus has created patient-facing and provider-facing websites and educational materials which are available in print format from our sales representatives or as digital downloads from the websites. Marinus also provides reprints of medical publications to providers upon request. This amount also includes promotional meals between sales representatives and HCPs to discuss the product.,,2000,,1,,,,,"CDD occurs in approximately 1 in 40,000 live births, or 90-100 newborns per year in the United States. We estimate there are currently about 2,000 addressable pediatric patients. References: 1. Symonds et al. 2019;142(8):2303-2318. The number provided for each NDC is reflective of total patients and represents an average over the next 18 years.",,,,,,,,,,,,,,, +"Marinus Pharmaceuticals, Inc.",81583010001,ZTALMY® (ganaxolone) oral suspension (50 mg/mL). Cherry flavored white to off white suspension in a 4 fl. oz (135 mL) round natural high density polyethylene bottle with a propylene child resistant cap containing 110 mL of ZTALMY. Carton with one bottle.,2022-08-22,2425,Marinus has created patient-facing and provider-facing websites and educational materials which are available in print format from our sales representatives or as digital downloads from the websites. Marinus also provides reprints of medical publications to providers upon request. This amount also includes promotional meals between sales representatives and HCPs to discuss the product.,,2000,,1,,,,,"CDD occurs in approximately 1 in 40,000 live births, or 90-100 newborns per year in the United States. We estimate there are currently about 2,000 addressable pediatric patients. References: 1. Symonds et al. 2019;142(8):2303-2318. The number provided for each NDC is reflective of total patients and represents an average over the next 18 years.",,,,,,,,,,,,,,, +Mayne Pharma Inc,68308034290,Dapsone External Gel 7.5 %,2022-02-15,801.53,,1,40627,,,,,,,The estimated number of patients is purely an estimate based on IMS TRx data. Mayne Pharma has no visibility into the prescribing habits of HCPs sufficient to provide a reliable number. Please refer to https://www.cdc.gov/ for additional information.,,,,,,,,,,,,,,, +"Medunik USA, Inc.",71770020010,PHEBURANE® (sodium phenylbutyrate) oral pellets,2022-09-01,4375,"Orphan drug, extremely rare disease and offered a at a similar cost to other NaPB products.",,7,,,,,,,,,,,,,,,,,,,,,, +Merck Sharp & Dohme LLC,85222402,"posaconazole, oral suspension, eight (8) single-use packets each containing 300 mg unit dose of powder for suspension",2022-11-07,1644.72,"Marketing: At the time of introduction of NOXAFIL PowderMix for delayed-release oral suspension to the market, Merck will send a communication to announce the availability of NOXAFIL PowderMix to payers and purchasers. There is no direct to consumer campaign currently planned. + +Pricing: Merck considers several factors in determining the price of our medications. These factors are listed below and are largely based on the value of the product, as well as the competitive landscape, and market for the medication. +•Value provided to patients: To what extent does a new medicine or vaccine establish a new standard of care that has the potential to significantly extend and improve patient lives? +•Value provided to healthcare systems: To what extent does a new medicine or vaccine reduce the costs associated with hospitalization and other costly complications of disease if not appropriately (or optimally) treated? +•Unmet need: Does a new medicine or vaccine address a critical unmet medical need for large numbers of people, + where few or no treatments exist? +•Access and Affordability: How can we assure that various customers-including national, regional or local institutional payers, physicians, employers and patients-can afford to pay for our products? +•R&D sustainability: Given the long-term risk and cost of capital, are we appropriately compensating our investors to ensure that we can continue the risky and capital-intensive biopharmaceutical research and development that will bring forward medically-important breakthroughs? +•Competition: What are the costs of other treatments and interventions currently on the market relative to the value provided by Merck's products?",,200,,,,,,,"Marketing/Pricing Plan (Non Public): Consistent with SB 17, Merck has limited its response to information publicly available or otherwise in the public domain. + +Breakthrough Therapy Designation and Priority Review Indicators: NOXAFIL PowderMix was not granted breakthrough therapy designation or priority review. + +Estimated Patients: Noxafil is an azole antifungal indicated as follows: +Noxafil injection and Noxafil delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. +Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graftversus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: +- Noxafil injection: adults and pediatric patients 2 years of age and older +- Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg +- Noxafil oral suspension: adults and pediatric patients 13 years of age and older +- Noxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 40 kg or less +Noxafil oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adult and pediatric patients aged 13 years and older. + +To estimate the average number of patients, data from The Center for International Blood and Marrow Transplant Research (CIBMTR), US Health Resources and Services Administration HRSA) and US Centers for Disease Control and Prevention (CDC) was examined. Stem cell transplants were identified in the US between 2016 and 2020 for patients age 0-10. The occurrence rate for pediatrics patients, with GVHD, was applied to determine the number of potential patients per year. Estimated average number of patients who will be prescribed Noxafil PowderMix for delayed-release oral suspension annually in the U.S is approximately 200, or approximately 16-17 patients monthly. + +Acquisition Date / Acquisition Price: Acquisition fields are not applicable as Merck has not acquired this product.",,,,,,,,,,,,,,, +"Mirati Therapeutics, Inc.",80739081218,"KRAZATI (adagrasib) tablets, 200 mg,180 count",2022-12-21,19750,"There is no direct-to-consumer marketing for Krazati via TV or magazine ads. Promotional activities in support of patients include a patient specific website www.Krazati.com, search and standard patient educational materials. The intent of the website is to support patient education around KRASG12C testing, Krazati’s clinical profile, Krazati’s approved label and USPI, including important safety information. +Promotional activities to HCPs include sales representative detailing, speaker programs, congresses and non-personal promotion such as HCP website, www.krazatihcp.com, search, banner advertising, and other digital educational programming in line with the Krazati USPI. Mirati in support of Lung Cancer patients is providing patient support services as described on www.miratiandme.com website. Mirati appreciates that the cost of prescription drugs is a concern for many people. Thus, Mirait is committed to responsible pricing of our cancer therapies. We factored in pre-launch research, post launch-sales and operational costs. Mirati believes in pricing our therapies in line with similar therapies and according to the value they provide. Mirati's global pricing focus is to ensure patient access. Krazati is available at a 30-day WAC of $19,750 and priced in line with comparable targeted cancer therapies.",,5000,1,1,,,,,,,,,,,,,,,,,,,, +"Mitsubishi Tanabe Pharma America, Inc.",70510232201,Radicava ORS Kit Oral Suspension 105mg/5mL dose 1 bottle x 50mL,2022-06-15,12719.3,,1,16000,,1,,,,,,,,,,,,,,,,,,,, +"Mitsubishi Tanabe Pharma America, Inc.",70510232102,Radicava ORS Starter Kit Oral Suspension 105mg/5mL dose 2 bottles x 35mL,2022-06-15,17807.02,,1,16000,,1,,,,,,,,,,,,,,,,,,,, +"Mycovia Pharmaceuticals, Inc. ",74695082318,"VIVJOA, 150mg, capsule, carton of 18",2022-07-18,2700,"VIVJOA will be promoted by our sales force to healthcare professionals to educate them on our product. We will use various means of promotion including in-office visits, ad campaigns, and multimedia marketing. + +VIVJOA's pricing was established following comprehensive analysis and reflects the competitive marketplace, product development investments, and various operational costs.",,7000,,1,,,,,,,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378667828,Sunitinib Malate 12.5mg Oral Capsule,2022-01-04,4883.64,,1,83020,,,,,,,"Sunitinib Malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, adult patients with advanced renal cell carcinoma (RCC), adult patients at high risk of recurrent RCC following nephrectomy, and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. Based on the literature, approximately 4,000 to about 6,000 GIST cases are diagnosed each year in the United States (https://www.cancer.org/cancer/gastrointestinal-stromal-tumor/about/key-statistics.html); approximately 73,820 new cases of renal cell carcinoma will be diagnosed in the United States (https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21551) ; and approximately 4,200 patients will be diagnosed with pancreatic NET in the United States (https://www.cancer.org/cancer/pancreatic-neuroendocrine-tumor/about/key-statistics.html#:~:text=Pancreatic%20neuroendocrine%20tumors%20(NETs)%20are,with%20pancreatic%20NET%20in%202021). Therefore, an estimated (using available data) 83,020 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378667928,Sunitinib Malate 25mg Oral Capsule,2022-01-04,9767.3,,1,83020,,,,,,,"Sunitinib Malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, adult patients with advanced renal cell carcinoma (RCC), adult patients at high risk of recurrent RCC following nephrectomy, and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. Based on the literature, approximately 4,000 to about 6,000 GIST cases are diagnosed each year in the United States (https://www.cancer.org/cancer/gastrointestinal-stromal-tumor/about/key-statistics.html); approximately 73,820 new cases of renal cell carcinoma will be diagnosed in the United States (https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21551) ; and approximately 4,200 patients will be diagnosed with pancreatic NET in the United States (https://www.cancer.org/cancer/pancreatic-neuroendocrine-tumor/about/key-statistics.html#:~:text=Pancreatic%20neuroendocrine%20tumors%20(NETs)%20are,with%20pancreatic%20NET%20in%202021). Therefore, an estimated (using available data) 83,020 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378668128,Sunitinib Malate 37.5mg Oral Capsule,2022-01-04,14650.95,,1,83020,,,,,,,"Sunitinib Malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, adult patients with advanced renal cell carcinoma (RCC), adult patients at high risk of recurrent RCC following nephrectomy, and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. Based on the literature, approximately 4,000 to about 6,000 GIST cases are diagnosed each year in the United States (https://www.cancer.org/cancer/gastrointestinal-stromal-tumor/about/key-statistics.html); approximately 73,820 new cases of renal cell carcinoma will be diagnosed in the United States (https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21551) ; and approximately 4,200 patients will be diagnosed with pancreatic NET in the United States (https://www.cancer.org/cancer/pancreatic-neuroendocrine-tumor/about/key-statistics.html#:~:text=Pancreatic%20neuroendocrine%20tumors%20(NETs)%20are,with%20pancreatic%20NET%20in%202021). Therefore, an estimated (using available data) 83,020 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378668028,Sunitinib Malate 50mg Oral Capsule,2022-01-04,17003.48,,1,83020,,,,,,,"Sunitinib Malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, adult patients with advanced renal cell carcinoma (RCC), adult patients at high risk of recurrent RCC following nephrectomy, and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. Based on the literature, approximately 4,000 to about 6,000 GIST cases are diagnosed each year in the United States (https://www.cancer.org/cancer/gastrointestinal-stromal-tumor/about/key-statistics.html); approximately 73,820 new cases of renal cell carcinoma will be diagnosed in the United States (https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21551) ; and approximately 4,200 patients will be diagnosed with pancreatic NET in the United States (https://www.cancer.org/cancer/pancreatic-neuroendocrine-tumor/about/key-statistics.html#:~:text=Pancreatic%20neuroendocrine%20tumors%20(NETs)%20are,with%20pancreatic%20NET%20in%202021). Therefore, an estimated (using available data) 83,020 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378120178,"Sorafenib Tosylate Tablets, 200mg",2022-06-01,20239.83,,1,159934,,,,,,,"The Product was not the result of a product acquisition. + +Sorafenib tosylate tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC), patients with advanced renal cell carcinoma (RCC), and patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment. Based on the literature, Hepatocellular carcinoma (HCC) accounts for 90% of primary liver cancer(https://www.nature.com/articles/s12276-020-00527-1), and about 41,260 new cases of liver cancer will be diagnosed (https://www.cancer.org/cancer/liver-cancer/about/what-is-key-statistics.html). About 79,000 new cases of kidney cancer will be diagnosed in the US (https://www.cancer.org/cancer/kidney-cancer/about/key-statistics.html), and there will be about 43,800 new cases of thyroid cancer this year in the US (https://www.cancer.org/cancer/thyroid-cancer/about/key-statistics.html). Therefore, an estimated (using available data) 159,934 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378193701,"Lenalidomide 10mg Oral capsule, 100",2022-09-06,71990.62,,1,70792,,,,,,,"The Product was not the result of a product acquisition. + +Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378193728,"Lenalidomide 10mg Oral capsule, 28",2022-09-06,20157.36,,1,70792,,,,,,,"The Product was not the result of a product acquisition. + +Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378194101,"Lenalidomide 15mg Oral capsule, 100",2022-09-06,71990.62,,1,70792,,,,,,,"The Product was not the result of a product acquisition. + +Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378194121,"Lenalidomide 15mg Oral capsule, 21",2022-09-06,15118.04,,1,70792,,,,,,,"The Product was not the result of a product acquisition. + +Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378194001,"Lenalidomide 25mg Oral capsule, 100",2022-09-06,71990.62,,1,70792,,,,,,,"The Product was not the result of a product acquisition. + +Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378194021,"Lenalidomide 25mg Oral capsule, 21",2022-09-06,15118.04,,1,70792,,,,,,,"The Product was not the result of a product acquisition. + +Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378193601,"Lenalidomide 5mg Oral capsule, 100",2022-09-06,71990.62,,1,70792,,,,,,,"The Product was not the result of a product acquisition. + +Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378193628,"Lenalidomide 5mg Oral capsule, 28",2022-09-06,20157.36,,1,70792,,,,,,,"The Product was not the result of a product acquisition. + +Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378452593,"Fingolimod Capsules, 0.5mg, 30",2022-09-22,8883.89,,1,830000,,1,,,,,"The Product was not the result of a product acquisition. + +Fingolimod Capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older. Based on the literature, nearly one million people are living with MS in the United States (https://www.nationalmssociety.org/About-the-Society/MS-Prevalence). Relapsing–remitting MS (RRMS) is the most common type of MS, affecting approximately 80–85% of all patients with MS (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3916439/). Therefore, an estimated (using available data) 830,000 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378309985,"Everolimus Tablets, 10mg",2022-12-15,1678.66,,1,274523,,1,,,,,"The Product was not the result of a product acquisition. + +Everolimus Tabs is indicated for oral suspension for adult and pediatric patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer and Tuberous Sclerosis Complex. Based on the literature, approximately 50,000 patients in the United States have Tuberous Sclerosis Complex (https://www.tscalliance.org/about-tsc/what-is-tsc/). According to the National Cancer Institute (NCI), an estimated 78 percent of breast cancers are HER2-negative (https://seer.cancer.gov/statfacts/html/breast-subtypes.html ), and about 70-80 percent of newly diagnosed breast cancers are hormone receptor-positive (https://www.komen.org/breast-cancer/diagnosis/factors-that-affect-prognosis/tumor-characteristics ). The American Cancer Society's estimates 287,850 new cases of invasive breast cancer will be diagnosed in women (https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html ). Therefore, an estimated (using available data) 274,523 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +"NextWave Pharmaceuticals, Inc.",24478010201,Dyanavel XR (amphetamine) Suspension 2.5gm/mL 464mL Bottle,2022-09-07,1341.99,,1,26000,,,,,,,"The NDA approval is in the name of TRIS Pharma, parent of Nextwave Pharma. This is not an acquisition.",,,,,,,,,,,,,,, +"Nobelpharma America, LLC",73683010110,HYFTOR (sirolimus topical gel) 0.2%,2022-08-22,1750,,1,30000,,1,,,,,"Nobelpharma America, LLC considers the process of assessing and developing a marketing and pricing plan to be a trade secret using confidential information and cannot release this data into the public domain.",,,,,,,,,,,,,,, +Novartis,78102884,Vijoice (alpelisib) 125 mg 28 tablets,2022-04-05,32500,"Novartis considered many factors in determining the price of Vijoice. Vijoice is a treatment for adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies impacting an estimated 14 people per million. We priced in parity to other branded treatments in this therapeutic area and are focused on access to Vijoice for this patient population.",,4800,1,1,,,,,"Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Novartis,78103502,Vijoice (alpelisib) 250 mg 56 tablets,2022-04-05,32500,"Novartis considered many factors in determining the price of Vijoice. Vijoice is a treatment for adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies impacting an estimated 14 people per million. We priced in parity to other branded treatments in this therapeutic area and are focused on access to Vijoice for this patient population.",,4800,1,1,,,,,"Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Novartis,78102184,Vijoice (alpelisib) 50 mg 28 tablets,2022-04-05,32500,"Novartis considered many factors in determining the price of Vijoice. Vijoice is a treatment for adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies impacting an estimated 14 people per million. We priced in parity to other branded treatments in this therapeutic area and are focused on access to Vijoice for this patient population.",,4800,1,1,,,,,"Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Novugen Pharma USA LLC,82293000210,ABIRATERONE ACETATE,2022-08-15,4219.54,"This is a generic drug that will be distributed through typical generic channels such as wholesalers, distributors and retail pharmacy chains. Pricing was established by reviewing competitive generic products and aligning WAC prices with the lowest available price for the product.",,350,,,,,,,,,,,,,,,,,,,,,, +Padagis US LLC,574016712,Diclofenac Sodium Topical Solution 2% w/w 3.8 FL. OZ (112 grams),2022-11-22,1616.82,Product is be priced to deliver value to the market as compared to the Brand referenced drug.,,32500000,,,,,,,"Diclofenac 2% Topical Solution is indicated for treatment of the pain of osteoarthritis of the knee. According to the CDC, osteoarthritis affects 32.5 million US Adults. +As a generic manufacturer, Padagis does not have information available to accurately determinate the number of patients that could potentially have a condition for which the drug may be prescribed. Padagis neither collects nor uses estimated patient information and does not believe there is publicly available data that accurately represents the number of patients for all indications. +Based on IQVIA NPA data available to Padagis, Padagis estimates that approximately 268,000 prescriptions were filled for the product in the past 12 months, but number of prescriptions filled should not be misinterpreted as an accurate estimate of the number of patients with a condition for which the new drug may be prescribed, as dosage and therapy may vary across individual patients.",,,,,,,,,,,,,,, +Par Pharmaceutical ,49884004233,Glycopyrrolate Oral Solution 1 mg/5 mL (0.2 mg/mL),2022-01-04,399.6,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data. + +Par notes that this product is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy). + +The forum on Child and Family Statistics estimates as of 2022 there are approximately 74.3 million children in the United States ( https://www.childstats.gov/americaschildren/tables/pop1.asp). + +The Centers for Disease Control state that 1 in 345 children have been identified with Cerebral Palsy. (https://www.cdc.gov/ncbddd/cp/features/cerebral-palsy-11-things.html ). + +The National Institutes of Health reported in 2016 between 10% and 58% of children with Cerebral Palsy have excess drooling, with estimates that 10% of children with excessive drooling have embarrassing drooling ( +https://pubmed.ncbi.nlm.nih.gov/27281791/ , https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2827743/ ). + +Par has not independently verified this information. + +Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. + +2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,49884028302,Everolimus Tablets 1mg 60s,2022-01-25,1780.45,,1,,,,,,,,"1. Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data. + +Par notes this product indicated for the prophylaxis of organ rejection in adult patients who have had kidney or liver transplants. + +The Centers for Disease Control and Prevention (“CDC”) states that 20,167 patients had a kidney transplant in the United States in 2017. ( https://nccd.cdc.gov/ckd/detail.aspx?Qnum=Q234 ) + +The National Institutes of Health (“NIH”) states that about 7,100 liver transplants were performed in the United States in 2015. ( https://www.niddk.nih.gov/health-information/liver-disease/liver-transplant/definition-facts ) + +Par has not independently verified this information. + +Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. +2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,42023023710,"Vasostrict (Vasopressin Inj., USP) 10 units/100mL (0.2 units/mL)",2022-02-03,2123.77,,1,,,,,,,,"1) The information contained in this report is subject to the following limitations and assumptions. +Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. + +Par has not been able to identify an estimate of the average number of patients in the U.S. who may experience vasodilatory shock. Additionally Vasostrict is indicated as a secondary treatment for vasodilatory shock for patients who remain hypotensive despite fluids and catecholamines. Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. +2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,42023021910,"Vasostrict (Vasopressin Inj., USP) 40 units/100mL (0.4 units/mL)",2022-02-03,4247.54,,1,,,,,,,,"1) The information contained in this report is subject to the following limitations and assumptions. +Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. + +Par has not been able to identify an estimate of the average number of patients in the U.S. who may experience vasodilatory shock. Additionally Vasostrict is indicated as a secondary treatment for vasodilatory shock for patients who remain hypotensive despite fluids and catecholamines. Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. +2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,49884076854,Tolvaptan Tablets 15mg 10s,2022-03-10,3302.04,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data. + +Par notes this product indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia. +The National Center for Biotechnology Information (“NCBI”) states that hyponatremia has a 20 to 35% prevalence in hospitalized patients. ( https://www.ncbi.nlm.nih.gov/books/NBK470386/#_article-23274_s4_ ) + +Par has not independently verified this information. + +Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. +2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,49884077054,Tolvaptan Tablets 30mg 10s,2022-03-10,3496.5,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data. + +Par notes this product indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia. +The National Center for Biotechnology Information (“NCBI”) states that hyponatremia has a 20 to 35% prevalence in hospitalized patients. ( https://www.ncbi.nlm.nih.gov/books/NBK470386/#_article-23274_s4_ ) + +Par has not independently verified this information. + +Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. +2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,49884012891,Everolimus Tablets 10mg 28s,2022-11-29,1272.17,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +1. Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. + Par notes this product indicated for the treatment of numerous diseases including Hormone Receptor-Positive, HER2-Negative Breast Cancer, Neuroendocrine Tumors (NET), Renal Cell Carcinoma (RCC), Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma, and Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA). + +Because of the product’s widespread indications, and because +Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. +2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,49884016002,Everolimus Tablets 0.75mg 60s,2022-12-13,1335.34,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data. + +Par notes this product indicated for the prophylaxis of organ rejection in adult patients who have had kidney or liver transplants. + +The Centers for Disease Control and Prevention (“CDC”) states that 20,167 patients had a kidney transplant in the United States in 2017. ( https://nccd.cdc.gov/ckd/detail.aspx?Qnum=Q234 ) + +The National Institutes of Health (“NIH”) states that about 7,100 liver transplants were performed in the United States in 2015. ( https://www.niddk.nih.gov/health-information/liver-disease/liver-transplant/definition-facts ) + +Par has not independently verified this information. + +Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. + +2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Pfizer,409082901,AZTREONAM 1gm SFDPO 1x10 VL US,2022-01-24,330,,1,21528,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 21,528 patients across the United States, could potentially receive aztreonam. Comment regarding Fields 10-13: Aztreonam was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,409083001,AZTREONAM 2gm SFDPO 1x10 VL US,2022-01-24,650,,1,21528,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 21,528 patients across the United States, could potentially receive aztreonam. Comment regarding Fields 10-13: Aztreonam was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,69150130,TALZENNA (Talazoparib) 0.5MG CAP 1X30 40CC BTL US,2022-01-31,16231.76,,1,3500,,1,2016-09-28,14300000000,,"On September 28, 2016, Pfizer Inc. acquired Medivation for approximately $14.3 billion in cash ($13.9 billion, net of cash acquired).","Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 3500 patients in the U.S. could potentially receive a TALZENNA prescription. (Total pool of gBRCA-mutated metastatic breast cancer patients tested and eligible for treatment with a PARP inhibitor)",,,,,,,,,,,,,,, +Pfizer,69175130,TALZENNA (Talazoparib) 0.75MG CAP 1X30 40CC BTL US,2022-01-31,16231.76,,1,3500,,1,2016-09-28,14300000000,,"On September 28, 2016, Pfizer Inc. acquired Medivation for approximately $14.3 billion in cash ($13.9 billion, net of cash acquired).","Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 3500 patients in the U.S. could potentially receive a TALZENNA prescription. (Total pool of gBRCA-mutated metastatic breast cancer patients tested and eligible for treatment with a PARP inhibitor)",,,,,,,,,,,,,,, +Pfizer,69033530,CIBINQO 100mg TAB 1x30 BTL US,2022-02-08,4914,,1,1200000,1,1,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 1.2M patients in the United States that could potentially receive CIBINQO® for the treatment of moderate-to-severe atopic dermatitis. Comment regarding Fields 10-13: CIBINQO® was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,69043530,CIBINQO 200mg TAB 1x30 BTL US,2022-02-08,4914,,1,1200000,1,1,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 1.2M patients in the United States that could potentially receive CIBINQO® for the treatment of moderate-to-severe atopic dermatitis. Comment regarding Fields 10-13: CIBINQO® was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,69023530,CIBINQO 50mg TAB 1x30 BTL US,2022-02-08,4914,,1,1200000,1,1,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 1.2M patients in the United States that could potentially receive CIBINQO® for the treatment of moderate-to-severe atopic dermatitis. Comment regarding Fields 10-13: CIBINQO® was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,409170401,BORTEZOMIB 1mg SFDPO 1x1 VL US,2022-05-16,81.17,,1,481000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 481,000 patients across the United States, could potentially receive bortezomib. Comment regarding Fields 10-13: Bortezomib was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,409170301,BORTEZOMIB 2.5mg SFDPO 1x1 VL US,2022-05-16,192.01,,1,481000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 481,000 patients across the United States, could potentially receive bortezomib. Comment regarding Fields 10-13: Bortezomib was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,409106001,PEMETREXED 100mg SPO 1x1 VL,2022-06-21,110,,1,130000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pemetrexed is a secondary treatment for locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Pfizer estimates that in total, approximately 130,000 patients across the United States, could potentially receive pemetrexed. Comment regarding Fields 10-13: Pemetrexed was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,409106101,PEMETREXED 500mg SPO 1x1 VL,2022-06-21,497.84,,1,130000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pemetrexed is a secondary treatment for locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Pfizer estimates that in total, approximately 130,000 patients across the United States, could potentially receive pemetrexed. Comment regarding Fields 10-13: Pemetrexed was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,409104501,PEMETREXED 100mg/4ml SLIQ 1x1 FTGVIAL US,2022-06-27,110,,1,130000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pemetrexed is a secondary treatment for locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Pfizer estimates that in total, approximately 130,000 patients across the United States, could potentially receive pemetrexed. Comment regarding Fields 10-13: Pemetrexed was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,409353201,PEMETREXED 1gm/40ml SLIQ 1x1 FTGVIAL US,2022-06-27,900,,1,130000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pemetrexed is a secondary treatment for locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Pfizer estimates that in total, approximately 130,000 patients across the United States, could potentially receive pemetrexed. Comment regarding Fields 10-13: Pemetrexed was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,409218801,PEMETREXED 500mg/20ml SLIQ 1x1 FTGVIAL US,2022-06-27,497.84,,1,130000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pemetrexed is a secondary treatment for locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Pfizer estimates that in total, approximately 130,000 patients across the United States, could potentially receive pemetrexed. Comment regarding Fields 10-13: Pemetrexed was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,409170001,BORTEZOMIB 3.5mg SFDPO 1x1 VL US,2022-07-27,250,,1,481000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 481,000 patients across the United States, could potentially receive bortezomib. Comment regarding Fields 10-13: Bortezomib was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +Pfizer,69025310,FRAGMIN 2500IU SSOL 10x4ml GVL US,2022-10-17,279.6,,1,3,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer is the sole market manufacture for Fragmin®. Since a pediatric dosing has never been available before, we cannot confirm usage. The pediatric formulation launch was developed at the request from the FDA for pediatric dosing. Therefore, Pfizer estimates the number of patients to range from 0-3 annually. Comment regarding Fields 10-13: Fragmin was not acquired; therefore, Columns 10 – 13 are intentionally left blank.",,,,,,,,,,,,,,, +"Pharmaceutical Associates, Inc",121097400,SUCRALFATE ORAL SUSPENSION - 1g/10mL - 10mL - 100/cs,2022-09-15,899.7,"PAI will utilize its sales team to market this product to customers across the country. PAI will offer market competitive pricing to retail chains, independent pharmacies, hospitals, long-term care facilities and government agencies in order to provide value for our customers",,15000,,,,,,,,,,,,,,,,,,,,,, +Pharmacyclics an AbbVie Company,57962000712,Imbruvica® (ibrutinib) Oral Suspension 70mg/mL,2022-09-12,9614.63,,1,20,,,,,,,"Pharmacyclcis is providing information for pediatrics only as there is very limited market intelligence available as to whether the suspension will be utilized by adults with trouble swallowing pills, or only pediatric patients as studied in the clinical setting. The pediatric market only of 15-20 patients annually.",,,,,,,,,,,,,,, +Piramal Critical Care,66794023942,Zinc Sulfate injection 25mg/5mL 1 box of 25 vials,2022-06-27,950,"Piramal considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply) + +Piramal's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment with Zinc Sulfate.",,303036,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Piramal is limiting its response to that which is otherwise in the public domain or publicly available. As a manufacturer, Piramal does not estimate the number of patients that may be prescribed our products. We manufacture volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. This product was not acquired; however, Piramal distributes on a non-exclusive basis. Piramal does not believe this information is publicly available and has not released this information in the public domain.",,,,,,,,,,,,,,, +Piramal Critical Care,66794024042,Zinc Sulfate injection 30mg/10mL 1 box of 25 vials,2022-06-27,1100,"Piramal considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply) + +Piramal's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment with Zinc Sulfate.",,8800,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Piramal is limiting its response to that which is otherwise in the public domain or publicly available. As a manufacturer, Piramal does not estimate the number of patients that may be prescribed our products. We manufacture volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. This product was not acquired; however, Piramal distributes on a non-exclusive basis. Piramal does not believe this information is publicly available and has not released this information in the public domain.",,,,,,,,,,,,,,, +Primus Pharmaceuticals Inc,68040071338,IMPOYZ® External Cream; Clobetasol propionate 0.025%; Cream; 100g,2022-01-24,1235,,1,25000,,,2021-03-01,,1,"The manufacturer believes that this information should be protected as trade secret. The acquisition cost information is not patented. Since the manufacturer is a private company, the acquisition cost is not publicly available and is only known to certain individuals within its organization or consultants subject to confidentiality obligations. The information is also subject to confidentiality agreements with the selling entity. If this information were disclosed, it could negatively impact the manufacturer's negotiation power in future acquisitions and allow competitors to gain insight into the manufacturer's costs and margins for the product. This information is not necessary for consumers (HCPs or patients) to make a decision whether to use the manufacturer's product, as that decision would be made on publicly available information like clinical data, price for the product and its competition and insurance coverage.",,,,,,,,,,,,,,,, +"Provention Bio, Inc.",73650031610,TZIELD (teplizumab injection 2mg/2ml) 10 Vial Carton,2022-12-02,138500,"Provention conducted extensive market research and analysis on appropriate pricing, taking into account a variety of factors, including, without limitation,  the unmet need,  the competitive landscape, and the potential value that treatment could provide",,1000,1,1,,,,,,,,,,,,,,,,,,,, +"Provention Bio, Inc.",73650031614,TZIELD (teplizumab injection 2mg/2ml) 14 Vial Carton,2022-12-02,193900,"Provention conducted extensive market research and analysis on appropriate pricing, taking into account a variety of factors, including, without limitation,  the unmet need,  the competitive landscape, and the potential value that treatment could provide.",,1000,1,1,,,,,,,,,,,,,,,,,,,, +"Provention Bio, Inc.",73650031601,TZIELD (teplizumab injection 2mg/2ml) Single Vial,2022-12-02,13850,"Provention conducted extensive market research and analysis on appropriate pricing, taking into account a variety of factors, including, without limitation,  the unmet need,  the competitive landscape, and the potential value that treatment could provide",,1000,1,1,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088052454,"Dotremin (30ct), Folate (as folic acid) 1700mcg DFE (1000mcg folic acid) + Vitamin D3 (cholecalciferol) 250mcg (1000IU)",2022-01-17,1704,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,250000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088052554,Multitam Multivitamin (30ct),2022-01-17,1800,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,275000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088078500,"Diclotrex II, Diclofenac Sodium Topical Solution 1.5% w/w 5floz (150ml), Camphotrex 3oz (85g)",2022-03-02,3275,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,300000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088078400,"Lexitral Pharmapak II, Diclofenac SodiumTopical Solution 1.5%w/w 5floz (150mL), Penetral Cream Capsaicin 8fl. oz.",2022-03-02,3748.93,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,185000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088042907,"Lydexa 4.12% Cream, Lidocaine HCI 4.12%, (3oz)",2022-03-02,1398.4,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,275000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088078300,"Xrylix II, Diclofenac Sodium Topical Solution 1.5% w/w 5floz (150ml),Xrylix sheets (30ct)",2022-03-02,3969.57,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,225000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088048916,"Urea 41% Cream, Urea 41%, (8oz)",2022-06-01,3162,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,300000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088069554,"Davimet Multivitamin, Vitamin A 83%, Vitamin C 67%, Vitamin D3 50%, Vitamin E 67%, Thiamin 88%, Riboflavin 92%, Niacin 84%, Vitamin B6 62%, Folate 417%, Vitamin B12 18%, Chewable tablets, grape flavor, (30ct)",2022-09-19,1800,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,250000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088048307,"Lidotran Cream, Lidocaine 3.88%, cream, (3oz)",2022-09-19,1123.81,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,325000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088063000,"Naprotin, Naproxen tablets, USP, 500mg, (100 ct)_Penetral Cream (Capsaicin 0.025%, 8fl oz/ 237ml)",2022-09-27,3510,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,175000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +QOL Medical LLC,67871011107,"Sucraid (Sacrosidase) Oral Solution 8500IU/mL, 6ct, 2mL Vials",2022-09-13,10535,,1,2000,,,,,,,QOL anticipates the first shipments of this product in the next few weeks.,,,,,,,,,,,,,,, +"Rigel Pharmaceuticals, Inc.",71332000501,"Rezlidhia Capsules 150mg, 30 caps.",2022-12-21,16100,"Rezlidhia (Olutasidenib) 150 mg capsules is an FDA approved treatment for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Rigel’s approach for a new product launch is to develop marketing materials for our sales teams to educate healthcare professionals on the appropriate utilization of REZLIDHIA consistent with the US FDA approved indication. Rigel utilizes printed materials, websites, and other digital media to communicate this information to relevant healthcare professionals. We provide patient assistance programs, including a copay assistance program which can be found at www.rezlidhia.com, and our Rigel OneCare program which aids in patient support services, benefit verifications, prior authorizations, temporary and long term free drug supply, and adherence support. Additional company and product information is included on Rigel’s website at www.rigel.com. Rigel gives careful consideration to a number of interdependent factors when setting the price of the Company’s pharmaceutical products, some of which include the clinical and economic value that a particular therapy provides to the patients and the nation’s healthcare system overall (e.g. objective and subjective measures of individual health outcomes and overall costs of therapy in both inpatient and outpatient settings, for public and private facilities and payors). Fundamentally, Rigel gives serious consideration to a number of factors impacting the final price determined for each of its products, including Rezlidhia, including but not limited to; (1) clinical and economic value of a particular therapy, (2) the therapeutic category, its market dynamics, and competitor pricing, (3) discounts provided to customers in both the commercial and government channels, (4) patient support provided by Rigel to ensure patient access to life-saving and life-changing medications, (5) ongoing capital investments, and (6) overall research and development or product acquisition costs. This consideration into pricing is based on an overall assessment of the particular circumstances of these and other interdependencies and the judgement and expertise of Rigel’s leadersip team, and does not follow a fixed algorithm. Related to the product pricing is the discounted pricing available in certain circumstances, generally a fixed percent off the wholesale acquisition cost, which is set by contract or regulation, and is based on assessment of market dynamics, product access, and overall commercial economics.",,20380,,,2022-07-27,2000000,,"Under the terms of the agreement, Forma will receive an upfront payment of $2.0 million, and is eligible to receive an additional $17.5 million upon the achievement of certain near-term regulatory, approval, and first commercial sale milestones. In addition, Forma is eligible to receive a total of up to an additional $215.5 million in connection with the achievement of certain development and commercial milestones. Forma is also eligible to receive tiered royalties in the low-teens to mid-thirties. Moving forward, Rigel will be responsible for the potential launch and commercialization of olutasidenib in the U.S., and intends to work with potential partners to further develop and commercialize olutasidenib outside the U.S.",The estimated number of patients is per year. See: https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html,,,,,,,,,,,,,,, +Sagent Pharmaceuticals,25021019111,Micafungin Injection (100mg 1x10),2022-10-25,1870,No amount spent on marketing,,2083,,,,,,,,,,,,,,,,,,,,,, +Sagent Pharmaceuticals,25021019011,Micafungin Injection (50mg 1x10),2022-10-25,935,No amount spent on marketing,,2083,,,,,,,,,,,,,,,,,,,,,, +Sandoz Inc.,781808532,PIRFENIDONE 267MG 270FCT BO US,2022-05-02,9130.57,This launch is specific to the U.S. Sandoz Inc. is contracting within the wholesaler and/or specialty pharmacy space. The WAC is priced lower than the WAC of the reference product.,,100000,,,,,,,"According to Cortellis data from July 2021, IPF is rare disease, with an estimated prevalence of 44,000 to 135,000 cases and an incidence of 21,000 new cases per year in the U.S. +Source: https://insights.decisionresourcesgroup.com/disease/idiopathic-pulmonary-fibrosis. + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. + +Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,781808692,PIRFENIDONE 801MG 90FCT BO US,2022-05-02,9130.57,This launch is specific to the U.S. Sandoz Inc. is contracting within the wholesaler and/or specialty pharmacy space. The WAC is priced lower than the WAC of the reference product.,,100000,,,,,,,"According to Cortellis data from July 2021, IPF is rare disease, with an estimated prevalence of 44,000 to 135,000 cases and an incidence of 21,000 new cases per year in the U.S. +Source: https://insights.decisionresourcesgroup.com/disease/idiopathic-pulmonary-fibrosis. + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. + +Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,781351990,PEMETREXED FOR INJ 500MG/20ML,2022-06-07,3369.17,This launch is specific to the U.S. Sandoz Inc. is contracting within the oncology and hospital space. The WAC is priced lower than the WAC of the reference product.,,53482,,,,,,,"According to Decision Resources Group, now part of Clarivate, an estimated 53,482 patients in 2022 are treated with pemetrexed, (all branded and generic prescriptions, not just Sandoz) for non-small cell lung cancer (NSCLC) in the United States. +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. +Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,781349895,ARSENIC TRIOXIDE 12MG/6ML 6ML 10LIVI,2022-07-14,4784.4,This launch is specific to the U.S. Sandoz Inc. is contracting within the oncology and hospital space. The WAC is priced lower than the WAC of the reference product.,,39743,,,,,,,"According to Decision Resources Group, now part of Clarivate, an estimated 39,743 patients in 2022 are treated for Acute Myeloid Leukemia. +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. +Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sanofi,80203034701,ENJAYMO® (Sutimlimab-jome),2022-02-21,1800,"In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with CAD, materials to be used by sales representatives to share information on Enjaymo with prescribers, and materials to educate patients about CAD and Enjaymo. Direct to Consumer (DTC) outreach for Enjaymo will include search, website and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising. +Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with CAD, materials to be used by sales representatives to share information on Enjaymo with prescribers, and materials to educate patients about CAD and Enjaymo. +Sanofi’s commitment to pricing rests on three pillars: a holistic assessment of value when setting launch prices, year-over-year price increases that are limited to National Health Expenditure projections, and disclosure of our aggregate gross and net prices changes to provide greater transparency about the pricing of our medicines. + Given the growing concerns over rising health care costs, our approach to pricing reflects our commitment to patient access while minimizing our contribution to health care inflation. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need + Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system.",,4000,1,1,,,,,"In the United States, it is estimated that there are ~5,000 people living with Cold Agglutinin Disease. While there are no US-specific population-based studies, national studies in European countries estimate a prevalence between 12-16 cases per million (Bylsma 2019, Berentsen 2006). CAD is a chronic autoimmune hemolytic anemia caused by an auto-antibody that targets red blood cells. The amount of autoimmune hemolytic anemia that a patient experiences will differ between patients and is in part determined by the temperature at which the cold agglutinin binds to the patients red blood cells. As a result, patients may experience mild, moderate or severe levels of anemia with intermittent exacerbations of symptoms and anemia. While Enjaymo is indicated for the treatment of all CAD patients regardless of severity, physicians may prefer to reserve pharmacologic treatment for symptomatic patients. In observational studies, the proportion of patients observed experiencing moderate to severe levels of anemia ranged from ~ 45% to 80% (Mullins 2017). Under the assumption that these patients are more likely to be symptomatic, the potential number of patients prescribed Enjaymo may range from 2,250 to 4,000.",,,,,,,,,,,,,,, +Sanofi,58468005001,"XENPOZYME™ (olipudase alfa-rpcp) for injection, for intravenous use",2022-09-12,7142,"Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with acid sphingomyelinase deficiency (ASMD) disease, materials to be used by sales representatives to share information on XENOPZYME™ with prescribers, and materials to educate patients about ASMD and XENOPZYME™. Direct to Consumer (DTC) outreach for XENOPZYME™ will include search, website, online ad placements, email, and webinars. DTC initiatives are not expected to include any TV, radio, or national magazine advertising. + +Sanofi’s commitment to pricing rests on three principles: a holistic assessment of value when setting launch prices, year-over-year price increases that are limited to National Health Expenditure projections, and disclosure of our aggregate gross and net prices changes to provide greater transparency about the pricing of our medicines. These comprehensive principles were drafted to address questions around the price of medicines in the United States. Our goal is to make our medicines accessible and affordable to all patients. + +Given the growing concerns over rising health care costs, our approach to pricing reflects our commitment to patient access while minimizing our contribution to health care inflation. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need?. + +Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system.",,1339,1,1,,,,,"Historically, referred to as Niemann-Pick disease (NPD) types A, A/B, and B, acid sphingomyelinase deficiency (ASMD) is a rare, progressive genetic disease with significant morbidity and mortality. XENPOZYME™ is the first therapy indicated specifically for the treatment of ASMD, and is currently the only approved treatment for this disease. www.rarediseases.org estimates ASMD prevalence at 1 in 250,000. Based on the US population in 2023, the estimated number of patients in the US with ASMD for which XENPOZYME™ may be prescribed is 1,339. However, because some cases go misdiagnosed or undiagnosed, determining the true frequency of ASMD in the general US population is difficult. It has been estimated that there are fewer than 120 patients diagnosed with ASMD in the U.S. Approximately two-thirds of patients with ASMD in the U.S. are pediatric.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=670,,,,,,,,,,,,,, +Santen US,65086000112,Verkazia .01%,2022-05-02,1465,This drug is addressing a rare disease within VRC market. There are estimated to be around 115k patients at any given time within the US. The WAC price is based upon modeling of this market within the US. product is the first drug specially indicated for this condition.,,115000,1,,,,,,,,,,,,,,,,,,,,, +"Secura Bio, Inc.",7311622556,"Copiktra 25 mg oral capsule, 56 capsules per package, Secura labeler code",2022-07-01,18074.31,,1,200000,,,,,,,,,,,,,,,,,,,,,, +Slayback Pharma LLC,71225012001,"VIVIMUSTA- bendamustine hydrochloride injection 100mg/4mL, 4 mL in 1 VIAL",2022-12-22,3209.54,,1,8300,,,,,,,This product was not acquired.,,,,,,,,,,,,,,, +SpecGx,406771160,Noxafil (posaconazole),2022-07-18,970,,1,2500,,,,,,,"Consistent with Section 127681(c) of the California Health and Safety Code with respect to average number of patients, the information is not otherwise in the public domain or publicly available. Noxafil is used in the treatment of fungal infections, this number is an estimate of the number of patients that the product may be used for in the state. This is a generic product, not marketed directly to consumers or healthcare professionals. WAC price is based upon an analysis of existing generic and brand WAC prices. The details of this analysis are considered proprietary information.",,,,,,,,,,,,,,, +"Spectrum Pharmaceuticals, Inc.",76961010101,Rolvedon 13.2 mg/0.6 mL solution 1 prefilled syringe,2022-10-18,4500,"Marketing: Rolvedon is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Educational materials will be provided to HCPs along with being available on the product website, and highlight access and affordability support for Rolvedon to ensure appropriate access to therapy. + +Pricing: Rolvedon is an injectable drug administered subcutaneously after cytotoxic chemotherapy by healthcare professionals (i.e., a Part B drug), not a tablet, capsule, or similar self-administered drug covered by Part D. Rolvedon’s WAC is comparable to that of other drugs indicated for similar conditions, and is priced responsibly taking into account Rolvedon’s development costs; complex manufacturing (Rolvedon is a biologic); distribution and storage requirements (Rolvedon is a cold-chain product); and Spectrum’s ongoing operational costs (G&A, overhead) and patient assistance/support programs.",,150000,,,,,,,,,,,,,,,,,,,,,, +"Strides Pharma, Inc.",64380015301,VALGANCICLOVIR 450MG TAB 60-STR,2022-09-07,1009.59,Marketed as a generic. WAC has been reduced considerably to match competition since launch,,720,,,2022-06-01,133333,,,,,,,,,,,,,,,,,, +"Strides Pharma, Inc.",64380018901,"Zileuton ER Tablets 600mg, 120ct",2022-12-31,1500,,1,1200,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,62756006483,"Fingolimod Oral Capsule 0.5MG, 30 count",2022-10-25,2220.97,,1,296700,,,,,,,,,,,,,,,,,,,,,, +Telix Pharmaceuticals (US) Inc,74725010025,Illuccix (kit for the preparation of gallium Ga 68) - produced from a cyclotron and purified via GE FASTlab™ or Eckert & Ziegler GalliaPharm® Ge 68/Ga-68 generator gozetotide injection,2022-04-08,4700,"Telix will market Illuccix® through a variety of channels, including sales conversations with health care professionals, digital banners, email marketing, patient education, professional associations, trade shows, and public relations. +Telix participates in Medicaid and agrees to provide outpatient drugs to 340B covered entities at significantly reduced prices.",,170000,,,,,,,,,,,,,,,,,,,,,, +Telix Pharmaceuticals (US) Inc,74725010064,Illuccix (kit for the preparation of gallium Ga 68) - produced from an IRE Galli Eo® Ge 68/Ga-68 generator gozetotide injection -,2022-04-08,4700,"Telix will market Illuccix® through a variety of channels, including sales conversations with health care professionals, digital banners, email marketing, patient education, professional associations, trade shows, and public relations. +Telix participates in Medicaid and agrees to provide outpatient drugs to 340B covered entities at significantly reduced prices.",,170000,,,,,,,,,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480124328,LENALIDOMIDE CAPSULE 10MG 28,2022-03-03,20157.36,,1,70000,,,,,,,"Estimated average of up to 10,310 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that there are as many as 70,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Natco Pharma.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480124421,LENALIDOMIDE CAPSULE 15MG 21,2022-03-03,15118.04,,1,70000,,,,,,,"Estimated average of up to 10,310 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that there are as many as 70,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Natco Pharma.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480124621,LENALIDOMIDE CAPSULE 25MG 21,2022-03-03,15118.04,,1,70000,,,,,,,"Estimated average of up to 10,310 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that there are as many as 70,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Natco Pharma.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480124228,LENALIDOMIDE CAPSULE 5MG 28,2022-03-03,20157.36,,1,70000,,,,,,,"Estimated average of up to 10,310 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that there are as many as 70,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Natco Pharma.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480943589,Diclofenac Potassium Caps 25mg 120,2022-03-24,1609.11,,1,12000000,,,,,,,"Estimated average of up to 1,243 prescriptions per month, based on historic IQVIA data, although research suggests that there are as many as 12,000,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Bionpharma Inc.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480361087,PIRFENIDONE TABLETS 267MG 270,2022-05-11,7147.41,,1,140000,,1,,,,,"Estimated average of up to 4,708 prescriptions per month (across both dosage strengths), based on historic IQVIA data, although research suggests that as many as 140,000 Americans suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480361198,PIRFENIDONE TABLETS 801MG 90,2022-05-11,7147.41,,1,140000,,1,,,,,"Estimated average of up to 4,708 prescriptions per month (across both dosage strengths), based on historic IQVIA data, although research suggests that as many as 140,000 Americans suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480451501,PEMETREXED INJECTION 1 G/40 ML 1,2022-05-31,6849.33,,1,51000,,,,,,,"Although Teva launched this NDC at a WAC of $6,849.33, it subsequently lowered the WAC to $1,882.77. + +Estimated average of 116 prescriptions per month (across both dosage strengths), based on historic IQVIA data and related internal forecasting, although research suggests that as many as 51,000 Americans may be eligible to take this product, based on its approved indications. Acquisition fields left blank; Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480451401,PEMETREXED INJECTION 500 MG/20 ML 1,2022-05-31,3424.67,,1,51000,,,,,,,"Although Teva launched this NDC at a WAC of $3,424.67, it subsequently lowered the WAC to $990.93. + +Estimated average of 116 prescriptions per month (across both dosage strengths), based on historic IQVIA data and related internal forecasting, although research suggests that as many as 51,000 Americans may be eligible to take this product, based on its approved indications. Acquisition fields left blank; Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480449056,TASIMELTEON CAPSULE 20MG 30,2022-12-29,20570.96,,1,90000,,,,,,,"Research suggests that there are as many as 90,000 patients in the US whose condition matches the product’s approved indication and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed the product.",,,,,,,,,,,,,,, +Tolmar Inc,69087015812,"Jatenza, 158 mg, 12 BOTTLES in 1 BOX, 120 Liquid Filled Capsules in 1 Bottle",2022-10-28,962.64,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers, patients, and caregivers about the approved indication, efficacy and safety data contained within the medicine's FDA approved label. Generally, Tolmar markets in the US at medical conferences in the urology, endocrinology, and general medicine community, as well as promoting to appropriate healthcare professionals, patients, and caregivers",,2361,,,2022-10-27,7500000,,,prices are for 120 tabs.,,,,,,,,,,,,,,, +Tolmar Inc,69087019812,"Jatenza, 198 mg, 12 BOTTLES in 1 BOX, 120 Liquid Filled Capsules in 1 Bottle",2022-10-28,962.64,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers, patients, and caregivers about the approved indication, efficacy and safety data contained within the medicine's FDA approved label. Generally, Tolmar markets in the US at medical conferences in the urology, endocrinology, and general medicine community, as well as promoting to appropriate healthcare professionals, patients, and caregivers",,2361,,,2022-10-27,7500000,,,prices are for 120 tabs.,,,,,,,,,,,,,,, +Tolmar Inc,69087023712,"Jatenza, 237 mg, 12 BOTTLES in 1 BOX, 120 Liquid Filled Capsules in 1 Bottle",2022-10-28,1925.26,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers, patients, and caregivers about the approved indication, efficacy and safety data contained within the medicine's FDA approved label. Generally, Tolmar markets in the US at medical conferences in the urology, endocrinology, and general medicine community, as well as promoting to appropriate healthcare professionals, patients, and caregivers",,2361,,,2022-10-27,7500000,,,prices are for 120 tabs.,,,,,,,,,,,,,,, +"TruPharma, LLC",52817072005,"Apomorphine Hydrochloride Injection, 30mg/3mL (10mg/mL), 5-Count",2022-03-01,5207.85,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,1500,,,,,,,,https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=588,,,,,,,,,,,,,, +"TWi Pharmaceuticals USA, Inc.",24979071051,"Paclitaxel Protein-Bound Particles for Injectable Suspension 100mg, vial",2022-04-07,1422.05,"Selling to hospitals and clinics as they represent 98% of the market. +Generic product discounted between 10-15% of brand product list price.",,32000,,,2022-04-01,,1,,,,,,,,,,,,,,,,, +"TWi Pharmaceuticals USA, Inc.",24979071544,Sorafenib 200mg 120ct,2022-12-28,15000,Sold as a low volume generic in a limited competition environment.,,552,,,,,,,,,,,,,,,,,,,,,, +United Therapeutics,66302063203,Tyvaso DPI Maintenance Kit Inhalation Powder 112 cartridges of 32 MCG with 5 inhalers per box,2022-06-22,20906.09,"United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). + +Tyvaso DPI is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment.",,75000,,,,,,,"Estimated patients is confidential and proprietary, and not publicly available or within the public domain.",,,,,,,,,,,,,,, +United Therapeutics,66302064803,Tyvaso DPI Maintenance Kit Inhalation Powder 112 cartridges of 48 MCG with 5 inhalers per box,2022-06-22,20906.09,"United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). + +Tyvaso DPI is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment.",,75000,,,,,,,"Estimated patients is confidential and proprietary, and not publicly available or within the public domain.",,,,,,,,,,,,,,, +United Therapeutics,66302066403,Tyvaso DPI Maintenance Kit Inhalation Powder 112 cartridges of 64 MCG with 5 inhalers per box,2022-06-22,20906.09,"United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). + +Tyvaso DPI is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment.",,75000,,,,,,,"Estimated patients is confidential and proprietary, and not publicly available or within the public domain.",,,,,,,,,,,,,,, +United Therapeutics,66302060002,TYVASO DPI Titration Kit Inhalation Powder 112 cartridges of 16 MCG and 84 cartridges of 32 MCG with 5 inhalers per box,2022-07-27,20906.09,"""United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). + +Tyvaso DPI is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment.""",,75000,,1,,,,,,https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=664,,,,,,,,,,,,,, +United Therapeutics,66302061603,Tyvaso DPI Maintenance Kit Inhalation Powder 112 cartridges of 16 MCG with 5 inhalers per box,2022-08-02,20906.09,"United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). + +Tyvaso DPI is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment.",,75000,,1,,,,,,,,,,,,,,,,,,,, +United Therapeutics,66302061002,Tyvaso DPI Titration Kit Inhalation Powder 112 cartridges of 16 MCG and 112 cartridges of 32 MCG and 28 cartridges of 48 MCG with 5 inhalers per box,2022-08-04,20906.09,"United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). + +Tyvaso DPI is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment.",,75000,,1,,,,,,,,,,,,,,,,,,,, +"USWM, LLC",78670014002,ZIMHI Injection 5 mg/.5mL,2022-03-31,125,"To help reduce the number of deaths resulting from the opioid crisis by increasing access to higher dose naloxone. This will be achieved by educating public health entities (including State supported naloxone distribution programs, Harm Reduction, Law Enforcement and Emergency First Responders, Community Support programs) and all other channels including specialty distributors, specialty pharmacies, advocacy groups, physicians, patients, and health systems on the approved indication, efficacy, safety, and administration of the pre-filled naloxone device. ZIMHI will utilize a multitude of marketing resources including a Public Health & Advocacy relations team for the US, a small field sales force to educate HCP’s, digital education and ordering, a website, medical conferences, advocacy meetings, etc. to compliantly engage the aforementioned interest groups.",,10000000,,1,,,,,"USWM, LLC has a distribution and commercialization agreement with Adamis Pharmaceuticals Corp to distribute this product. USWM purchases the finished product from Adamis through terms specified in a supply agreement.",,,,,,,,,,,,,,, +Validus Pharmaceuticals,30698022010,Anzemet 50mg tablets 10 count,2022-05-24,295.62,,1,1000000,,,2015-12-21,,1,The NDA # 20-623 was part of a portfolio purchased from Sanofi Aventis in 2015.,"Anzemet Tablets NDA #20-623 was approved by the FDA on 09/11/1997 +NDC # 30698-0220-10 is a relaunch under a new packing size +There is a price decrease per pill. The prior WAC price was $72.05 per pill. The new WAC price is $29.56 under NDC # 30698-0220-10 + +Anzemet Tablets is a antiemetic used primarily (but not exclusively) by patients +receiving chemotherapy. This is only one of several options for antiemetics.",,,,,,,,,,,,,,, +Vifor (International) Inc.,59353006512,KORSUVA (difelikefalin) injection Carton containing 12 single-dose vials,2022-05-02,1800,"Vifor (International) Inc. plans to market Korsuva to appropriate healthcare professionals who treat moderate to severe CKD-aP adult patients on hemodialysis. Currently, Vifor does not plan to engage in television or radio advertising or promotional campaigns. The current WAC is set at $150.00 per single-dose vial, and at $1,800.00 for a standard 30-day supply. The list price of Korsuva is not reflective of discounts and rebates which may be available to various government and private payers and purchasers.",,33000,1,1,,,,,Vifor did not acquire Korsuva and has therefore left acquisition-related data fields blank.,,,,,,,,,,,,,,, +Vifor (International) Inc.,59353006501,KORSUVA (difelikefalin) injection 65 mcg/1.3 mL single-dose vial,2022-05-02,150,"Vifor (International) Inc. plans to market Korsuva to appropriate healthcare professionals who treat moderate to severe CKD-aP adult patients on hemodialysis. Currently, Vifor does not plan to engage in television or radio advertising or promotional campaigns. The current WAC is set at $150.00 per single-dose vial, and at $1,800.00 for a standard 30-day supply. The list price of Korsuva is not reflective of discounts and rebates which may be available to various government and private payers and purchasers.",,33000,1,1,,,,,"The data entered in the “WAC at Intro to Market” data field is based on the WAC for a single therapeutic dose, however a normal course of therapy would have a monthly WAC price of 1800, therefore necessitating reporting.",,,,,,,,,,,,,,, +ViiV Healthcare,49702026423,APRETUDE (cabotegravir 600mg/3 mL),2022-01-24,3700,,1,1200000,1,1,,,,,"Regarding Marketing/Pricing Plan Description, ViiV has not released APRETUDE's marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). +The 1,200,000 patient number does not reflect the number of persons that are estimated to be prescribed Apretude; it represents the estimated number of persons in the US that had indications for PrEP (Pre-exposure Prophylaxis) in 2019. According to the CDC, an estimated 1.2 million persons in the US had indications for PrEP and approximately 284,000 were prescribed PrEP in 2019. The 2019 approximations for California were about 165,000 persons with PrEP indications and 44,000 persons prescribed PrEP. The 2019 US and California estimates are based on Centers for Disease Control and Prevention. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data—United States and 6 dependent areas, 2019. HIV Surveillance Supplemental Report 2021;26(No. 2), published May 2021. Apretude is indicated in at-risk adults and adolescents weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating Apretude (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP. +APRETUDE was granted a priority review and breakthrough therapy designation by the Food And Drug Administration. +Note on Acquisition Fields: APRETUDE was developed by ViiV Healthcare, therefore the following fields related to drug acquisition have been left blank: ACQUISITION_DATE, ACQUISITION_PRICE, ACQUISITION_PRICE_NONPUBLIC, ACQUISITION_PRICE_COMMENT.",,,,,,,,,,,,,,, +ViiV Healthcare,49702025837,TRIUMEQ PD Tablets for Oral Suspension (abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg),2022-05-04,1001.72,,1,1900,,1,,,,,"Regarding Marketing/Pricing Plan Description, ViiV has not released TRIUMEQ PD's marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). + +The 1,900 patient number does not reflect the number of persons that are estimated to be prescribed TRIUMEQ PD; it represents the estimated number of children aged less than 13 years living with diagnosed HIV infection, Year-end 2018 - United States and 6 Dependent Areas. This 2018 estimate is based on the Centers for Disease Control and Prevention, HIV Surveillance Report, 2018 Updated Edition, Volume 31: Diagnoses of HIV Infection in the United States and Dependent Areas, 2018: Children Aged < 13 years. Data for the year 2018 are preliminary and based on deaths reported to CDC as of December 2019. This estimate does not reflect new infections for 2019-2021. TRIUMEQ PD is indicated for the treatment of pediatric patients weighing 10 kgs to < 25 kgs with human immunodeficiency virus type 1 (HIV-1). + +TRIUMEQ PD was granted priority review by the Food And Drug Administration. + +Note on Acquisition Fields: TRIUMEQ PD was developed by ViiV Healthcare, therefore the following fields related to drug acquisition have been left blank: ACQUISITION_DATE, ACQUISITION_PRICE, ACQUISITION_PRICE_NONPUBLIC, ACQUISITION_PRICE_COMMENT.",,,,,,,,,,,,,,, +Woodward Pharma Services LLC,69784061025,"Leukeran® Tablets, 2mg, 25ct",2022-10-21,6009.15,"Product is priced at a discount to comparable therapies, and patient assistance programs have been made available.",,10000,,,,,,,,,,,,,,,,,,,,,, +Woodward Pharma Services LLC,69784062025,"Myleran® Tablets, 2mg, 25ct",2022-10-21,3125,"Product is priced at a discount to comparable therapies, and patient assistance programs have been made available.",,9000,,,,,,,,,,,,,,,,,,,,,, +Woodward Pharma Services LLC,69784063025,"Tabloid® Tablets, 40mg, 25ct",2022-10-21,5624.5,"Product is priced at a discount to comparable therapies, and patient assistance programs have been made available.",,10000,,,,,,,,,,,,,,,,,,,,,, +"Xeris Pharmaceuticals, INC.",72065000301,RECORLEV™ (levoketoconazole) 150mg Tablets 50 in 1 Bottle,2022-01-26,13500,,1,25000,,,,,,,,,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710128701,Vigabatrin 500mg Tablets 100 Count,2022-02-10,10511.89,,1,400000,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “400000” in the “Estimated Number of Patients” column, howvever: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Vigabatrin is indicated for the treatment of adults and childer 10 years of age and older with refractory complex partial seizures (CPS) who have not responded well enough to other treatments. It is noted that it should not be the first medication used to treat CPS. As per the UpToDate link (https://www.uptodate.com/contents/evaluation-and-management-of-drug-resistant-epilepsy) it estimates that as many as 20 to 40 percent of patients with epilepsy (roughly 400,000 people living in the United States) are likely to have refractory epilepsy. Zydus based its esimate on this number.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710167401,Pemetrexed Inj 1000mg/1ml (1x1ml),2022-05-26,1882.77,,1,203599,,,,,,,"This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “203,599” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Pemetrexed is a chemotherapy medication for the treatment of pleural mesothelioma and non-small cell lung cancer. As per the Pleural Mesothelioma link (https://www.pleuralmesothelioma.com/cancer/pleural/) of the 3,000 cases of mesothelioma diagnosed per year about 2,100 to 2,370 are pleural mesothelioma. Also, as per the Cancer.Net link (https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics) an estimated 236,740 adults in the United States will be diagnosed with lung cancer and approximately 80% - 85% of lung cancers are non-small cell lung cancer (https://www.cancer.org/cancer/lung-cancer/about/). Zydus has based its patient estimate by adding 2,370 of the possible pleural mesothelioma diagnoses with 201,229, 85% of the estimated potential lung cancer diagnoses.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710165501,Pemetrexed Inj 500mg/1ml (1x1ml),2022-05-26,990.93,,1,203599,,,,,,,"This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “203,599” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Pemetrexed is a chemotherapy medication for the treatment of pleural mesothelioma and non-small cell lung cancer. As per the Pleural Mesothelioma link (https://www.pleuralmesothelioma.com/cancer/pleural/) of the 3,000 cases of mesothelioma diagnosed per year about 2,100 to 2,370 are pleural mesothelioma. Also, as per the Cancer.Net link (https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics) an estimated 236,740 adults in the United States will be diagnosed with lung cancer and approximately 80% - 85% of lung cancers are non-small cell lung cancer (https://www.cancer.org/cancer/lung-cancer/about/). Zydus has based its patient estimate by adding 2,370 of the possible pleural mesothelioma diagnoses with 201,229, 85% of the estimated potential lung cancer diagnoses.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710183908,Nelarabine Inj Nova+ 250mg/50mL (6X50mL),2022-07-15,3966,,1,8060,,,,,,,"This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “8,060” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Nelarabine Injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. As per the Lymphoma Info link (https://www.lymphomainfo.net/articles/non-hodgkins/what-is-t-cell-lymphoblastic-lymphoma) of the 70,000 new lymphoma diagnoses in the United States each year, no more than 2% are lymphoblastic lymphoma. That comes out to around 1,400 new cases each year. Also, as per the Key Statistics for Acute Lymphocytic Leukemia (ALL) (https://www.cancer.org/cancer/acute-lymphocytic-leukemia/about/key-statistics.html) the American Cancer Society estimates about 6,660 new cases of ALL (including both children and adults). Zydus has based its patient estimate by adding 1,400 of the T-Cell Lymphoblastic lymphoma cases with 6,660 of the possible Acute Lymphocytic Leukemia cases (totaling 8,060).",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710103207,Lenalidomide 10mg Capsule (28 CAPS),2022-09-14,20157.36,,1,60000,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “60,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Lenalidomide is indicated for the treatment of Multiple Myeloma. As per the University of California San Francisco link (https://www.ucsfhealth.org/conditions/multiple-myeloma#) about 60,000 people have this disease and 20,000 new cases are diagnosed each year in the United States.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710103308,Lenalidomide 15mg Capsule (21 CAPS),2022-09-14,15118.04,,1,60000,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “60,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Lenalidomide is indicated for the treatment of Multiple Myeloma. As per the University of California San Francisco link (https://www.ucsfhealth.org/conditions/multiple-myeloma#) about 60,000 people have this disease and 20,000 new cases are diagnosed each year in the United States.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710103508,Lenalidomide 25mg Capsule (21 CAPS),2022-09-14,15118.04,,1,60000,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “60,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Lenalidomide is indicated for the treatment of Multiple Myeloma. As per the University of California San Francisco link (https://www.ucsfhealth.org/conditions/multiple-myeloma#) about 60,000 people have this disease and 20,000 new cases are diagnosed each year in the United States.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710103107,Lenalidomide 5mg Capsule (28 CAPS),2022-09-14,20157.36,,1,60000,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “60,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Lenalidomide is indicated for the treatment of Multiple Myeloma. As per the University of California San Francisco link (https://www.ucsfhealth.org/conditions/multiple-myeloma#) about 60,000 people have this disease and 20,000 new cases are diagnosed each year in the United States.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,68382091206,Fingolimod 0.5mg Capsule (30 Caps),2022-10-20,2220.97,,1,913925,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “913,925” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Fingolimod is indicated for the treatment of Multiple Sclerosis. As per the National Multiple Sclerosis Society link (https://www.nationalmssociety.org/What-is-MS/Who-Gets-MS/How-Many-People) about 913,925 adults are living with MS in the United States.",,,,,,,,,,,,,,, +AbbVie,74357501,LUPRON DEPOT PED 6M 45MG,2023-04-27,23578.59,"LUPRON DEPOT-PED is a prescription medicine used to treat pediatric patients with central precocious puberty (CPP). The Wholesale Acquisition Cost (WAC) of LUPRON DEPOT PED is $23,578.59 per kit (6 month supply).",,5802,,,,,,,"Response on estimated volume of patients who may be prescribed the drug (see Cal. Health & Saf. Code § 96076(b)(2): + +The estimated patients per month of 5,802 represents the average number of patients on LUPRON DEPOT-PED 45mg for 6-month administration at any given time during the year. The estimated number of prescriptions filled each month is approximately 967.",,,,,,,,,,,,,,, +ACADIA Pharmaceuticals Inc.,63090066001,"Daybue Oral Solution 200 MG/ML, 450 ML, Bottle",2023-03-21,9495,,1,574,,1,,,,,,,,,,,,,,,,,,,, +Acer Therapeutics Inc.,72542020009,OLPRUVA™ 2 G Kit (sodium phenylbutyrate),2023-07-13,17100,,1,2100,,,,,,,,,,,,,,,,,,,,,, +Acer Therapeutics Inc.,72542030009,OLPRUVA™ 3 G Kit (sodium phenylbutyrate),2023-07-13,25650,,1,2100,,,,,,,,,,,,,,,,,,,,,, +Acer Therapeutics Inc.,72542060018,OLPRUVA™ 6 G Kit (sodium phenylbutyrate),2023-07-13,51300,,1,2100,,,,,,,,,,,,,,,,,,,,,, +Acer Therapeutics Inc.,72542066718,OLPRUVA™ 6.67 G Kit (sodium phenylbutyrate),2023-07-13,57028.5,,1,2100,,,,,,,,,,,,,,,,,,,,,, +Acer Therapeutics Inc.,72542040018,OLPRUVA™ 4 G Kit (sodium phenylbutyrate),2023-07-19,34200,,1,2100,,,,,,,,,,,,,,,,,,,,,, +Acer Therapeutics Inc.,72542050018,OLPRUVA™ 5 G Kit (sodium phenylbutyrate),2023-07-19,42750,,1,2100,,,,,,,,,,,,,,,,,,,,,, +Aimmune Therapeutics,71881040012,"fecal microbiota spores, live-brpk",2023-06-01,17500,,1,1295,,,,,,,,,,,,,,,,,,,,,, +"Almaject, Inc",72611087410,"Regadenoson Injection, 0.4mg/5ml (0.08 mg/ml)",2023-07-07,850,"Almaject considers various factors in deciding the wholesale acquisition cost (WAC) at which to set its prescription drugs, including Regadenoson.  These factors include, but are not limited to: market based factors such as the competitive landscape and pricing environment; manufacturing and supply considerations; profitability; inflation and costs, including cost of administrative and commercial activities; therapeutic class and patient population, as well as patient needs and access; and contracts and relationships with customers.",,1000000,,,,,,,,,,,,,,,,,,,,,, +Almatica,52427085060,"Gralise Tablets, 750mg",2023-04-20,957.72,"Gralise is promoted by our commercial field team to healthcare professionals to educate them on our product. We use various means of promotion including in-office visits, virtual meetings, and non-personal digital marketing. A website www.gralise.com provides further information about Gralise. + +Almatica considers various factors in deciding the wholesale acquisition cost (WAC) at which to set its prescription drugs, including Gralise. These factors include but are not limited to: market-based factors such as the competitive landscape and pricing environment; manufacturing and supply considerations; profitability; inflation and costs, including increased cost of administrative and commercial activities; therapeutic class and patient population, as well as patient needs and access; and contracts and relationships with customers.",,137,,,,,,,,,,,,,,,,,,,,,, +Almatica,52427089060,"Gralise Tablets, 900mg",2023-04-20,957.72,"Gralise is promoted by our commercial field team to healthcare professionals to educate them on our product. We use various means of promotion including in-office visits, virtual meetings, and non-personal digital marketing. A website www.gralise.com provides further information about Gralise. + +Almatica considers various factors in deciding the wholesale acquisition cost (WAC) at which to set its prescription drugs, including Gralise. These factors include but are not limited to: market-based factors such as the competitive landscape and pricing environment; manufacturing and supply considerations; profitability; inflation and costs, including increased cost of administrative and commercial activities; therapeutic class and patient population, as well as patient needs and access; and contracts and relationships with customers.",,273,,,,,,,,,,,,,,,,,,,,,, +American Regent ,517430001,"Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-bound), 100mg per Vial SDV",2023-05-02,1575.32,"We do intend to engage in domestic only marketing activities relating to the Paclitaxel launch to create market awareness of this new vial presentation. Our marketing efforts to promote the new drug are generally through digital media, eblasts and the American Regent website. Printed marketing materials are only for the use of the sales force and are used to facilitate a conversation. Our pricing plans are not in the public domain.",,82584,,,,,,,,https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=681,,,,,,,,,,,,,, +American Regent ,517107501,Levocarnitine 200mg/mL 20mL Vial,2023-06-26,142.68,"We do intend to engage in domestic only marketing activities relating to the Levocarnitine launch to create market awareness of this new product. Our marketing efforts to promote the new drug are generally through digital media, eblasts and the American Regent website. Printed marketing materials are only for the use of the sales force and are used to facilitate a conversation. Our pricing plans are not in the public domain.",,20000,,,,,,,,,,,,,,,,,,,,,, +Amgen,55513041101,"AMJEVITA (20 mg/0.4 mL prefilled syringe, 1 pk)",2023-01-31,3288.24,"There is a direct-to-consumer marketing plan for AMJEVITA. Efforts in the public domain consist of: (1) patient website www.AMJEVITA.com, (2) patient education brochures (1 brochure in print & digital form) and (3) emails for those patients that opt into communications & enroll in patient support. The purpose of the website is to educate patients on AMJEVITA (aligned to USPI), biosimilars, and patient support services. Patients can also enroll directly to patient support services via AMJEVITA.com. The purpose of the emails is to provide patients with important reminders following their being prescribed AMJEVITA such as to look out for a call from their specialty pharmacy call, education on how to inject AMJEVITA using the SureClick device or the pre-filled syringe and tips on how to stay on track with AMJEVITA. + +Promotional activities to HCPs include the HCP website, www.AMJEVITAPro.com, printed resources, a national webinar program, email blasts and other digital resources in line with the AMJEVITA USPI. The purpose of these tools is to educate HCPs about the availability of the therapy, clinical aspects including efficacy, safety, dosing and administration, along with applicable support services. AMJEVITA offers a sample program as well.",,,,,,,,,"Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Amgen,72511040001,"AMJEVITA (40 mg/0.8 mL Autoinjector, 1 pack)",2023-01-31,1557.59,"There is a direct-to-consumer marketing plan for AMJEVITA. Efforts in the public domain consist of: (1) patient website www.AMJEVITA.com, (2) patient education brochures (1 brochure in print & digital form) and (3) emails for those patients that opt into communications & enroll in patient support. The purpose of the website is to educate patients on AMJEVITA (aligned to USPI), biosimilars, and patient support services. Patients can also enroll directly to patient support services via AMJEVITA.com. The purpose of the emails is to provide patients with important reminders following their being prescribed AMJEVITA such as to look out for a call from their specialty pharmacy call, education on how to inject AMJEVITA using the SureClick device or the pre-filled syringe and tips on how to stay on track with AMJEVITA. + +Promotional activities to HCPs include the HCP website, www.AMJEVITAPro.com, printed resources, a national webinar program, email blasts and other digital resources in line with the AMJEVITA USPI. The purpose of these tools is to educate HCPs about the availability of the therapy, clinical aspects including efficacy, safety, dosing and administration, along with applicable support services. AMJEVITA offers a sample program as well.",,,,,,,,,"Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Amgen,55513040001,"AMJEVITA (40 mg/0.8 mL Autoinjector, 1 pk)",2023-01-31,3288.24,"There is a direct-to-consumer marketing plan for AMJEVITA. Efforts in the public domain consist of: (1) patient website www.AMJEVITA.com, (2) patient education brochures (1 brochure in print & digital form) and (3) emails for those patients that opt into communications & enroll in patient support. The purpose of the website is to educate patients on AMJEVITA (aligned to USPI), biosimilars, and patient support services. Patients can also enroll directly to patient support services via AMJEVITA.com. The purpose of the emails is to provide patients with important reminders following their being prescribed AMJEVITA such as to look out for a call from their specialty pharmacy call, education on how to inject AMJEVITA using the SureClick device or the pre-filled syringe and tips on how to stay on track with AMJEVITA. + +Promotional activities to HCPs include the HCP website, www.AMJEVITAPro.com, printed resources, a national webinar program, email blasts and other digital resources in line with the AMJEVITA USPI. The purpose of these tools is to educate HCPs about the availability of the therapy, clinical aspects including efficacy, safety, dosing and administration, along with applicable support services. AMJEVITA offers a sample program as well.",,,,,,,,,"Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Amgen,72511040002,"AMJEVITA (40 mg/0.8 mL Autoinjector, 2 pack)",2023-01-31,3115.18,"There is a direct-to-consumer marketing plan for AMJEVITA. Efforts in the public domain consist of: (1) patient website www.AMJEVITA.com, (2) patient education brochures (1 brochure in print & digital form) and (3) emails for those patients that opt into communications & enroll in patient support. The purpose of the website is to educate patients on AMJEVITA (aligned to USPI), biosimilars, and patient support services. Patients can also enroll directly to patient support services via AMJEVITA.com. The purpose of the emails is to provide patients with important reminders following their being prescribed AMJEVITA such as to look out for a call from their specialty pharmacy call, education on how to inject AMJEVITA using the SureClick device or the pre-filled syringe and tips on how to stay on track with AMJEVITA. + +Promotional activities to HCPs include the HCP website, www.AMJEVITAPro.com, printed resources, a national webinar program, email blasts and other digital resources in line with the AMJEVITA USPI. The purpose of these tools is to educate HCPs about the availability of the therapy, clinical aspects including efficacy, safety, dosing and administration, along with applicable support services. AMJEVITA offers a sample program as well.",,,,,,,,,"Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Amgen,55513040002,"AMJEVITA (40 mg/0.8 mL Autoinjector, 2 pk)",2023-01-31,6576.48,"There is a direct-to-consumer marketing plan for AMJEVITA. Efforts in the public domain consist of: (1) patient website www.AMJEVITA.com, (2) patient education brochures (1 brochure in print & digital form) and (3) emails for those patients that opt into communications & enroll in patient support. The purpose of the website is to educate patients on AMJEVITA (aligned to USPI), biosimilars, and patient support services. Patients can also enroll directly to patient support services via AMJEVITA.com. The purpose of the emails is to provide patients with important reminders following their being prescribed AMJEVITA such as to look out for a call from their specialty pharmacy call, education on how to inject AMJEVITA using the SureClick device or the pre-filled syringe and tips on how to stay on track with AMJEVITA. + +Promotional activities to HCPs include the HCP website, www.AMJEVITAPro.com, printed resources, a national webinar program, email blasts and other digital resources in line with the AMJEVITA USPI. The purpose of these tools is to educate HCPs about the availability of the therapy, clinical aspects including efficacy, safety, dosing and administration, along with applicable support services. AMJEVITA offers a sample program as well.",,,,,,,,,"Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Amgen,55513041001,"AMJEVITA (40 mg/0.8 mL prefilled syringe, 1 pk)",2023-01-31,3288.24,"There is a direct-to-consumer marketing plan for AMJEVITA. Efforts in the public domain consist of: (1) patient website www.AMJEVITA.com, (2) patient education brochures (1 brochure in print & digital form) and (3) emails for those patients that opt into communications & enroll in patient support. The purpose of the website is to educate patients on AMJEVITA (aligned to USPI), biosimilars, and patient support services. Patients can also enroll directly to patient support services via AMJEVITA.com. The purpose of the emails is to provide patients with important reminders following their being prescribed AMJEVITA such as to look out for a call from their specialty pharmacy call, education on how to inject AMJEVITA using the SureClick device or the pre-filled syringe and tips on how to stay on track with AMJEVITA. + +Promotional activities to HCPs include the HCP website, www.AMJEVITAPro.com, printed resources, a national webinar program, email blasts and other digital resources in line with the AMJEVITA USPI. The purpose of these tools is to educate HCPs about the availability of the therapy, clinical aspects including efficacy, safety, dosing and administration, along with applicable support services. AMJEVITA offers a sample program as well.",,,,,,,,,"Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,60219164207,Pirfenidone 267mg Capsules,2023-01-12,1000,This is a generic product that is not marketed.,,463901,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121250301,Lioresal ® Intrathecal 40 mg/20 mL (2000 mcg/mL) 1,2023-03-14,945.14,,1,60168,,1,2022-02-09,,1,,Amneal Pharmaceuticals considers the process of assessing and developing a marketing plan to be a trade secret using confidential information and cannot release this data into the public domain. Amneal is launching a drug that was previously launched in the market with new NDC's to align this product to our labeler.,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121250502,Lioresal ® Intrathecal 40 mg/20 mL (2000 mcg/mL) 2,2023-03-14,1890.28,,1,31080,,1,2022-02-09,,1,,Amneal Pharmaceuticals considers the process of assessing and developing a marketing plan to be a trade secret using confidential information and cannot release this data into the public domain. Amneal is launching a drug that was previously launched in the market with new NDC's to align this product to our labeler.,,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238254803,Tasimelteon IR,2023-03-27,20570.96,,1,412,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121174304,Nelarabine Injection,2023-04-26,3966,,1,60900,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,60219175406,"Abiraterone Acetate 500mg Tablets, 60ct",2023-06-19,2109.77,Amneal Pharmaceuticals LLC considers the process of assessing and developing a marketing and pricing plan to be a trade secret using confidential information and cannot release this data into the public domain.,,340795,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,69238239101,Sodium Oxybate Oral Solution 0.5 g/mL (180mL),2023-07-03,5535,,1,280,,1,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Amneal Pharmaceuticals,70121169402,Plerixafor Injection,2023-07-24,3987.23,,1,22000,,,,,,,"This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house.",,,,,,,,,,,,,,, +Analog Pharma,70505022060,"NITISINONE capsules, for oral use. 20 mg",2023-06-05,43594,"Orphan drug, extremely rare disease with less than 300 patients and 25% less than the brand.",,300,,,,,,,,,,,,,,,,,,,,,, +Apellis Pharmaceuticals,73606002001,"Syfovre 15 MG/0.1ML Solution, Intravitreal Injection, 1 vial in carton",2023-02-27,2190,"Marketing: SYFOVRE is a FDA approved treatment for Geographic Atophy (GA), secondary to age-related macular degeneration (AMD).  SYFOVRE is the first and only FDA-approved therapy indicated for GA.  Apellis' Marketing plan consists of items for HCP promotions covering salaries and compensation for promotional field teams calling on HCPs, electronic and print materials for direct promotion to HCPs, HCP focused websites, digital and print HCP media, educational events for HCPs for information about GA and SYFOVRE, and sponsorships and exhibit production costs for HCP congresses. The Marketing plan also includes items to educate consumers on GA and SYFOVRE via TV, magazines, internet and social media advertising, search engine marketing, consumer focused websites, and print materials.  + +Pricing: SYFOVRE has been developed for the treatment of patients with Geographic Atrophy (GA), secondary to age-related macular degeneration (AMD).  SYFOVRE provides an option to deliver a safe, effective treatment that slows lesion progression.  SYFOVRE is priced responsibly.  Pricing accounts for development costs, complexity of manufacturing, distribution, and storage.  Apellis places a priority on patient access and ensuring all eligible patients with the potential to benefit can receive SYFOVRE.  Apellis performed a thorough analysis of the clinical value of SYFOVRE in GA, examined relevant benchmarks, and considered patient access to determine the list price.  Pricing Methodology for Syfovre was based on the fact that EMPAVELI demonstrated a clinically meaningful effect on lesion size reduction. Based on market research and analog products within the retinal class, a cross functional team evaluated the clinical value of the product, based on the entirety of the data available, to establish the list price.",,1000000,,1,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505361305,Varenicline 0.5mg,2023-01-26,415.55,,1,110000,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505361405,Varenicline 1mg,2023-01-26,415.55,,1,110000,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505447803,Teriflunomide Tab 14 mg,2023-04-06,2058.78,,1,16000,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505447703,Teriflunomide Tab 7 mg,2023-04-06,2058.78,,1,1300,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505453202,LENALIDOMIDE CAP 2.5MG 28 BTL,2023-04-14,20157.36,,1,11065,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505453602,LENALIDOMIDE CAP 20MG 21 BTL,2023-04-14,15118.04,,1,11065,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505622800,BENDAMUSTINE INJ 100MG/4ML VIAL,2023-04-26,3209.54,,1,30,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505451203,GEFITINIB TAB 250MG 30 BTL,2023-05-30,7103.46,,1,54,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505609600,BENDAMUSTINE FOR INJ 100 MG 20ML SDV,2023-06-19,1600,,1,10,,,,,,,,,,,,,,,,,,,,,, +Apotex Corp,60505609500,BENDAMUSTINE FOR INJ 25 MG 10ML SDV,2023-06-19,400,,1,10,,,,,,,,,,,,,,,,,,,,,, +Archis Pharma LLC,72819015404,"Mitomycin for Injection USP, 40mg/Vial Vial",2023-06-22,1263.96,,1,100,,,2020-11-01,,1,This ANDA 202670 purchased from Mylan on 11/01/2020. The acquisition price is proprietary information.,This is a new NDC for Archis Pharma currently in production and will be available in the next few weeks. The presentation consists of one 40mg vial of Mitomycin Intravenous Solution Reconstituted.,,,,,,,,,,,,,,, +Archis Pharma LLC,72819015608,Mycophenolate Sodium Oral Tablet Delayed Release 360 MG,2023-06-22,877.2,,1,100,,,2020-11-01,,1,The ANDA 091248 was acquired from Mylan on 11/01/2020. The acquisition price is proprietary information.,This is a new NDC for Archis Pharma currently in production and will be available in the next few weeks.,,,,,,,,,,,,,,, +Archis Pharma LLC,72819016003,Paliperidone ER Oral tablet Extended Release 24Hr 9mg 30 Count Bottle,2023-06-22,1100.23,,1,100,,,2020-11-01,,1,The ANDA 203802 was acquired from Mylan on 11/01/2020. The acquisition price is proprietary information.,This is a new NDC for Archis Pharma currently in production and will be available in the next few weeks.,,,,,,,,,,,,,,, +argenx US Inc.,73475310203,VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection 180 mg/mL & 2000 Units/mL,2023-07-10,15773,,1,17000,,1,,,,,,,,,,,,,,,,,,,, +AstraZeneca ,310320005,ANDEXXA PWD 200MG VI 5X20ML US,2023-07-03,12500,"When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers.",,6100,,,,,,,This launch introduces a new package option of Andexxa with 5 vials per package. The existing 4-vial package option will continue to be available. The price per vial remains the same.,,,,,,,,,,,,,,, +AuroMedics Pharma LLC,55150045910,Carboprost Tromethamine Injection 250mcg/mL - 10s,2023-06-09,2700,,1,1000,,,,,,,,,,,,,,,,,,,,,, +Avadel CNS Pharmaceuticals,13551000130,sodium oxybate 4.5g powder in pack 30 each,2023-05-01,8730.02,"LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials.",,140000,,,,,,,"There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ.",,,,,,,,,,,,,,, +Avadel CNS Pharmaceuticals,13551000107,sodium oxybate 4.5g powder in pack 7 each,2023-05-01,2037,"LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials.",,140000,,,,,,,"There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ.",,,,,,,,,,,,,,, +Avadel CNS Pharmaceuticals,13551000230,sodium oxybate 6.0g powder in pack 30 each,2023-05-01,11640.02,"LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials.",,140000,,,,,,,"There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ.",,,,,,,,,,,,,,, +Avadel CNS Pharmaceuticals,13551000207,sodium oxybate 6.0g powder in pack 7 each,2023-05-01,2716,"LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials.",,140000,,,,,,,"There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ.",,,,,,,,,,,,,,, +Avadel CNS Pharmaceuticals,13551000330,sodium oxybate 7.5g powder in pack 30 each,2023-05-01,14550.03,"LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials.",,140000,,,,,,,"There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ.",,,,,,,,,,,,,,, +Avadel CNS Pharmaceuticals,13551000307,sodium oxybate 7.5g powder in pack 7 each,2023-05-01,3395.01,"LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials.",,140000,,,,,,,"There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ.",,,,,,,,,,,,,,, +Avadel CNS Pharmaceuticals,13551000430,sodium oxybate 9.0g powder in pack 30 each,2023-05-01,17460.03,"LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials.",,140000,,,,,,,"There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ.",,,,,,,,,,,,,,, +Avadel CNS Pharmaceuticals,13551000407,sodium oxybate 9.0g powder in pack 7 each,2023-05-01,4074.01,"LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials.",,140000,,,,,,,"There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ.",,,,,,,,,,,,,,, +AvKare,69097060473,Lenalidomide Capsules 2.5mg 28ct,2023-04-11,20157.36,,1,34000,1,,,,,,,,,,,,,,,,,,,,, +AvKare,69097038481,Lenalidomide Capsules 20mg 21ct,2023-04-11,15118.04,,1,34000,1,,,,,,,,,,,,,,,,,,,,, +AvKare,72291007201,Bexaratone 75mg Capsule 100ct,2023-05-10,1152,,1,18000,,,,,,,,,,,,,,,,,,,,,, +AvKare,42291091960,Posaconazole DR Tabs 100mg 60ct,2023-06-01,852.74,,1,300000,,,,,,,Confirming product was not available on the market prior to 6/1/2023,,,,,,,,,,,,,,, +AvKare,42291083130,Teriflunomide 14mg Tablet 30ct,2023-06-13,2139.89,,1,1000000,,,,,,,Confirming that this poduct was not available on the market prior to 6/13/2023,,,,,,,,,,,,,,, +AvKare,42291083030,Teriflunomide 7mg Tablet 30ct,2023-06-13,2139.89,,1,1000000,,,,,,,Confirming that this poduct was not available on the market prior to 6/13/2023,,,,,,,,,,,,,,, +AvKare,70377001311,Everolimus 10mg Tablets 30ct,2023-07-11,1600,"Change of packing configuration from 28ct blister to 30ct bottle. Supplied to large wholesalers and specialty pharmacies including AmerisourceBergen, Oncology Supply, Cardinal Health, McKesson, CVS Health Specialty, and Acaria. Biocon offers an eVoucherRx® program to lower patient co-pays at the point of sale.",,11000,,,,,,,,,,,,,,,,,,,,,, +Baxter Healthcare Corporation,10019007901,Bendamustine HCl Injection,2023-02-08,2340,,1,1000,,,,,,,Estimated number of patients is based on per year.,,,,,,,,,,,,,,, +Bayer,50419039302,VITRAKVI 20MG/ML SOLU BT 1X50ML,2023-04-19,8250.5,Product is not new. Oral Solution has changed from 1x100ml bottle to 2x50ml bottles. Everything remains consistent with previous marketing plan.,,60,,,,,,,Price setting is a part of the company?s overall global competitive strategy and is developed by the company?s senior leadership both in the U.S. and Globally. The ultimate factors considered in determining the price increase is on a need-to-know basis and known only to a handful of key global and U.S. executives. The information is not protected under patent or trademark laws and can be protected only by treating it as trade secret. Price setting has actual commercial value to the company and is key to competition in the market place and in obtaining competitive advantage over our competitors. It is not to the best interest of the public to disclose this information because such disclosure will reduce competition in the marketplace,https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=679,,,,,,,,,,,,,, +Bayer,50419039303,VITRAKVI 20MG/ML SOLU BT 2X50ML US,2023-04-19,16501,Product is not new. Oral Solution has changed from 1x100ml bottle to 2x50ml bottles. Everything remains consistent with previous marketing plan.,,60,,,,,,,Price setting is a part of the company?s overall global competitive strategy and is developed by the company?s senior leadership both in the U.S. and Globally. The ultimate factors considered in determining the price increase is on a need-to-know basis and known only to a handful of key global and U.S. executives. The information is not protected under patent or trademark laws and can be protected only by treating it as trade secret. Price setting has actual commercial value to the company and is key to competition in the market place and in obtaining competitive advantage over our competitors. It is not to the best interest of the public to disclose this information because such disclosure will reduce competition in the marketplace,https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=680,,,,,,,,,,,,,, +BE Pharmaceuticals Inc.,71839013710,"Carboprost Tromethamine Intramuscular Solution, 250 MCG/mL, 1mL vials, 10 count in 1 box.",2023-06-09,1330,,1,14000,,,,,,,,,,,,,,,,,,,,,, +Biogen,64406010901,Qalsody 100 mg/15 mL (6.7 mg/mL) solution in a single-dose vial,2023-04-25,14230,"QALSODY will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. + +Biogen has a set of Pricing Principles that inform pricing decisions for its products. Those principles are: 1. Value to Patients, 2. Present and Future Benefit to Society, 3. Fulfilling our commitment to Innovation, 4. Evolution toward Value Based Care, and 5. Affordability & Sustainability. + +Further information can be found at: +https://www.biogen.com/content/dam/corporate/en_us/pdfs/BIOGEN_PricingPrinciplesInfographic_4-26-19.pdf",,330,,1,,,,,QALSODY ™ (tofersen) is a 100 mg/15 mL injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. The estimated number of patients provided in column #7 is the number of people in the U.S. living with the disease.,,,,,,,,,,,,,,, +BioMarin Pharmaceutical Inc,68135092748,ROCTAVIAN (valoctocogene roxaparvovec-rvox) suspension for intravenous infusion is supplied in vials designed to deliver 8 mL. Each mL contains 2 × 10^13 vector genomes. The recommended dose of ROCTAVIAN is 16 × 10^13 vector genomes per kg of body weight.,2023-08-16,90625,"Consistent with Cal Health & Safety Code 127681(c), BioMarin’s response is limited to information publicly available/in public domain. The marketing and pricing plans are confidential and proprietary and are not in the public domain or publicly available.",,27,1,,,,,,,,,,,,,,,,,,,,, +Boehringer Ingelheim,597044587,PRADAXA® 110mg Oral Pellets,2023-02-14,4717.16,"Specific Marketing and Pricing Plans for Pradaxa Pellets® are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price. These factors included: the value of innovative medicines; investments made (including in research and development), manufacturing, and other costs and the risks undertaken. Boehringer Ingelheim invests 20% of its net sales into research and development.",,3500,,1,,,,,"The WAC at Intro to Market is $4717.46 (not $4717.16) and we have been unable to make the correction in Column 4 in the online system for this NDC. Pursuant to SB17, the information reported is limited to that which is otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Boehringer Ingelheim,597045016,PRADAXA® 150mg Oral Pellets,2023-02-14,4717.16,"Specific Marketing and Pricing Plans for Pradaxa Pellets® are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price. These factors included: the value of innovative medicines; investments made (including in research and development), manufacturing, and other costs and the risks undertaken. Boehringer Ingelheim invests 20% of its net sales into research and development.",,3500,,1,,,,,"The WAC at Intro to Market is $4717.46 (not $4717.16) and we have been unable to make the correction in Column 4 in the online system for this NDC. Pursuant to SB17, the information reported is limited to that which is otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Boehringer Ingelheim,597042578,PRADAXA® 20mg Oral Pellets,2023-02-14,4717.46,"Specific Marketing and Pricing Plans for Pradaxa Pellets® are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price. These factors included: the value of innovative medicines; investments made (including in research and development), manufacturing, and other costs and the risks undertaken. Boehringer Ingelheim invests 20% of its net sales into research and development.",,3500,,1,,,,,"Pursuant to SB17, the information reported is limited to that which is otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Boehringer Ingelheim,597043018,PRADAXA® 30mg Oral Pellets,2023-02-14,4717.46,"Specific Marketing and Pricing Plans for Pradaxa Pellets® are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price. These factors included: the value of innovative medicines; investments made (including in research and development), manufacturing, and other costs and the risks undertaken. Boehringer Ingelheim invests 20% of its net sales into research and development.",,3500,,1,,,,,"Pursuant to SB17, the information reported is limited to that which is otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Boehringer Ingelheim,597043596,PRADAXA® 40mg Oral Pellets,2023-02-14,4717.46,"Specific Marketing and Pricing Plans for Pradaxa Pellets® are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price. These factors included: the value of innovative medicines; investments made (including in research and development), manufacturing, and other costs and the risks undertaken. Boehringer Ingelheim invests 20% of its net sales into research and development.",,3500,,1,,,,,"Pursuant to SB17, the information reported is limited to that which is otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Boehringer Ingelheim,597044053,PRADAXA® 50mg Oral Pellets,2023-02-14,4717.46,"Specific Marketing and Pricing Plans for Pradaxa Pellets® are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price. These factors included: the value of innovative medicines; investments made (including in research and development), manufacturing, and other costs and the risks undertaken. Boehringer Ingelheim invests 20% of its net sales into research and development.",,3500,,1,,,,,"Pursuant to SB17, the information reported is limited to that which is otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Boehringer Ingelheim,597037597,Cyltezo Pen 40mg/0.8mL (50mg/mL) 2ct,2023-07-01,6576.49,"Specific Marketing and Pricing Plans for Cyltezo are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials.",,20000000,,,,,,,"Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Boehringer Ingelheim,597037523,Cyltezo Pen 40mg/0.8mL (50mg/mL) 4ct,2023-07-01,13152.98,"Specific Marketing and Pricing Plans for Cyltezo are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials.",,20000000,,,,,,,"Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Boehringer Ingelheim,597037516,Cyltezo Pen 40mg/0.8mL (50mg/mL) 6ct,2023-07-01,19729.47,"Specific Marketing and Pricing Plans for Cyltezo are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials.",,20000000,,,,,,,"Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Boehringer Ingelheim,597040089,Cyltezo PFS 10mg/0.2mL (50mg/mL) 2ct,2023-07-01,6576.49,"Specific Marketing and Pricing Plans for Cyltezo are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials.",,20000000,,,,,,,"Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Boehringer Ingelheim,597040580,Cyltezo PFS 20mg/0.4mL (50mg/mL) 2ct,2023-07-01,6576.49,"Specific Marketing and Pricing Plans for Cyltezo are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials.",,20000000,,,,,,,"Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Boehringer Ingelheim,597037082,Cyltezo PFS 40mg/0.8mL (50mg/mL) 2ct,2023-07-01,6576.49,"Specific Marketing and Pricing Plans for Cyltezo are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials.",,20000000,,,,,,,"Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available.",,,,,,,,,,,,,,, +Braeburn Rx,58284022801,"BRIXADI 128 mg/0.36 mL; injection, solution",2023-08-15,1595,,1,3000000,,,,,,,,,,,,,,,,,,,,,, +Braeburn Rx,58284021601,"BRIXADI 16 mg/0.32 mL; injection, solution",2023-08-15,415,,1,3000000,,,,,,,"This is a weekly product. The total cost for a four week supply is $1,660.00.",,,,,,,,,,,,,,, +Braeburn Rx,58284022401,"BRIXADI 24 mg/0.48 mL; injection, solution",2023-08-15,415,,1,3000000,,,,,,,"This is a weekly product. The total cost for a four week supply is $1,660.00.",,,,,,,,,,,,,,, +Braeburn Rx,58284023201,"BRIXADI 32 mg/0.64 mL; injection, solution",2023-08-15,415,,1,3000000,,,,,,,"This is a weekly product. The total cost for a four week supply is $1,660.00.",,,,,,,,,,,,,,, +Braeburn Rx,58284026401,"BRIXADI 64 mg/0.18 mL; injection, solution",2023-08-15,1595,,1,3000000,,,,,,,,,,,,,,,,,,,,,, +Braeburn Rx,58284020801,"BRIXADI 8 mg/0.16 mL; injection, solution",2023-08-15,415,,1,3000000,,,,,,,"This is a weekly product. The total cost for a four week supply is $1,660.00.",,,,,,,,,,,,,,, +Braeburn Rx,58284029601,"BRIXADI 96 mg/0.27 mL; injection, solution",2023-08-15,1595,,1,3000000,,,,,,,,,,,,,,,,,,,,,, +"Camber Pharmaceuticals, Inc.",31722025928,"Lenalidomide Capsules 10mg, 28ct",2023-05-30,20157.36,,1,32000,,,,,,,,,,,,,,,,,,,,,, +"Camber Pharmaceuticals, Inc.",31722026021,"Lenalidomide Capsules 15mg, 21ct",2023-05-30,15118.04,,1,32000,,,,,,,,,,,,,,,,,,,,,, +"Camber Pharmaceuticals, Inc.",31722025728,"Lenalidomide Capsules 2.5mg, 28ct",2023-05-30,20157.36,,1,32000,,,,,,,,,,,,,,,,,,,,,, +"Camber Pharmaceuticals, Inc.",31722026121,"Lenalidomide Capsules 20mg, 21ct",2023-05-30,15118.04,,1,32000,,,,,,,,,,,,,,,,,,,,,, +"Camber Pharmaceuticals, Inc.",31722026221,"Lenalidomide Capsules 25mg, 21ct",2023-05-30,15118.04,,1,32000,,,,,,,,,,,,,,,,,,,,,, +"Camber Pharmaceuticals, Inc.",31722025828,"Lenalidomide Capsules 5mg, 28ct",2023-05-30,20157.36,,1,32000,,,,,,,,,,,,,,,,,,,,,, +"Camber Pharmaceuticals, Inc.",31722003032,Deferasirox Oral Granules 180mg 30ct,2023-06-12,2000,,1,16000000,,,,,,,,,,,,,,,,,,,,,, +"Camber Pharmaceuticals, Inc.",31722003132,Deferasirox Oral Granules 360mg 30ct,2023-06-12,4000,,1,16000000,,,,,,,,,,,,,,,,,,,,,, +"Camber Pharmaceuticals, Inc.",31722002932,Deferasirox Oral Granules 90mg 30ct,2023-06-12,1000,,1,16000000,,,,,,,,,,,,,,,,,,,,,, +Celgene,59572089028,"ZEPOSIA® (ozanimod) Capsules, 0.23,0.46,0.92MG, bottle of 28 count",2023-06-07,7636.64,"We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 25% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply.",,280000,,,,,,,"Comment regarding ""Estimated Number of Patients"": Total class of RRMS (Relapsing-remitting multiple sclerosis) and SPMS (Secondary-progressive multiple sclerosis) is estimated at 280,000 patients. BMS is unable to provide an estimate of the number of patients who will be prescribed ZEPOSIA® + +Bristol-Myers Squibb obtained rights to ZEPOSIA® as part of the Celgene acquisition, which completed on November 20, 2019. This acquisition did not consist of costs for individual assets.",,,,,,,,,,,,,,, +"Celltrion USA, Inc.",72606001101,Vegzelma bevacizumab-adcd INTRAVENOUS 4 ml,2023-04-04,677.4,"Vegzelma will be launched in the U.S. for appropriate and eligible patients treated at oncology clinics and hospitals. All marketing, sales, and promotional activities messages will be limited to the approved product label data and information. + +A Wholesale Acquisition Cost has been set and published. Celltrion USA will offer discounts and rebates to hospitals and clinics off the Wholesale Acquisition Cost.",,2235,,,,,,,,,,,,,,,,,,,,,, +"Celltrion USA, Inc.",72606001201,"Vegzelma bevacizumab-adcd INTRAVENOUS +16ml",2023-04-04,2709.6,"Vegzelma will be launched in the U.S. for appropriate and eligible patients treated at oncology clinics and hospitals. All marketing, sales, and promotional activities messages will be limited to the approved product label data and information. + +A Wholesale Acquisition Cost has been set and published. Celltrion USA will offer discounts and rebates to hospitals and clinics off the Wholesale Acquisition Cost.",,2235,,,,,,,,,,,,,,,,,,,,,, +"Celltrion USA, Inc.",72606003009,"Yuflyma Subcutaneous Auto-injector Kit 40 MG/0.4ML, 1 Each, Unit-Dose, Box",2023-07-05,3288.25,"Marketing plans: In support of the launch of Yuflyma, Celltion has employed highly trained Immunology Sales Specialists that will make on-site visits to healthcare providers. During these visits, the sales specialists will provide an educational brochure to showcase the patient financial assistance options and how to enroll in the program. This patient assistance program will include an application that is downloadable and can be printed and provided to the health care provider at the time of a visit. An additional feature of the program is a video that is embedded on the website to assist the patient with self-inject guidance. Instructional video’s will be available via a YouTube platform and will also be embedded in the CelltrionConnect website. The sales team will attend industry appropriate conferences such as American College of Rheumatology conference and support the launch process of Yuflyma with focused efforts on patient education and support through website presentations and on-site efforts. Pricing methodology: Celltrion’s product is priced 5% below the referenced product and is priced the same as the other competitors within the class that has launched a biosimilar with this packaging configuration containing the same delivery system. Additional packaging configurations of Yuflyma will be launched as they become available thereby providing further options for eligible patients, leading to increased patient choice and access.",,398619,,,,,,,,,,,,,,,,,,,,,, +"Celltrion USA, Inc.",72606003010,"Yuflyma Subcutaneous Auto-injector Kit 40 MG/0.4ML, 1 Each, Unit-Dose, Box Qty 2",2023-07-05,6576.5,"Marketing plans: In support of the launch of Yuflyma, Celltion has employed highly trained Immunology Sales Specialists that will make on-site visits to healthcare providers. During these visits, the sales specialists will provide an educational brochure to showcase the patient financial assistance options and how to enroll in the program. This patient assistance program will include an application that is downloadable and can be printed and provided to the health care provider at the time of a visit. An additional feature of the program is a video that is embedded on the website to assist the patient with self-inject guidance. Instructional video’s will be available via a YouTube platform and will also be embedded in the CelltrionConnect website. The sales team will attend industry appropriate conferences such as American College of Rheumatology conference and support the launch process of Yuflyma with focused efforts on patient education and support through website presentations and on-site efforts. Pricing methodology: Celltrion’s product is priced 5% below the referenced product and is priced the same as the other competitors within the class that has launched a biosimilar with this packaging configuration containing the same delivery system. Additional packaging configurations of Yuflyma will be launched as they become available thereby providing further options for eligible patients, leading to increased patient choice and access.",,398619,,,,,,,,,,,,,,,,,,,,,, +Chiesi USA,10122010405,Ferrirprox 1000mg 50 ct bottle,2023-03-06,10423.12,,1,150,,,,,,,Acquired while in development. Approved while owned by Chiesi USA.,,,,,,,,,,,,,,, +Chiesi USA,10122018002,Lamzede® (velmanase alfa-tycv).,2023-04-13,4000,,1,22,,1,,,,,Lamzede has been approved but will not be commercially available until Q2 2023.,,,,,,,,,,,,,,, +Chiesi USA,10122016005,Elfabrio Five Single 20?mg/10?mL (2?mg/mL) dose vials in a carton,2023-05-23,20675.55,,1,120,,,,,,,Product was developed by Chiesi,,,,,,,,,,,,,,, +Chiesi USA,10122016002,Elfabrio One single 20?mg/10?mL (2?mg/mL) dose vial in a carton,2023-05-23,4135.11,,1,120,,,,,,,Product was developed by Chiesi,,,,,,,,,,,,,,, +Chiesi USA,10122016010,Elfabrio Ten single 20?mg/10?mL (2?mg/mL) dose vials in a carton,2023-05-23,41351.1,,1,120,,,,,,,Product was developed by Chiesi,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097094093,Pirfenidone Caps 267 mg 270 Ct,2023-01-17,1800,,1,100000,,1,,,,,,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097056053,Deferasirox Oral Granues 180mg 30ct Sachets,2023-06-01,2000,,1,19500,,,,,,,,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097057053,Deferasirox Oral Granues 360mg 30ct Sachets,2023-06-01,4000,,1,19500,,,,,,,,,,,,,,,,,,,,,, +"Cipla USA, Inc.",69097055053,Deferasirox Oral Granues 90mg 30ct Sachets,2023-06-01,1025.01,,1,19500,,,,,,,,,,,,,,,,,,,,,, +"Civica, Inc",72572006710,Cisatracurium Besylate Intravenous Solution 200 MG/20ML 10 Vials,2023-02-27,940,"Civica selects products (including Cisatracurium Besylate) that are identified and prioritized by Civica's member health systems - by doctors and pharmacists on the front lines - as the medications most important for quality patient care. Each Civica member health system has the option to make a long-term commitment to purchase Cisatracurium from Civica by executing a Purchase Commitment Form. The Purchase Commitment Form contains the required duration of the purchase commitment and the expected annual minimum volume purchase commitment for each participating member (based on the member's historical pro rata usage volume relative to the other members). + +Civica sets a single, transparent price per Cisatracurium Besylate product for each of its members, regardless of the volume purchased. Civica sets its Cisatracurium Besylate prices at approximately cost plus a margin to cover Civica's overhead and research and development expenses.",,1,,,,,,,"Civica is selling under a product supply agreement under the manufacturer. There was no licensing fee, or acquisition price, only a fee per unit purchased from the manufacturer. + +Civica does not have access to a reliable estimate of “the number of patients in the United States with a condition for which the new prescription drug may be prescribed.” Cisatracurium Besylate Injection has three indications listed in the drug label information (available at: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c93166b5-43fe-4ba1-9222-14eb71a24dd5): (1) as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age, (2) to provide skeletal muscle relaxation during surgical procedures or during mechanical ventilation in the ICU, and (3) to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older. According to the NIH, between 13 and 20 million intubations are performed annually in the United States (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7517927/#:~:text=Between%2013%20and%2020%20million,emergency%20to%20secure%20the%20airway.), but Civica is not in a position to estimate the proportion of those intubations for which Cisatracurium would be indicated. Likewise, Civica is unable to estimate the proportion of the estimated 40 to 50 million major surgeries performed in the United States annually (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7388795/#:~:text=Globally%2C%20a%20staggering%20310%20million,be%20readmitted%20within%2030%20days.) for which Cisatracurium would be indicated. Civica does not believe there is any publicly available data that accurately represents the estimated number of patients for these indications and we are not comfortable speculating about such information.",,,,,,,,,,,,,,, +CMP Pharma,46287005501,Sildenafil oral suspension 122 mL,2023-06-12,1895,"LIQREV will be promoted by our sales force to healthcare professionals to educate them on our product. We will use various means of promotion including in-office visits, ad campaigns, and multimedia marketing. Pricing was established by a comprehensive review to reflect the competitive market, years of product development investments, and various operational costs.",,130,,,,,,,,,,,,,,,,,,,,,, +CSL Behring LLC,53021021,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 101-105kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53022022,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 106-110kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53023023,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 111-115kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53024024,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 116-120kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53025025,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 121-125kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53026026,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 126-130kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53027027,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 131-135kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53028028,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 136-140kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53029029,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 141-145kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53030030,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 146-150kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53031031,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 151-155kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53032032,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 156-160kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53033033,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 161-165kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53034034,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 166-170kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53035035,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 171-175kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53036036,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 176-180kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53037037,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 181-185kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53038038,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 186-190kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53039039,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 191-195kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53040040,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 196-200kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53041041,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 201-205kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53042042,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 206-210kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53043043,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 211-215kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53044044,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 216-220kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53045045,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 221-225kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53046046,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 226-230kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53047047,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 231-235kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53048048,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 236-240kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53011011,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 51-55kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53012012,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 56-60kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53013013,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 61-65kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53014014,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 66-70kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53015015,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 71-75kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53016016,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 76-80kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53017017,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 81-85kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53018018,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 86-90kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53019019,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 91-95kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53020020,"HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 96-100kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +CSL Behring LLC,53010010,"HEMGENIX (etranacogene dezaparovovec-drlb?) Injection, for IV Infusion, 46-50kg",2023-06-14,3500000,"HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system.",,800,1,1,2021-05-06,450000000,,"CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.?",,,,,,,,,,,,,,,, +"Daiichi Sankyo, Inc.",65597050404,Vanflyta 17.7mg capsule 14 count,2023-08-09,7644,See attached,,6033,1,1,,,,,"In the U.S., an estimated 20,380 new cases of AML will be diagnosed in 2023. Up to 37% of newly diagnosed cases of AML have a FLT3 gene mutation and approximately 80% of these have FLT3-ITD mutations. The total estimated patient population is derived from these estimates provided by the American Cancer Society (https://www.cancer.org/cancer/types/acute-myeloid-leukemia/about/key-statistics.html)",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=707,,,,,,,,,,,,,, +"Daiichi Sankyo, Inc.",65597050428,Vanflyta 17.7mg capsule 28 count,2023-08-09,15288,See attached,,6033,1,1,,,,,"In the U.S., an estimated 20,380 new cases of AML will be diagnosed in 2023. Up to 37% of newly diagnosed cases of AML have a FLT3 gene mutation and approximately 80% of these have FLT3-ITD mutations. The total estimated patient population is derived from these estimates provided by the American Cancer Society (https://www.cancer.org/cancer/types/acute-myeloid-leukemia/about/key-statistics.html)",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=706,,,,,,,,,,,,,, +"Daiichi Sankyo, Inc.",65597051104,Vanflyta 26.5mg capsule 14 count,2023-08-09,7644,See attached,,6033,1,1,,,,,"In the U.S., an estimated 20,380 new cases of AML will be diagnosed in 2023. Up to 37% of newly diagnosed cases of AML have a FLT3 gene mutation and approximately 80% of these have FLT3-ITD mutations. The total estimated patient population is derived from these estimates provided by the American Cancer Society (https://www.cancer.org/cancer/types/acute-myeloid-leukemia/about/key-statistics.html)",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=709,,,,,,,,,,,,,, +"Daiichi Sankyo, Inc.",65597051128,Vanflyta 26.5mg capsule 28 count,2023-08-09,15288,See attached,,6033,1,1,,,,,"In the U.S., an estimated 20,380 new cases of AML will be diagnosed in 2023. Up to 37% of newly diagnosed cases of AML have a FLT3 gene mutation and approximately 80% of these have FLT3-ITD mutations. The total estimated patient population is derived from these estimates provided by the American Cancer Society (https://www.cancer.org/cancer/types/acute-myeloid-leukemia/about/key-statistics.html)",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=708,,,,,,,,,,,,,, +"Dash Pharmaceuticals, LLC",69339016803,Gefitinib 250mg,2023-06-05,3995,Marketed as a typical generic to wholesalers and distributors,,12,,,,,,,"Not Acquired, priced in line with other generic competitors in this low volume product",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598014206,Nelarabine Inj. 250mg/50mL 6's USA,2023-01-12,3966,,1,6000,,,,,,,"1) Dr. Reddy’s did not acquire the product. 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with T-cell acute lymphoblastic leukemia.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598004563,Sunitinib Malate Caps 12.5mg 28s,2023-01-16,4151.09,,1,6000,,,,,,,"1) Dr. Reddy’s did not acquire the product. 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with gastrointestinal stromal tumors (GIST) per year.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598004863,Sunitinib Malate Caps 50mg 28s,2023-01-20,14452.96,,1,6000,,,,,,,"1) Dr. Reddy’s did not acquire the product. 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with gastrointestinal stromal tumors (GIST) per year.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598004663,Sunitinib Malate Caps 25mg 28s,2023-02-16,8302.21,,1,6000,,,,,,,"1) Dr. Reddy’s did not acquire the product. 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with gastrointestinal stromal tumors (GIST) per year.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598023531,"Cycloserine Capsules 250mg, 30s",2023-03-30,2297,,1,8300,,,,,,,"Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is the number of pulmonary tuberculosis patients in the US.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598064711,"Treprostinil Injection 100 mg/20 mL (5 mg/mL), 20ml",2023-04-20,5729.94,,1,1000,,,,,,,"1) This product was not acquired; 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of cases of pulmonary arterial hypertension in the US per year.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598064911,"Treprostinil Injection 20 mg/20 mL (1 mg/mL), 20ml",2023-04-20,1145.99,,1,1000,,,,,,,"1) This product was not acquired; 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the +total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of cases of pulmonary arterial hypertension in the US per year.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598064811,"Treprostinil Injection 200 mg/20 mL (10 mg/mL), 20ml",2023-04-20,11459.88,,1,1000,,,,,,,"1) This product was not acquired; 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of cases of pulmonary arterial hypertension in the US per year.",,,,,,,,,,,,,,, +"Dr. Reddy's Laboratories, Inc.",43598064611,"Treprostinil Injection 50 mg/20 mL (2.5 mg/mL), 20ml",2023-04-20,2864.97,,1,1000,,,,,,,"1) This product was not acquired; 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of cases of pulmonary arterial hypertension in the US per year.",,,,,,,,,,,,,,, +Eisai Inc.,62856021201,Leqembi 200mg/2ml,2023-01-18,254.81,"Marketing Plan - During accelerated approval, Eisai's marketing engagements with healthcare professionals generally will be limited to and focused on understanding how an AD therapy will be integrated into practice. + +Pricing Plan - Eisai considered a holistic approach in assessing value and making decisions that may affect patient access, so that our LEQEMBI pricing approach can maximize value for all stakeholders (patients, families, caregivers, healthcare providers, payers, employees and shareholders). This approach includes clinical outcome assessments of our medicines and the benefits we deliver to patients, their families and caregivers as the ""clinical value,"" as well as the projected ""social value"" that help improve patients' and caregivers' quality of life and productivity. Moreover, we assess the simulated impact of our medicines on reducing demand for health services and global burden of disease as potential ""economic value"" while enhancing further innovations in AD.? + +?Eisai decided to price LEQEMBI below the quantified societal value. For further details, including Eisai’s calculation of the societal value, please see Eisai’s press release dated January 6, 2023 titled EISAI'S APPROACH TO U.S. PRICING FOR LEQEMBI™ (LECANEMAB), A TREATMENT FOR EARLY ALZHEIMER'S DISEASE, SETS FORTH OUR CONCEPT OF ""SOCIETAL VALUE OF MEDICINE"" IN RELATION TO ""PRICE OF MEDICINE""",,100000,1,1,,,,,"Estimated Volume of Patients - ""In the U.S., we estimate that the diagnosed eligible Early AD population will reach approximately 100,000 individuals by year 3 representing a measured initial attainment in the real world and will increase gradually over the mid-to-long term given the time required to advance new screening and diagnostic technologies such as blood-based biomarkers to confirm amyloid beta pathology.""",,,,,,,,,,,,,,, +Eisai Inc.,62856021501,Leqembi 500mg/5ml,2023-01-18,637.02,"Marketing Plan - During accelerated approval, Eisai's marketing engagements with healthcare professionals generally will be limited to and focused on understanding how an AD therapy will be integrated into practice. + +Pricing Plan - Eisai considered a holistic approach in assessing value and making decisions that may affect patient access, so that our LEQEMBI pricing approach can maximize value for all stakeholders (patients, families, caregivers, healthcare providers, payers, employees and shareholders). This approach includes clinical outcome assessments of our medicines and the benefits we deliver to patients, their families and caregivers as the ""clinical value,"" as well as the projected ""social value"" that help improve patients' and caregivers' quality of life and productivity. Moreover, we assess the simulated impact of our medicines on reducing demand for health services and global burden of disease as potential ""economic value"" while enhancing further innovations in AD.? + +?Eisai decided to price LEQEMBI below the quantified societal value. For further details, including Eisai’s calculation of the societal value, please see Eisai’s press release dated January 6, 2023 titled EISAI'S APPROACH TO U.S. PRICING FOR LEQEMBI™ (LECANEMAB), A TREATMENT FOR EARLY ALZHEIMER'S DISEASE, SETS FORTH OUR CONCEPT OF ""SOCIETAL VALUE OF MEDICINE"" IN RELATION TO ""PRICE OF MEDICINE""",,100000,1,1,,,,,"Estimated Volume of Patients - ""In the U.S., we estimate that the diagnosed eligible Early AD population will reach approximately 100,000 individuals by year 3 representing a measured initial attainment in the real world and will increase gradually over the mid-to-long term given the time required to advance new screening and diagnostic technologies such as blood-based biomarkers to confirm amyloid beta pathology.""",,,,,,,,,,,,,,, +Eli Lilly and Company,2702660,Jaypirca 100mg 60 tablets,2023-01-27,21000,,1,3500,,,2019-02-15,6920000000,,"Lilly acquired Loxo Oncology, Inc, on February 15, 2019 for a purchase price of approximately $6.92 billion, net of cash acquired. Under the terms of the agreement, Lilly acquired a pipeline of investigational medicines, including pirtobrutinib (Loxo-305). [https://investor.lilly.com/static-files/cd4a37af-ec28-449c-9bfb-ae380700209a]","Pirtobrutinib is a highly selective, non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor. BTK plays a key role in the B-cell antigen receptor signaling pathway, which is required for the development, activation and survival of normal white blood cells, known as B-cells, and malignant B-cells. + +Based on data from the National Cancer Institutes’ SEER Cancer Statistics Review, approximately 3500 patients in the US are diagnosed with Mantle-cell lymphoma (MCL) per year. MCL incidence is 0.8 per 100,000 people. (SEER, 2017. Trends in SEER Incidence and US Mortality; 1975-2017. Table 19.26 All Lymphoid Neoplasms with Detailed Non-Hodgkin Lymphoma Subtypes 2008-2017. Available at: Non-Hodgkin Lymphoma, CSR 1975-2017 (cancer.gov)). People with MCL may or may not use Jaypirca. + +All information is provided by Eli Lilly and Company (""Lilly"") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-jaypircatm-pirtobrutinib-first-and-only-non.",,,,,,,,,,,,,,, +Eli Lilly and Company,2690230,Jaypirca 50mg 30 tablets,2023-01-27,7000,,1,3500,,,2019-02-15,6920000000,,"Lilly acquired Loxo Oncology, Inc, on February 15, 2019 for a purchase price of approximately $6.92 billion, net of cash acquired. Under the terms of the agreement, Lilly acquired a pipeline of investigational medicines, including pirtobrutinib (Loxo-305). [https://investor.lilly.com/static-files/cd4a37af-ec28-449c-9bfb-ae380700209a]","Pirtobrutinib is a highly selective, non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor. BTK plays a key role in the B-cell antigen receptor signaling pathway, which is required for the development, activation and survival of normal white blood cells, known as B-cells, and malignant B-cells. + +Based on data from the National Cancer Institutes’ SEER Cancer Statistics Review, approximately 3500 patients in the US are diagnosed with Mantle-cell lymphoma (MCL) per year. MCL incidence is 0.8 per 100,000 people. (SEER, 2017. Trends in SEER Incidence and US Mortality; 1975-2017. Table 19.26 All Lymphoid Neoplasms with Detailed Non-Hodgkin Lymphoma Subtypes 2008-2017. Available at: Non-Hodgkin Lymphoma, CSR 1975-2017 (cancer.gov)). People with MCL may or may not use Jaypirca. + +All information is provided by Eli Lilly and Company (""Lilly"") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-jaypircatm-pirtobrutinib-first-and-only-non.",,,,,,,,,,,,,,, +Epic Pharma,42806037230,Deferasirox 180mg Oral Granules 30 sachets,2023-04-12,2049.98,,1,1000,,,,,,,,,,,,,,,,,,,,,, +Epic Pharma,42806037330,Deferasirox 360mg Oral Granules 30 sachets,2023-04-12,4099.87,,1,1000,,,,,,,,,,,,,,,,,,,,,, +Epic Pharma,42806037130,Deferasirox 90mg Oral Granules 30 sachets,2023-04-12,1025.01,,1,1000,,,,,,,,,,,,,,,,,,,,,, +"Exelan Pharmaceuticals, Inc.",76282071527,Pirfenidone Capsules 267mg 270ct,2023-01-23,5194.56,,1,100000,,,,,,,,,,,,,,,,,,,,,, +Ferring Pharmaceuticals,55566980010,"REBYOTA (Fecal microbiota, live -jslm)",2023-01-23,9000,,1,4500,1,1,,,,,"REBYOTA was not acquired. Comment regarding estimated patients: Ferring estimates the annual patient estimate to be in the range of 4,000-5,000. This patient estimate is based on a national annual projection for the product based on disease state and indication. We do not have estimates for individual states at this time.",,,,,,,,,,,,,,, +"Florida Pharmaceutical Products, LLC ",71921017706,"Purple oval shaped, biconvex bevel edged film-coated tablets, debossed with ""A"" on one side and ""500"" on the other side",2023-05-08,1800,"Since this ANDA is already generic in the US market and there are other generics available to pharmacies, there is no additional marketing plan required. Our general marketing plan for generic pharmaceuticals is to speak to buyers at wholesale distributors and retail pharmacy chains. Our pricing per bottle will be in alignment with average net pricing currently available. There is no intention to speak to prescribers.",,24000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219037110,Stimufend Subcutaneous Solution Prefilled Syringe 6 MG/0.6ML Package Size 0.6 Package Quantity 1,2023-02-08,4175,,1,1500,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219040303,Zinc Sulfate Intravenous Solution 3 MG/ML Package Size 10 Package Quantity 25,2023-02-15,1050,None,,83,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219040505,Zinc Sulfate Intravenous Solution 5 MG/ML Package Size 5 Package Quantity 25,2023-02-15,875,None,,3900,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219056420,Mitomycin intravenous solution reconstituted 5 MG 1 Vial,2023-03-01,243.27,None- generic product.,,100,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219056620,mitoMYcin Intravenous Solution Reconstituted 20 MG Package Size 1 Package Quantity 1,2023-03-07,631.98,None- generic product. $0 – There was no budgeted or actual spending for direct-to-consumer or physician marketing.,,100,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219056800,mitoMYcin Intravenous Solution Reconstituted 40 MG Package Size 1 Package Quantity 1,2023-03-28,1263.96,None- generic product. $0 – There was no budgeted or actual spending for direct-to-consumer or physician marketing.,,100,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,63323057905,Sincalide Injection Solution Reconstituted 5 MCG Package Size 1 Package Quantity 10,2023-06-20,1241.3,,1,800000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219055438,Idacio for Crohns Disease/UC Subcutaneous Auto-injector Kit 40 MG/0.8ML Package Size 1 Package Quantity 3,2023-07-01,19729.47,,1,600000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219055428,Idacio for Plaque Psoriasis Subcutaneous Auto-injector Kit 40 MG/0.8ML Package Size 1 Package Quantity 2,2023-07-01,13152.98,,1,600000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219055408,Idacio Subcutaneous Auto-injector Kit 40 MG/0.8ML Package Size 1 Package Quantity 1,2023-07-01,6576.49,,1,600000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219055618,Idacio Subcutaneous Prefilled Syringe Kit 40 MG/0.8ML Package Size 1 Package Quantity 1,2023-07-01,6576.49,,1,600000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219002805,Ganirelix Acetate Subcutaneous Solution Prefilled Syringe 250 MCG/0.5ML,2023-07-07,216.45,,1,230000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219025810,Cardioplegic Perfusion Solution Package Size 1000 ML Package Quantity 10,2023-07-18,495.1,None,,21600,,,,,,,WAC is 495.10 with a package quantity of 10 bags however a 30 day course of therapy can range from 2-20 bags. Therefore if 20 bags are needed in a 30 day course of therapy the WAC would be $990.20,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219028110,Gadobutrol Intravenous Solution Package Size 10 ML Package Quantity 20,2023-07-31,1162,,1,13200000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219028107,Gadobutrol Intravenous Solution Package Size 7.5 ML Package Quantity 20,2023-07-31,871.6,,1,13200000,,,,,,,,,,,,,,,,,,,,,, +Fresenius Kabi USA LLC,65219028115,Gadobutrol Intravenous Solution Package Size 15 ML Package Quantity 20,2023-07-31,1743,,1,13200000,,,,,,,,,,,,,,,,,,,,,, +Gamida Cell Inc.,73441080004,"Omisirge Cultured Fraction =8.0x10^8 TVNC and Non-Cultured Fraction =4.0x10^8 TVNC Intravenous, 1 each",2023-04-18,338000,"OMISIRGE® will be promoted by our account management team to healthcare professionals to educate them on our product. We will use various means of promotion including in-office visits and through online channels such as websites. Pricing was established by performing extensive market research and analysis on our clinical and healthcare resource utilization data. Additionally, it involved years of product development investments and various operational costs. +Gamida Cell’s detailed marketing or pricing plans for OMISIRGE® are not publicly available.",,2200,1,1,,,,,,,,,,,,,,,,,,,, +Genentech USA,50242015901,1 mg/1 mL vial,2023-01-09,594.06,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. + +We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,589,1,1,,,,,,,,,,,,,,,,,,,, +Genentech USA,50242014201,30 mg/30 mL vial,2023-01-09,17821.78,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. + +We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,589,1,1,,,,,,,,,,,,,,,,,,,, +Genentech USA,50242012701,Columvi 10mg/10mL Vial,2023-06-27,10218.98,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. + +We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,216,,1,,,,,,,,,,,,,,,,,,,, +Genentech USA,50242012501,Columvi 2.5mg/2.5mL Vial,2023-06-27,2554.74,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. + +We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.",,216,,1,,,,,,,,,,,,,,,,,,,, +"GENMAB US, INC.",82705001001,EPKINLY 48mg/0.8mL Injection,2023-05-31,15225.56,"Marketing Plan +Activities that support the launch of EPKINLY™ (epcoritamab-bysp) include interactions with healthcare professionals, patients, and payers. These activities are designed to raise awareness and understanding of the approved indication, efficacy and safety data contained in the medicine's FDA approved label. Awareness of EPKINLY™ will be raised through educational websites, print and digital media, and the use of sales representatives to educate about the FDA-approved indication. +Pricing Plan +At Genmab, we are driven by patient impact. We positively impact the lives of people with cancer when our transformational science becomes medicine, and our medicines reach the people who need them and help them live better. +The price of our medicines reflects the novelty of our science, its impact on patients, and our commitment to bringing that science to patients. +The price of EPKINLY™ (epcoritamab-bysp) takes into consideration its transformational potential as the first and only T-cell engaging bispecific antibody treatment administered subcutaneously for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), which is an aggressive disease with limited treatment options.",,30400,,1,,,,,"EPKINLY™ (epcoritamab-bysp) is the first-and-only bispecific antibody given by subcutaneous injection and approved to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma that has come back or that didn't respond after 2 or more prior treatments. DLBCL is the most common type of Non-Hodgkin’s lymphoma (NHL) worldwide, accounting for approximately 30 percent of all NHL cases and comprising an estimated 30,400 U.S. cases in 2022. Exact information for the EPKINLY™ indicated patient population is not available in the public domain.",,,,,,,,,,,,,,, +"GENMAB US, INC.",82705000201,EPKINLY 4mg/0.8mL Injection,2023-05-31,1268.8,"Marketing Plan +Activities that support the launch of EPKINLY™ (epcoritamab-bysp) include interactions with healthcare professionals, patients, and payers. These activities are designed to raise awareness and understanding of the approved indication, efficacy and safety data contained in the medicine's FDA approved label. Awareness of EPKINLY™ will be raised through educational websites, print and digital media, and the use of sales representatives to educate about the FDA-approved indication. +Pricing Plan +At Genmab, we are driven by patient impact. We positively impact the lives of people with cancer when our transformational science becomes medicine, and our medicines reach the people who need them and help them live better. +The price of our medicines reflects the novelty of our science, its impact on patients, and our commitment to bringing that science to patients. +The price of EPKINLY™ (epcoritamab-bysp) takes into consideration its transformational potential as the first and only T-cell engaging bispecific antibody treatment administered subcutaneously for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), which is an aggressive disease with limited treatment options.",,30400,,1,,,,,"EPKINLY™ (epcoritamab-bysp) is the first-and-only bispecific antibody given by subcutaneous injection and approved to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma that has come back or that didn't respond after 2 or more prior treatments. DLBCL is the most common type of Non-Hodgkin’s lymphoma (NHL) worldwide, accounting for approximately 30 percent of all NHL cases and comprising an estimated 30,400 U.S. cases in 2022. Exact information for the EPKINLY™ indicated patient population is not available in the public domain.",,,,,,,,,,,,,,, +"Gilead Sciences, Inc.",61958300201,"SUNLENCA® (lenacapavir), sterile solution for injection, 309 mg/mL, 1.5 mL/vial, 2 vial kit",2023-01-09,19500,,1,5000,1,1,,,,,"Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product. + +The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Kite believes is in the public domain or otherwise publicly available. + +Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is providing the best publicly available estimated number of patients in the United States with a condition for which SUNLENCA may be prescribed.",,,,,,,,,,,,,,, +"Gilead Sciences, Inc.",61958300101,"SUNLENCA® (lenacapavir), tablet, 300 mg, 4 count, blister pack",2023-01-09,3250,,1,5000,1,1,,,,,"Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product. + +The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Kite believes is in the public domain or otherwise publicly available. + +Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is providing the best publicly available estimated number of patients in the United States with a condition for which SUNLENCA may be prescribed.",,,,,,,,,,,,,,, +"Gilead Sciences, Inc.",61958300102,"SUNLENCA® (lenacapavir), tablet, 300 mg, 5 count, blister pack",2023-01-09,4062.5,,1,5000,1,1,,,,,"Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product. + +The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Kite believes is in the public domain or otherwise publicly available. + +Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is providing the best publicly available estimated number of patients in the United States with a condition for which SUNLENCA may be prescribed.",,,,,,,,,,,,,,, +GlaxoSmithKline,173090913,"ZEJULA TABLET, 100 mg, 30 EA",2023-07-17,17289.3,,1,10348,,,,,,,"GSK has not released ZEJULA's (NDC: 00173090913) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). + +ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) is indicated for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy and for second-line maintenance of patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). There are an estimated 19,710 new cases of ovarian cancer in the US in 2023.1 Of those, around 70% are diagnosed at an advanced stage.2 The standard of care therapy for advanced ovarian cancer is surgery along with platinum-based chemotherapy. Approximately 75% of these patients will achieve a complete or partial response to the chemotherapy and would be eligible for maintenance treatment with a PARP inhibitor.3 Given that, there is an estimated 10,348 new patients that would be eligible for maintenance PARP inhibitor therapy each year. Eligible patients may or may not be prescribed ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with ZEJULA (NDC: 00173090913, 00173091213, and 00173091513). + +Sources +1. https://seer.cancer.gov/statfacts/html/ovary.html +2. Cortez, Alexander J., et al. ""Advances in ovarian cancer therapy."" Cancer chemotherapy and pharmacology 81 (2018): 17-38. +3. Kemp, Z., and J. A. Ledermann. ""Update on first-line treatment of advanced ovarian carcinoma."" International journal of women's health (2013): 45-51.",,,,,,,,,,,,,,, +GlaxoSmithKline,173091213,"ZEJULA TABLET, 200 mg, 30 EA",2023-07-17,17289.3,,1,10348,,,,,,,"GSK has not released ZEJULA's (NDC: 00173090913) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). + +ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) is indicated for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy and for second-line maintenance of patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). There are an estimated 19,710 new cases of ovarian cancer in the US in 2023.1 Of those, around 70% are diagnosed at an advanced stage.2 The standard of care therapy for advanced ovarian cancer is surgery along with platinum-based chemotherapy. Approximately 75% of these patients will achieve a complete or partial response to the chemotherapy and would be eligible for maintenance treatment with a PARP inhibitor.3 Given that, there is an estimated 10,348 new patients that would be eligible for maintenance PARP inhibitor therapy each year. Eligible patients may or may not be prescribed ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with ZEJULA (NDC: 00173090913, 00173091213, and 00173091513). + +Sources +1. https://seer.cancer.gov/statfacts/html/ovary.html +2. Cortez, Alexander J., et al. ""Advances in ovarian cancer therapy."" Cancer chemotherapy and pharmacology 81 (2018): 17-38. +3. Kemp, Z., and J. A. Ledermann. ""Update on first-line treatment of advanced ovarian carcinoma."" International journal of women's health (2013): 45-51.",,,,,,,,,,,,,,, +GlaxoSmithKline,173091513,"ZEJULA TABLET, 300 mg, 30 EA",2023-07-17,17289.3,,1,10348,,,,,,,"GSK has not released ZEJULA's (NDC: 00173090913) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). + +ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) is indicated for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy and for second-line maintenance of patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). There are an estimated 19,710 new cases of ovarian cancer in the US in 2023.1 Of those, around 70% are diagnosed at an advanced stage.2 The standard of care therapy for advanced ovarian cancer is surgery along with platinum-based chemotherapy. Approximately 75% of these patients will achieve a complete or partial response to the chemotherapy and would be eligible for maintenance treatment with a PARP inhibitor.3 Given that, there is an estimated 10,348 new patients that would be eligible for maintenance PARP inhibitor therapy each year. Eligible patients may or may not be prescribed ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with ZEJULA (NDC: 00173090913, 00173091213, and 00173091513). + +Sources +1. https://seer.cancer.gov/statfacts/html/ovary.html +2. Cortez, Alexander J., et al. ""Advances in ovarian cancer therapy."" Cancer chemotherapy and pharmacology 81 (2018): 17-38. +3. Kemp, Z., and J. A. Ledermann. ""Update on first-line treatment of advanced ovarian carcinoma."" International journal of women's health (2013): 45-51.",,,,,,,,,,,,,,, +"Glenmark Pharmaceuticals Inc., USA",68462012190,NICARDIPINE HCL CAP 30MG 90,2023-01-09,1046.14,,1,3352,,,,,,,"Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending November 22 is 3,352 prescriptions for 30 mg. Acquisition fields left blank as drug was developed by Glenmark.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54962857,"Sodium Oxybate Oral Solution 500 MG/ML, 180 ML Bottle",2023-01-01,5535,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,200000,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. + +Hikma has not evaluated the volume of patients in the USA. Sodium Oxybate oral solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age an older with narcolepsy. According to the National Institute of Neurological Disorders and Stroke, approximately 135,000 to 200,000 people in the U.S. have narcolepsy.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54043825,"Levorphanol Tartrate Tablets, 2mg USP, CII, 1 bottle of 100",2023-02-02,3337.5,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,110000000,,,2022-11-30,,1,"Hikma manufactured this product for Sentynl pursuant to a CMO relationship. Hikma, who acquired Roxane, now has re-acquired the ANDA and has transitioned this product back to Hikma owned and Hikma labeling.","Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. + +Hikma has not evaluated the volume of patients in the USA. Levorphanol Tartrate is indicated for the management of pain severe enough to require an opioid analgesic. According to the CDC, 1/3 of the US population have received an opioid prescription, therefore approximately 110,000,000.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54044949,"Posaconazole Oral Suspension, 200mg/5mL, 105mL bottle",2023-03-29,1312.87,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,25000,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. + +Hikma has not evaluated the volume of patients in the USA. Posaconazole is indicated for the treatment of oropharyngeal candidiasis. According to the CDC, approximately 25,000 cases of candidemia occur nationwide each year.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54037025,"Lisdexamfetamine Dimesylate Capsules, CII, 20mg, 1 bottle of 100",2023-08-25,1052.55,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,8700000,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. + +Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54037125,"Lisdexamfetamine Dimesylate Capsules, CII, 30mg, 1 bottle of 100",2023-08-25,1052.55,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,8700000,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. + +Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54037225,"Lisdexamfetamine Dimesylate Capsules, CII, 40mg, 1 bottle of 100",2023-08-25,1052.55,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,8700000,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. + +Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54037325,"Lisdexamfetamine Dimesylate Capsules, CII, 50mg, 1 bottle of 100",2023-08-25,1052.55,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,8700000,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. + +Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54037425,"Lisdexamfetamine Dimesylate Capsules, CII, 60mg, 1 bottle of 100",2023-08-25,1052.55,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,8700000,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. + +Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States.",,,,,,,,,,,,,,, +Hikma Pharmaceuticals USA Inc,54037525,"Lisdexamfetamine Dimesylate Capsules, CII, 70mg, 1 bottle of 100",2023-08-25,1052.55,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,8700000,,,,,,,"Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. + +Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States.",,,,,,,,,,,,,,, +Incyte Corporation,50881000603,Zynyz Intravenous Solution 500mg/ 20ml 1 Vial per Carton,2023-04-06,14240,"To market Zynyz, Incyte designed activities to increase awareness and understanding with healthcare providers about the product. Marketing activities will include education and training provided by our sales force. Consumer-directed communications to educate patients on the disease state and Zynyz are planned. At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. + +We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations. Zynyz is indicated for the treatment of metastatic or recurrent locally advanced merkel cell carcinoma (MCC).",,1000,,1,,,,,"Comment regarding Field 7: Literature was used to derive an estimate of the MCC patient population because MCC is a niche tumor and is not included in recent SEER, American Cancer Facts or Globocan Cancer Fact Sheets. Literature included 1) D. Jacobs Assessment of Age, Period, and Birth Control Effects and Trends in Merkel Cell Carcinoma Incidence in the United States; JAMA Dermatology Jan. 2021 Volume 157 Number 1 2) Becker J. Merkel cell carcinoma. Ann Oncol 2010;21(suppl 7):81–85 and 3) Information from 21,445 cases of MCC in the USA. Data for 2001–2014 from National Program of Cancer Registries and SEER*Stat Database. + +Comment regarding Fields 8 and 9: Acquisition fields left blank as drug was developed by Incyte. + +Comment regarding Field 7: MCC is a rare and aggressive type of skin cancer and impacts less than 1 per 100,000 people in the U.S., but incidence rates are rapidly rising, especially in adults over the age of 65. There are ~1,000 estimated patients per year with locally advanced or metastatic MCC disease. + +General Comment: In the event 2017 California Senate Bill 17 (“SB-17”) and the laws it implements, including Cal. Health & Safety Code § 127677, are found unconstitutional or otherwise unlawful, Incyte reserves all of its legal rights. In issuing this report in an attempt to comply with Cal. Health & Safety Code § 127677, Incyte does not waive any legal claims or legal rights related to SB-17. Please note that portions of this report and its contents may be exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes Incyte’s proprietary commercial information and otherwise would not be in the public interest to disclose. We ask that you please contact the Incyte legal department at 1801 Augustine Cut-Off, Wilmington, DE 19803 if you receive any PRA requests so that we may take appropriate steps to work with you to protect such information.",,,,,,,,,,,,,,, +"Ingenus Pharmaceuticals, LLC",50742036630,Gefitinib Tablets 250mg,2023-05-02,3995,"Gefitinib 250 mg, 30 count tablets (ANDA 211591) have been priced in accordance with Ingenus Pharmaceuticals Contracts and Management Team policies and procedures. Establishing the WAC price at $3,995.00 constitutes a substantial reduction in the WAC pricing of the referenced listed drug, Iressa, listed at $7,788.88. At the time our pricing analysis was completed, our price represented a 49% reduction in price. Several factors were taken into consideration while determining Ingenus’ WAC pricing including but limited to API, production, packaging, and shipping costs. Ingenus’ WAC pricing will enable it to: i) recoup the costs it incurred in evaluating the economic landscape surrounding prospective products; ii) cover distribution costs; iii) provide rebates and discounts as required by partners in the supply chain; and iv) earn a reasonable return on investment.",,15000,,,,,,,"As a generic pharmaceutical manufacturer, Ingenus does not estimate the number of patients. The number entered in that field is based on a simple google search.",,,,,,,,,,,,,,, +"Krystal Biotech, Inc.",82194051002,Vyjuvek Gel 5x10^9 PFU/mL,2023-07-07,24250,"Marketing plans: HCP and Patient websites, HCP detailing, conferences/seminars, journal reprints. Pricing methodology: Krystal Biotech developed Vyjuvek based on a need to address a treatment for a rare genetic disease; dystrophic epidermolysis bullosa (“DEB”). DEB affects approximately 3,000 patients in the US and over time, in patients with DEB, repeated blistering and fibrosis can lead to squamous-cell carcinoma, life-threatening infections and limb deformities. Development of this drug product led to the FDA granting the following designations: Orphan Drug, Fast Track, Regenerative Medicine Advance Therapy, Rare Pediatric Disease Priority Review and Priority Review designations. Considerable efforts were expended in drug development and research, as Vyjuvek is the first and only treatment that addresses the genetic cause of DEB. Given the rarity of the condition Vyjuvek treats, Krystal Biotech employed methodologies based on research and development costs, as well as the value this product brings to the limited patient population that is affected by DEB. The clinical research costs (past and future), the cost of manufacturing, distribution to the marketplace including administrative requirements, patient availability and access were all contributing factors that shaped Krystal Biotech determination of Vyjuvek's pricing.",,1000,,1,,,,,,,,,,,,,,,,,,,, +Mayne Pharma Inc,68308066830,Doxycycline 40mg Capsules 30 count,2023-02-23,782.62,,1,17000,,,,,,,"The 17,000 estimated number of patients is per month and on a national level.",,,,,,,,,,,,,,, +Mayne Pharma Inc,68308066510,Calcitriol Ointment 3mcg/g 100g,2023-07-27,823.31,,1,1800,,,2023-07-18,0,1,There was no upfront cost for the license of this product.,The 1800 estimated number of patients is per month and on a national level.,,,,,,,,,,,,,,, +"Meitheal Pharmaceuticals, Inc.",71288013951,"Mitomycin for Injection, USP 40mg 100mL SDV",2023-03-14,1263.96,"Meitheal markets generic Mitomycin for Injection 40mg as a therapeutic equivalent to the innovator (brand) drug in the U.S. As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product.",,90550,,,,,,,"Since Mitomycin for Injection is a generic product that has a few alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed Mitomycin for Injection. Mitomycin for Injection is primarily used for the treatment of cancer of the stomach or pancreas that has spread to other parts of the body and has not improved or worsened after treatment with other medications, surgery, or radiation therapy. The website Cancer.org states a patient population of 90,550 stomach or pancreas cancer patients on an annual basis.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=672,,,,,,,,,,,,,, +"Meitheal Pharmaceuticals, Inc.",71288010320,"Bendamustine HCl for Injection, USP 100 mg 20 mL SDV",2023-06-14,1600,"Meitheal markets generic Bendamustine HCl as a therapeutic equivalent to Cephalon's NDA# 022249 Treanda for Injection (marketed by Teva). As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the reference listed drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product.",,18740,,,,,,,"As Bendamustine is a generic product and there are a number of alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed Bendamustine. As such, given Bendamustine primary use for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen, Meitheal's best estimate regarding a patient population is 18,740 new cases of CLL and 80,550 people diagnosed with NHL in the US per American Cancer Society's estimates for the US in 2023.",https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=683,,,,,,,,,,,,,, +"Meitheal Pharmaceuticals, Inc.",71288015501,"Plerixafor Injection, 24 mg per 1.2 mL (20mg/mL) SDV",2023-07-26,1490.5,"Meitheal markets generic Plerixafor Injection as a therapeutic equivalent to Genzyme's NDA#022311 Mozobil (marketed by Sanofi). As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the reference listed drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product.",,22827,,,,,,,"As Plerixafor product is a generic product and there are a number of alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed Plerixafor. As such, given Plerixafor injection is used in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSC) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin lymphoma (NHL) or multiple myeloma, Meitheal's best estimate regarding a patient population is 7,722 transplants for multiple myeloma and 3,184 transplants for NHL per Center for International Blood and Marrow Transplant Research (CIBMTR).",,,,,,,,,,,,,,, +"Melinta Therapeutics, LLC",70842024001,"REZZAYO packaged with 1 VIAL in 1 CARTON / one 200 MG INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",2023-07-31,1950,,1,200000,,1,2022-07-27,0,1,The information is not publicly available.,"Rezzayo was granted Orphan Drug status by the FDA. To qualify for Orphan Drug designation, the number of people affected by the disease or condition for which the drug is to be developed is fewer than 200,000 persons.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378193501,"Lenalidomide 2.5mg Oral capsule, 100",2023-03-07,71990.62,,1,70792,,,,,,,"The Product was not the result of a product acquisition. + +Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378193528,"Lenalidomide 2.5mg Oral capsule, 28",2023-03-07,20157.36,,1,70792,,,,,,,"The Product was not the result of a product acquisition. + +Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378194201,"Lenalidomide 20mg Oral capsule, 100",2023-03-07,71990.62,,1,70792,,,,,,,"The Product was not the result of a product acquisition. + +Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,378194221,"Lenalidomide 20mg Oral capsule, 21",2023-03-07,15118.04,,1,70792,,,,,,,"The Product was not the result of a product acquisition. + +Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year.",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,49502038102,Hulio®(CF) (adalimumab-fkjp) Injection 20 mg/0.4 mL Syringe,2023-07-06,6576.49,,1,12957128,,1,,,,,"HULIO injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of HULIO. + +HULIO injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of HULIO. + +HULIO injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of HULIO. + +HULIO injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of HULIO. + +HULIO injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of HULIO. + +HULIO injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of HULIO. + +HULIO injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of HULIO. + +HULIO injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of HULIO. + +Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year. + +The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited (""Biocon Biologics""), creating what Viatris expects to be a unique fully vertically integrated global biosimilars leader. Viatris and Biocon Biologics have entered a Transition Services Agreement (TSA) pursuant to which Viatris will provide commercialization and certain",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,49502038202,Hulio®(CF) (adalimumab-fkjp) Injection 40 mg/0.8 mL Syringe,2023-07-06,6576.49,,1,12957128,,1,,,,,"HULIO injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of HULIO. + +HULIO injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of HULIO. + +HULIO injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of HULIO. + +HULIO injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of HULIO. + +HULIO injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of HULIO. + +HULIO injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of HULIO. + +HULIO injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of HULIO. + +HULIO injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of HULIO. + +Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year. + +The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited (""Biocon Biologics""), creating what Viatris expects to be a unique fully vertically integrated global biosimilars leader. Viatris and Biocon Biologics have entered a Transition Services Agreement (TSA) pursuant to which Viatris will provide commercialization and certain",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,49502038002,Hulio®(CF) (adalimumab-fkjp) Pen Injection 40 mg/0.8 mL,2023-07-06,6576.49,,1,12957128,,1,,,,,"HULIO injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of HULIO. + +HULIO injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of HULIO. + +HULIO injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of HULIO. + +HULIO injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of HULIO. + +HULIO injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of HULIO. + +HULIO injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of HULIO. + +HULIO injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of HULIO. + +HULIO injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of HULIO. + +Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year. + +The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited (""Biocon Biologics""), creating what Viatris expects to be a unique fully vertically integrated global biosimilars leader. Viatris and Biocon Biologics have entered a Transition Services Agreement (TSA) pursuant to which Viatris will provide commercialization and certain",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,49502041702,Adalimumab-fkjp(CF) Injection 20 mg/0.4 mL Syringe,2023-07-07,995,,1,12957128,,,,,,,"Adalimumab injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). In the United States, there are currently 258 million adults over the age of 18, meaning an estimated .6% to 1% of the American adult population has moderate to severe RA. Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of Adalimumab. + +Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year. + +The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited (""Biocon Biologic",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,49502041802,Adalimumab-fkjp(CF) Injection 40 mg/0.8 mL Syringe,2023-07-07,995,,1,12957128,,,,,,,"Adalimumab injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). In the United States, there are currently 258 million adults over the age of 18, meaning an estimated .6% to 1% of the American adult population has moderate to severe RA. Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of Adalimumab. + +Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year. + +The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited (""Biocon Biologic",,,,,,,,,,,,,,, +Mylan Pharmaceuticals Inc,49502041602,Adalimumab-fkjp(CF) Pen Injection 40 mg/0.8 mL,2023-07-07,995,,1,12957128,,,,,,,"Adalimumab injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). In the United States, there are currently 258 million adults over the age of 18, meaning an estimated .6% to 1% of the American adult population has moderate to severe RA. Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of Adalimumab. + +Adalimumab injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of Adalimumab. + +Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year. + +The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited (""Biocon Biologic",,,,,,,,,,,,,,, +Novartis,78116147,Mekinist® (trametinib) for oral solution 4.7MG,2023-05-16,1548.98,"Novartis considered many factors in determining the price of Mekinist. Tafinlar + Mekinist, the worldwide targeted therapy leader in BRAF/MEK-inhibition, is the first and only therapy to be approved with a tumor-agnostic indication for adult and pediatric patients with solid tumors that have a BRAF V600E mutation. We priced in parity to other branded treatments in this therapeutic area and are focused on access to Mekinist for this patient population.",,400,1,1,,,,,"Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Novartis,78115421,Tafinlar® (dabrafenib) tablets for oral suspension 10MG 210,2023-05-16,3663.27,"Novartis considered many factors in determining the price of Tafinlar. Tafinlar + Mekinist, the worldwide targeted therapy leader in BRAF/MEK-inhibition, is the first and only therapy to be approved with a tumor-agnostic indication for adult and pediatric patients with solid tumors that have a BRAF V600E mutation. We priced in parity to other branded treatments in this therapeutic area and are focused on access to Tafinlar for this patient population.",,400,1,1,,,,,"Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Novo,169203011,Sogroya® 10 mg/1.5 mL (6.7 mg/mL) pen; 1.5mL in 1 prefilled syringe,2023-06-09,2635.8,,1,33000,,,,,,,"""Sogroya® is a human growth hormone analog indicated for: +Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH) (1). +Adults Patients: Replacement of endogenous growth hormone in adults with growth hormone deficiency (1). +The full Prescribing Information for Sogroya® is available at https://www.novo-pi.com/sogroya.pdf. +According to Komodo’s longitudinal claims data in 2023 there are approximately 33,000 GHD patients, on average, who could potentially use Sogroya® in any one-month period. For the estimated patients per month requirement, Novo Nordisk utilizes the number of estimated patients on pharmacotherapy who could potentially use Sogroya®. However, we note that the total number of patients diagnosed with GHD is roughly 1 in 5,000 adults and 1 in 4,000 to 6,000 pediatric. Please note, this is not an estimate of prescriptions that might be written for Sogroya® or each available dose of Sogroya®. Sogroya® will represent a portion of the broader market for growth hormone therapies +Sogroya® was developed by Novo Nordisk. """,,,,,,,,,,,,,,, +Novo,169203711,Sogroya® 15 mg/1.5 mL (10 mg/mL) pen; 1.5mL in 1 prefilled syringe,2023-06-09,3953.7,,1,33000,,,,,,,"""Sogroya® is a human growth hormone analog indicated for: +Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH) (1). +Adults Patients: Replacement of endogenous growth hormone in adults with growth hormone deficiency (1). +The full Prescribing Information for Sogroya® is available at https://www.novo-pi.com/sogroya.pdf. +According to Komodo’s longitudinal claims data in 2023 there are approximately 33,000 GHD patients, on average, who could potentially use Sogroya® in any one-month period. For the estimated patients per month requirement, Novo Nordisk utilizes the number of estimated patients on pharmacotherapy who could potentially use Sogroya®. However, we note that the total number of patients diagnosed with GHD is roughly 1 in 5,000 adults and 1 in 4,000 to 6,000 pediatric. Please note, this is not an estimate of prescriptions that might be written for Sogroya® or each available dose of Sogroya®. Sogroya® will represent a portion of the broader market for growth hormone therapies +Sogroya® was developed by Novo Nordisk. """,,,,,,,,,,,,,,, +Novo,169203511,Sogroya® 5 mg/1.5 mL (3.3 mg/mL) pen; 1.5mL in 1 prefilled syringe,2023-06-09,1317.9,,1,33000,,,,,,,"""Sogroya® is a human growth hormone analog indicated for: +Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH) (1). +Adults Patients: Replacement of endogenous growth hormone in adults with growth hormone deficiency (1). +The full Prescribing Information for Sogroya® is available at https://www.novo-pi.com/sogroya.pdf. +According to Komodo’s longitudinal claims data in 2023 there are approximately 33,000 GHD patients, on average, who could potentially use Sogroya® in any one-month period. For the estimated patients per month requirement, Novo Nordisk utilizes the number of estimated patients on pharmacotherapy who could potentially use Sogroya®. However, we note that the total number of patients diagnosed with GHD is roughly 1 in 5,000 adults and 1 in 4,000 to 6,000 pediatric. Please note, this is not an estimate of prescriptions that might be written for Sogroya® or each available dose of Sogroya®. Sogroya® will represent a portion of the broader market for growth hormone therapies +Sogroya® was developed by Novo Nordisk. """,,,,,,,,,,,,,,, +Organon,78206018701,Hadlima Carton two singledose autoinjector pens 40 mg/0.4 ml,2023-07-01,1038,,1,400000,,,,,,,,,,,,,,,,,,,,,, +Organon,78206018401,Hadlima Carton two singledose autoinjector pens 40 mg/0.8 ml,2023-07-01,1038,,1,400000,,,,,,,,,,,,,,,,,,,,,, +Organon,78206018601,Hadlima Carton two singledose prefilled syringes 40 mg/0.4 ml,2023-07-01,1038,,1,400000,,,,,,,,,,,,,,,,,,,,,, +Organon,78206018301,Hadlima Carton two singledose prefilled syringes 40 mg/0.8 ml,2023-07-01,1038,,1,400000,,,,,,,,,,,,,,,,,,,,,, +Orphalan,81802000108,"CUVRIOR, 300mg, tablet, 8 tablets per blister pack",2023-04-01,1528,,1,9000,,,,,,,,,,,,,,,,,,,,,, +Orphalan,81802000172,"CUVRIOR, 300mg, tablet, 8 tablets per blister pack, 9 blister packs total",2023-04-01,13752,,1,9000,,,,,,,,,,,,,,,,,,,,,, +"Otsuka America Pharmaceutical, Inc.",59148010280,Abilify Asimtufii® 720mg Kit (aripiprazole),2023-06-05,4078.84,,1,,,,,,,,,,,,,,,,,,,,,,, +"Otsuka America Pharmaceutical, Inc.",59148011480,Abilify Asimtufii® 960mg Kit (aripiprazole),2023-06-05,5438.46,,1,,,,,,,,,,,,,,,,,,,,,,, +Padagis US LLC,45802043601,Tazarotene Gel 0.05% 100g,2023-06-05,1316.71,Product is be priced to deliver value to the market as compared to the Brand referenced drug.,,655,,1,,,,,"""As a generic manufacturer, Padagis does not have information available to accurately determinate the number of patients that could potentially have a condition for which the drug may be prescribed. Padagis neither collects nor uses estimated patient information and does not believe there is publicly available data that accurately represents the number of patients for all indications. +Based on IQVIA data available to Padagis, Padagis estimates that approximately 655 prescriptions were filled for the gel in the past 12 months, but number of prescriptions filled should not be misinterpreted as an accurate estimate of the number of patients with a condition for which the new drug may be prescribed, as dosage and therapy may vary across individual patients.""",,,,,,,,,,,,,,, +Padagis US LLC,45802044201,Tazarotene Gel 0.1% 100g,2023-06-05,1399.07,Product is be priced to deliver value to the market as compared to the Brand referenced drug.,,1657,,1,,,,,"""As a generic manufacturer, Padagis does not have information available to accurately determinate the number of patients that could potentially have a condition for which the drug may be prescribed. Padagis neither collects nor uses estimated patient information and does not believe there is publicly available data that accurately represents the number of patients for all indications. +Based on IQVIA data available to Padagis, Padagis estimates that approximately 1,657 prescriptions were filled for the gel in the past 12 months, but number of prescriptions filled should not be misinterpreted as an accurate estimate of the number of patients with a condition for which the new drug may be prescribed, as dosage and therapy may vary across individual patients.""",,,,,,,,,,,,,,, +Par Pharmaceutical ,10370036801,Topiramate ER Caps 200mg 100s,2023-03-24,3472.92,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Par notes Topiramate extended-release capsules are indicated: + +1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older. +2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older. +3) For the preventive treatment of migraine in patients 12 years of age and older. + +The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy ) + +The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ ) + +Par has not independently verified this information. + +Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. + +2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,10370036811,Topiramate ER Caps 200mg 30s,2023-03-24,1041.89,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Par notes Topiramate extended-release capsules are indicated: + +1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older. +2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older. +3) For the preventive treatment of migraine in patients 12 years of age and older. + +The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy ) + +The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ ) + +Par has not independently verified this information. + +Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. + +2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,49884015802,Everolimus Tablets 0.25mg 60s,2023-03-27,445.11,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data. + +Par notes this product indicated for the prophylaxis of organ rejection in adult patients who have had kidney or liver transplants. + +The Centers for Disease Control and Prevention (“CDC”) states that 20,167 patients had a kidney transplant in the United States in 2017. ( https://nccd.cdc.gov/ckd/detail.aspx?Qnum=Q234 ) + +The National Institutes of Health (“NIH”) states that about 7,100 liver transplants were performed in the United States in 2015. ( https://www.niddk.nih.gov/health-information/liver-disease/liver-transplant/definition-facts ) + +Par has not independently verified this information. + +Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. + +(2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,49884015902,Everolimus Tablets 0.5mg 60s,2023-03-27,890.23,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data. + +Par notes this product indicated for the prophylaxis of organ rejection in adult patients who have had kidney or liver transplants. + +The Centers for Disease Control and Prevention (“CDC”) states that 20,167 patients had a kidney transplant in the United States in 2017. ( https://nccd.cdc.gov/ckd/detail.aspx?Qnum=Q234 ) + +The National Institutes of Health (“NIH”) states that about 7,100 liver transplants were performed in the United States in 2015. ( https://www.niddk.nih.gov/health-information/liver-disease/liver-transplant/definition-facts ) + +Par has not independently verified this information. + +Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. + +(2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,10370036701,Topiramate Extended-Release Capsules 100mg 100s,2023-05-24,2538.82,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Par notes Topiramate extended-release capsules are indicated: + +1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older. +2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older. +3) For the preventive treatment of migraine in patients 12 years of age and older. + +The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy ) + +The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ ) + +Par has not independently verified this information. + +Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. +2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,10370036711,Topiramate Extended-Release Capsules 100mg 30s,2023-05-24,761.64,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Par notes Topiramate extended-release capsules are indicated: + +1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older. +2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older. +3) For the preventive treatment of migraine in patients 12 years of age and older. + +The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy ) + +The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ ) + +Par has not independently verified this information. + +Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. +2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,10370036501,Topiramate Extended-Release Capsules 25mg 100s,2023-05-24,983.71,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Par notes Topiramate extended-release capsules are indicated: + +1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older. +2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older. +3) For the preventive treatment of migraine in patients 12 years of age and older. + +The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy ) + +The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ ) + +Par has not independently verified this information. + +Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. +2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,10370036511,Topiramate Extended-Release Capsules 25mg 30s,2023-05-24,295.11,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Par notes Topiramate extended-release capsules are indicated: + +1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older. +2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older. +3) For the preventive treatment of migraine in patients 12 years of age and older. + +The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy ) + +The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ ) + +Par has not independently verified this information. + +Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. +2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,10370036601,Topiramate Extended-Release Capsules 50mg 100s,2023-05-25,1281.38,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Par notes Topiramate extended-release capsules are indicated: + +1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older. +2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older. +3) For the preventive treatment of migraine in patients 12 years of age and older. + +The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy ) + +The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ ) + +Par has not independently verified this information. + +Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. +2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,10370036611,Topiramate Extended-Release Capsules 50mg 30s,2023-05-25,384.41,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Par notes Topiramate extended-release capsules are indicated: + +1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older. +2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older. +3) For the preventive treatment of migraine in patients 12 years of age and older. + +The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy ) + +The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ ) + +Par has not independently verified this information. + +Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. +2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,254301255,Alvimopan Caps 12mg 30s,2023-06-27,4713.29,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Par notes Alvimopan capsules are indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. + +The National Institutes of Health (“NIH”) estimates that in the United States, there are more than 300,000 operations for diseases of the colon each year. ( https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5380454/ ) + +Par has not independently verified this information. + +Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. + +2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Par Pharmaceutical ,42023019501,Posaconazole Inj 18mg/mL 1vial,2023-06-28,530.45,,1,,,,,,,,"The information contained in this report is subject to the following limitations and assumptions. +Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. +Par notes Posaconazole Injection are indicated for: + +1) the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. +2) the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised + + +The Centers for Disease Control and Prevention (“CDC”) estimates 15,000 aspergillosis-associated hospitalizations occurred in the United States in 2014. The CDC further notes “because aspergillosis is not a reportable infection in the United States, the exact number of cases is difficult to determine.” (https://www.cdc.gov/fungal/diseases/aspergillosis/statistics.html ) + +The CDC estimates that approximately 25,000 cases of candidemia occur nationwide each year. ( https://www.cdc.gov/fungal/diseases/candidiasis/invasive/statistics.html ) + +Par has not independently verified this information. + +Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month. + +Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: +“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: + https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. +Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. + +2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. +3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank.",,,,,,,,,,,,,,, +Pfizer,69350002,ZAVZPRET 10mg Nasal Spray 1x6 GVL,2023-05-25,1100,,1,6500000,1,,2022-10-03,1285800000,,"Pfizer Inc. acquired Biohaven, the maker of Nurtec ODT/Vydura (rimegepant), on October 3, 2022, an innovative therapy approved for both acute treatment of migraine and prevention of episodic migraine in adults. The transaction includes the acquisition of Biohaven’s CGRP programs, including rimegepant, zavegepant and a portfolio of five pre-clinical CGRP assets. Under the terms of the agreement, we acquired all outstanding common shares of Biohaven not already owned by us for $148.50 per share, in cash, for payments of approximately $11.5 billion, plus repayment of third-party debt of $863 million and redemption of Biohaven’s redeemable preferred stock for $495 million. Effective immediately prior to the closing of the acquisition, Biohaven completed the spin-off of Biohaven Ltd. (NYSE: BHVN), distributing Biohaven Ltd.’s shares to Biohaven shareholders. Biohaven Ltd. is a new publicly traded company that retained Biohaven’s non-CGRP development stage pipeline compounds. Pfizer, a Biohaven shareholder, received a pro rata portion of Biohaven Ltd.’s shares in the distribution and owns approximately 1.5% of Biohaven Ltd. as of December 31, 2022.","Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 6.5M patients in the United States that could potentially receive ZAVZPRET™, an innovative therapy approved for the acute treatment of migraine. Comment regarding Fields 8-9: ZAVZPRET™ did not receive breakthrough status and did not receive priority review; therefore, Columns 8-9 are intentionally left blank. Comment regarding Field 11 - The acquisition price is $12,858,000,000. The system would not allow us to enter the full acquisition price.",,,,,,,,,,,,,,, +Pfizer,69103130,TALZENNA 0.1mg Capsule 1x30 Bottle,2023-06-21,17514.07,,1,12000,,1,2016-09-28,1430000000,,"On September 28, 2016, Pfizer Inc. acquired Medivation for approximately $14.3 billion in cash ($13.9 billion, net of cash acquired).","Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 12,000 patients in the U.S. could potentially receive TALZENNA™ in HRR-gene mutated metastatic castration-resistant prostate cancer. Comment regarding Field 8 - TALZENNA™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Field 11 - The acquisition price is $14,300,000,000. The system would not allow us to enter the full acquisition price.",,,,,,,,,,,,,,, +Pfizer,69123530,TALZENNA 0.35mg Capsule 1x30 Bottle,2023-06-21,17514.07,,1,12000,,1,2016-09-28,1430000000,,"On September 28, 2016, Pfizer Inc. acquired Medivation for approximately $14.3 billion in cash ($13.9 billion, net of cash acquired).","Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 12,000 patients in the U.S. could potentially receive TALZENNA™ in HRR-gene mutated metastatic castration-resistant prostate cancer. Comment regarding Field 8 - TALZENNA™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Field 11 - The acquisition price is $14,300,000,000. The system would not allow us to enter the full acquisition price.",,,,,,,,,,,,,,, +Pfizer,69033428,LITFULO 50MG CAP 1X28 BTL US,2023-07-06,3769.23,,1,500000,,,,,,,"Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 0.5M patients in the United States that could potentially receive LITFULO™ in 2023 for the treatment of alopecia areata, an autoimmune disease. Comment regarding Fields 8-9: LITFULO™ did not receive breakthrough status and did not receive priority review; therefore, Columns 8-9 are intentionally left blank. Comment regarding Fields 10-13: LITFULO™ was not acquired; therefore, Columns 10-13 are intentionally left blank.",,,,,,,,,,,,,,, +"Pharmaceutical Associates, Inc",121494800,Potassium Chloride Oral Solution USP 10% Rx - 20mEq/15mL 100/cs,2023-03-17,1205,,1,13000,,,,,,,,,,,,,,,,,,,,,, +"Pharmaceutical Associates, Inc",121189600,Potassium Chloride Oral Solution USP 10% Rx - 40mEq/30mL 100/cs,2023-03-17,1849,,1,13000,,,,,,,,,,,,,,,,,,,,,, +Pharming Healthcare Inc,71274017060,Joenja 70mg Tablets 60 Count Bottle,2023-04-03,45000,,1,400,,1,2019-08-13,20000000,,,,,,,,,,,,,,,,,, +Piramal Critical Care,66794023741,"Doxycycline for Injection, USP, 20 mL vial, 100mg, Single use vial, 1 carton of 10 vials",2023-06-16,251,"""For Doxycycline, Piramal conducts the following marketing activities; telemarketing and direct to HCP’s notifications via email and sales representatives visits conducting calls on HCP’s where sell sheets are provided. Piramal marketing activities are minimal since this is a generic product; and the spend on marketing activities on an annual basis is the following amounts: Direct to consumer was $0; Direct to physician (HCPs) was $3,250.00. +Piramal conducts market research utilizing IQVIA data to determine the competitive landscape for any new product launch. We review this information and determine how many generic manufacturers are in the market and determine a market share position based on this approach. We establish our WAC pricing by reviewing IQVIA data and setting our WAC at a competitive rate by researching all competitive WAC pricing for both brand and generic competitors and then we establish a commercial contract price of 70% below current Average Manufacturer Selling Price (AMSP). WAC was set at 1% below Average WAC Price (AWP) of the existing market. Additionally, multiple factors are considered for selecting a product beyond the pricing; such as the difficulties in producing the product, distribution cost for speciality products, administrative costs related to contracts, chargeback management, as well as the value this product would bring to patients. """,,1596000,,,,,,,,,,,,,,,,,,,,,, +PureTek Corporation,59088043510,"Diclofenac Sodium Topical Solution 1.5%, w/w 5fl oz (150ml)",2023-01-16,1308,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,750000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088073000,"Triasil, Triamcinolone Acetonide Ointment USP, 0.025%, 80g+ Gauze pads, sterile, 20ct + silicon Tape roll (1ct)",2023-01-20,2888,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,250000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088069816,Urea 39.5% Cream (8oz),2023-01-20,1581.2,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,1500000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088064354,"Dexatran Multivitamin (30ct), Vit C 200mg, Thiamin 10 mg, Riboflavin 6 mg, Niacin 30 mg, Vitamin B6 5 mg, Folate 1667 mcg DFE, Vitamin B12 15 mcg, Pantothenic Acid 10 mg, Iron 18 mg, Magnesium 6.9 mg, Zinc 18.2 mg, Copper 0.8 mg, Manganese 1.3 mg",2023-02-20,1800,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,725000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088021016,Urea 39.5% + 2% Salicylic Acid Cream (8oz)_ Urea 39.5%_ Salicylic Acid 2%,2023-03-24,3370.4,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,500000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088020903,"Hydroxym Gel (1oz), Hydrocortisone 2%",2023-07-14,1158.4,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,250000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088090554,"Lidocan (30ct), Lidocaine Patch 5%, Lidocaine 700mg (50mg per gram adhesive) in an aqueous base.",2023-07-19,1540,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,700000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +PureTek Corporation,59088073100,"Xyliderm, Lidocan (30ct), Alcohol Prep Pads Sterile (200ct), Xrylix Sheets (30ct)",2023-07-19,2560,"While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. +There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products.",,200000,,,,,,,Dispensed by prescription only,,,,,,,,,,,,,,, +QOL Medical LLC,67871011106,"Sucraid Oral Solution 8500Unit/Ml, 2 ML Plastic Container, 25 count",2023-02-16,1826,,1,167,,,,,,,"This drug was approved in 1998. This particular NDC should be released in the next week for distribution, as well as 67871-0111-05, which will have a WAC price at introduction of 365.20.",,,,,,,,,,,,,,, +"Reata Pharmaceuticals, Inc.",73179025090,Skyclarys 50 mg 90 count,2023-06-28,30833.33,"Because there has been no FDA-approved drug for Friedrich's ataxia (FA) until SKYCLARYS, most patients seek routine care by their local neurologist or primary care physician.? Important commercial launch targets include CCRN centers, or Collaborative Clinical Research Network sites, ataxia centers and HCPs with FA patients linked to their practice. Through the evaluation of ICD-10 claims data, we've identified healthcare providers treating patients with Friedrich's ataxia today.??? + +We also have marketing outreach efforts through digital, social, email, and print to reach additional practicing neurologists to raise awareness of SKYCLARYS’ approval as newly diagnosed patients are identified and others return to their neurologist for treatment.? + +With SKYCLARYS approval, our commercial team began to inform the FA network of patients, caregivers, and healthcare providers. Omni-channel outreach efforts started with the launch of our brand websites, online search, social media, and digital campaigns that went live upon drug approval.?? +Our sales organization consists of a team of region business directors and neurology account managers responsible for educating HCPs. Our field access team consists of national account directors focused on SKYCLARYS coverage by national and regional payers, and the patient access liaisons team hired to support practice level access needs.?? + +We offer Reata REACH or the Reata Education, Access, and Care Helpline as an integrated, exclusive specialty pharmacy and patient services program. It will serve as the single point of contact for HCPs prescribing SKYCLARYS, FA patients receiving drug and their caregivers. REACH is designed to create a simple and positive experience through new patient start process, insurance navigation, therapy adherence, and access. + +A WAC price of $30,833.33 per bottle (30 day supply) was established for SKYCLARYS.",,4500,,1,,,,,acquisition price is N/A,,,,,,,,,,,,,,, +"Regeneron Pharmaceuticals, Inc.",61755005001,EYLEA® HD (aflibercept) Injection 8mg Vial Kit,2023-08-21,2625,"Marketing + +Planned marketing activities that will support the approval of EYLEA® HD (aflibercept) Injection 8mg include raising awareness about the extended dosing regimens while maintaining noninferior BCVA-ETDRS letter gains to EYLEA® (aflibercept) Injection 2mg at week 48, with a safety form consistent to EYLEA for the treatment of wet age related macular degeneration and diabetic macular edema, and EYLEA® HD (aflibercept) Injection 8mg among healthcare professionals through physician-focused product and disease education websites, other digital media, print media, and use of sales representatives to promote the FDA-approved indications. Anticipated direct-to-consumer marketing activities include a consumer-focused product website and other digital media. + + +Pricing + +Regeneron approaches pricing with fairness, affordability and access at the forefront. Our pricing philosophy is guided by several principles. + +First, medicines should be priced fairly. We take a value-based pricing approach that reflects their benefit to patients, society and the healthcare system. We consider the long-term investment and risk inherent in science and technology innovation, which is required to bring novel medicines to patients. + +Second, medicines are only useful if patients in need can access and afford them. We are committed to supporting patients’ access by providing financial assistance for eligible patients. + +Third, our growth is driven by scientific innovation, not pricing. Any price changes Regeneron makes is designed to keep pace with the medicine’s value and our costs, and in careful consideration of commercial competitiveness. + +Regeneron also seeks to work collaboratively with other stakeholders in the healthcare system and welcome their input on fair and cost-effective pricing. These principles taken together help to ensure advancing our goal of setting fair, value-based prices for our medicines and breaking down barriers to patient access.",,600000,,1,,,,,"All information submitted by Regeneron Pharmaceuticals, Inc. to the California Office of Statewide Health Planning and Development under Cal. Code. Regs. Tit. 22, § 96076, including all information contained in this submission, is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act.  Regeneron requests that the confidentiality of this submission and of all Regeneron’s related information herein be maintained to the maximum extent permitted by law.  To the extent that any of this designated information is requested, whether under the California Public Records Act or otherwise, Regeneron requests that it be notified of the request and afforded an opportunity to submit objections to disclosure.”",,,,,,,,,,,,,,, +"Regeneron Pharmaceuticals, Inc.",61755001401,VEOPOZ™ (pozelimab-bbfg) 400 mg/2 mL (200 mg/mL),2023-09-01,34615.38,"Marketing + +Planned marketing activities that will support the approval of VEOPOZ™ (pozelimab-bbfg) include raising awareness about CD55-deficient protein losing enteropathy (also known as CHAPLE disease) and VEOPOZ™ among healthcare professionals through physician-focused product website and other digital media to promote the FDA-approved indication. Anticipated direct-to-consumer marketing activities include a consumer-focused disease awareness website and other digital media. + +Pricing + +Regeneron approaches pricing with fairness, affordability and access at the forefront. Our pricing philosophy is guided by several principles. + +First, medicines should be priced fairly. We take a value-based pricing approach that reflects their benefit to patients, society and the healthcare system. We consider the long-term investment and risk inherent in science and technology innovation, which is required to bring novel medicines to patients. + +Second, medicines are only useful if patients in need can access and afford them. We are committed to supporting patients’ access by providing financial assistance for eligible patients. + +Third, our growth is driven by scientific innovation, not pricing. Any price changes Regeneron makes is designed to keep pace with the medicine’s value and our costs, and in careful consideration of commercial competitiveness. + +Regeneron also seeks to work collaboratively with other stakeholders in the healthcare system and welcome their input on fair and cost-effective pricing. These principles taken together help to ensure advancing our goal of setting fair, value-based prices for our medicines and breaking down barriers to patient access.",,3,,1,,,,,"All information submitted by Regeneron Pharmaceuticals, Inc. to the California Office of Statewide Health Planning and Development under Cal. Code. Regs. Tit. 22, § 96076, including all information contained in this submission, is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act. Regeneron requests that the confidentiality of this submission and of all Regeneron’s related information herein be maintained to the maximum extent permitted by law. To the extent that any of this designated information is requested, whether under the California Public Records Act or otherwise, Regeneron requests that it be notified of the request and afforded an opportunity to submit objections to disclosure. + +VEOPOZ™ (pozelimab-bbfg) Injection is approved for the treatment of CHAPLE disease, an ultra-rare disease for which there are no reliable estimates on prevalence in the United States. The response provided in Column 7 herein reflects Regeneron’s good faith attempt to estimate the patient population such disease in the United States.”",,,,,,,,,,,,,,, +"RISING PHARMA HOLDINGS, INC.",64980058851,"Edetate Calcium Disodium injection, USP 5 mL single-dose vial (NDC 64980-588-05) containing 200 mg of edetate calcium disodium per mL (1000 mg per vial), in boxes containing 5 vials (NDC 64980-588-51).",2023-07-15,32609,,1,400,,,,,,,,,,,,,,,,,,,,,, +Sandoz Inc.,781215832,PIRFENIDONE 267MG 270HGC BO US,2023-01-09,9130.57,This launch is specific to the U.S. Sandoz Inc. is contracting within the wholesaler and/or specialty pharmacy space. The WAC is priced lower than the WAC of the reference product.,,100000,,,,,,,"According to Cortellis data from July 2021, IPF is rare disease, with an estimated prevalence of 44,000 to 135,000 cases and an incidence of 21,000 new cases per year in the U.S. +Source: https://insights.decisionresourcesgroup.com/disease/idiopathic-pulmonary-fibrosis. + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. + +Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,781402822,CHLORPROMAZINE 100MG/ML 240ML,2023-03-31,2160,This launch is specific to the U.S. Sandoz Inc. is contracting within the wholesaler and/or specialty pharmacy space. The WAC is priced equal to the previous manufacturer.,,139710,,,2022-12-14,1400000,,"Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.","Chlorpromazine Oral Soultion is indicated for the treatment of multiple conditions including but not limited to the following: the management of manifestations of psychotic disorders, the treatment of schizophrenia, to control nausea and vomiting. +For relief of restlessness and apprehension before surgery, for acute intermittent porphyria, as an adjunct in the treatment of tetanus. +To control the manifestations of the manic type of manic-depressive illness, for relief of intractable hiccups, for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance. There is an estimated 139,710 patients treated with Chlorpromazine Oral Solution in the United States. Source: DailyMEd, FDA label Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,61314032764,Adalimumab 40MG/0.4ML 2LISY BI US,2023-07-05,1315.3,"Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product.",,33782,,,,,,,"Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states : +1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. +2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. +3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. +4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. +5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. +6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. +7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. +8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. +9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov) + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,61314032720,Adalimumab 40MG/0.4ML 2LISY PE BI US,2023-07-05,1315.3,"Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product.",,376201,,,,,,,"Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states : +1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. +2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. +3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. +4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. +5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. +6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. +7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. +8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. +9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov) + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,61314050964,HYRIMOZ 10MG/0.1ML 2LISY BI US,2023-07-05,6576.49,"Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product.",,202,,,,,,,"Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states : +1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. +2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. +3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. +4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. +5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. +6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. +7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. +8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. +9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov) + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,61314047664,HYRIMOZ 20MG/0.2ML 2LISY BI US,2023-07-05,6576.49,"Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product.",,2630,,,,,,,"Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states : +1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. +2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. +3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. +4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. +5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. +6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. +7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. +8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. +9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov) + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,61314047364,HYRIMOZ 40MG/0.4ML 2LISY BI US,2023-07-05,6576.49,"Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product.",,33782,,,,,,,"Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states : +1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. +2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. +3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. +4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. +5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. +6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. +7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. +8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. +9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov) + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,61314047320,HYRIMOZ 40MG/0.4ML 2LISY PE BI US,2023-07-05,6576.49,"Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product.",,376201,,,,,,,"Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states : +1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. +2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. +3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. +4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. +5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. +6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. +7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. +8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. +9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov) + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,61314051736,HYRIMOZ 80+40MG 3 KIT PE BI US,2023-07-05,13153.01,"Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product.",,14213,,,,,,,"Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states : +1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. +2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. +3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. +4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. +5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. +6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. +7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. +8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. +9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov) + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,61314045420,HYRIMOZ 80MG/0.8ML 2LISY PE BI US,2023-07-05,13153.01,"Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product.",,12896,,,,,,,"Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states : +1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. +2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. +3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. +4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. +5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. +6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. +7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. +8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. +9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov) + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,61314045468,HYRIMOZ 80MG/0.8ML 3LISY BI US,2023-07-05,19729.54,"Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product.",,273,,,,,,,"Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states : +1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. +2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. +3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. +4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. +5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. +6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. +7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. +8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. +9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov) + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,61314045436,HYRIMOZ 80MG/0.8ML 3LISY PE BI US,2023-07-05,19729.54,"Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product.",,34745,,,,,,,"Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states : +1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. +2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. +3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. +4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. +5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. +6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. +7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. +8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. +9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov) + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sandoz Inc.,61314053164,HYRIOZ  80+40MG 2KIT MP BI US,2023-07-05,9864.76,"Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product.",,407,,,,,,,"Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states : +1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. +2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. +3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. +4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. +5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. +6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. +7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. +8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. +9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov) + +Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure.",,,,,,,,,,,,,,, +Sanofi,71104098101,"ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 1000 IU nominally, Single Dose Vial in a Kit",2023-03-27,5.11,"In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising. +Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs +At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need. +Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system. +When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.).",,25000,1,1,,,,,"Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups. + +ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO.",,,,,,,,,,,,,,, +Sanofi,71104098201,"ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 2000 IU nominally, Single Dose Vial in a Kit",2023-03-27,5.11,"In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising. +Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs +At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need. +Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system. +When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.).",,25000,1,1,,,,,"Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups. + +ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO.",,,,,,,,,,,,,,, +Sanofi,71104097801,"ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 250 IU nominally, Single Dose Vial in a Kit",2023-03-27,5.11,"In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising. +Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs +At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need. +Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system. +When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.).",,25000,1,1,,,,,"Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups. + +ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO.",,,,,,,,,,,,,,, +Sanofi,71104098301,"ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 3000 IU nominally, Single Dose Vial in a Kit",2023-03-27,5.11,"In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising. +Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs +At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need. +Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system. +When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.).",,25000,1,1,,,,,"Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups. + +ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO.",,,,,,,,,,,,,,, +Sanofi,71104098401,"ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 4000 IU nominally, Single Dose Vial in a Kit",2023-03-27,5.11,"In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising. +Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs +At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need. +Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system. +When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.).",,25000,1,1,,,,,"Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups. + +ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO.",,,,,,,,,,,,,,, +Sanofi,71104097901,"ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 500 IU nominally, Single Dose Vial in a Kit",2023-03-27,5.11,"In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising. +Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs +At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need. +Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system. +When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.).",,25000,1,1,,,,,"Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups. + +ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO.",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923050110,Delandistrogene Moxeparvovec 10 Vial 100 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923050211,Delandistrogene Moxeparvovec 11 Vial 110 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923050312,Delandistrogene Moxeparvovec 12 Vial 120 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923050413,Delandistrogene Moxeparvovec 13 Vial 130 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923050514,Delandistrogene Moxeparvovec 14 Vial 140 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923050615,Delandistrogene Moxeparvovec 15 Vial 150 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923050716,Delandistrogene Moxeparvovec 16 Vial 160 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923050817,Delandistrogene Moxeparvovec 17 Vial 170 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923050918,Delandistrogene Moxeparvovec 18 Vial 180 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923051019,Delandistrogene Moxeparvovec 19 Vial 190 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923051120,Delandistrogene Moxeparvovec 20 Vial 200 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923051221,Delandistrogene Moxeparvovec 21 Vial 210 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923051322,Delandistrogene Moxeparvovec 22 Vial 220 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923051423,Delandistrogene Moxeparvovec 23 Vial 230 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923051524,Delandistrogene Moxeparvovec 24 Vial 240 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923051625,Delandistrogene Moxeparvovec 25 Vial 250 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923051726,Delandistrogene Moxeparvovec 26 Vial 260 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923051827,Delandistrogene Moxeparvovec 27 Vial 270 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923051928,Delandistrogene Moxeparvovec 28 Vial 280 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923052029,Delandistrogene Moxeparvovec 29 Vial 290 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923052130,Delandistrogene Moxeparvovec 30 Vial 300 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923052231,Delandistrogene Moxeparvovec 31 Vial 310 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923052332,Delandistrogene Moxeparvovec 32 Vial 320 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923052433,Delandistrogene Moxeparvovec 33 Vial 330 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923052534,Delandistrogene Moxeparvovec 34 Vial 340 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923052635,Delandistrogene Moxeparvovec 35 Vial 350 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923052736,Delandistrogene Moxeparvovec 36 Vial 360 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923052837,Delandistrogene Moxeparvovec 37 Vial 370 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923052938,Delandistrogene Moxeparvovec 38 Vial 380 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923053039,Delandistrogene Moxeparvovec 39 Vial 390 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923053140,Delandistrogene Moxeparvovec 40 Vial 400 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923053241,Delandistrogene Moxeparvovec 41 Vial 410 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923053342,Delandistrogene Moxeparvovec 42 Vial 420 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923053443,Delandistrogene Moxeparvovec 43 Vial 430 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923053544,Delandistrogene Moxeparvovec 44 Vial 440 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923053645,Delandistrogene Moxeparvovec 45 Vial 450 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923053746,Delandistrogene Moxeparvovec 46 Vial 460 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923053847,Delandistrogene Moxeparvovec 47 Vial 470 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923053948,Delandistrogene Moxeparvovec 48 Vial 480 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923054049,Delandistrogene Moxeparvovec 49 Vial 490 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923054150,Delandistrogene Moxeparvovec 50 Vial 500 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923054251,Delandistrogene Moxeparvovec 51 Vial 510 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923054352,Delandistrogene Moxeparvovec 52 Vial 520 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923054453,Delandistrogene Moxeparvovec 53 Vial 530 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923054554,Delandistrogene Moxeparvovec 54 Vial 540 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923054655,Delandistrogene Moxeparvovec 55 Vial 550 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923054756,Delandistrogene Moxeparvovec 56 Vial 560 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923054857,Delandistrogene Moxeparvovec 57 Vial 570 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923054958,Delandistrogene Moxeparvovec 58 Vial 580 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923055059,Delandistrogene Moxeparvovec 59 Vial 590 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923055160,Delandistrogene Moxeparvovec 60 Vial 600 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923055261,Delandistrogene Moxeparvovec 61 Vial 610 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923055362,Delandistrogene Moxeparvovec 62 Vial 620 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923055463,Delandistrogene Moxeparvovec 63 Vial 630 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923055564,Delandistrogene Moxeparvovec 64 Vial 640 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923055665,Delandistrogene Moxeparvovec 65 Vial 650 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923055766,Delandistrogene Moxeparvovec 66 Vial 660 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923055867,Delandistrogene Moxeparvovec 67 Vial 670 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923055968,Delandistrogene Moxeparvovec 68 Vial 680 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923056069,Delandistrogene Moxeparvovec 69 Vial 690 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Sarepta Therapeutics Inc,60923056170,Delandistrogene Moxeparvovec 70 Vial 700 ML Kit,2023-06-22,3200000,"Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518 +With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available.",,1,,1,,,,,"Response to ""Estimated Number of Patients"": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product",,,,,,,,,,,,,,, +Shorla Oncology,81927011106,NELARABINE (NELARABINE) 250MG/50ML (5MG/ML) 6 x 50 ML VIAL,2023-05-16,3960,Nelarabine is a generic physician administered oncology product. Shorla Oncology will be marketing the product to pharmacists and oncologists and will be pricing the product at parity to the market/competitors,,555,,1,,,,,,,,,,,,,,,,,,,, +Slayback Pharma LLC,71225014001,"Baclofen Oral Suspension, 25mg/5mL, 250 mL in one bottle in one carton.",2023-06-28,1361.23,,1,2600,,,,,,,This is a newly approved drug in production. The first lots should be ready for market in the coming days or within two weeks. This was not an acquired drug. The total number of monthly patients has been estimated as we are not sure as to the amount of sales we will have the first year and competition is strong as there are more that 100 manufacturers with labeled Baclofen vying for market share.,,,,,,,,,,,,,,, +Stemline Therapeutics,72187010203,"ORDERDU 345 MG tablet, 30 ct",2023-02-03,21369,"When pricing Ordersu, Stemline considered a variety of factors, including the benefit to the patients, patient assistance programs, reinvestment to support lifecycle development of the compound, as well as development of new therapies, supply chain and other factors. Orserdu is the first oral estrogen receptor antagonist (commonly referred to as a SERD) and the first FDA approved therapy for appropriate mBC patients with ESR1 mutations.",,13000,,1,2020-07-23,30000000,,"Stemline's parent company, the Menarini Group, licensed Ordersdu from Radius Health, Inc. with an upfront payment of $30 million and potential additional payments of up to $320 million based on the successful achievement of future development and sales milestones. Menarini Group will make tiered, low to mid-teen percentage royalty payments to Radius Health, Inc. on global net sales.","In reference to Estimated Patients: While the overall incidence of ESR1 mutations is uncertain and reported only from small patient cohorts, it is estimated to affect ~13,000 patients with mBC in the US. We do not anticipate that Orserdu will be prescribed for that entire patient population. Orserdu is the first oral estrogen receptor antagonist (commonly referred to as a SERD) and the first FDA approved therapy for appropriate mBC patients with ESR1 mutations. Orserdu is an estrogen receptor agonist (commonly referred to as a SERD) indicated for the treatment of postmenopausal women or adult men with ER+/HER2- , ESR1 mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Orserdu is the first FDA approved therapy for these patients. In 2022, the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program estimated that there would be 287,850 new cases of breast cancer diagnosed in the United States (US) (Siegel 2022). Approximately 6% of women have mBC at the time of their initial diagnosis and 20% to 40% of women initially diagnosed with localized or regional breast cancers will develop metastatic disease (SEER 2022; Vera-Llonch 2011). Approximately 68% of breast cancers diagnosed in women are ER/PR-positive and HER2- negative (SEER Cancer Stat Facts: Female Breast Cancer Subtypes. National Cancer Institute. Cyclin dependent kinase 4/6 (CDK4/6) inhibitors, combined with either an aromatase inhibitor or fulvestrant has since become the mainstay for first-line management of postmenopausal women with ER/PR-positive, HER2-negative mBC (Finn 2016b; Hortobagyi 2018; Goetz 2017; Tripathy 2018; Burstein 2021; NCCN v2.2023). However, tumors eventually develop endocrine resistance, often through the development of an estrogen receptor 1 gene (ESR1) mutation. Development of an acquired mutation in ESR1 is one of the key mechanisms of endocrine therapy resistance. The prevalence of ESR1 mutations in patients depends on prior duration and setting of endocrine therapy. ESR1 mutations have been reported in up to 39% of patients with ER/PR-positive, HER2 negative advanced or mBC who have received prior treatment with an aromatase inhibitor in the metastatic setting (Reinert 2017).",,,,,,,,,,,,,,, +Stemline Therapeutics,72187010103,"ORSERDU 86 MG tablets, 30 ct",2023-02-03,7123,"When pricing Ordersu, Stemline considered a variety of factors, including the benefit to the patients, patient assistance programs, reinvestment to support lifecycle development of the compound, as well as development of new therapies, supply chain and other factors. Orserdu is the first oral estrogen receptor antagonist (commonly referred to as a SERD) and the first FDA approved therapy for appropriate mBC patients with ESR1 mutations.",,13000,,1,2020-07-23,30000000,,"Stemline's parent company, the Menarini Group, licensed Ordersdu from Radius Health, Inc. with an upfront payment of $30 million and potential additional payments of up to $320 million based on the successful achievement of future development and sales milestones. Menarini Group will make tiered, low to mid-teen percentage royalty payments to Radius Health, Inc. on global net sales.","In reference to Estimated Patients: While the overall incidence of ESR1 mutations is uncertain and reported only from small patient cohorts, it is estimated to affect ~13,000 patients with mBC in the US. We do not anticipate that Orserdu will be prescribed for that entire patient population. Orserdu is the first oral estrogen receptor antagonist (commonly referred to as a SERD) and the first FDA approved therapy for appropriate mBC patients with ESR1 mutations. Orserdu is an estrogen receptor agonist (commonly referred to as a SERD) indicated for the treatment of postmenopausal women or adult men with ER+/HER2- , ESR1 mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Orserdu is the first FDA approved therapy for these patients. In 2022, the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program estimated that there would be 287,850 new cases of breast cancer diagnosed in the United States (US) (Siegel 2022). Approximately 6% of women have mBC at the time of their initial diagnosis and 20% to 40% of women initially diagnosed with localized or regional breast cancers will develop metastatic disease (SEER 2022; Vera-Llonch 2011). Approximately 68% of breast cancers diagnosed in women are ER/PR-positive and HER2- negative (SEER Cancer Stat Facts: Female Breast Cancer Subtypes. National Cancer Institute. Cyclin dependent kinase 4/6 (CDK4/6) inhibitors, combined with either an aromatase inhibitor or fulvestrant has since become the mainstay for first-line management of postmenopausal women with ER/PR-positive, HER2-negative mBC (Finn 2016b; Hortobagyi 2018; Goetz 2017; Tripathy 2018; Burstein 2021; NCCN v2.2023). However, tumors eventually develop endocrine resistance, often through the development of an estrogen receptor 1 gene (ESR1) mutation. Development of an acquired mutation in ESR1 is one of the key mechanisms of endocrine therapy resistance. The prevalence of ESR1 mutations in patients depends on prior duration and setting of endocrine therapy. ESR1 mutations have been reported in up to 39% of patients with ER/PR-positive, HER2 negative advanced or mBC who have received prior treatment with an aromatase inhibitor in the metastatic setting (Reinert 2017).",,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304004327,Lenalidomide Caps 10Mg 28ct,2023-03-20,20157.36,,1,235000,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304004422,Lenalidomide Caps 15Mg 21ct,2023-03-20,15118.04,,1,235000,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304004127,Lenalidomide Caps 2.5Mg 28ct,2023-03-20,20157.36,,1,235000,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304004522,Lenalidomide Caps 20Mg 21ct,2023-03-20,15118.04,,1,235000,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304004622,Lenalidomide Caps 25Mg 21ct,2023-03-20,15118.04,,1,235000,,,,,,,,,,,,,,,,,,,,,, +SUN PHARMACEUTICALS,63304004227,Lenalidomide Caps 5Mg 28ct,2023-03-20,20157.36,,1,235000,,,,,,,,,,,,,,,,,,,,,, +"Taiho Oncology, Inc.",64842012004,"Lytgobi tablets, 12MG (3 tablets); 4MG 21 tablet count DosePak",2023-02-10,5835,,1,1,1,1,,,,,,,,,,,,,,,,,,,, +"Taiho Oncology, Inc.",64842012005,"Lytgobi tablets, 16MG (4 tablets); 4MG 28 tablet count DosePak",2023-02-10,5835,,1,1,1,1,,,,,,,,,,,,,,,,,,,, +"Taiho Oncology, Inc.",64842012006,"Lytgobi tablets, 20MG (5 tablets); 4MG 35 tablet count DosePak",2023-02-10,5835,,1,1,1,1,,,,,,,,,,,,,,,,,,,, +"Teva Neuroscience, Inc.",68546047156,AUSTEDO XR® 12mg (30ct),2023-05-08,4720.5,,1,533000,,,,,,,"Research suggests that the diagnosed prevelance for Huntington's is about 33,000. Tardive dyskinesia affects about 500,000 individuals in the United States; Teva developed this product.",,,,,,,,,,,,,,, +"Teva Neuroscience, Inc.",68546047256,AUSTEDO XR® 24mg (30ct),2023-05-08,7080.7,,1,533000,,,,,,,"Research suggests that the diagnosed prevelance for Huntington's is about 33,000. Tardive dyskinesia affects about 500,000 individuals in the United States; Teva developed this product.",,,,,,,,,,,,,,, +"Teva Neuroscience, Inc.",68546047056,AUSTEDO XR® 6mg (30ct),2023-05-08,2360.25,,1,533000,,,,,,,"Research suggests that the diagnosed prevelance for Huntington's is about 33,000. Tardive dyskinesia affects about 500,000 individuals in the United States; Teva developed this product.",,,,,,,,,,,,,,, +"Teva Neuroscience, Inc.",51759052010,UZEDY ER Inj. 100mg/0.28 ML,2023-05-17,2464,,1,3300000,,,,,,,"Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +"Teva Neuroscience, Inc.",51759063010,UZEDY ER Inj. 125mg/0.35 ML,2023-05-17,3080,,1,3300000,,,,,,,"Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +"Teva Neuroscience, Inc.",51759074010,UZEDY ER Inj. 150mg/0.42 ML,2023-05-17,3696,,1,3300000,,,,,,,"Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +"Teva Neuroscience, Inc.",51759085010,UZEDY ER Inj. 200mg/0.56 ML,2023-05-17,4928,,1,3300000,,,,,,,"Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +"Teva Neuroscience, Inc.",51759096010,UZEDY ER Inj. 250mg/0.70 ML,2023-05-17,6160,,1,3300000,,,,,,,"Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +"Teva Neuroscience, Inc.",51759030510,UZEDY ER Inj. 50mg/0.14 ML,2023-05-17,1232,,1,3300000,,,,,,,"Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +"Teva Neuroscience, Inc.",51759041010,UZEDY ER Inj. 75mg/0.21 ML,2023-05-17,1848,,1,3300000,,,,,,,"Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product.",,,,,,,,,,,,,,, +"Teva Neuroscience, Inc.",68546049052,AUSTEDO® XR Patient Titration Kit,2023-08-01,6608.68,,1,533000,,,,,,,"Research suggests that the diagnosed prevelance for Huntington's is about 33,000. Tardive dyskinesia affects about 500,000 individuals in the United States; Teva developed this product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480542589,SORAFENIB TOSYLATE TABLET 200MG 120,2023-01-03,10874.47,,1,50000,,,,,,,"Research suggests that there are roughly 50,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480124128,LENALIDOMIDE CAPSULE 2.5MG 28,2023-03-08,20157.36,,1,70000,,,,,,,"Research suggests that there are as many as 70,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Natco Pharma.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480124521,LENALIDOMIDE CAPSULE 20MG 21,2023-03-08,15118.04,,1,70000,,,,,,,"Research suggests that there are as many as 70,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Natco Pharma.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480235901,TOPIRAMATE ER CAPSULE 200MG 100,2023-03-31,3750.75,,1,21300000,,1,,,,,"Research suggests that as many as 21.3 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480235956,TOPIRAMATE ER CAPSULE 200MG 30,2023-03-31,1125.24,,1,21300000,,1,,,,,"Research suggests that as many as 21.3 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480235801,TOPIRAMATE ER CAPSULE 100MG 100,2023-05-03,2741.92,,1,21300000,,1,,,,,"Research suggests that as many as 21.3 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480235601,TOPIRAMATE ER CAPSULE 25MG 100,2023-05-03,1062.41,,1,21300000,,1,,,,,"Research suggests that as many as 21.3 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480235701,TOPIRAMATE ER CAPSULE 50MG 100,2023-05-03,1383.9,,1,21300000,,1,,,,,"Research suggests that as many as 21.3 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product.",,,,,,,,,,,,,,, +Teva Pharmaceuticals USA,480405356,GEFITINIB TABLET 250MG 30,2023-06-21,4439.66,,1,80000,,,,,,,"Research suggests that as many as 80,000 Americans, in total, suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product.",,,,,,,,,,,,,,, +"TG Therapeutics, Inc.",73150015006,BRIUMVI (ublituximab-xiiy) 150 mg/6 mL Vial,2023-01-26,9833.33,"Marketing Plan: + +BRIUMVI was approved on 12/28/22 as a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TG Therapeutics has designed marketing activities to raise awareness and understanding with Healthcare Providers, Patients and Care Partners about the approved indications, efficacy, safety and patient support services offerings available. + + TG Therapeutics will take a very targeted approach to paid advertising to both Healthcare Providers, Patients and Care Partners. TG is not planning on executing DTC advertising via TV executions at this time, instead there will be a focus on leveraging digital platforms such as banner, social media, paid search, etc. We will, however, have a patient-facing website that provides information about BRIUMVI, the diseases it is approved to treat, and the BRIUMVI Patient Support Program. + +At launch TG will not offer coupons or free trials or other promotional incentives. However, at launch TG will offer copayment assistance to commercially insured patients through the BRIUMVI Patient Support Program. Information about the BRIUMVI Patient Support Program, including the commercial co-pay program, will be provided to healthcare providers (“HCPs”) by our sales representatives and via an HCP website, and to patients via a patient-facing website. + +In preparation for launch over the 2022 calendar year, promotional spend was focused on creating content for HCPs to raise awareness of TG Therapeutics, including medical congress activities and unbranded speaker programs. From a branded perspective promotional spend was focused on developing content in anticipation for the launch of BRIUMVI, including non-personal promotion (branded website and in office resources). + +Pricing Plans: + +TG Therapeutics was founded with one broad mission: to develop novel and valuable treatment options for patients with B-cell diseases. Our commitment to patients, however, goes beyond science. We believe that access is essential in ensuring advances are available to patients who are in need of treatment options. This is why we created a unique approach to our decision-making around access and pricing anchored on the clinical value of our products and guided by three core pillars: fiercely focused on patients, access and solutions. TG Therapeutics is committed to responsible pricing and partnership across the healthcare system and we listened carefully to the MS community, including neurologists, patients, payers and advocacy groups to ensure that we priced BRIUMVI to optimize access for patients.",,70000,,,2012-01-30,,1,"TG Therapeutics does not believe the acquisition price is in the public domain or publicly available. Accordingly, TG Therapeutics is limiting its response to this item pursuant to California Health & Safety Code § 127681(c).","Comment regarding number of Estimated Patients field: There are currently 900,000 – 1,000,000 patients diagnosed with MS in the US, with ~350,000 receiving an MS DMT in any given year. Each year there are approximately 80,000 – 90,000 patients in the US who are in need of a new MS treatment. Approximately ~85% of MS patients fall within our FDA labelled indications (Relapsing MS).",,,,,,,,,,,,,,, +Tolmar Inc,62935046150,ELIGARD® 45mg (leuprolide acetate for injectable suspension) 6 months of therapy,2023-03-08,2710.13,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers, patients, and caregivers about the approved indication, efficacy and safety data contained within the medicine's FDA approved label. Generally, Tolmar markets in the US at medical conferences in the urology and oncology community, as well as promoting to appropriate healthcare professionals, patients, and caregivers",,12000,,,,,,,"As part of Tolmar’s commitment to advancing science and patient care, Tolmar has launched a new Eligard®(leuprolide acetate) for injectable suspension. The new Eligard is designed to streamline the mixing and administration process by providing the product in a single, pre-connected unit",,,,,,,,,,,,,,, +Tolmar Inc,62935016360,FENSOLVI® 45mg (leuprolide acetate for injectable suspension) 6 months of therapy,2023-04-01,24891.68,"Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers, patients, and caregivers about the approved indication, efficacy and safety data contained within the medicine's FDA approved label. Generally, Tolmar markets in the US at medical conferences in the pediatric Endocrinology community, as well as promoting to appropriate healthcare professionals, patients, and caregivers",,1200,,,,,,,"As part of Tolmar’s commitment to advancing science and patient care, Tolmar has launched a new Fensolvi®(leuprolide acetate) for injectable suspension. The new Fensolvi® is designed to streamline the mixing and administration process by providing the product in a single, pre-connected unit",,,,,,,,,,,,,,, +"Travere Therapeutics, Inc.",68974020030,"Filspari (sparsentan) Oral tablets, 200mg, 30 tablets",2023-02-28,9900,"Our marketing and market access teams, supported by third-party agencies with rare disease experience, drives our commercialization and disease awareness efforts in the United States. Specifically, we implement a variety of industry accepted programs to educate physicians, including direct-to-physician contact by sales representatives, peer-to-peer educational programs, and participation in targeted medical convention programs. +We plan to distribute FILSPARI through three direct to patient pharmacies, and operate Travere TotalCare, pursuant to which we will provide our comprehensive patient support services. This patient support program for FILSPARI in the United States will provide services, assistance and resources that will help patients understand IgAN, manage the insurance process, fill their prescriptions and initiate treatment. Travere has a long-standing commitment to setting prices responsibly based on the value our medicines bring to patients, society and healthcare systems. Our approach reflects our commitment to continued transparency in how we price our prescription medicines in the United States while minimizing our contribution to health system spending. + +When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers the following factors +1) Clinical value and outcomes, or the benefit the medicine delivers to patients, and how well it works compared to a standard of care; +2) Economic value, or how the medicine reduces the need—and therefore costs—of other healthcare interventions +3) Social value, or how the medicine contributes to quality of life, and productivity.",,1500,,1,,,,,,,,,,,,,,,,,,,, +"Travere Therapeutics, Inc.",68974040030,"Filspari (sparsentan) Oral tablets, 400mg, 30 tablets",2023-03-01,9900,"Our marketing and market access teams, supported by third-party agencies with rare disease experience, drives our commercialization and disease awareness efforts in the United States. Specifically, we implement a variety of industry accepted programs to educate physicians, including direct-to-physician contact by sales representatives, peer-to-peer educational programs, and participation in targeted medical convention programs. +We plan to distribute FILSPARI through three direct to patient pharmacies, and operate Travere TotalCare, pursuant to which we will provide our comprehensive patient support services. This patient support program for FILSPARI in the United States will provide services, assistance and resources that will help patients understand IgAN, manage the insurance process, fill their prescriptions and initiate treatment. Travere has a long-standing commitment to setting prices responsibly based on the value our medicines bring to patients, society and healthcare systems. Our approach reflects our commitment to continued transparency in how we price our prescription medicines in the United States while minimizing our contribution to health system spending. + +When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers the following factors +1) Clinical value and outcomes, or the benefit the medicine delivers to patients, and how well it works compared to a standard of care; +2) Economic value, or how the medicine reduces the need—and therefore costs—of other healthcare interventions +3) Social value, or how the medicine contributes to quality of life, and productivity.",,1500,,1,,,,,,,,,,,,,,,,,,,, +"TruPharma, LLC",52817061516,"Tramadol 5mg/mL Solution, Oral 473mL",2023-01-27,471.05,This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only.,,48790,,,,,,,,,,,,,,,,,,,,,, +"UCB, Inc",50474098079,RYSTIGGO 140 MG/ML 2 ML VIAL,2023-06-27,6050,,1,176,1,1,,,,,"UCB estimates that the average number of patients in the USA who may be prescribed Rystiggo for calendar year 2023 is approximately 176 and for calendar year 2024 is 563. The foregoing estimates are based on UCB analysis of the estimated number of generalized myasthenia gravis (gMG) patients that are (i) anti-acetylcholine receptor antibody-positive (AChR+) with low to moderate restrictiveness, or (ii) muscle-specific tyrosine kinase antibody seropositive with low restrictiveness. UCB used the following sources for the foregoing analysis: IQVIA Pharmetrics, IQVIA LAAD, Symphony Health data and Komodo Heath data",,,,,,,,,,,,,,, +United Therapeutics,66302030002,Orenitram 0.125MG Tab 10 ct. Blister Pack,2023-03-01,66.2,"United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). + +Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment.",,2180,,,,,,,"Estimated patients is confidential and proprietary, and not publicly available or within the public domain.",,,,,,,,,,,,,,, +United Therapeutics,66302030202,Orenitram 0.25MG Tab 10 ct. Blister Pack,2023-03-01,132.38,"United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). + +Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment.",,2180,,,,,,,"Estimated patients is confidential and proprietary, and not publicly available or within the public domain.",,,,,,,,,,,,,,, +United Therapeutics,66302031002,Orenitram 1.0MG Tab 10 ct. Blister Pack,2023-03-01,529.57,"United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). + +Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment.",,2180,,,,,,,"Estimated patients is confidential and proprietary, and not publicly available or within the public domain.",,,,,,,,,,,,,,, +United Therapeutics,66302032502,Orenitram 2.5MG Tab 10 ct. Blister Pack,2023-03-01,1323.91,"United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). + +Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment.",,2180,,,,,,,"Estimated patients is confidential and proprietary, and not publicly available or within the public domain.",,,,,,,,,,,,,,, +United Therapeutics,66302035002,Orenitram 5MG Tab 10 ct. Blister Pack,2023-03-01,2647.83,"United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). + +Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment.",,2180,,,,,,,"Estimated patients is confidential and proprietary, and not publicly available or within the public domain.",,,,,,,,,,,,,,, +United Therapeutics,66302036384,Orenitram Titration Kit 7-Blister Card Pack 0.125mg and 0.25mg and 1 mg Month 3,2023-03-01,5838.84,"United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). + +Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment.",,2180,,,,,,,"Estimated patients is confidential and proprietary, and not publicly available or within the public domain.",,,,,,,,,,,,,,, +United Therapeutics,66302036128,Orenitram Titration Kit 7-Blister Card Pack 0.125mg and 0.25mg Month 1,2023-03-01,1390.2,"United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). + +Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment.",,2180,,,,,,,"Estimated patients is confidential and proprietary, and not publicly available or within the public domain.",,,,,,,,,,,,,,, +United Therapeutics,66302036256,Orenitram Titration Kit 7-Blister Card Pack 0.125mg and 0.25mg Month 2,2023-03-01,3614.52,"United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). + +Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment.",,2180,,,,,,,"Estimated patients is confidential and proprietary, and not publicly available or within the public domain.",,,,,,,,,,,,,,, +"Upsher-Smith Laboratories, LLC",245600111,VIGADRONE® Tablets contain the antiepileptic agent vigabatrin in a strength of 500 mg and are indicated for certain patients with infantile spasms and refractory complex partial seizures.,2023-07-28,14929,"• The Marketing Plan is to focus on providing patients and providers with a low cost alternative to the brand Sabril, and to provide education about the services Upsher-Smith offers through a specialty pharmacy to help parents and patients manage side effects, provide speed to therapy via rapid shipments, offer bridge supply during insurance interruption, manage transitions from powder dosage form to tablet dosage form & to provide education about the disease state. The marketing activities include a web site, email activities, attending medical conferences, and supporting a small account management team that focuses on centers of excellence.",,11,,,,,,,There are ~114 new Vigabatrin patients enrolled in the REMS program each month; 10-15% of those patients are vigabatrin tablet patients,,,,,,,,,,,,,,, +USAntibiotics,81964000354,AUGMENTIN ES-600- amoxicillin and clavulanate potassium for suspension,2023-04-29,915.36,,1,251100000,,,,,,,number of patients represents number of annual patients in US receiving anitibiotic prescriptions,,,,,,,,,,,,,,, +Vericel Corporation,69866200503,NexoBrid (anacaulase-bcdb) For topical gel - 4.85 g anacaulase-bcdb in 5 g lyophilized powder. For Topical Use Only.,2023-01-16,3150,,1,25500,,,2019-05-07,17500000,,"The agreement states an upfront payment of $17.5 million, with an additional $7.5 million payment contingent upon U.S. approval and up to $125 million contingent upon meeting certain annual sales milestones.",,,,,,,,,,,,,,,, +XGen Pharmaceuticals DJB,39822303002,Pentamidine for Inhalation 300mg/vial,2023-07-01,90,,1,7800,,,,,,,The marketing date for this item has been updated with a marketing launch date of 6/30/2023 in the CMS date bank (and other databanks as needed).,,,,,,,,,,,,,,, +XGen Pharmaceuticals DJB,39822305002,Pentamidine for Injection 300mg/vial x10,2023-07-01,900,,1,5364,,,,,,,The marketing date for this item has been updated with a marketing launch date of 6/30/2023 in the CMS date bank (and other databanks as needed).,,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,68382076906,Topiramate ER Capsules 100mg 30ct,2023-01-04,822.26,,1,42400000,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “42,400,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Topiramate ER Capsules is indicated for the treatment of epileptic seizures and for the treatment of migraines. As per the CDC link ""Frequently asked questions about Epilepsy"" (https://www.cdc.gov/epilepsy/about/faq.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fepilepsy%2Fbasics%2Ffaq.htm) about 3.4 million people in the United States have active epilepsy. Also, as per the link ""How Common is Migraine?"" (https://migraine.com/migraine-statistics) roughly 39 million people in the United States have migraine. For this reason we have put in a number of 42.4 million in estimated number of patients.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710103007,Lenalidomide 2.5mg Capsule (28 CAPS),2023-03-06,20157.36,,1,60000,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “60,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Lenalidomide is indicated for the treatment of Multiple Myeloma. As per the University of California San Francisco link (https://www.ucsfhealth.org/conditions/multiple-myeloma#) about 60,000 people have this disease and 20,000 new cases are diagnosed each year in the United States.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710103408,Lenalidomide 20mg Capsule (21 CAPS),2023-03-06,15118.04,,1,60000,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “60,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Lenalidomide is indicated for the treatment of Multiple Myeloma. As per the University of California San Francisco link (https://www.ucsfhealth.org/conditions/multiple-myeloma#) about 60,000 people have this disease and 20,000 new cases are diagnosed each year in the United States.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,68382035201,Sirolimus 2mg Tablets (100 ct),2023-03-23,1186.34,,1,25000,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “25,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Sirolimus is indicated to prevent rejction of a kidney transplant. As per Organ Procurement & Transplantation Network (OPTN) link (https://optn.transplant.hrsa.gov/news/2022-organ-transplants-again-set-annual-records-organ-donation-from-deceased-donors-continues-12-year-record-setting-trend/) upwards of 25,000 people in the United States had first time kidney transplants in 2022. For this reason we are estimating approximately 25,000 patients.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710189506,Arsenic Trioxide Injection (NovaPlus N+) 10mg/10ml,2023-04-24,3790.5,,1,5000,,,,,,,"This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “5,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Arsenic Trioxide is indicated for the treatment of acute promyelocytic leukemia (APL). As per NIH GARD (Genetic and Rare Diseases Information Center) link (https://rarediseases.info.nih.gov/diseases/538/acute-promyelocytic-leukemia) fewer than 5,000 people in the United States have this disease. For this reason we are estimating approximately 5,000 patients.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710189606,Arsenic Trioxide Injection (NovaPlus N+) 12mg/6ml,2023-04-24,5388.77,,1,5000,,,,,,,"This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “5,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Arsenic Trioxide is indicated for the treatment of acute promyelocytic leukemia (APL). As per NIH GARD (Genetic and Rare Diseases Information Center) link (https://rarediseases.info.nih.gov/diseases/538/acute-promyelocytic-leukemia) fewer than 5,000 people in the United States have this disease. For this reason we are estimating approximately 5,000 patients.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710120801,Plerixafor Inj. 24mg/1.2mL (1X1.2mL),2023-07-26,1200,,1,20000,,,,,,,"This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “20,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Plerixafor is indicated for the peripheral mobilization of hematopoietic stem cells for those patients with certain types of cancer (non-Hodgkin's lymphoma-NHL, multiple myeloma-MM) to prepare them for stem cell transplant. As per NIH LIbrary of Medicine National Center for Biotechnology Information link regarding the Prevalence of Hemtopoietic Cell Transplant Survivors in the United States (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3779514/#) approximately 20,000 patients receive HCT (hematopoietic cell transplantation) each year in the USA. For this reason we are estimating approximately 20,000 patients.",,,,,,,,,,,,,,, +Zydus Pharmaceuticals (USA) Inc.,70710185207,Indomethacin Suppositories 50mg,2023-08-03,10314.29,,1,1300000,,,,,,,"This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “1,300,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into ""Estimated Number of Patients"" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Indomethacin Suppository is indicated for for moderate to severe ankylosing spondylitis, osteoarthritis, rheumatoid arthritis or gouty arthritis in adults and children older than 14 years of age. As per NIH LIbrary of Medicine National Center for Biotechnology Information link regarding the Prevalence Trend and Disparities in Rheumatoid Arthritis amound US Adults 2005-2018 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8348893/#) approximately 1.3 million adults suffer from RA, representing 0.6% to 1% of the adult population. For this reason we are estimating approximately 1.3 million patients.",,,,,,,,,,,,,,,