Table: q1_q4_2019_prescription_drugs_intro_to_market , manufacturer_name like all*

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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	705.6700	None	1	None	None	None	None	None	None	None	ESTIMATED_PATIENTS: unknown to Sun; MARKETING_PRICING_NONPUBLIC:This information is proprietary to Sun and as such, is non-public.	None
SUN PHARMACEUTICALS	47335023683	Ambrisentan 5 mg Tabs 30ct	2019-04-25	7500.0000	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.	None	0	None	None	None	None	None	None	Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space.	None
SUN PHARMACEUTICALS	47335023783	Ambrisentan 10 mg Tabs 30ct	2019-04-25	7500.0000	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.	None	0	None	None	None	None	None	None	Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space.	None
SUN PHARMACEUTICALS	47335003886	Bosentan Tablets 62.5mg 60ct	2019-06-14	6281.0700	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.	None	0	None	None	None	None	None	None	Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space.	None
SUN PHARMACEUTICALS	47335003986	Bosentan Tablets 125mg 60ct	2019-06-14	6281.0700	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.	None	0	None	None	None	None	None	None	Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space.	None
SUN PHARMACEUTICALS	63304073410	Esomeprazole 20mg DR Cap 1000ct	2019-05-15	826.7100	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.	None	0	None	None	None	None	None	None	Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space.	None
SUN PHARMACEUTICALS	63304073510	Esomeprazole 40mg DR Cap 1000ct	2019-05-07	826.7100	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.	None	0	None	None	None	None	None	None	Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space.	None
SUN PHARMACEUTICALS	47335037983	Cinacalcet HCL Oral Tablet 30MG	2019-08-27	685.7000	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.	None	0	None	None	None	None	None	None	Estimated average of patients per month is unknown to Sun Pharma; Sun received FDA approval for the drug’s ANDA application (Application number A207008)	None
SUN PHARMACEUTICALS	47335038083	Cinacalcet HCL Oral Tablet 60MG	2019-08-27	1371.3900	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.	None	0	None	None	None	None	None	None	Estimated average of patients per month is unknown to Sun Pharma; Sun received FDA approval for the drug’s ANDA application (Application number A207008)	None
SUN PHARMACEUTICALS	47335060083	Cinacalcet HCL Oral Tablet 90MG	2019-08-27	2057.0900	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.	None	0	None	None	None	None	None	None	Estimated average of patients per month is unknown to Sun Pharma; Sun received FDA approval for the drug’s ANDA application (Application number A207008)	None
SUN PHARMACEUTICALS	63304009530	Erlotinib Tab 25mg/30ct	2019-11-11	2481.0000	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.	None	None	None	None	None	None	None	None	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.	None
SUN PHARMACEUTICALS	63304009630	Erlotinib Tab 100mg/30ct	2019-11-11	6445.8200	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.	None	None	None	None	None	None	None	None	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	None
SUN PHARMACEUTICALS	63304013530	Erlotinib Tab 150mg/30ct	2019-11-11	7302.0100	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.	None	None	None	None	None	None	None	None	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	None
SUN PHARMACEUTICALS	62756009045	MEDROXYPROGESTERONE 150 mg/ml 1 ml Vial 25pk	2019-10-02	2036.3800	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.	None	None	None	None	None	None	None	None	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	None
SUN PHARMACEUTICALS	62756057083	Deferasirox OS Tab 500mg 30ct	2019-12-17	760.0800	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.	None	0	None	None	None	None	None	None	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	00409111201	Busulfan Injection 60 mg/10mL (6mg/mL)	2019-02-28	7786.0000	None	1	70000	None	None	None	None	None	None	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.	None
Pfizer	00069197540	VYNDAQEL® (tafamidis meglumine) 20MG CAP 4X30 BLST US	2019-05-06	187500.0000	None	1	None	1	1	2010-10-06	None	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%.	None
Pfizer	00069873030	VYNDAMAX™ 61MG CAP 3X10 BLST US	2019-08-27	18750.0000	None	1	3000	None	None	2010-10-06	None	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%.	None
Pfizer	00409139051	MEROPENEM 500mg SPO 1x10 GVIAL US	2019-10-08	145.0000	None	1	None	None	None	None	None	None	None	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.	None
Pfizer	00409139122	MEROPENEM 1gm SPO 1x10 GVIAL US	2019-10-08	291.4000	None	1	None	None	None	None	None	None	None	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.	None
Pfizer	00409110301	CISATRACURIUM 200MG/20ML SSOL 1X10 GVL	2019-11-06	2705.0000	None	1	None	None	None	None	None	None	None	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.	None
Pfizer	00069034201	ZIRABEV™ 400MG/16ML SSOL 1x1 GVL US	2019-12-31	2453.6000	None	1	75000	None	None	None	None	None	None	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.	None
Pfizer	00069031501	ZIRABEV™ 100MG/4ML SSOL 1X1 GVL US	2019-12-31	613.4000	None	1	75000	None	None	None	None	None	None	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.	None
Sanofi	05846802271	Cablivi (caplacizumab-yhdp)	2019-04-02	7300.0000	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.	None	1800	None	1	None	None	None	None	Ablynx, a Sanofi Company, was acquired by Sanofi in 2018.	None
AstraZeneca	00310183030	Name- Fasenra Pen (benralizumab) Dosage- 30mg/mL solution Form- Injection: In a single dose pre-filled autoinjector	2019-10-28	4895.7400	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.	None	1000000	None	None	None	None	None	None	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.	None
Janssen	50458002802	SPRAVATO Estekamine Nasal Spray 56mg (2X28mg)	2019-03-08	590.0000	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.	None	None	1	1	None	None	None	None	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.	None
Janssen	50458002803	SPRAVATO Estekamine Nasal Spray 84mg (3X28mg)	2019-03-08	885.0000	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.	None	None	1	1	None	None	None	None	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.	None
Janssen	59676003056	BALVERSA Erdafitinib 3mg 56 tablets	2019-04-15	15120.0000	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.	None	None	1	1	None	None	None	None	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.	None
Janssen	59676003084	BALVERSA Erdafitinib 3mg 84 tablets	2019-04-15	22680.0000	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.	None	None	1	1	None	None	None	None	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.	None
Janssen	59676004028	BALVERSA Erdafitinib 4mg 28 tablets	2019-04-15	10080.0000	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.	None	None	1	1	None	None	None	None	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.	None
Janssen	59676004056	BALVERSA Erdafitinib 4mg 56 tablets	2019-04-15	20160.0000	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.	None	None	1	1	None	None	None	None	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.	None
Janssen	59676005028	BALVERSA Erdafitinib 5mg 28 tablets	2019-04-15	12600.0000	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.	None	None	1	1	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00093526398	SOLIFENACIN SUCCINATE TABLETS 5MG 90	2019-04-22	999.2400	None	1	80000	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00093526498	SOLIFENACIN SUCCINATE TABLETS 10MG 90	2019-04-22	999.2400	None	1	86000	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00093766356	ERLOTINIB HCL TABLETS EQ 100MG 30	2019-05-09	6455.8200	None	1	660	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00093765256	VARDENAFIL HCL TABLETS 2.5MG 30	2019-01-03	704.5900	None	1	101361	None	None	None	None	None	Acquisition date and acquisition price not applicable; Teva developed this product.	Projected count of 101,361 patients in 2018, based on IQVIA data.	None
Teva Pharmaceuticals USA	00093765356	VARDENAFIL HCL TABLETS 5MG 30	2019-01-03	704.5900	None	1	101361	None	None	None	None	None	Acquisition date and acquisition price not applicable; Teva developed this product.	Projected count of 101,361 patients in 2018, based on IQVIA data.	None
Teva Pharmaceuticals USA	00093765456	VARDENAFIL HCL TABLETS 10MG 30	2019-01-03	704.5900	None	1	101361	None	None	None	None	None	Acquisition date and acquisition price not applicable; Teva developed this product.	Projected count of 101,361 patients in 2018, based on IQVIA data.	None
Teva Pharmaceuticals USA	00093765556	VARDENAFIL HCL TABLETS 20MG 30	2019-01-03	704.5900	None	1	101361	None	None	None	None	None	Acquisition date and acquisition price not applicable; Teva developed this product.	Projected count of 101,361 patients in 2018, based on IQVIA data.	None
Teva Pharmaceuticals USA	00591385101	VIGABATRIN 500MG TABLETS 100	2019-02-06	11487.3000	None	1	5000	None	1	None	None	None	Acquisition date and acquisition price not applicable; Teva developed this product.	Estimated count of approximately 5,000 patients per year.	None
Teva Pharmaceuticals USA	45963045430	DEFERASIROX 125MG TABLETS 30	2019-03-22	750.9900	None	1	900	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	45963045530	DEFERASIROX 250MG TABLETS 30	2019-03-22	1501.9500	None	1	900	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	45963045630	DEFERASIROX 500MG TABLETS 30	2019-03-22	3003.8400	None	1	900	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00591240530	AMBRISENTAN 5MG FC TABLETS 30	2019-04-30	2766.8100	None	1	650	None	1	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00591240630	AMBRISENTAN 10MG FC TABLETS 30	2019-04-30	2766.8100	None	1	1600	None	1	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00093766456	ERLOTINIB HCL TABLETS EQ 150MG 30	2019-05-09	7302.0100	None	1	1120	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	45963041850	RANOLAZINE 500MG ER TABLETS 500	2019-05-28	711.2500	None	1	145000	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	45963041950	RANOLAZINE 1000MG ER TABLETS 500	2019-05-28	1167.7500	None	1	145000	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00591251160	BOSENTAN 62.5MG FC TABLETS 60	2019-06-20	1326.0000	None	1	375	None	1	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00591251260	BOSENTAN 125MG FC TABLETS 60	2019-06-20	1326.0000	None	1	375	None	1	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00591417101	PENCILLAMINE 250MG CAPSULES 100	2019-06-24	22626.9900	None	1	310	None	1	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00093306634	ICATIBANT ACETATE 10MG/ML PFS SOL 3ML 1	2019-07-15	5083.2600	None	1	720	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00093306693	ICATIBANT ACETATE 10MG/ML PFS SOL 3ML 3	2019-07-15	15249.7800	None	1	720	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00591455022	DOXYCYCLINE HYCLATE DR TABLET 50MG 120	2019-08-14	1134.6000	None	1	270	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00591457560	DOXYCYCLINE HYCLATE DR TABLET 200MG 60	2019-08-14	2100.5100	None	1	270	None	None	None	None	None	None	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	00591501902	FULVESTRANT INJ 250MG/50ML INJ PFS SOL	2019-08-22	1675.3500	None	1	345	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00093363020	ACYCLOVIR CREAM 5% 5GM	2019-08-29	729.4700	None	1	8400	None	None	2016-08-02	-1.0000	None	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.	None
Teva Pharmaceuticals USA	00703066601	TREPROSTINIL SODIUM INJ 1MG/ML 20ML 1	2019-09-30	1209.6500	None	1	550	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00703067601	TREPROSTINIL SODIUM INJ 2.5MG/ML 20ML 1	2019-09-30	3024.1400	None	1	550	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00703068601	TREPROSTINIL SODIUM INJ 5MG/ML 20ML 1	2019-09-30	6048.2700	None	1	550	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00703069601	TREPROSTINIL SODIUM INJ 10MG/ML 20ML 1	2019-09-30	12096.5400	None	1	550	None	None	None	None	None	None	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.	None
Mylan Pharmaceuticals Inc	00378713293	Erlotinib Hydrochloride Tablets, 100mg, 30s	2019-05-09	6814.4800	None	1	613554	None	None	None	None	None	None	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.	None
Mylan Pharmaceuticals Inc	00378713393	Erlotinib Hydrochloride Tablets, 150mg, 30s	2019-05-09	7707.6800	None	1	613554	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	63459010310	TRUXIMA® (rituximab-abbs) 100 MG / 10 ML	2019-11-11	845.5500	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.	None	2415	None	None	2016-10-04	1.0000	None	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."	None	None
Teva Pharmaceuticals USA	63459010450	TRUXIMA® (rituximab-abbs) 500 MG / 50 ML	2019-11-11	4227.7500	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.	None	1469	None	None	2016-10-04	1.0000	None	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."	None	None
Teva Pharmaceuticals USA	00093351556	DEFERASIROX TABLETS 360MG 30	2019-11-25	2021.8100	None	1	1950	None	None	None	None	None	None	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.	None
Teva Pharmaceuticals USA	00591385330	DEFERASIROX 180MG TABLETS 30	2019-12-17	2189.0700	None	1	590	None	None	None	None	None	None	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.	None
Acorda Therapeutics, Inc.	10144034260	INBRIJA (levodopa inhalation powder)	2019-02-25	950.0000	o	INBRIJA™ is currently only approved in the United States and is under review of the CHMP in Europe. INBRIJA is a unique drug-device combination, consisting of a proprietary inhaled formulation of levodopa delivered by a breath-actuated inhaler. INBRIJA is the first and only inhaled levodopa formulation to treat symptoms of OFF periods as needed in patients taking a carbidopa/levodopa regimen. o	Acorda markets INBRIJA in the U.S. through our own specialty sales force. The marketing plan includes multiple comprehensive education and training initiatives, provided by our specialty sales force and account directors, for all stakeholders including health care practitioner (HCP) offices, patients, caregivers and Specialty Pharmacies. This includes training materials such as demonstration kits for HCP offices and specialty pharmacies and start kits for patients. People with Parkinson’s can suffer from cognitive challenges which make it very difficult for them to navigate the complex health insurance environment. Acorda has an active patient hub in place (Prescription Support Services) to assist patients in that health insurance navigation process to support access to INBRIJA. Our internal team of Regional Reimbursement Directors work directly with HCP offices on specific patient cases to help gain access through their insurance. Acorda offers a free sampling program to help patients and physicians evaluate effectiveness and tolerability, and a free drug Patient Assistance Program for uninsured patients with demonstrated financial hardship who satisfy eligibility criteria. Acorda provides co-pay assistance for commercially insured patients. INBRIJA is a specialty drug distributed through a closed network of specialty pharmacies under contract with Acorda. o	When considering the price of INBRIJA one must consider that INBRIJA required over 20 years to develop, from the time the inhaled ARCUS technology was invented at MIT at the lab of Bob Langer. The ARCUS technology transforms molecules in a light, dry powder allowing delivery of an effective therapeutic dose of INBRIJA through the lungs. INBRIJA is a major innovation; it is one of only three pulmonary-delivered treatments approved for a non-pulmonary indication. The innovation of ARCUS – the dry powder inhalation system – allows for pulmonary delivery that bypasses the challenges that can be associated with oral levodopa that can lead to variability in absorption, contributing to OFF periods.	None	350000	None	None	2014-10-22	525000000.0000	None
Bayer	50419039501	Nubeqa® (darolutamide) 300 mg tablet	2019-08-05	11550.0000	None	1	200	None	1	2014-06-02	68000000.0000	None	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.	None	None
Mylan Pharmaceuticals Inc	00378427093	Ambrisentan Tablets, 5mg, 30s	2019-05-07	1152.0400	None	1	5270	None	1	None	None	None	None	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.	None
Sandoz Inc.	00781342080	TREPROSTINIL INJECTION 20MG/20ML (1MG/ML) 1LIVI	2019-03-25	1145.9900	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.	None	52000	None	None	None	None	None	None	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.	00781342580	TREPROSTINIL INJECTION 50MG/20ML (2.5MG/ML) 1LIVI	2019-03-25	2864.9700	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.	None	52000	None	None	None	None	None	None	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.	00781342780	TREPROSTINIL INJECTION 100MG/20ML (5MG/ML) 1LIVI	2019-03-25	5729.9400	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.	None	52000	None	None	None	None	None	None	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.	00781343080	TREPROSTINIL INJECTION 200MG/20ML (10MG/ML) 1LIVI	2019-03-25	11459.8800	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.	None	52000	None	None	None	None	None	None	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.	00781307912	FULVESTRANT 250MG/5ML 2LISY	2019-05-29	1745.1500	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.	None	187628	None	None	None	None	None	None	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	3925.5300	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.	None	108419	None	None	None	None	None	None	>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.	None
Servier Pharmaceuticals LLC	72694051501	Asparlas 750 U/mL 5 mL vials	2019-11-29	24000.0000	None	1	None	None	None	None	None	None	None	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.	None
GlaxoSmithKline	00173089201	NUCALA INJ 100 MG/ML	2019-06-17	2954.7300	None	1	None	None	None	None	None	None	None	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.	None
GlaxoSmithKline	00173089242	NUCALA INJ 100 MG/ML	2019-06-17	2954.7300	None	1	None	None	None	None	None	None	None	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.	None
Novo	00169430313	Rybelsus Oral Tablet 3mg	2019-10-22	772.4300	None	1	1400000	None	1	None	None	None	None	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.	None
Novo	00169430713	Rybelsus Oral Tablet 7mg	2019-10-22	772.4300	None	1	1400000	None	1	None	None	None	None	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.	None
Novo	00169431413	Rybelsus Oral Tablet 14mg	2019-10-22	772.4300	None	1	1400000	None	1	None	None	None	None	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.	None
Genentech USA	50242014301	Actemra Pen - 162mg (0.9mL)	2019-01-07	984.7200	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.	None	None	1	1	None	None	None	None	Genentech does not publicly disclose the estimated volume of patients who may be prescribed Actemra Pen - 162mg (0.9mL).	None
Genentech USA	50242091801	Tecentriq 840 mg (14mL)	2019-03-23	6216.3800	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.	None	0	None	None	None	None	None	None	Genentech does not publicly disclose the estimated volume of patients who may be prescribed Tecentriq – 840mg (14mL). Tecentriq – 840mg (14mL) was developed by Genentech.	None
Genentech USA	50242007701	Herceptin Hylecta - 600mg (5mL) Inject Sol	2019-04-08	4675.2400	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.	None	0	None	None	None	None	None	None	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.	None
Genentech USA	50242010501	Polivy 140mg Vial	2019-06-10	15000.0000	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.	None	0	1	1	None	None	None	None	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	None
Genentech USA	50242009130	Rozlytrek 100 mg 30 capsules	2019-08-22	5600.0000	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.	None	0	1	1	None	None	None	None	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.	None
Genentech USA	50242009490	Rozlytrek 200 mg 90 capsules	2019-08-21	16800.0000	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.	None	0	1	1	None	None	None	None	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.	None
AMAG Pharmaceuticals, Inc.	64011070104	Vyleesi (bremelanotide Injection) 1.75 mg/0.3mL	2019-08-19	899.0000	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.	None	None	None	None	None	None	None	None	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.	None
Mylan Institutional Inc	42292005105	Erlotinib Hydrochloride Tablets, 25mg, Unit Dose, 20s	2019-05-29	1654.0000	None	1	540000	None	None	None	None	None	None	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.	None
Mylan Institutional Inc	42292005205	Erlotinib Hydrochloride Tablets, 100mg, Unit Dose, 20s	2019-05-29	4542.9900	None	1	540000	None	None	None	None	None	None	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.	None
Mylan Institutional Inc	42292005305	Erlotinib Hydrochloride Tablets, 150mg, Unit Dose, 20s	2019-05-29	5138.4500	None	1	540000	None	None	None	None	None	None	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.	None
Mylan Pharmaceuticals Inc	00378427193	Ambrisentan Tablets, 10mg, 30s	2019-05-07	1152.0400	None	1	5270	None	1	None	None	None	None	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.	None
Mylan Institutional Inc	67457096701	Hydroxyprogesterone Caproate 250mg/mL 1mL Injection 1PK	2019-08-23	682.5500	None	1	29011965	None	1	None	None	None	None	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.	None
Mylan Institutional Inc	67457031105	Fulvestrant 50mg/mL 5mL PFS 2PK	2019-09-09	1745.1500	None	1	179962	None	1	None	None	None	None	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	3697.2600	None	1	40151	None	None	None	None	None	None	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).	None
Mylan Institutional Inc	67457099115	Ogivri (trastuzumab-dkst) for Injection 150mg/vial, 1 vial	2019-11-29	1324.6600	None	1	40151	None	None	None	None	None	None	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).	None
Mylan Pharmaceuticals Inc	00378713193	Erlotinib Hydrochloride Tablets, 25mg, 30s	2019-05-09	2481.0000	None	1	613554	None	None	None	None	None	None	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.	None
Mylan Pharmaceuticals Inc	00378619793	Cinacalcet Hydrochloride Tablets, 30mg, 30s	2019-05-23	685.7000	None	1	None	None	None	None	None	None	None	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.	None
Mylan Pharmaceuticals Inc	00378619693	Cinacalcet Hydrochloride Tablets, 60mg, 30s	2019-05-23	1371.3900	None	1	None	None	None	None	None	None	None	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.	None
Mylan Pharmaceuticals Inc	00378619593	Cinacalcet Hydrochloride Tablets, 90mg, 30s	2019-05-23	2057.0900	None	1	None	None	None	None	None	None	None	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.	None
Asegua Therapeutics LLC	72626260101	agLDV/SOF (ledipasvir 90 mg/sofosbuvir 400 mg) tablets	2019-01-02	8000.0000	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.	None	None	None	None	None	None	None	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.	None
Asegua Therapeutics LLC	72626270101	agSOF/VEL (sofosbuvir 400 mg/velpatasvir 100 mg) tablets	2019-01-02	12000.0000	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.	None	None	None	None	None	None	None	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.	None
Astellas Pharma US, Inc.	00469133050	Prograf Granules (tacrolimus for oral suspension) 1mg	2019-03-12	388.0500	None	1	None	None	None	None	None	None	None	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.	None
Astellas Pharma US, Inc.	00469123050	Prograf Granules (tacrolimus for oral suspension) 0.2mg	2019-03-12	260.0000	None	1	None	None	None	None	None	None	None	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.	None
Baxter Healthcare Corporation	00338955810	EPTIFIBATIDE	2019-02-21	240.0000	None	1	None	None	None	None	None	None	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.	None
Baxter Healthcare Corporation	00338006301	Doxil 20mg-10ml Vial	2019-10-02	1248.9600	None	1	None	None	None	2019-10-01	None	1	None	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.	None
Baxter Healthcare Corporation	00338006701	Doxil 50mg-25ml Vial	2019-10-02	3122.4000	None	1	None	None	None	2019-10-01	None	1	None	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.	None
Baxter Healthcare Corporation	00338008001	Doxorubicin HCL, 2mg/ml x 10ml vial	2019-10-02	969.0000	None	1	None	None	None	2019-10-01	None	1	None	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.	None
Baxter Healthcare Corporation	00338008601	Doxorubicin HCL, 2mg/ml x 25ml vial	2019-10-02	2422.5500	None	1	None	None	None	2019-10-01	None	1	None	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.	None
Paratek Pharmaceuticals, Inc.	71715000221	NUZYRA 150mg omadacycline tablets 6ct blister pack	2019-02-01	1185.0000	None	1	12000	None	1	None	None	None	None	None	None
Paratek Pharmaceuticals, Inc.	71715000223	NUZYRA 150mg omadacycline tablets 14ct Blister Pack	2019-02-01	2765.0000	None	1	12000	None	1	None	None	None	None	None	None
Paratek Pharmaceuticals, Inc.	71715000224	NUZYRA 150mg omadacycline tablets 16ct blister pack	2019-02-01	3160.0000	None	1	12000	None	1	None	None	None	None	None	None
Paratek Pharmaceuticals, Inc.	71715000102	NUZYRA 150mg single dose vial 10ct carton	2019-02-01	3450.0000	None	1	12000	None	1	None	None	None	None	None	None
Titan Pharmaceuticals, Inc.	52440010014	Probuphine Implant	2019-03-01	4950.0000	None	1	800	None	None	None	None	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.	None	None
Theratechnologies Inc.	62064024130	EGRIFTA SV (tesamorelin for injection) - sterile lyophilized powder 2mg/vial	2019-11-25	5300.0000	Parity pricing to original Egrifta. Print Ad In-office detailing On-line advertising	None	108	None	None	None	None	None	None	Estimated volume of patients in CA is 108	None
Kyowa Kirin, Inc.	42747060290	20 mg 90 Tablet, Film Coated in 1 Bottle	2019-09-19	4500.0000	None	1	None	None	None	None	None	None	None	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.	None
Kyowa Kirin, Inc.	42747060490	40 mg 90 Tablet, Film Coated in 1 Bottle	2019-09-19	4500.0000	None	1	None	None	None	None	None	None	None	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.	None
Ferring Pharmaceuticals	55566100001	ganirelix	2019-02-14	184.0200	None	1	None	1	None	2018-12-14	None	1	None	1) report previously submitted so we do not agree we are delinquent 2)number of patients is non public	None
ViiV Healthcare	49702024613	DOVATO TAB 50-300MG	2019-04-23	2295.0000	None	1	None	None	None	None	None	None	None	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.	None
Otsuka America Pharmaceutical, Inc.	59148002985	ABILIFY MYCITE 2mg (aripiprazole tablets with sensor)	2019-03-04	1650.0000	None	1	None	None	None	None	None	None	None	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	1650.0000	None	1	None	None	None	None	None	None	None	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	1650.0000	None	1	None	None	None	None	None	None	None	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	1650.0000	None	1	None	None	None	None	None	None	None	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	1650.0000	None	1	None	None	None	None	None	None	None	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	1650.0000	None	1	None	None	None	None	None	None	None	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	1825.0000	None	1	None	None	None	None	None	None	None	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	None
Amgen	55513013201	KANJINTI (420 mg multi dose vial)	2019-07-19	3697.2600	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).	None	None	None	None	None	None	None	None	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	None
Amgen	55513020601	MVASI (100 mg/4mL single dose vial)	2019-07-19	677.4000	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).	None	None	None	None	None	None	None	None	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	None
Amgen	55513020701	MVASI (400 mg/16mL single dose vial)	2019-07-19	2709.6000	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).	None	None	None	None	None	None	None	None	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	None
TWi Pharmaceuticals USA, Inc.	24979003504	Cyclobenzaprine Hydrochloride ER Capsule 15mg-60’s	2019-03-01	900.0000	None	1	3534	None	None	None	None	1	None	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.	None
TWi Pharmaceuticals USA, Inc.	24979003604	Cyclobenzaprine HCl ER Oral Capsule Extended Release 24 Hour 30 MG	2019-03-01	900.0000	None	1	1485	None	None	None	None	1	None	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.	None
Sarepta Therapeutics Inc	60923046502	VYONDYS 53 Golodirsen 100MG/2ML Injection vial in carton	2019-12-12	1600.0000	None	1	None	None	1	None	None	None	None	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.)	None
Mayne Pharma Inc	51862060602	Halobetasol Propionate 0.05% Foam - Hydroalcoholic	2019-01-14	1473.4600	None	1	None	None	None	2018-10-25	15000000.0000	None	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	None
Mayne Pharma Inc	51862060650	Halobetasol Propionate 0.05% Foam - Hydroalcoholic	2019-01-14	770.7200	None	1	None	None	None	2018-10-25	15000000.0000	None	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	None
Mayne Pharma Inc	51862063428	Fentanyl Buccal 100mcg Tabs 28	2019-06-19	1300.5100	None	1	None	None	None	None	None	None	None	License deal June 2019. Please be advised that the number of patients reported is not reported as Mayne Pharma does not have this data.	None
Mayne Pharma Inc	51862063528	Fentanyl Buccal 200mcg Tabs 28	2019-06-19	1643.1400	None	1	None	None	None	None	None	None	None	License deal June 2019. Please be advised that the number of patients reported is not reported as Mayne Pharma does not have this data.	None
Mayne Pharma Inc	51862063628	Fentanyl Buccal 400mcg Tabs 28	2019-06-19	2384.0600	None	1	None	None	None	None	None	None	None	License deal June 2019. Please be advised that the number of patients reported is not reported as Mayne Pharma does not have this data.	None
Mayne Pharma Inc	51862063728	Fentanyl Buccal 600mcg Tabs 28	2019-06-19	3095.2100	None	1	None	None	None	None	None	None	None	License deal June 2019. Please be advised that the number of patients reported is not reported as Mayne Pharma does not have this data.	None
Mayne Pharma Inc	51862063828	Fentanyl Buccal 800mcg Tabs 28	2019-06-19	3813.1700	None	1	None	None	None	None	None	None	None	License deal June 2019. Please be advised that the number of patients reported is not reported as Mayne Pharma does not have this data.	None
Daiichi Sankyo, Inc.	65597040601	Enhertu	2019-12-20	2295.9700	None	1	None	1	1	None	None	None	None	Average patient will need 4 vials each 3 week cycle. Estimated patient count forecasts are not made public.	None
Novartis	00078098615	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	7273.9700	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.	None	320000	None	1	None	None	None	None	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.	None
Novartis	00078097950	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	1697.2600	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.	None	320000	None	1	None	None	None	None	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.	None
Novartis	00078070802	Piqray 300 mg /56 tablets (150mg tabs)	2019-05-24	15500.0000	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.	None	43000	None	None	None	None	None	None	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.	None
Novartis	00078071502	Piqray 250 mg / 56 tablets (28 of the 200 mg tabs & 28 of the 50 mg tabs)	2019-05-24	15500.0000	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.	None	43000	None	None	None	None	None	None	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.	None
Novartis	00078070184	Piqray 200 mg / 28 tablets (28 of the 200mg tabs)	2019-05-24	15500.0000	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.	None	43000	None	None	None	None	None	None	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.	None
Novartis	00078082761	BEOVU® (brolucizumab-dbll)	2019-10-08	1850.0000	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.	None	700000	None	1	None	None	None	None	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.	None
Zydus Pharmaceuticals (USA) Inc.	70710102108	Albendazole 200mg Tablets	2019-01-18	366.2800	None	1	0	None	None	None	0.0000	None	None	This is an AB rated generic product that was developed by Zydus.	None
Zydus Pharmaceuticals (USA) Inc.	70710117903	Ambrisentan 5mg Tablets	2019-04-15	2500.0000	None	1	0	None	None	None	0.0000	None	None	This is an AB rated generic product that was developed by Zydus.	None
Zydus Pharmaceuticals (USA) Inc.	70710118003	Ambrisentan 10mg Tablets	2019-04-15	2500.0000	None	1	0	None	None	None	0.0000	None	None	This is an AB rated generic product that was developed by Zydus	None
Zydus Pharmaceuticals (USA) Inc.	70710101401	Phytonadione 5mg Tablet	2019-03-01	5358.9100	None	1	0	None	None	None	0.0000	None	None	This is an AB rated generic product that was developed by Zydus	None
Zydus Pharmaceuticals (USA) Inc.	68382044614	Bosentan 62.5mg Tablet	2019-06-03	10038.5400	None	1	0	None	None	None	0.0000	None	None	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.	None
Novartis	00078088361	ADAKVEO® (crizanlizumab-tmca) injection is a sterile, clear to opalescent, colorless to slightly brownish-yellow solution for intravenous infusion supplied as:	2019-11-18	2357.1400	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®.	None	2048	1	1	2016-11-18	665000000.0000	None	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.	None
Sigmapharm Laboratories, LLC	42794005108	Ambrisentan 5 mg tab 30ct	2019-04-29	5980.0000	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).	None	None	None	None	None	None	None	None	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.	None
Sigmapharm Laboratories, LLC	42794005208	Ambrisentan 10 mg tab 30ct	2019-04-29	5980.0000	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).	None	None	None	None	None	None	None	None	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.	None
Cameron Pharmaceuticals, LLC	42494042810	LORZONE (CHLORZOXAZONE 750 MG)	2019-11-27	832.2500	Selling to wholesalers and retailers as a less expensive alternative to the brand, Lorzone.	None	2000000	None	None	None	None	None	None	Cameron co-developed this product. Novitium Pharma, LLC is the manufacturer and Cameron Pharmaceuticals, LLC is acting as the Distributor.	None
AbbVie	00074204202	SKYRIZI (risankizuman-rzaa) 150mg (carton containing two 75mg/0.83mL single-dose, pre-filled syringes)	2019-04-29	14750.0000	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.	None	None	None	None	None	None	None	None	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.	None
AbbVie	00074230630	RINVOQ (upadacitinib); 15mg extended-release tablets, 30 count bottle	2019-08-20	4916.6700	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.	None	None	None	None	None	None	None	None	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.	None
EMD Serono, Inc.	44087040004	Mavenclad (cladribine) 10 mg per tablet (4)	2019-04-02	28428.5600	None	1	None	None	None	None	None	None	None	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)	None
EMD Serono, Inc.	44087040005	Mavenclad (cladribine) 10 mg per tablet (5)	2019-04-02	35535.7000	None	1	None	None	None	None	None	None	None	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)	None
EMD Serono, Inc.	44087040006	Mavenclad (cladribine) 10 mg per tablet (6)	2019-04-02	42642.8400	None	1	None	None	None	None	None	None	None	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)	None
EMD Serono, Inc.	44087040007	Mavenclad (cladribine) 10 mg per tablet (7)	2019-04-02	49749.9800	None	1	None	None	None	None	None	None	None	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)	None
EMD Serono, Inc.	44087040008	Mavenclad (cladribine) 10 mg per tablet (8)	2019-04-02	56857.1200	None	1	None	None	None	None	None	None	None	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)	None
EMD Serono, Inc.	44087040009	Mavenclad (cladribine) 10 mg per tablet (9)	2019-04-02	63964.2600	None	1	None	None	None	None	None	None	None	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)	None
EMD Serono, Inc.	44087040010	Mavenclad (cladribine) 10 mg per tablet (10)	2019-04-02	71071.4000	None	1	None	None	None	None	None	None	None	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)	None
EMD Serono, Inc.	44087353501	Bavencio (avelumab) Injection	2019-05-14	1572.7000	None	1	None	1	1	None	None	None	None	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).	None
Daiichi Sankyo, Inc.	65597040228	Turalio	2019-08-06	19800.0000	None	1	None	1	1	None	None	None	None	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.	None
Daiichi Sankyo, Inc.	65597040220	Turalio	2019-08-06	19800.0000	None	1	None	1	1	None	None	None	None	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.	None
Zydus Pharmaceuticals (USA) Inc.	68382044714	Bosentan 125mg Tablet	2019-06-03	10038.5400	None	1	0	None	None	None	0.0000	None	None	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.	None
Zydus Pharmaceuticals (USA) Inc.	70710120301	Trientine HCl 250mg Capsules	2019-05-29	15618.3400	None	1	0	None	None	None	0.0000	None	None	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.	None
Zydus Pharmaceuticals (USA) Inc.	70710161006	Arsenic Trioxide Inj 12mg/6ml (10x6ml)	2019-09-16	7698.2400	None	1	0	None	None	None	None	None	None	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.	None
Zydus Pharmaceuticals (USA) Inc.	70710127703	Deferasirox Tab 90mg 30 Count	2019-11-21	1093.3000	None	1	None	None	None	None	None	None	None	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.	None
Zydus Pharmaceuticals (USA) Inc.	70710115201	Isosorbide Dinitrate Tab 40mg 100 Ct	2019-12-11	1335.3700	None	1	None	None	None	None	None	None	None	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.	None
Akorn Inc	17478044708	Aminocaproic Acid Oral Solution, USP	2019-11-04	2549.0200	None	1	1800	None	None	None	None	None	None	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.	None
Seattle Genetics, Inc.	51144002001	PADCEV (enfortumab vedotin-ejfv) 20 mg	2019-12-18	2110.0000	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.	None	None	1	1	None	None	None	None	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.	None
Karyopharm Therapeutics Inc.	72237010105	XPOVIO (selinexor) 100mg (20 Tablets)	2019-07-03	22000.0000	None	1	6000	None	1	None	None	None	None	None	None
Granules Pharmaceuticals Inc.	70010004101	Amphetamine Sulfate Tablets USP 10 MG, 100 count	2019-10-07	465.5000	None	1	0	None	None	None	None	None	None	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.	None
Seattle Genetics, Inc.	51144003001	PADCEV (enfortumab vedotin-ejfv) 30 mg	2019-12-18	3165.0000	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.	None	None	1	1	None	None	None	None	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.	None
Epic Pharma	42806005030	Meperidine Hcl 50mg 30 Tab Epic	2019-12-30	783.0000	None	1	None	None	None	None	None	None	None	lauching new size-30 count Epic Pharma developed the drugs	None
Valeant Pharmaceuticals North America, LLC	00187065301	Duobrii External Lotion 0.01-0.045 %	2019-06-03	825.0000	None	1	5240000	None	None	None	None	None	None	This product was developed internally, not acquired	None
Biogen	64406002001	VUMERITY™ (diroximel fumarate) 231mg Starter Bottle (106 capsules)	2019-11-22	6388.6200	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	None	344000	None	None	None	None	None	None	Vumerity is not an acquired product, nor was it granted breakthrough status or given a priority review by the FDA.	None
Biogen	64406002003	VUMERITY™ (diroximel fumarate) 231mg Maintenance Bottle (120 capsules)	2019-11-22	7232.8800	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	None	344000	None	None	None	None	None	None	Vumerity is not an acquired product, nor was it granted breakthrough status or given a priority review by the FDA.	None
Cameron Pharmaceuticals, LLC	42494042510	LORZONE (CHLORZOXAZONE 375 MG)	2019-11-27	744.2900	Selling to wholesalers and retailers as a less expensive alternative to the brand, Lorzone.	None	2000000	None	None	None	None	None	None	Cameron co-developed this product. Novitium Pharma, LLC is the manufacturer and Cameron Pharmaceuticals, LLC is acting as the Distributor.	None
Par Pharmaceutical	49884082011	Alosetron HCl Tablets 1mg 30s	2019-04-12	950.0000	None	1	None	1	None	None	None	None	None	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 Pharmaceutical	49884035362	Ambrisentan Oral Tablet 5 MG 10s	2019-04-29	2588.8200	None	1	None	None	None	None	None	None	None	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 Pharmaceutical	49884035311	Ambrisentan Oral Tablet 5 MG 30s	2019-04-29	7766.4700	None	1	None	None	None	None	None	None	None	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 Pharmaceutical	49884035462	Ambrisentan Oral Tablet 10 MG 10s	2019-04-29	2588.8200	None	1	None	None	None	None	None	None	None	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 Pharmaceutical	49884035411	Ambrisentan Oral Tablet 10 MG 30s	2019-04-29	7766.4700	None	1	None	None	None	None	None	None	None	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 Pharmaceutical	49884005802	Bosentan Tablets 62.5mg 60s	2019-06-03	1163.1600	None	1	None	None	None	None	None	None	None	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 Pharmaceutical	49884005902	Bosentan Tablets 125mg 60s	2019-06-03	1163.1600	None	1	None	None	None	None	None	None	None	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 Pharmaceutical	00254302002	Nitisinone Capsules 2 mg 60 Capsules	2019-09-20	4359.5100	None	1	150	None	None	None	None	None	None	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 Pharmaceutical	00254302102	Nitisinone Capsules 5 mg 60 Capsules	2019-09-20	10898.7100	None	1	150	None	None	None	None	None	None	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 Pharmaceutical	00254302202	Nitisinone Capsules 10 mg 60 Capsules	2019-09-20	21797.4500	None	1	150	None	None	None	None	None	None	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 Pharmaceutical	42023020601	Treprostinil Injection 20 mg/20 mL (1 mg/mL)	2019-09-25	1209.6500	None	1	750	None	None	None	None	None	None	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 Pharmaceutical	42023020701	Treprostinil Injection 50 mg/20 mL (2.5 mg/mL)	2019-09-25	3024.1400	None	1	750	None	None	None	None	None	None	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 Pharmaceutical	42023020801	Treprostinil Injection 100 mg/20 mL (5 mg/mL)	2019-09-25	6048.2700	None	1	750	None	None	None	None	None	None	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 Pharmaceutical	42023020901	Treprostinil Injection 200 mg/20 mL (10 mg/mL)	2019-09-25	12096.5400	None	1	750	None	None	None	None	None	None	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 Pharmaceutical	49884006001	Trientine Hydrochloride Capsules, USP 250 mg 100 Capsules	2019-10-07	5000.0000	None	1	2500	None	None	None	None	None	None	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 Pharmaceutical	49884011991	Everolimus Tablets 2.5mg 28s	2019-12-10	12012.9800	None	1	None	None	None	None	None	None	None	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 Pharmaceutical	49984012591	Everolimus Tablets 5mg 28s	2019-12-10	12565.3700	None	1	None	None	None	None	None	None	None	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 Pharmaceutical	49884012791	Everolimus Tablets 7.5mg 28s	2019-12-10	12565.3700	None	1	None	None	None	None	None	None	None	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 Pharmaceutical	49884072308	Zileuton Extended Release Tablets 600mg 120s	2019-12-16	3007.2300	None	1	None	None	None	None	None	None	None	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)
Ajanta Pharma USA, Inc.	27241017529	Sildenafil Citrate For Suspension 10 MG/ML, 112 ML, Bottle	2019-12-11	3000.0000	None	1	197	None	None	None	None	None	None	This drug was not acquired	None
Biocodex USA	68418793906	Stiripentol Oral Capsule 250 MG	2019-04-26	1500.0000	None	1	196	None	None	None	None	None	None	This drug was not acquired	None
Biocodex USA	68418794006	Stiripentol Oral Capsule 500 MG	2019-04-26	3000.0000	None	1	196	None	None	None	None	None	None	This drug was not acquired	None
Biocodex USA	68418794106	Stiripentol Oral Packet 250 MG	2019-04-26	1500.0000	None	1	196	None	None	None	None	None	None	This drug was not acquired	None
Biocodex USA	68418794206	Stiripentol Oral Packet 500 MG	2019-04-26	3000.0000	None	1	196	None	None	None	None	None	None	This drug was not acquired	None
Sage Therapeutics, Inc.	72152054720	ZULRESSO (brexanolone) injection CIV	2019-06-20	7450.0000	None	1	None	1	1	None	None	None	None	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.	None
Sentynl Therapeutics, Inc.	42358010310	Levorphanol Tartrate Tablets 3mg	2019-01-21	6675.0000	None	1	None	None	None	None	None	None	None	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.	None
AveXis	07189412002	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189412103	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189412203	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189412303	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189412404	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189412504	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189412604	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189412705	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189412805	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189412905	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189413006	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189413106	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189413206	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189413307	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189413407	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189413507	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189413608	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189413708	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189413808	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189413909	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189414009	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
AveXis	07189414109	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	2125000.0000	The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs)	None	150	1	1	None	None	None	None	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.	None
Progenics Pharmaceuticals, Inc.	71258001502	AZEDRA (iobenguane I 131) injection	2019-06-03	9060.0000	None	1	380	1	1	None	None	None	None	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) •
Progenics Pharmaceuticals, Inc.	71258001522	AZEDRA (iobenguane I 131) injection	2019-06-03	101925.0000	None	1	380	1	1	None	None	None	None	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) •
Perrigo Pharmaceuticals	45802004475	Acyclovir 5% Cream 5gm	2019-02-11	759.8600	None	1	23360000	None	None	None	None	None	None	Perrigo developed this product. It was not an acquisition.	None
Amneal Pharmaceuticals	69238147101	Erythromycin Tab Delayed Release 250 MG Bottle 100 x1	2019-07-18	671.0800	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	69238147201	Erythromycin Tab Delayed Release 333 MG Bottle 100 x1	2019-07-18	844.9600	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	69238147301	Erythromycin Tab Delayed Release 500 MG Bottle 100 x1	2019-07-18	1040.3500	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	69238179701	Hydroxyprogesterone Caproate IM in Oil 250 MG/ML Vial 1 x1	2019-03-08	682.5500	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	70121158505	Verapamil HCl IV Soln 2.5 MG/ML Vial 2 x25	2019-03-06	759.0000	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	70121163705	Ephedrine Sulfate IV Soln 50MG/ML Vial 1 x25	2019-10-28	726.0000	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	69238159403	Sirolimus Oral Soln 1 MG/ML Kit Bottle 60 x1	2019-10-28	1052.6200	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	69238159406	Sirolimus Oral Soln 1 MG/ML Bottle 60 x1	2019-10-28	1052.6200	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	65162028303	Paliperidone Tab ER 24HR 9 MG Bottle 30 x1	2019-10-10	825.1700	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	70121146302	Fulvestrant Inj 250 MG/5ML Syringe 5 x2	2019-10-01	1745.1500	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	65162087406	Bosentan Tab 125 MG Bottle 60 x1	2019-06-03	10608.0200	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	65162087306	Bosentan Tab 62.5 MG Bottle 60 x1	2019-06-03	10608.0200	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	69238159608	Aminocaproic Acid Oral Soln 0.25 GM/ML Bottle 236.5 x1	2019-09-05	2549.0200	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	69238154501	Trientine HCl Cap 250 MG Bottle 100 x1	2019-08-21	5000.0000	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	70121164707	Tigecycline For IV Soln 50 MG Vial 1 x10	2019-08-09	1040.0000	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	69238105103	Phytonadione Tab 5 MG Bottle 30 x1	2019-02-26	1607.6800	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	69238116507	Abiraterone Acetate Tab 250 MG Bottle 120 x1	2019-01-08	3499.4000	This is a generic product this is not marketed.	None	None	None	None	None	None	None	None	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.	None
Amneal Pharmaceuticals	69238157401	Sildenafil Oral Susp 10MG/ML	2019-12-02	3500.5000	This is a generic product that is not marketed.	None	None	None	None	None	None	None	None	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.	None
Dr. Reddy's Laboratories, Inc.	43598041311	Daptomycin 500mg Powder for Injection	2019-05-06	445.0000	None	1	0	None	None	None	None	None	None	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	3189.9000	None	1	0	None	None	None	None	None	None	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	None
Dr. Reddy's Laboratories, Inc.	43598069750	Vigabatrin for Oral Solution,USP 500 mg	2019-08-19	3652.9400	None	1	0	None	1	None	None	None	None	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.	None
Dr. Reddy's Laboratories, Inc.	43598086560	Bortezomib for Injection 3.5mg/vial	2019-12-03	1602.9800	None	1	0	None	None	None	None	None	None	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.	None
Dr. Reddy's Laboratories, Inc.	43598085330	Deferasirox Film coated tablets 90MG	2019-12-05	190.0300	None	1	1	None	None	None	None	None	None	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.	None
Dr. Reddy's Laboratories, Inc.	43598085130	Deferasirox Film coated tablets 360MG	2019-12-05	760.0800	None	1	1	None	None	None	None	None	None	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.	None
Dr. Reddy's Laboratories, Inc.	43598085530	Deferasirox Tablets for Oral Suspension 125MG	2019-12-05	190.0300	None	1	1	None	None	None	None	None	None	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.	None
Dr. Reddy's Laboratories, Inc.	43598085630	Deferasirox Tablets for Oral Suspension 250MG	2019-12-05	380.0500	None	1	1	None	None	None	None	None	None	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.	None
Dr. Reddy's Laboratories, Inc.	43598085430	Deferasirox Tablets for Oral Suspension 500MG	2019-12-05	760.0800	None	1	1	None	None	None	None	None	None	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.	None
Karyopharm Therapeutics Inc.	72237010101	XPOVIO (selinexor) 60mg (12 Tablets)	2019-07-03	22000.0000	None	1	6000	None	1	None	None	None	None	None	None
Karyopharm Therapeutics Inc.	72237010102	XPOVIO (selinexor) 80mg (16 Tablets)	2019-07-03	22000.0000	None	1	6000	None	1	None	None	None	None	None	None
Karyopharm Therapeutics Inc.	72237010104	XPOVIO (selinexor) 160mg (32 Tablets)	2019-07-03	22000.0000	None	1	6000	None	1	None	None	None	None	None	None
American Regent	00517656025	SELENIOUS ACID INJECTION	2019-07-09	8575.0000	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.	None	None	None	None	None	None	None	None	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.	None
Fresenius Kabi USA LLC	63323082320	Ertapenem for Injection, 1g Vial. (10 vials per pack)	2019-12-09	1286.6000	None	1	None	None	None	2019-09-16	None	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 LLC	65219016010	Busulfan Injection 60mg 10mL Vial (8 vials per pack)	2019-12-04	2500.0000	None	1	None	None	None	2019-05-21	None	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)
Glenmark Pharmaceuticals Inc., USA	68462042121	Atovaquone Oral Suspension USP	2019-01-15	800.0000	None	1	None	None	None	None	None	None	None	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.	None
Glenmark Pharmaceuticals Inc., USA	68462044626	Sevelamer Hydrochloride Tablets	2019-02-08	1158.3200	None	1	None	None	None	None	None	None	None	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.	None
Glenmark Pharmaceuticals Inc., USA	68462044718	Sevelamer Hydrochloride Tablets	2019-02-08	1158.3200	None	1	None	None	None	None	None	None	None	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.	None
Glenmark Pharmaceuticals Inc., USA	68462060994	Pimecrolimus Cream, 1%	2019-09-24	845.4300	None	1	None	None	None	None	None	None	None	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.	None
Glenmark Pharmaceuticals Inc., USA	68462031732	Fulvestrant Injection, 250 mg/5 mL (50 mg/mL)	2019-11-04	1745.1500	None	1	None	None	None	None	None	None	None	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.	None
Glenmark Pharmaceuticals Inc., USA	68462052001	Metformin Hydrochloride Extended-Release Tablets USP 500 mg	2019-12-27	1615.0000	None	1	None	None	None	None	None	None	None	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.	None
Glenmark Pharmaceuticals Inc., USA	68462052190	Metformin Hydrochloride Extended-Release Tablets USP 1000 mg	2019-12-27	2625.0000	None	1	None	None	None	None	None	None	None	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.	None
Pharmaceutical Associates, Inc	00121168040	Potassium Chloride Oral Solution	2019-04-05	507.2000	Marketing is done periodically in Pharmaceutical Trade Magazines Pricing plan is to remain competitive as determined by our pricing committee	None	None	None	None	None	None	None	None	Pharmaceutical Associates, Inc did not acquire the drug. This is our formulation that we submitted an ANDA to manufacture	None
Pharmaceutical Associates, Inc	00121168000	Potassium Chloride Oral Solution	2019-04-05	1205.0000	Marketing is done periodically in Pharmaceutical Trade Magazines Pricing plan is to remain competitive as determined by our pricing committee	None	None	None	None	None	None	None	None	Pharmaceutical Associates, Inc did not acquire the drug. This is our formulation that we submitted an ANDA to manufacture	None
Pharmaceutical Associates, Inc	00121252000	Potassium Chloride Oral Solution	2019-04-05	1849.0000	Marketing is done periodically in Pharmaceutical Trade Magazines Pricing plan is to remain competitive as determined by our pricing committee	None	None	None	None	None	None	None	None	Pharmaceutical Associates, Inc did not acquire the drug. This is our formulation that we submitted an ANDA to manufacture	None
Pharmaceutical Associates, Inc	00121252040	Potassium Chloride Oral Solution	2019-04-05	779.6000	Marketing is done periodically in Pharmaceutical Trade Magazines Pricing plan is to remain competitive as determined by our pricing committee	None	None	None	None	None	None	None	None	Pharmaceutical Associates, Inc did not acquire the drug. This is our formulation that we submitted an ANDA to manufacture	None
BeiGene USA	72579001102	Brukinsa 80MG CAPSULES 120	2019-11-18	12935.0000	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.	None	150	1	1	None	None	None	None	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).	None
Celgene	59572072012	INREBIC (fedtratinib) 100mg CAPSULES 120ct	2019-08-16	21000.0000	None	1	None	None	1	2018-02-12	1100000000.0000	None	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	3441.1800	None	1	None	None	1	2011-08-02	25000000.0000	None	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.	None
Celgene	59572077501	REBLOZYL (luspatercept-aamt) 75 mg powder for solution for injection	2019-11-08	10323.5300	None	1	None	None	1	2011-08-02	25000000.0000	None	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.	None
Ascend Laboratories, LLC	67877050330	Cinacalcet 30mg 30 Tabs	2019-06-17	685.5000	None	1	468000	None	None	2019-06-17	0.0000	1	None	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).	None
Ascend Laboratories, LLC	67877050430	Cinacalcet 60mg 30 Tabs	2019-06-17	1371.2500	None	1	468000	None	None	2019-06-17	None	1	None	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).	None
Ascend Laboratories, LLC	67877050530	Cinacalcet 90mg 30 Tabs	2019-06-17	2057.0000	None	1	468000	None	None	2019-06-17	None	1	None	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).	None
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	23896.1300	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.	None	17300	1	1	None	None	None	None	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	995.0000	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.	None	15000000	None	None	2019-06-17	218840450.0000	None	The acquisition price amount entered reflects the price of a combination portfolio acquisition which includes future royalties based on estimated sales.	None	None
Grifols USA, LLC	13553081005	Xembify immune globulin subcutaneous, human-klhw, 20% 1GM	2019-11-12	171.0000	None	1	500000	None	None	None	None	None	None	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)
Grifols USA, LLC	13553081010	Xembify immune globulin subcutaneous, human-klhw, 20% 2GM	2019-11-12	342.0000	None	1	500000	None	None	None	None	None	None	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)
Grifols USA, LLC	13553081020	Xembify immune globulin subcutaneous, human-klhw, 20% 4GM	2019-11-12	684.0000	None	1	500000	None	None	None	None	None	None	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)
Grifols USA, LLC	13553081050	Xembify immune globulin subcutaneous, human-klhw, 20% 10GM	2019-11-12	1710.0000	None	1	500000	None	None	None	None	None	None	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)
Kadmon Pharmaceuticals, LLC	66435070010	Trientine Hydrochloride Capsules, USP 250 mg (100 capsules)	2019-10-21	15618.0000	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).	None	7000	None	None	None	None	None	None	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.	None
Kadmon Pharmaceuticals, LLC	66435070020	Clovique™ (Trientine Hydrochloride Capsules, USP) 250 mg (120 capsules)	2019-10-21	18741.6000	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).	None	7000	None	None	None	None	None	None	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.	None
Celltrion USA, Inc.	72606000201	Temixys (lamivudine and tenofovir disoproxil fumarate	2019-09-03	850.0000	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.	None	3000	None	None	None	None	None	None	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.	None
Alnylam Pharmaceuticals, Inc.	71336100101	GIVLAARI (givosiran)(189 mg/ml single dose vial)	2019-12-12	39000.0000	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.	None	3000	1	1	None	None	None	None	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.	None
Global Blood Therapeutics, Inc.	72786010101	Oxbryta™ (voxelotor) 500 mg Tablets 90ct (recommended dosage of 1,500 mg/day)	2019-12-04	10417.0000	None	1	None	1	1	None	None	None	None	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	2842.5000	None	1	None	1	1	None	None	None	None	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.	None
Harmony Biosciences, LLC	72028017803	WAKIX™ (pitolisant) 17.8 MG 30 Tablets	2019-10-01	5685.0000	None	1	None	1	1	None	None	None	None	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.	None
Coherus BioSciences, Inc.	70114010101	UDENYCA (pegfilgrastim-cbqv) 6mg/.06mL solution in a single-dose prefilled syringe	2019-01-03	4175.0000	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.	None	11000	None	None	None	None	None	None	The drug UDENYCA (pegfilgrastim-cbqv) was not acquired.	None
Accord Healthcare, Inc.	16729035192	Busulfan 6 mg/ml injection 8 pk	2019-07-22	4000.0000	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.	None	0	None	None	None	None	None	None	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.	None
Accord Healthcare, Inc.	16729042101	Tacrolimus Ointment 0.03%/100g tube	2019-06-05	694.5300	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.	None	0	None	None	None	None	None	None	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.	None
Accord Healthcare, Inc.	16729042201	Tacrolimus Ointment 0.10%/100g tube	2019-06-05	694.5300	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.	None	0	None	None	None	None	None	None	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.	None
Accord Healthcare, Inc.	16729036468	Tigecycline SDV 50 mg 10 pack	2019-03-28	1252.0000	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.	None	0	None	None	None	None	None	None	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.	None
Granules Pharmaceuticals Inc.	70010049101	Metformin Hydrochloride Extended-Release Tablets USP 500 MG, 100 count	2019-03-21	4.7500	None	1	0	None	None	None	None	None	None	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.	None
Granules Pharmaceuticals Inc.	70010049105	Metformin Hydrochloride Extended-Release Tablets USP 500 MG, 500 count	2019-03-21	21.4500	None	1	0	None	None	None	None	None	None	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.	None
Granules Pharmaceuticals Inc.	70010049201	Metformin Hydrochloride Extended-Release Tablets USP 750 MG, 100 count	2019-03-21	7.2200	None	1	0	None	None	None	None	None	None	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.	None
Granules Pharmaceuticals Inc.	70010049205	Metformin Hydrochloride Extended-Release Tablets USP 750 MG, 500 count	2019-03-21	36.1200	None	1	0	None	None	None	None	None	None	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.	None
Granules Pharmaceuticals Inc.	70010001201	Methylphenidate Hydrochloride Extended-Release Capsules 10 MG 100 count	2019-09-19	305.0000	None	1	0	None	None	None	None	None	None	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.	None
Granules Pharmaceuticals Inc.	70010001301	Methylphenidate Hydrochloride Extended-Release Capsules 20 MG 100 count	2019-09-10	204.0200	None	1	0	None	None	None	None	None	None	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.	None
Granules Pharmaceuticals Inc.	70010001401	Methylphenidate Hydrochloride Extended-Release Capsules 30 MG 100 count	2019-09-16	208.9100	None	1	0	None	None	None	None	None	None	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.	None
Granules Pharmaceuticals Inc.	70010001501	Methylphenidate Hydrochloride Extended-Release Capsules 40 MG 100 count	2019-09-16	213.8100	None	1	0	None	None	None	None	None	None	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.	None
Granules Pharmaceuticals Inc.	70010001603	Methylphenidate Hydrochloride Extended-Release Capsules 60 MG 30 count	2019-09-19	322.9300	None	1	0	None	None	None	None	None	None	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.	None
Granules Pharmaceuticals Inc.	70010004201	Methylphenidate Hydrochloride Extended-Release Tablets USP 10 MG 100 count	2019-05-16	55.4400	None	1	0	None	None	None	None	None	None	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.	None
Granules Pharmaceuticals Inc.	70010004301	Methylphenidate Hydrochloride Extended-Release Tablets USP 20 MG 100 count	2019-05-16	57.1100	None	1	0	None	None	None	None	None	None	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.	None
Granules Pharmaceuticals Inc.	70010004001	Amphetamine Sulfate Tablets USP 5 MG, 100 count	2019-10-15	465.5000	None	1	0	None	None	None	None	None	None	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.	None