| AbbVie |
00074101756 |
ORIAHNN (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) copackaged for oral use--56 capsules; 4 blister-pack carton: 28 capsules of elagolix 300 mg, estradiol 1 mg, norethindrone acetate 0.5 mg; 28 capsules of elagolix 300mg |
2020-06-22 |
907.3900 |
* ORIAHNN will be marketed for premenopausal women suffering from heavy menstrual bleeding associated with uterine leiomyomas (fibroids).
* The Wholesale Acquisition Cost (WAC) of ORIAHNN is $907.39 per a month supply. Pricing is the same for ORIAHNN as the previously approved AbbVie elagolix product, ORILISSA, which is indicated for moderate-to-severe endometriosis related pain.
* To date AbbVie has not filed for regulatory approval of ORIAHNN in jurisdictions outside the United States. |
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):
ORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Based upon a review of published analyses of uterine fibroid prevalence approximately .3% of pre-menopausal women suffer from heavy menstrual bleeding associated with uterine fibroids, have not had a hysterectomy, and are seeking treatment for their condition: approximately 200,000 women. See Fuldeore et al, Patient-reported prevalence and symptomatic burden of uterine fibroids among women in the United States: findings from a cross-sectional survey analysis. Int J Women’s Health. 2017; 9: 403–411; Borah et al, The Impact of Uterine Leiomyomas: A National Survey of Affected Women. Am J Obstet Gynecol. 2013 Oct; 209(4): 319.e1–319.e20; Wang et al. Burden of Heavy Menstrual Bleeding Associated with Uterine Fibroids: Retrospective Analysis of A Large Commercially Insured Population in the US. Poster presented at Academy of Managed Care Pharmacy (AMCP) Nexus Annual Meeting 2019. Journal of Managed Care & specialty Pharmacy, Supplement. Vol 25; Number 10-a. October 2019. ORIAHNN may be prescribed for that fraction of those patients for whom a physician and patient in consultation may consider this treatment appropriate.
Additional Context for Report
ORIAHNN was developed by AbbVie under its collaboration agreement with Neurocrine Biosciences, with research and development funded and conducted in part by AbbVie. On June 16, 2010 AbbVie publicly announced its collaboration with Neurocrine Biosciences for the development of elagolix. The parties worked together on a collaborative development program through 2012 with funding provided by AbbVie, after which time AbbVie assumed sole responsibility for all development and commercialization activities. AbbVie made an upfront payment of $75 million and funded all ongoing development activities. Under the agreement, Neurocrine is eligible to receive additional milestone payments of approximately $530 million for the achievement of development, regulatory and commercial milestones, funding for certain internal collaboration expenses, and royalty payments on any future product sales. |
None |
| Accord Healthcare, Inc. |
16729043445 |
Daptomycin (SDV); 350 mg; 10 pk [lyo] Vial |
2020-02-27 |
680.0000 |
Marketing: Accord markets generic Daptomycin in a ten pack of 350 mg vials. The drug is therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share.
Pricing: In order to set the wholesale acquisition price (“WAC”) of Daptomycin, Accord matched the lowest generic WAC available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information. Accord launched single vials of this product last year and set the WAC for the new NDC of 10 packs at equivalent pricing. |
None |
None |
None |
None |
None |
None |
None |
None |
Accord did not acquire the ANDA for Daptomycin, the generic product was developed in house.
Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Daptomycin but is reporting the WAC of 10 pack of vials, which is the unit by which Accord sells the drug.
Accord does not have data related to Estimated Number of Patients for Daptomycin 10 packs. Although there may be publications that show statistical data in previous years, Accord does not use this data to make business decisions. Further, Accord has not been informed of the methods or procedures as to how this statistical information was developed, nor does Accord have internal methods or procedures to estimate a reasonable number of patients with a disease state and, therefore, cannot answer this question with any level of accuracy that is needed in order to comply with the requirement. In making decisions about whether to market a product, Accord does not consider patient number, it considers total market size based on dollar amount. It is a generic manufacturer and as such does not manufacture or market products based upon specific conditions or to sets of patients, but based upon price and availability only. Finally, the specific details regarding number of patients treated by a given drug in the previous year are not freely available to the public. |
None |
| Accord Healthcare, Inc. |
16729044210 |
Cinacalcet Tab; 90 mg; 30 ct |
2020-06-16 |
925.6900 |
Marketing: Accord markets generic Cinacalcet in both 30 and 90 tablet count bottles. The drug is therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share.
Pricing: In order to set the wholesale acquisition price (“WAC”) of Cinacalcet, Accord matched the lowest generic WAC available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information. |
None |
0 |
None |
None |
None |
None |
None |
None |
Accord did not acquire the NDC for Cinacalcet, the generic product was developed in house.
Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Cinacalcet but is reporting the WAC of both 30 and 90 tablet count bottles, which are the units by which Accord sells the drug. |
None |
| Accord Healthcare, Inc. |
16729044015 |
Cinacalcet Tab; 30 mg; 90 ct |
2020-06-19 |
925.7100 |
Marketing: Accord markets generic Cinacalcet in both 30 and 90 tablet count bottles. The drug is therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share.
Pricing: In order to set the wholesale acquisition price (“WAC”) of Cinacalcet, Accord matched the lowest generic WAC available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information. |
None |
0 |
None |
None |
None |
None |
None |
None |
Accord did not acquire the NDC for Cinacalcet, the generic product was developed in house.
Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Cinacalcet but is reporting the WAC of both 30 and 90 tablet count bottles, which are the units by which Accord sells the drug. |
None |
| Accord Healthcare, Inc. |
16729044115 |
Cinacalcet Tab; 60 mg; 90 ct |
2020-06-19 |
1851.3900 |
Marketing: Accord markets generic Cinacalcet in both 30 and 90 tablet count bottles. The drug is therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share.
Pricing: In order to set the wholesale acquisition price (“WAC”) of Cinacalcet, Accord matched the lowest generic WAC available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information. |
None |
0 |
None |
None |
None |
None |
None |
None |
Accord did not acquire the NDC for Cinacalcet, the generic product was developed in house.
Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Cinacalcet but is reporting the WAC of both 30 and 90 tablet count bottles, which are the units by which Accord sells the drug. |
None |
| Accord Healthcare, Inc. |
16729044215 |
Cinacalcet Tab; 90 mg; 90 ct |
2020-06-25 |
2777.0700 |
Marketing: Accord markets generic Cinacalcet in both 30 and 90 tablet count bottles. The drug is therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share.
Pricing: In order to set the wholesale acquisition price (“WAC”) of Cinacalcet, Accord matched the lowest generic WAC available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information. |
None |
0 |
None |
None |
None |
None |
None |
None |
Accord did not acquire the NDC for Cinacalcet, the generic product was developed in house.
Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Cinacalcet but is reporting the WAC of both 30 and 90 tablet count bottles, which are the units by which Accord sells the drug. |
None |
| Acella Pharamceuticals, LLC |
42192061916 |
Naproxen Suspension: 125 mg/5 mL (contains 39 mg sodium): Available in 1 pint (473 mL) light-resistant bottles; Type 0: Not a Combination Product |
2020-11-12 |
837.0000 |
None |
1 |
7250 |
None |
None |
2020-11-11 |
0.0000 |
1 |
This product is a licensed Authorized Generic. There was no acquisition price paid by Acella, however, Acella does share revenues with the Licensor. Factors affecting the acquisition price are only know to a small group of individuals at Acella – namely the Commercial, Government Pricing, Compliance and Legal departments consisting of less than 10 people within those departments with access to that information. |
This product was not launched on November 12, 2020 as indicated in Medispan, the various compendiums and our recent New Drug Notice filed with OSHPD. While we did sign the license agreement to market this product on November 11, 2020, we did not have the labeling or inventory ready to market/sell until December 2, 2020. The incorrect Marketing Start Date listed in DailyMed and in the compendiums was a result of confusion in our regulatory department regarding the business realities of the execution of the license agreement versus truly marketing the product with available inventory. Our understanding is that the “introduced to market date” for OSHPD should be consistent with the FDA “Marketing Start Date” reported to the FDA and reflected in DailyMed and the compendiums. |
None |
| Acerus Pharmaceuticals Corporation |
42667551101 |
Natesto Nasal Gel 5.5 MG/ACT/7.32GM |
2020-07-20 |
275.0000 |
None |
1 |
634211 |
None |
None |
None |
None |
None |
None |
This Drug was not acquired. 30 day supply is 3 packs @ a WAC of $275.08 each |
None |
| Aimmune Therapeutics |
71881011313 |
PALFORZIA Initial Dose Escalation Card -- 0.5 mg-6 mg |
2020-03-10 |
30.0000 |
Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label.
Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients. |
None |
1600000 |
1 |
None |
None |
None |
None |
None |
In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens. |
None |
| Aimmune Therapeutics |
71881011130 |
PALFORZIA Maintenance Dosing Pack -- 300 mg, 30 count sachet |
2020-03-10 |
890.0000 |
Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label.
Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients. |
None |
1600000 |
1 |
None |
None |
None |
None |
None |
In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens. |
None |
| Aimmune Therapeutics |
71881010345 |
PALFORZIA Up-Dosing Pack -- 12 mg |
2020-03-10 |
445.0000 |
Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label.
Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients. |
None |
1600000 |
1 |
None |
None |
None |
None |
None |
In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens. |
None |
| Aimmune Therapeutics |
71881010730 |
PALFORZIA Up-Dosing Pack -- 120 mg |
2020-03-10 |
445.0000 |
Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label.
Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients. |
None |
1600000 |
1 |
None |
None |
None |
None |
None |
In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens. |
None |
| Aimmune Therapeutics |
71881010860 |
PALFORZIA Up-Dosing Pack -- 160 mg |
2020-03-10 |
445.0000 |
Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label.
Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients. |
None |
1600000 |
1 |
None |
None |
None |
None |
None |
In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens. |
None |
| Aimmune Therapeutics |
71881010415 |
PALFORZIA Up-Dosing Pack -- 20 mg |
2020-03-10 |
445.0000 |
Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label.
Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients. |
None |
1600000 |
1 |
None |
None |
None |
None |
None |
In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens. |
None |
| Aimmune Therapeutics |
71881010930 |
PALFORZIA Up-Dosing Pack -- 200 mg |
2020-03-10 |
445.0000 |
Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label.
Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients. |
None |
1600000 |
1 |
None |
None |
None |
None |
None |
In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens. |
None |
| Aimmune Therapeutics |
71881011060 |
PALFORZIA Up-Dosing Pack -- 240 mg |
2020-03-10 |
445.0000 |
Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label.
Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients. |
None |
1600000 |
1 |
None |
None |
None |
None |
None |
In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens. |
None |
| Aimmune Therapeutics |
71881010145 |
PALFORZIA Up-Dosing Pack -- 3 mg |
2020-03-10 |
445.0000 |
Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label.
Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients. |
None |
1600000 |
1 |
None |
None |
None |
None |
None |
In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens. |
None |
| Aimmune Therapeutics |
71881011115 |
PALFORZIA Up-Dosing Pack -- 300 mg, 15 count sachet |
2020-03-10 |
445.0000 |
Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label.
Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients. |
None |
1600000 |
1 |
None |
None |
None |
None |
None |
In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens. |
None |
| Aimmune Therapeutics |
71881010530 |
PALFORZIA Up-Dosing Pack -- 40 mg |
2020-03-10 |
445.0000 |
Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label.
Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients. |
None |
1600000 |
1 |
None |
None |
None |
None |
None |
In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens. |
None |
| Aimmune Therapeutics |
71881010290 |
PALFORZIA Up-Dosing Pack -- 6 mg |
2020-03-10 |
445.0000 |
Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label.
Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients. |
None |
1600000 |
1 |
None |
None |
None |
None |
None |
In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens. |
None |
| Aimmune Therapeutics |
71881010660 |
PALFORZIA Up-Dosing Pack -- 80 mg |
2020-03-10 |
445.0000 |
Marketing activities that support the launch of a new treatment are designed to raise awareness and understanding with healthcare providers and patients about the approved indication(s), efficacy and safety data contained within the treatment's FDA approved label.
Our pricing is intended to facilitate access for all eligible patients, support timely reimbursement and financial assistance for the commercially-insured, as well as patient assistance for eligible uninsured or under-insured patients. |
None |
1600000 |
1 |
None |
None |
None |
None |
None |
In 2017, 1.25 million Peanut Allergy patients ages 4-17 were diagnosed in the United States, and today is estimated to affect more than 1.6 million children and teens. |
None |
| Ajanta Pharma USA, Inc. |
27241015919 |
Valganciclovir Hydrochlor Oral Sol 100ml |
2020-02-17 |
800.2600 |
None |
1 |
321 |
None |
None |
None |
None |
None |
None |
This drug was not acquired. Please note that Ajanta has no information as to what the total market may be and no has no way currently of knowing what the total market may be and no data to make a reasonable guess. Ajanta is only able to certify their estimates of patients using the drugs based on their sales. |
None |
| Alexion Pharmaceuticals |
25682002501 |
ULTOMIRIS is a complement inhibitor indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). |
2020-10-09 |
6404.0000 |
Alexion prices both 3 mL and 11 mL vials at-parity-per-milligram to the existing ULTOMIRIS 10mg (300 mg/30 mL) vial that is available on the market. We have an established commercial organization that supports our marketed products in the U.S., Europe, Japan, Latin America, Asia Pacific countries, and other territories. We employ a sales force and commercial marketing functions to ensure that health care providers are informed about our products. |
None |
3936 |
None |
None |
None |
None |
None |
None |
Based on reports in the published medical literature, the prevalence of PNH ranges from 0.5 to 2 per million people, and the prevalence of aHUS ranges from 2 to 10 per million people. Based on a US population of 328 million, the treatable population for each condition may be as large as 656 people for PNH and 3280 people for aHUS. |
None |
| Alexion Pharmaceuticals |
25682002801 |
ULTOMIRIS is a complement inhibitor indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). The dosage form and strength is 1,100 mg/11 mL (100 mg/mL) in a single-dose vial. Package size is 11 ml |
2020-10-09 |
23481.3300 |
Alexion prices both 3 mL and 11 mL vials at-parity-per-milligram to the existing ULTOMIRIS 10mg (300 mg/30 mL) vial that is available on the market. We have an established commercial organization that supports our marketed products in the U.S., Europe, Japan, Latin America, Asia Pacific countries, and other territories. We employ a sales force and commercial marketing functions to ensure that health care providers are informed about our products. |
None |
3936 |
None |
None |
None |
None |
None |
None |
Based on reports in the published medical literature, the prevalence of PNH ranges from 0.5 to 2 per million people, and the prevalence of aHUS ranges from 2 to 10 per million people. Based on a US population of 328 million, the treatable population for each condition may be as large as 656 people for PNH and 3280 people for aHUS. |
None |
| Allergan |
00023650110 |
Ubrelvy Oral Tablet 100 MG, 10 tabs per Pack |
2020-01-21 |
850.0000 |
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 migraine community, as well as promoting to appropriate healthcare professionals and patients. The pricing plan has a WAC/ list price set at $850 per 10ct package. The list price of Ubrelvy is not reflective of discounts and rebates which may be available to patients and payers including but not limited to, Medicaid, Medicare, and commercial insurance. |
None |
31000000 |
None |
None |
2015-07-06 |
250000000.0000 |
None |
Allergan acquired exclusive worldwide rights to develop and commercialize certain products, including Ubrelvy (ubrogepant), from Merck Sharp & Dohme Corp. on July 6, 2015 for $250M. Allergan remained responsible for Phase III Clinical Trials and continues to remain responsible for further development of Ubrelvy (ubrogepant). |
Migraine is a chronic disease with episodic attacks defined by neurological symptoms such as headache pain, sensitivity to light and sound, and nausea. Migraine is highly prevalent, affecting approximately 31 million Americans, and is associated with significant disability leading to high personal, family, occupational, societal, and economic burden. Based on the current standard of care, there are still unmet needs for new acute treatments for migraine.Each NDC could be used for any eligible patient. |
None |
| Allergan |
00023649810 |
Ubrelvy Oral Tablet 50 MG, 10 tabs per Pack |
2020-01-21 |
850.0000 |
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 migraine community, as well as promoting to appropriate healthcare professionals and patients. The pricing plan has a WAC/ list price set at $850 per 10ct package. The list price of Ubrelvy is not reflective of discounts and rebates which may be available to patients and payers including but not limited to, Medicaid, Medicare, and commercial insurance. |
None |
31000000 |
None |
None |
2015-07-06 |
250000000.0000 |
None |
Allergan acquired exclusive worldwide rights to develop and commercialize certain products, including Ubrelvy (ubrogepant), from Merck Sharp & Dohme Corp. on July 6, 2015 for $250M. Allergan remained responsible for Phase III Clinical Trials and continues to remain responsible for further development of Ubrelvy (ubrogepant). |
Migraine is a chronic disease with episodic attacks defined by neurological symptoms such as headache pain, sensitivity to light and sound, and nausea. Migraine is highly prevalent, affecting approximately 31 million Americans, and is associated with significant disability leading to high personal, family, occupational, societal, and economic burden. Based on the current standard of care, there are still unmet needs for new acute treatments for migraine. Each NDC could be used for any eligible patient. |
None |
| Allergan |
00023965201 |
Durysta Intraocular Implant 10 MCG |
2020-06-22 |
1950.0000 |
• DURYSTA will be marketed to adults for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
• The Wholesale Acquisition Cost (WAC) of DURYSTA is $1950 per implant.
• To date Allergan has not filed for regulatory approval of DURYSTA in jurisdictions outside the United States. |
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):
DURYSTA is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT). A 2012 published study identified 2.71 million patients in the US with open angle glaucoma and projected greater than 3 million patients in 2020. See Vajaranant, T et al., The Changing Face of Primary Open-Angle Glaucoma in the United States: Demographic and Geographic Changes From 2011 to 2050, Am. J. of Ophthalmology, 154:303-314 (2012). See also Glaucoma Research Foundation website, at https://www.glaucoma.org/glaucoma/glaucoma-facts-and-stats.php. DURYSTA may be prescribed for that fraction of patients for whom a physician and patient in consultation may consider this treatment appropriate.
Additional Context for Report
DURYSTA was developed by Allergan. On May 8, 2020 AbbVie Inc. completed its acquisition of Allergan plc at a cost of approximately $63 billion. |
None |
| ALVOGEN |
47781065289 |
TERIPARATIDE INJECTION 250MCG/ML |
2020-06-11 |
2475.0000 |
Alvogen is committed to the highest quality standards for all products and services with the continuous focus on operational efficiency and cost optimization. Alvogen has invested $350,000 nationally in marketing this product, having created and distributed to physicians and pharmacies a detailed flyer with information regarding indications, safety information, contraindications, and the Alvogen Savings Program. Alvogen has also launched an informative, product-specific website for patients and providers alike (http://www.alvogenteriparatide.com). Alvogen utilizes a pricing methodology that takes into account a number of factors, including the cost of the product's acquisition, utilization estimates, the value rendered by this innovative product to patients and their providers, as well as the health care system, and ongoing marketing, manufacturing, and other operational costs. Alvogen also takes into account current market dynamics including competitor products along with the potential entry of generics into the drug class. Alvogen is committed to transparency and access for its products, and undertakes all of its marketing and pricing decisions with those goals in mind. |
None |
10200000 |
None |
None |
2018-06-30 |
2000000.0000 |
None |
Pfenex received an upfront payment of $2.5M for the license and rights. They may be eligible for an additional $25M in support and regulatory milestone payments. |
The price listed in a published compendium does not necessarily reflect the actual price that a particular patient, provider, or payer will pay for this product, which may vary based on mandatory and negotiated discounts, and in accordance with actual patient dosing.
The National Osteoporosis Foundation has estimated approximately 10.2M adults in the United States has osteoporosis, the condition for which this product may be prescribed. That number does not reflect the number of patients who will be prescribed this product, which will be a much lower number (which is not in the public domain or publicly available). |
None |
| American Health Packaging |
60687045901 |
PALIPERIDONE ER TABLET3MG100UD |
2020-01-14 |
1445.6200 |
Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice |
None |
3500000 |
None |
None |
None |
None |
None |
None |
The acquisition fields do not need to be filled out because the drug was not acquired within the previous 5 years. Number of patients based on treatment of schizophrenia (https://www.webmd.com/drugs/2/drug-146718/paliperidone-oral/details) and cross referenced at ( https://sardaa.org/resources/about-schizophrenia/#:~:text=Approximately%203.5%20million%20people%20in,is%20at%20least%20partially%20genetic). All the fields that are left blank are due to "Not Applicable". |
None |
| American Health Packaging |
60687047001 |
PALIPERIDONE ER TABLET6MG100UD |
2020-01-14 |
1445.6200 |
Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice |
None |
3500000 |
None |
None |
None |
None |
None |
None |
The acquisition fields do not need to be filled out because the drug was not acquired within the previous 5 years. Number of patients based on treatment of schizophrenia (https://www.webmd.com/drugs/2/drug-146718/paliperidone-oral/details) and cross referenced at ( https://sardaa.org/resources/about-schizophrenia/#:~:text=Approximately%203.5%20million%20people%20in,is%20at%20least%20partially%20genetic). All the fields that are left blank are due to "Not Applicable". |
None |
| American Health Packaging |
60687044901 |
SEVELAMER HCL TABLET800MG100UD |
2020-01-22 |
743.7500 |
Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice |
None |
6000000 |
None |
None |
None |
None |
None |
None |
The acquisition fields do not need to be filled out because the drug was not acquired within the previous 5 years. Number of patients based on treatment of kidney disease (https://www.webmd.com/drugs/2/drug-16748/sevelamer-hcl-oral/details) and cross referenced at (https://www.cdc.gov/nchs/fastats/kidney-disease.htm). All the fields that are left blank are due to "Not Applicable". |
None |
| American Health Packaging |
68001042485 |
FULVESTRANT INJECTION250MG (50MG/5ML) 25 syr |
2020-02-28 |
1939.0500 |
Gathering Market Intelligence, Setting Competitive pricing for PRxO, executing product launches, managing master data files. |
None |
325000 |
None |
None |
2020-02-25 |
1372.0000 |
None |
BluePoint Laboratories and AHP are both owned by AmerisourceBergen - the acquisition price listed is the quarter total for all units received within the date listed. AHP is the US distributor for Bluepoint product. Amount represented for acquisition is in total US dollars. |
Bluepoint Laboratories is a sibling company with AHP as its sole distributor and is the responsible party for distribution of their products.
Number of patients based on treatment of breast cancer (https://medlineplus.gov/druginfo/meds/a607031.html) and cross referenced at (https://www.breastcancer.org/symptoms/understand_bc/statistics), it is not a representation of AHP's estimated market capture. |
None |
| American Health Packaging |
60687050525 |
AMINOCAPROIC ACID TABLET500MG30UD |
2020-05-18 |
800.0000 |
Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice |
None |
4500000 |
None |
None |
None |
None |
None |
None |
The acquisition fields do not need to be filled out because the drug was not acquired within the previous 5 years. Number of patients based on treatment of severe liver disease (https://www.medicinenet.com/aminocaproic_acid-oral/article.htm) and cross referenced at CDC.gov (https://www.cdc.gov/nchs/fastats/liver-disease.htm). All the fields that are left blank are due to "Not Applicable". |
None |
| American Health Packaging |
60687052321 |
POSACONAZOLE DR TABLET100MG30UD |
2020-06-11 |
1415.0000 |
Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice |
None |
650000 |
None |
None |
None |
None |
None |
None |
The acquisition fields do not need to be filled out because the drug was not acquired within the previous 5 years. Number of patients based on treatment with chemotherapy (https://www.webmd.com/drugs/2/drug-145142-1598/posaconazole-oral/posaconazole-delayed-release-oral/details) and cross referenced at (https://www.cdc.gov/cancer/preventinfections/providers.htm#:~:text=Each%20year%2C%20about%20650%2C000%20cancer,chemotherapy%20schedules%2C%20and%20even%20death.). All the fields that are left blank are due to "Not Applicable". |
None |
| American Health Packaging |
60687053478 |
Atovaquone Oral Sus 750mg/5mL 5mL |
2020-10-21 |
1245.0000 |
Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice |
None |
None |
None |
None |
2020-09-21 |
112176.0000 |
None |
As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC. There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC. |
ESTIMATED # PATIENTS: Patient Information - CANNOT BE DETERMINED: Atovaquone is used for treatment of Pneumocystis pneumonia (reference: https://www.webmd.com/drugs/2/drug-6077/atovaquone-oral/details) and number of patients cannot be quantified per CDC (https://www.cdc.gov/fungal/diseases/pneumocystis-pneumonia) as this information isn’t widely tracked. |
None |
| American Regent |
00517800525 |
ZINC SULFATE INJECTION USP, 25MG/5ML (5MG/ML), PKG OF 25 |
2020-01-28 |
1753.1300 |
We do not have plans to conduct any substantial marketing activities related to the new product. We do not have any plans to conduct any direct-to-consumer advertising for the product. Our marketing efforts to promote the new drug to physicians and other health care professionals are limited to marketing on our website as well as a digital announcement to announce the availability of the new product. The prices negotiated with customers are confidential and not in the public domain or publicly available. American Regent sells its products directly to wholesalers, distributors and closed door pharmacies. American Regent also sells it product indirectly to several entities, including independent pharmacies, managed care organizations, hospitals, etc. These customers, called, "indirect customers," purchase our products primarily through our wholesale customers. The Product has not yet launched in any international jurisdiction. |
None |
26250 |
None |
None |
None |
None |
None |
None |
The new product line is approved by the FDA to treat Zinc deficiency. It is administered intravenously as part of a parental nutrition regiment. It is estimated that the volume of patients that receive parental nutrition is over 290,000 hospital stays per year and that an additional 25,000 patients receive parental nutrition at home. If we assume that each hospital stay represents one unique patient then this total is 315,000 patients annually or 26,250 per month. We do not know how many of those potential patients might be prescribed the drug. |
None |
| American Regent |
00517610325 |
ZINC SULFATE INJECTION, USP 30MG/10ML (3MG/ML), PKG OF 25 |
2020-01-28 |
2107.5000 |
We do not have plans to conduct any substantial marketing activities related to the new product. We do not have any plans to conduct any direct-to-consumer advertising for the product. Our marketing efforts to promote the new drug to physicians and other health care professionals are limited to marketing on our website as well as a digital announcement to announce the availability of the new product. The prices negotiated with customers are confidential and not in the public domain or publicly available. American Regent sells its products directly to wholesalers, distributors and closed door pharmacies. American Regent also sells it product indirectly to several entities, including independent pharmacies, managed care organizations, hospitals, etc. These customers, called, "indirect customers," purchase our products primarily through our wholesale customers. The Product has not yet launched in any international jurisdiction. |
None |
26250 |
None |
None |
None |
None |
None |
None |
The new product line is approved by the FDA to treat Zinc deficiency. It is administered intravenously as part of a parental nutrition regiment. It is estimated that the volume of patients that receive parental nutrition is over 290,000 hospital stays per year and that an additional 25,000 patients receive parental nutrition at home. If we assume that each hospital stay represents one unique patient then this total is 315,000 patients annually or 26,250 per month. We do not know how many of those potential patients might be prescribed the drug. |
None |
| American Regent |
00517610125 |
Zinc Sulfate Injection, USP 1mg/mL 10mL |
2020-05-18 |
701.2500 |
We do not intend to engage in, nor have we engaged in to date, any substantial marketing activities relating to the Zinc Sulfate Products in the U.S. or internationally. Our marketing efforts to promote the new drug are generally limited to marketing on our website as well as digital announcements (including those at professional society events) to announce the availability of the new Zinc Sulfate Products. Our pricing plans are not in the public domain. |
None |
315000 |
None |
None |
None |
None |
None |
None |
We provide the following comment regarding the patient estimate: The new product line is approved by the FDA for adult and pediatric patients, as a source of zinc for parenteral nutrition, when oral or enteral nutrition is not indicated. It is administered intravenously as part of a parental nutrition regimen. It is estimated that the volume of patients that receive parental nutrition is over 290,000 hospital stays per year and that an additional 25,000 patients receive parental nutrition at home. If we assume that each hospital and each home stay represents one unique patient then this total is 315,000 patients annually. We do not know how many of those potential patients might be prescribed the drug.
We provide the following comment regarding the acquisition fields: This product was not acquired and the acquisition fields are not applicable. We provide the following general comment: We have limited the information included in this submission to that which is otherwise in the public domain or publicly available, as the California requirements permit. |
None |
| Amgen |
55513067001 |
AVSOLA 100mg Vial |
2020-07-06 |
500.0000 |
United States: There will be no direct-to-consumer marketing for AVSOLA such as TV ads, magazine or journal ads. The only platforms directed to patients is patient education brochure and a section of the AVSOLA.com website entitled “For Patients – Getting to Know AVSOLA”. This content is designed to educate patients about the 8 inflammation diseases aligned with the AVSOLA indications and potential treatment with AVSOLA, including important safety information.
Promotional activities to physicians will include professional detailing by Amgen sales representatives. Amgen is utilizing its existing inflammation sales force to educate health care professionals about AVSOLA, including the requirements for establishing biosimilarity to the reference product, Remicade, and important safety information. Professional detailing entails resources such as a core visual aid and promotional leave-behind literature. There is no free drug or sample program. Amgen also contracts with payors and providers such a hospitals and clinics to offer AVSOLA at a competitive price and ensure access to the product for appropriate patients.
AVSOLA’s Wholesale Acquisition Cost (WAC, sometimes referred to as list price) will be lower than its reference product, Remicade. The WAC of AVSOLA has been set at $50.00 per 10 mg or $500.00 per 100 mg single-dose vial, 57 percent less than the WAC of Remicade. |
None |
12800000 |
None |
None |
None |
None |
None |
None |
Rheumatoid arthritis (RA) is the most common form of autoimmune arthritis, affecting more than 1.3 million Americans.Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory disease of the gastrointestinal tract that mostly affect patients in their late adolescence and early adulthood. In 2018, the U.S. prevalence of CD and UC was ~900K and ~1.0M respectively. The National Psoriasis Foundation states more than 8M Americans have psoriasis, and CDC’s NHANES estimates that 6.7 million adults have psoriasis. Current estimates of the prevalence of ankylosing spondylitis in the United States range between 0.2% and 0.5%, or an estimated 0.6-1.6 million (based on 328M US population). |
None |
| Amneal Pharmaceuticals |
69238148803 |
Deferasirox Tablets 360mg |
2020-01-02 |
837.6100 |
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 |
| Amneal Pharmaceuticals |
69238173102 |
Pyridostigmine Bromide Oral Solution, USP 60mg/5mL |
2020-01-17 |
1071.5400 |
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 |
| Amneal Pharmaceuticals |
60219168101 |
Fluphenazine HCl 10mg |
2020-07-09 |
869.9000 |
This is a generic product that is not marketed. |
None |
1500000 |
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 |
60219168001 |
Fluphenazine HCl 5mg |
2020-07-09 |
689.9500 |
This is a generic product that is not marketed. |
None |
1500000 |
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 |
60219162101 |
Metyrosine Capsule 250mg (100 in 1 BOTTLE) |
2020-07-27 |
35005.3900 |
This is a generic product that is not marketed. |
None |
41 |
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 |
69238173002 |
Naproxen 125MG/5ML |
2020-08-03 |
896.4400 |
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 |
| Amneal Pharmaceuticals |
60219150201 |
Phenoxybenzamine HCl |
2020-10-27 |
3000.0000 |
This is a generic product that is not marketed. |
None |
1000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505619702 |
SIROLIMUS O/SLN |
2020-05-22 |
1052.6200 |
Market analysis efforts are not performed at this level. The macro approach applied is evaluation of aggregated scripts in the market basket, by quarter, for the therapeutic class of the drug. Please note figured entered into the Estimated Avg. Number of Patients per month, is the monthly average aggregated scripts for this product in the market basket analyzed for launch. |
None |
23401 |
None |
None |
None |
None |
None |
None |
Apotex received FDA approval for the drug. |
None |
| AstraZeneca |
00310061060 |
Name- Koselugo (selumetinib) Dosage- 25mg/m2 Form- Capsules: 10mg 60 count bottle |
2020-04-10 |
4362.0000 |
AstraZeneca will engage 2 sales representatives to cover the state of California. Patient brochures as well as therapy management guides, may be left behind in offices for informational purposes.
AstraZeneca provides online resources via KOSELUGO™ US healthcare professionals and patient websites. Patients may register for the KOSELUGO™ support program via the website which will enroll them in a digital relationship marketing program to receive materials such as welcome letters, patient brochures, etc. The KOSELUGO™ patient savings program for eligible commercially insured patients will be available for patients in California and can be found via AstraZeneca’s Product website.
The KOSELUGO™ is currently only marketed in the United States.
When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value.
Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers. |
None |
1556 |
1 |
1 |
2003-12-18 |
None |
1 |
AstraZeneca licensed Selumetinib from Array BioPharma Inc. in 2003 for a publicly undisclosed amount. |
KOSELUGO™ is an orally available, inhibitor of mitogen-activated protein kinases 1 and 2 (MEK1/2) and is indicated for the treatment of pediatric patients 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). |
None |
| AstraZeneca |
00310062560 |
Name- Koselugo (selumetinib) Dosage- 25mg/m2 Form- Capsules: 25mg 60 count bottle |
2020-04-10 |
10905.0000 |
AstraZeneca will engage 2 sales representatives to cover the state of California. Patient brochures as well as therapy management guides, may be left behind in offices for informational purposes.
AstraZeneca provides online resources via KOSELUGO™ US healthcare professionals and patient websites. Patients may register for the KOSELUGO™ support program via the website which will enroll them in a digital relationship marketing program to receive materials such as welcome letters, patient brochures, etc. The KOSELUGO™ patient savings program for eligible commercially insured patients will be available for patients in California and can be found via AstraZeneca’s Product website.
The KOSELUGO™ is currently only marketed in the United States.
When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value.
Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers. |
None |
1556 |
1 |
1 |
2003-12-18 |
None |
1 |
AstraZeneca licensed Selumetinib from Array BioPharma Inc. in 2003 for a publicly undisclosed amount. |
KOSELUGO™ is an orally available, inhibitor of mitogen-activated protein kinases 1 and 2 (MEK1/2) and is indicated for the treatment of pediatric patients 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). |
None |
| AuroMedics Pharma LLC |
55150031825 |
Chlorpromazine Hydrochloride Injection USP, Ampules 25mg/1mL - 25s |
2020-09-01 |
722.2500 |
we plan to market the drug to hospital customers. |
None |
500000 |
None |
None |
2020-07-07 |
0.0000 |
1 |
acquisition price is proprietary |
number of patients is an ESTIMATE. we do not know how many people will be admitted to a hospital and will require treatment with this drug. additionally, there are 2 manufacturers of the injectable form of chlorpromazine and 6 manufacturers of the ORAL form (which we can assume is the preferred treatment). |
None |
| AuroMedics Pharma LLC |
55150031925 |
Chlorpromazine Hydrochloride Injection USP, Ampules 50mg/2mL - 25s |
2020-09-01 |
827.5000 |
we plan to market the drug to hospital customers. |
None |
500000 |
None |
None |
2020-07-07 |
0.0000 |
1 |
acquisition price is proprietary |
number of patients is an ESTIMATE. we do not know how many people will be admitted to a hospital and will require treatment with this drug. additionally, there are 2 manufacturers of the injectable form of chlorpromazine and 6 manufacturers of the ORAL form (which we can assume is the preferred treatment). |
None |
| AvKare |
50268016515 |
Chlorpromazine Tab 100mg |
2020-04-01 |
725.2600 |
This drug is marketed as a typical generic drug would be, through the use of wholesalers to distributor the product. There is not a significant marketing campaign or active patient facing marketing. |
None |
274 |
None |
None |
None |
None |
None |
None |
This is a generic drug - acquisition price doesn't appear to be relevant since it's not a typical situation in which there was a one time purchase payment for the development/acquisition rights to manufacturer the drug.
Monthly usage based on AvKare's expected sale volume and patient base. This is a generic drug - AvKare does not have information related to overall market usage. |
None |
| Banner Life Sciences LLC |
69387000101 |
BAFIERTAM 95mg |
2020-09-01 |
5790.0000 |
Specific marketing and pricing plans for Bafiertam™ are not available in the public domain. Generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with multiple sclerosis.
Marketing: Promotional activities include detailing of the product by sales representatives, limited print distribution and digital resources to health care professionals.
Pricing: As a bioequivalent to Tecfidera, BAFIERTAM™ provides a market-based solution to health care spending with opportunity to deliver cost savings. The US wholesaler acquisition cost (WAC) of $5,790.00, represents a 30% discount to the current WAC of Tecfidera. The WAC is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. BAFIERTAM™ will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. WAC does not include discounts that may be paid on this product to payers, providers, distributors. |
None |
1000000 |
None |
None |
None |
0.0000 |
None |
None |
Drug was developed by Banner Life Sciences, therefore no acquisition data exists
A recently completed (2017) prevalence study, funded by the National MS Society, has estimated that nearly 1 million people over the age of 18 live with a diagnosis of MS. |
None |
| Bionpharma, Inc |
69452016113 |
Deferasirox Oral Tablet Soluble 500 MG |
2020-01-20 |
760.0800 |
Generic drug - Wholesaler Acquisition Cost |
None |
None |
None |
None |
None |
None |
None |
None |
The estimated number of patients is unknown to Bionpharma.
Bionpharma did not acquire this product; these fields are not relevant. |
None |
| Blueprint Medicines Corporation |
72064011030 |
AYVAKIT (avapritinib) Tablets 100 MG, 30 tablets per bottle |
2020-01-16 |
32000.0000 |
None |
1 |
None |
1 |
1 |
None |
None |
None |
None |
Acquisition Cost
Not applicable. Drug was not acquired.
FDA Approval Designation
On January 9, 2020, the U.S. Food and Drug Administration (FDA) approved AYVAKIT™ (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. AYVAKIT has FDA Breakthrough Therapy and Fast Track Designations for the treatment of patients with unresectable or metastatic GIST harboring PDGFRA D842V mutations and was approved under Priority Review.
Expected Utilization
GIST is a rare, genomically driven sarcoma of the gastrointestinal (GI) tract. There are approximately 5,000 patients diagnosed with primary GIST in the U.S. annually, and approximately five to six percent of patients with newly diagnosed GIST have PDGFRA exon 18 mutations. The most common PDGFRA exon 18 mutation is the D842V mutation, which is resistant to all other approved therapies. These incidence estimates are based on external data sources, and GIST epidemiology data are imprecise. We do not have state-specific estimates for anticipated AYVAKIT utilization.
Marketing Plan Disclosure
The company’s marketing plan is not in the public domain nor is this information otherwise publicly available, and therefore, not subject to disclosure.
Pricing Plan Disclosure
The company’s pricing plan is not in the public domain nor is this information otherwise publicly available, and therefore, not subject to disclosure. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=340 |
| Blueprint Medicines Corporation |
72064012030 |
AYVAKIT (avapritinib) Tablets 200 MG, 30 tablets per bottle |
2020-01-16 |
32000.0000 |
None |
1 |
None |
1 |
1 |
None |
None |
None |
None |
Acquisition Cost
Not applicable. Drug was acquired.
FDA Approval Designation
On January 9, 2020, the U.S. Food and Drug Administration (FDA) approved AYVAKIT™ (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. AYVAKIT has FDA Breakthrough Therapy and Fast Track Designations for the treatment of patients with unresectable or metastatic GIST harboring PDGFRA D842V mutations and was approved under Priority Review.
Expected Utilization
GIST is a rare, genomically driven sarcoma of the gastrointestinal (GI) tract. There are approximately 5,000 patients diagnosed with primary GIST in the U.S. annually, and approximately five to six percent of patients with newly diagnosed GIST have PDGFRA exon 18 mutations. The most common PDGFRA exon 18 mutation is the D842V mutation, which is resistant to all other approved therapies. These incidence estimates are based on external data sources, and GIST epidemiology data are imprecise. We do not have state-specific estimates for anticipated AYVAKIT utilization.
Marketing Plan Disclosure
The company’s marketing plan is not in the public domain nor is this information otherwise publicly available, and therefore, not subject to disclosure.
Pricing Plan Disclosure
The company’s pricing plan is not in the public domain nor is this information otherwise publicly available, and therefore, not subject to disclosure. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=341 |
| Blueprint Medicines Corporation |
72064013030 |
AYVAKIT (avapritinib) Tablets 300 MG, 30 tablets per bottle |
2020-01-16 |
32000.0000 |
None |
1 |
None |
1 |
1 |
None |
None |
None |
None |
Acquisition Cost
Not applicable. Drug was not acquired.
FDA Approval Designation
On January 9, 2020, the U.S. Food and Drug Administration (FDA) approved AYVAKIT™ (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. AYVAKIT has FDA Breakthrough Therapy and Fast Track Designations for the treatment of patients with unresectable or metastatic GIST harboring PDGFRA D842V mutations and was approved under Priority Review.
Expected Utilization
GIST is a rare, genomically driven sarcoma of the gastrointestinal (GI) tract. There are approximately 5,000 patients diagnosed with primary GIST in the U.S. annually, and approximately five to six percent of patients with newly diagnosed GIST have PDGFRA exon 18 mutations. The most common PDGFRA exon 18 mutation is the D842V mutation, which is resistant to all other approved therapies. These incidence estimates are based on external data sources, and GIST epidemiology data are imprecise. We do not have state-specific estimates for anticipated AYVAKIT utilization.
Marketing Plan Disclosure
The company’s marketing plan is not in the public domain nor is this information otherwise publicly available, and therefore, not subject to disclosure.
Pricing Plan Disclosure
The company’s pricing plan is not in the public domain nor is this information otherwise publicly available, and therefore, not subject to disclosure. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=342 |
| Blueprint Medicines Corporation |
72064021060 |
GAVRETO (pralsetinib) Capsule Bottle of 60 100MG |
2020-09-08 |
9621.6000 |
None |
1 |
2946 |
1 |
None |
None |
None |
None |
None |
None |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=446 |
| Blueprint Medicines Corporation |
72064021090 |
GAVRETO (pralsetinib) Capsule Bottle of 90 100MG |
2020-09-08 |
14432.4000 |
None |
1 |
2946 |
1 |
None |
None |
None |
None |
None |
None |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=445 |
| Bristol Myers Squibb |
59572082030 |
ZEPOSIA ® (ozanimod) 0.92 mg 30 count bottle |
2020-06-01 |
7068.4900 |
We consider multiple factors when setting a list price for a medicine, including:
• The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs.
• Market and business considerations, including:
• Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world;
• Medical- and patient-service costs; this includes funding growing patient assistance programs;
• Inflationary and capital-investment costs associated with manufacturing, storage and supply. |
None |
280000 |
None |
None |
2019-11-20 |
74000000000.0000 |
None |
BMS obtained rights for Zeposia as part of Celgene acquisition. This acquisition did not consist of costs for individual assets |
Total class of RRMS (Relapsing-remitting multiple sclerosis) and SPMS (Secondary-progressive multiple sclerosis) is estimated at 280,000 patients. BMS is unable to provide an estimate of the number of patients who will be prescribed Zeposia each month |
None |
| Bristol Myers Squibb |
59572089091 |
ZEPOSIA ® (ozanimod) starter kit (7 day titration pack + 0.92 mg 30 count bottle) |
2020-06-01 |
8717.8100 |
We consider multiple factors when setting a list price for a medicine, including:
• The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs.
• Market and business considerations, including:
• Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world;
• Medical- and patient-service costs; this includes funding growing patient assistance programs;
• Inflationary and capital-investment costs associated with manufacturing, storage and supply. |
None |
280000 |
None |
None |
2019-11-20 |
74000000000.0000 |
None |
BMS obtained rights for Zeposia as part of Celgene acquisition. This acquisition did not consist of costs for individual assets |
Total class of RRMS (Relapsing-remitting multiple sclerosis) and SPMS (Secondary-progressive multiple sclerosis) is estimated at 280,000 patients. BMS is unable to provide an estimate of the number of patients who will be prescribed Zeposia each month |
None |
| Bristol Myers Squibb |
59572081007 |
ZEPOSIA® (ozanimod) 7 day titration pack |
2020-06-01 |
1649.3200 |
We consider multiple factors when setting a list price for a medicine, including:
• The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs.
• Market and business considerations, including:
• Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world;
• Medical- and patient-service costs; this includes funding growing patient assistance programs;
• Inflationary and capital-investment costs associated with manufacturing, storage and supply. |
None |
280000 |
None |
None |
2019-11-20 |
74000000000.0000 |
None |
BMS obtained rights for Zeposia as part of Celgene acquisition. This acquisition did not consist of costs for individual assets |
Total class of RRMS (Relapsing-remitting multiple sclerosis) and SPMS (Secondary-progressive multiple sclerosis) is estimated at 280,000 patients. BMS is unable to provide an estimate of the number of patients who will be prescribed Zeposia each month |
None |
| Bristol Myers Squibb |
59572073014 |
ONUREG® (azacitidine) 200mg 14 count bottle |
2020-09-04 |
21158.1100 |
We consider multiple factors when setting a list price for a medicine, including:
• The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs.
• Market and business considerations, including:
• Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world;
• Medical- and patient-service costs; this includes funding growing patient assistance programs;
• Inflationary and capital-investment costs associated with manufacturing, storage and supply. |
None |
2700 |
None |
1 |
2019-11-20 |
74000000000.0000 |
None |
BMS obtained rights for Onureg as part of Celgene acquisition. This acquisition did not consist of costs for individual assets |
Total class of AML (Acute Myeloid Leukemia) is estimated at 18,000 patients. At peak, average monthly number of patients who will be prescribed with Onureg is estimated at 2,700. |
None |
| Bristol Myers Squibb |
59572074014 |
ONUREG® (azacitidine) 300mg 14 count bottle |
2020-09-04 |
21158.1100 |
We consider multiple factors when setting a list price for a medicine, including:
• The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs.
• Market and business considerations, including:
• Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world;
• Medical- and patient-service costs; this includes funding growing patient assistance programs;
• Inflationary and capital-investment costs associated with manufacturing, storage and supply. |
None |
2700 |
None |
1 |
2019-11-20 |
74000000000.0000 |
None |
BMS obtained rights for Onureg as part of Celgene acquisition. This acquisition did not consist of costs for individual assets |
Total class of AML (Acute Myeloid Leukemia) is estimated at 18,000 patients. At peak, average monthly number of patients who will be prescribed with Onureg is estimated at 2,700. |
None |
| CASPER PHARMA, LLC |
70199002114 |
HELIDAC THERAPY CHEW/TAB/CAP 224 |
2020-06-24 |
966.0000 |
Casper Pharma engages in strategic marketing to create awareness and understanding with healthcare providers and pharmacies about the approved indication, efficacy and safety data contained within the drug's FDA approved label.
We employ a comparative pricing model as compared to other H-Pylori therapies in the market. Our mission is to ensure a favorable patient cost benefit while also providing broad patient and market access. |
None |
59000 |
None |
None |
2017-07-18 |
0.0000 |
1 |
Trade Secret |
Additional Comments Relative to Estimated Number of Patients:
1. Per the attached Product Insert for HELIDAC, this therapy is indicated for treatment of H-Pylori & Duodenal Ulcers.
2. Out of total US population of ~340 Million, H-Pylori prevalence pool is ~35% which is about ~119 Million people.
Source for estimates https://publichealth.arizona.edu/outreach/health-literacy-awareness/hpylori/prevalence#:~:text=pylori%20prevalence%20is%2060%20percent,those%20older%20than%2060%20years.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3107911/
3. Although there is wide prevalence of H-Pylori, only ~10% of the prevalent pool are symptomatic. There are high chances of misdiagnosis based on symptoms alone and often acid suppressants or OTCs are prescribed for prevention of ulcers.
4. Our source of the market data is the industry standard, IQVIA data. During the time period Dec 2018 to Nov 2019, there have been a total of 59,534 patients diagnosed and undergoing treatment for H Pylori, with a total of 61,748 prescriptions filled with a drug from the same therapeutic class.
5. Despite high incidence and wide prevalence, the treatment choice is limited by wide spread resistance to some of the drugs and also the availability of other multi drug regimens and OTCs. |
None |
| Celltrion USA, Inc. |
72606055902 |
Busulfan Injection 60 mg/10 mL |
2020-02-04 |
1496.0100 |
N/A - generic product |
None |
33000 |
1 |
None |
None |
None |
None |
None |
Celltrion USA has confirmed that they are responsible for setting the WAC. Also, there are or may be other manufacturers selling these products under a different labeler code. |
None |
| Chiesi USA |
10122010401 |
FERRIPROX tablets twice-a-day 1000mg |
2020-07-02 |
8590.1500 |
None |
1 |
650 |
None |
None |
None |
None |
None |
None |
Acquired while in development; Approved while owned by Chiesi USA. |
None |
| Cipla USA, Inc. |
69097096453 |
Vigabatrin Powd Pack 500 MG, 50 Each, Unit-Dose, Box |
2020-04-30 |
1337.0600 |
None |
1 |
7500000 |
None |
1 |
None |
None |
None |
None |
Product was not acquired |
None |
| Cipla USA, Inc. |
69097082037 |
Plazomicin Sulfate IV Soln 500 MG/10ML (50 MG/ML) (Base Eq), 10 ML, Unit-Dose, Vial |
2020-05-01 |
315.0000 |
None |
1 |
20 |
None |
None |
None |
None |
None |
None |
Estimated number of patients is considered a trade secret and non-public information. This information is not generally known or disclosed publicly and is of a highly sensitive and competitive nature that are confidential and proprietary trade secrets. Cipla provides this information solely for purposes of compliance with applicable reporting requirements mandated by state law. Any authorized disclosure of this sensitive information would be against Cipla’s express objection and a misappropriation of Cipla’s trade secrets. |
None |
| Cipla USA, Inc. |
69097082096 |
Plazomicin Sulfate IV Soln 500 MG/10ML (50 MG/ML) (Base Eq), 10 ML, Unit-Dose, Vial Qty 10 |
2020-05-01 |
3150.0000 |
None |
1 |
20 |
None |
None |
None |
None |
None |
None |
Estimated number of patients is considered a trade secret and non-public information. This information is not generally known or disclosed publicly and is of a highly sensitive and competitive nature that are confidential and proprietary trade secrets. Cipla provides this information solely for purposes of compliance with applicable reporting requirements mandated by state law. Any authorized disclosure of this sensitive information would be against Cipla’s express objection and a misappropriation of Cipla’s trade secrets. |
None |
| Cipla USA, Inc. |
69097050327 |
Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL |
2020-05-23 |
3426.8400 |
None |
1 |
1700 |
None |
None |
None |
None |
None |
None |
Drug was not acquired. Estimated number of patients is 1,700 per month |
None |
| Cipla USA, Inc. |
69097066434 |
Icatibant Acetate Subcutaneous Solution 30 MG/3ML |
2020-07-20 |
5083.2600 |
None |
1 |
10000 |
None |
None |
None |
None |
None |
None |
Product not acquired |
None |
| Cipla USA, Inc. |
69097032303 |
Dimethyl Fumarate Oral Capsule Delayed Release 240 MG |
2020-09-25 |
2607.1600 |
None |
1 |
1000000 |
None |
None |
None |
None |
None |
None |
Drug not acquired |
None |
| Cipla USA, Inc. |
69097055203 |
Dimethyl Fumarate Starter Pack Oral Miscellaneous 120 & 240 MG |
2020-09-25 |
2607.1600 |
None |
1 |
1000000 |
None |
None |
None |
None |
None |
None |
Drug not acquired |
None |
| Cipla USA, Inc. |
69097066468 |
Icatibant Acetate Subcutaneous Solution 30 MG/3ML 3x3ml |
2020-11-03 |
15249.7800 |
None |
1 |
10000 |
None |
None |
None |
None |
None |
None |
Product was not acquired |
None |
| Deciphera Pharmaceuticals, LLC |
73207010130 |
Qinlock (ripretinib) 50mg |
2020-05-20 |
32000.0000 |
Marketing Plan in the U.S.
QINLOCK™ is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. For additional information about Qinlock, please see the full Prescribing Information, available at www.qinlock.com.
Qinlock will be marketed to healthcare professionals (HCPs) by a team of field-based professionals and its expenditures will include spending on the following areas.
Deciphera’s marketing initiatives will focus on raising awareness of this ultra-rare cancer, GIST, and its potential treatment. Supporting the launch of Qinlock may include comprehensive education and training initiatives that will be provided by Deciphera’s employees to HCPs about the approved indication, dosing administration, mechanism of action (MOA), efficacy and safety data contained within the FDA approved label. Deciphera will have available and provide to HCPs, various printed materials, patient brochures as well as offer peer to peer educational programs (in-person and virtual) depicting both the GIST disease state and the FDA-approved clinical profile of Qinlock. Additional activities may include the development of websites, webcasts, and other digital media offerings. Deciphera will participate in scientific meetings and congresses that will be attended by HCPs and may engage with HCPs through such attendance.
Pricing Plan in the U.S.
Deciphera is committed to ensuring patient access and the price for Qinlock was set after doing extensive research and understanding the value of Qinlock relative to other available treatments, as well as the unmet medical need, and disease burden of a gastrointestinal stromal tumor. Our research also entailed evaluating the competitive landscape, and payer environment, as well as business operational continuation needs. Deciphera is committed to supporting GIST patients and removing barriers to access. As part of that commitment, Deciphera has established Deciphera AccessPoint, a patient support program that provides reimbursement and financial assistance programs for eligible patients. |
None |
1100 |
1 |
1 |
None |
None |
None |
None |
Cal. Health & Safety Code §127681 does not currently define “release of the drug in the commercial market” and Deciphera is not aware of any guidance issued by California or any California regulation that defines “release of the drug in the commercial market” for the purpose of Cal. Health & Safety Code §127681. As a result, for the purposes of compliance with Cal. Health & Safety Code §127681, Deciphera considers a drug to be “release[d] . . . in the commercial market” when Deciphera makes product available for shipment to its Wholesalers, Specialty Pharmacies and other customers who purchase directly from Deciphera.
As authorized by Cal. Health & Safety Code §127681, this disclosure contains only information that Deciphera has identified as being in the public domain or publicly available.
Deciphera provides this report consistent with its good faith understanding and interpretation of Cal. Health & Safety Code § 127681 and its provisions. In providing this report, Deciphera does not waive any rights, claims, or legal challenges with respect to Cal. Health & Safety Code § 127681 and related legislation or any implementing regulations thereof. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598045901 |
Trientine Hydrochloride Capsules, USP 250 mg |
2020-02-06 |
5000.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
1) Although only about 2,000-3,000 cases have been diagnosed in the United States, other affected individuals may be misdiagnosed with other neurological, liver or psychiatric disorders. According to one estimate, there may actually be 9,000 people affected by Wilson’s disease in the United States. However, Trientine is used for a sub population of Wilson’s disease who are intolerant to penicillamine. We can therefore not be certain of the actual number of such patients. 2) Dr. Reddy’s Laboratories, Inc. did not acquire the product. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Dr. Reddy's Laboratories, Inc. |
55111028960 |
Naproxen and Esomeprazole Magnesium 375-20mg Delayed-Release Tablet, 60 ct |
2020-02-26 |
1613.4300 |
None |
1 |
1300000 |
None |
None |
None |
None |
None |
None |
1) As this is a generic product, with other generics available, Dr. Reddy’s cannot estimate the estimated patient population. Notwithstanding, the total US patient population for rheumatoid arthritis is 1.3 million. However, Naproxen Esomeprazole is used for a sub population of patients who are at a high risk of stomach bleeding/ulcer. Indications of Naproxen Esomeprazole is also wider and can be substituted by taking the two products separately or even using OTC versions, so it is difficult to estimate the actual number. 2) Dr. Reddy’s Laboratories, Inc. did not acquire the product. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Dr. Reddy's Laboratories, Inc. |
55111070160 |
Naproxen and Esomeprazole Magnesium 500-20mg Delayed-Release Tablet, 60 ct |
2020-02-26 |
1613.4300 |
None |
1 |
1300000 |
None |
None |
None |
None |
None |
None |
1) As this is a generic product, with other generics available, Dr. Reddy’s cannot estimate the estimated patient population. Notwithstanding, the total US patient population for rheumatoid arthritis is 1.3 million. However, Naproxen Esomeprazole is used for a sub population of patients who are at a high risk of stomach bleeding/ulcer. Indications of Naproxen Esomeprazole is also wider and can be substituted by taking the two products separately or even using OTC versions, so it is difficult to estimate the actual number. 2) Dr. Reddy’s Laboratories, Inc. did not acquire the product. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598067201 |
Pyrimethamine 25mg Tablet, USP 100ct |
2020-03-19 |
29250.0000 |
None |
1 |
4000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s Laboratories, Inc. did not acquire the product. 2) Between 400-4000 cases of toxoplasmosis are reported in the US each year. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Pyrimethamine given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) lack of data reported by the brand, which typically gives a leading indication to generic volume. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598089801 |
Amphetamine Sulfate 10mg Tablets,USP,100 ct |
2020-04-13 |
279.3000 |
None |
1 |
6300000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy's Laboratories, Inc. does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with other generics available. Notwithstanding, the total patient population for ADHD and Narcolepsy, is approximately 6.3 million. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed Dr. Reddy’s Amphetamine IR given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient. 2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from Cerovene. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598089701 |
Amphetamine Sulfate 5mg Tablets,USP,100 ct |
2020-04-13 |
279.3000 |
None |
1 |
6300000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s Laboratories, Inc. does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with other generics available. Notwithstanding, the total patient population for ADHD and Narcolepsy, is approximately 6.3 million. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed Dr. Reddy’s Amphetamine IR given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient. 2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from Cerovene. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598093109 |
Desmopressin Acetate Inj. USP 4mcg/mL, 10ct |
2020-05-05 |
380.0000 |
None |
1 |
33000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with other generics available. Notwithstanding, the total patient population for: Hemophilia A is approximately 33,000; Von Willebrand Disease is approximately 14,600; Diabetes Insipidus is approximately 13,000. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed Dr. Reddy’s Desmopressin Acetate Injection given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient. 2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from SUNGEN. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598085230 |
Deferasirox Film Coated Tablets 180MG, 30ct |
2020-07-27 |
228.0400 |
None |
1 |
6700 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, the total prescriptions written for Deferasirox in a yearly basis is approximately 6,700. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Deferasirox FCT 180MG product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient.
2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from MSN Labs. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598063401 |
Penicillamine Oral Capsule 250 MG, 100 ct |
2020-08-26 |
8642.2500 |
None |
1 |
1344000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for the conditions that Penicillamine is indicated to treat is as follows: i) Wilson’s Disease – approximately 10,941 ii) Cystinuria – approximately 32,824; and iii) Rheumatoid Arthritis – approximately 1.3 million. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Penicillamine Oral Capsule 250MG product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Penicillamine in rheumatoid arthritis patients should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product. 3) Penicillamine was introduced to market on August 26, 2020. That is the date when the product was available for sale. The August 24, 2020 date in Medi-Span is simply the date that the WAC pricing was listed with the pricing compendia. However, for generic products, listing of the WAC does not trigger the statute as that date is not the date that the product is available for sale. For purchases of Penicillamine, the drug was not available for sale in California until August 26, 2020. This was the same date that was filed in our 3-day reports, as well as the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598026202 |
Fulvestrant Injection 250 mg/5 mL, 2ct |
2020-09-04 |
700.0000 |
None |
1 |
276480 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the American Cancer Society's estimates for breast cancer in the United States for 2020 approximately 276,480 new cases of invasive breast cancer will be diagnosed in women. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Fulvestrant Injection 250 mg/5 mL product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescription drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598043060 |
Dimethyl Fumarate Capsule 240mg 60ct |
2020-09-25 |
827.5900 |
None |
1 |
1000000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for MS, the condition that Dimethyl Fumarate is indicated to treat is 1 million patients. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Dimethyl Fumarate 240 mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598067230 |
Pyrimethamine Tablets, USP 25mg, 30ct |
2020-09-26 |
8775.0000 |
None |
1 |
4000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for Toxoplasmosis, the condition that Pyrethamine is indicated to treat is 400 to 4000 cases per year. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Pyrimethamine Tablets, USP 25 mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Pyrimethamine in rheumatoid arthritis patients should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from Cerovene. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598042952 |
Dimethyl Fumarate Capsule 120mg 14ct |
2020-09-28 |
193.1100 |
None |
1 |
1000000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for MS, the condition that Dimethyl Fumarate is indicated to treat is 1 million patients. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Dimethyl Fumarate 120 mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598074904 |
Sapropterin Dihydrochloride Tablets, 100 mg, 120ct |
2020-10-01 |
3868.8000 |
None |
1 |
19000 |
None |
1 |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Organization for Rare Disorders, the reported incidence of Phenylketonuria (PKU) from newborn screening programs ranges from one in 13,500 to 19,000 newborns in the United States However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Sapropterin dihydrochloride tablets 100mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Penicillamine in rheumatoid arthritis patients should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product. Dr. Reddy’s is commercializing a limited supply of this product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598036930 |
Cinacalcet Oral Tablet 90 MG, 30 ct |
2020-10-27 |
292.5000 |
None |
1 |
537469 |
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, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, the total prescriptions written for Cinacalcet Oral Tablet 90MG in a yearly basis is approximately 433,615 (including all strengths). As to number of patients: approximately 445,579 Adults may have CKD on dialysis that may present with Secondary HPT. Approximately 56 Adults may develop Parathyroid Carcinoma that may present with hypercalcemia. Approximately 91,834 Adults may have Primary HPT that may present with severe hypercalcemia and are unable to undergo a parathyroidectomy, thus a total of 537,469. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Cinacalcet Oral Tablet 90MG product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient. Dr. Reddy's did not acquire the product. The WAC, although less than $670, exceeds the threshold based on the monthly therapy usage. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598034431 |
Imatinib Mesylate Tablets 100mg, 30ct |
2020-10-27 |
875.0000 |
None |
1 |
35870 |
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, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for the conditions that Imatinib Mesylate 100MG tablets is indicated to treat is as follows: 1) Philadelphia chromosome positive chronic myeloid leukemia approximately 19,940 individuals worldwide, 2) myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR(platelet-derived growth factor receptor) – approximately 10,000; and 3)Lymphoblastic lymphoma - approximately 5,930. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Imatinib Mesylate 100MG tablets product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Imatinib Mesylate in myeloid leukemia should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. Dr. Reddy's did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598034531 |
Imatinib Mesylate Tablets 400mg, 30ct |
2020-10-27 |
2700.0000 |
None |
1 |
35870 |
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, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for the conditions that Imatinib Mesylate 400mg tablets is indicated to treat is as follows: 1) Philadelphia chromosome positive chronic myeloid leukemia approximately 19,940 individuals worldwide, 2) myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR(platelet-derived growth factor receptor) – approximately 10,000; and 3)Lymphoblastic lymphoma - approximately 5,930. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Imatinib Mesylate 400MG tablets product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Imatinib Mesylate in myeloid leukemia should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. Dr. Reddy's did not acquire the product. |
None |
| Edenbridge Pharmaceuticals, LLC |
42799070815 |
Miglustat Capsules, 100mg |
2020-09-01 |
4018.5300 |
None |
1 |
100 |
None |
None |
None |
None |
None |
None |
None |
None |
| Eli Lilly and Company |
00002298026 |
Retevmo™ 80MG 120 CAPSULE |
2020-05-12 |
20600.0000 |
None |
1 |
3750 |
1 |
1 |
2019-02-15 |
None |
1 |
Lilly acquired Loxo Oncology, Inc, on February 15, 2019 for a purchase price of approximately $6.92 billion, net of cash acquired. Under the terms of the agreement, Lilly acquired a pipeline of investigational medicines, including selpercatinib (Loxo-292). [https://investor.lilly.com/static-files/cd4a37af-ec28-449c-9bfb-ae380700209a] |
Retevmo™ (selpercatinib) was approved by the FDA in May 2020 as the first therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
Surveillance, Epidemiology, and End Results (SEER) data were used to estimate rates of cancer incidence and metastatic disease. Publicly available peer-reviewed literature was reviewed to estimate the prevalence of RET alterations and rates of disease progression by tumor type. Based on this analysis, Lilly estimates that there are 2,500 – 5,000 patients who may be eligible for treatment with a RET kinase inhibitor such as Retevmo. The average of that range (3,750) is reflected in column H. Patients with these conditions may or may not take Retevmo.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. |
None |
| Eli Lilly and Company |
00002298060 |
Retevmo™ 80MG 60 CAPSULE |
2020-05-12 |
10300.0000 |
None |
1 |
3750 |
1 |
1 |
2019-02-15 |
None |
1 |
Lilly acquired Loxo Oncology, Inc, on February 15, 2019 for a purchase price of approximately $6.92 billion, net of cash acquired. Under the terms of the agreement, Lilly acquired a pipeline of investigational medicines, including selpercatinib (Loxo-292). [https://investor.lilly.com/static-files/cd4a37af-ec28-449c-9bfb-ae380700209a] |
Retevmo™ (selpercatinib) was approved by the FDA in May 2020 as the first therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
Surveillance, Epidemiology, and End Results (SEER) data were used to estimate rates of cancer incidence and metastatic disease. Publicly available peer-reviewed literature was reviewed to estimate the prevalence of RET alterations and rates of disease progression by tumor type. Based on this analysis, Lilly estimates that there are 2,500 – 5,000 patients who may be eligible for treatment with a RET kinase inhibitor such as Retevmo. The average of that range (3,750) is reflected in column H. Patients with these conditions may or may not take Retevmo.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. |
None |
| Eli Lilly and Company |
00002397760 |
Retevmo™ 40MG 60 CAPSULE |
2020-05-14 |
6866.6600 |
None |
1 |
3750 |
1 |
1 |
2019-02-15 |
6920000000.0000 |
None |
Lilly acquired Loxo Oncology, Inc, on February 15, 2019 for a purchase price of approximately $6.92 billion, net of cash acquired. Under the terms of the agreement, Lilly acquired a pipeline of investigational medicines, including selpercatinib (Loxo-292). Based on guidance from OSHPD, Lilly has entered the acquisition cost of Loxo Oncology, Inc. in the Acquisition Price field. [https://investor.lilly.com/static-files/cd4a37af-ec28-449c-9bfb-ae380700209a] |
Retevmo™ (selpercatinib) was approved by the FDA in May 2020 as the first therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
Surveillance, Epidemiology, and End Results (SEER) data were used to estimate rates of cancer incidence and metastatic disease. Publicly available peer-reviewed literature was reviewed to estimate the prevalence of RET alterations and rates of disease progression by tumor type. Based on this analysis, Lilly estimates that there are 2,500 – 5,000 patients who may be eligible for treatment with a RET kinase inhibitor such as Retevmo. The average of that range (3,750) is reflected in column H. Patients with these conditions may or may not take Retevmo.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=438 |
| Epizyme, Inc. |
72607010000 |
Tazverik (Tazemetostat) 200 mg Tablets |
2020-01-31 |
15500.0000 |
None |
1 |
138 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Eton Pharmaceuticals, Inc. |
71863011050 |
Alkindi Sprinkle 1mg |
2020-09-29 |
698.6400 |
None |
1 |
8000 |
None |
None |
None |
None |
None |
None |
Eton does not have patented marketing information. Any marketing information related to this product is know only to Eton’s Commercial team. Marketing information has potential commercial value and allowing this information to remain non-public and confidential, allows Eton to obtain a business advantage over its competitors who do not have or know Eton’s marketing information. Making the marketing information public would not serve the public interest and therefore disclosure is not required. The prevalence of patients in the US that have the condition for which our prescription drug is prescribed, children between the ages of 0 -17, is estimated to be between 5,000 and 11,000. For reporting purposes, we entered the midpoint of 8,000. |
None |
| Eton Pharmaceuticals, Inc. |
71863011150 |
Alkindi Sprinkle 2mg |
2020-09-29 |
1397.2800 |
None |
1 |
8000 |
None |
None |
None |
None |
None |
None |
Eton does not have patented marketing information. Any marketing information related to this product is know only to Eton’s Commercial team. Marketing information has potential commercial value and allowing this information to remain non-public and confidential, allows Eton to obtain a business advantage over its competitors who do not have or know Eton’s marketing information. Making the marketing information public would not serve the public interest and therefore disclosure is not required. The prevalence of patients in the US that have the condition for which our prescription drug is prescribed, children between the ages of 0 -17, is estimated to be between 5,000 and 11,000. For reporting purposes, we entered the midpoint of 8,000. |
None |
| Eton Pharmaceuticals, Inc. |
71863011250 |
Alkindi Sprinkle 5mg |
2020-09-29 |
3493.2000 |
None |
1 |
8000 |
None |
None |
None |
None |
None |
None |
Eton does not have patented marketing information. Any marketing information related to this product is know only to Eton’s Commercial team. Marketing information has potential commercial value and allowing this information to remain non-public and confidential, allows Eton to obtain a business advantage over its competitors who do not have or know Eton’s marketing information. Making the marketing information public would not serve the public interest and therefore disclosure is not required. The prevalence of patients in the US that have the condition for which our prescription drug is prescribed, children between the ages of 0 -17, is estimated to be between 5,000 and 11,000. For reporting purposes, we entered the midpoint of 8,000. |
None |
| Exelan Pharmaceuticals, Inc. |
76282067630 |
Cinacalcet HCl Oral Tablet 90 MG, 30ct |
2020-06-15 |
956.4900 |
None |
1 |
454848 |
None |
None |
None |
None |
None |
None |
Full Drug Description: Cinacalcet HCl Oral Tablet 90 MG, 30ct |
None |
| Ferring Pharmaceuticals |
55566100201 |
ORTIKOS(Budesonide) extended release capsules 6mg |
2020-07-20 |
1200.0000 |
None |
1 |
800000 |
None |
None |
2018-10-04 |
None |
1 |
Ferring Pharmaceuticals Inc. acquired the Rights to Distribute Ortikos in the US from SUN on October 4, 2019 |
Sources
1. ORTIKOS [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc. 2. Crohn’s & Colitis Foundation. The Facts About Inflammatory Bowel Diseases. November 2014. 3. Crohn’s & Colitis Foundation. Living with Crohn’s Disease. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/living-with-crohnsdisease.pdf. Last accessed: May 2020. 4. Crohn’s & Colitis Foundation. Overview of Crohn’s Disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Last accessed: May 2020. |
None |
| Ferring Pharmaceuticals |
55566102001 |
ORTIKOS(Budesonide) extended release capsules 9mg |
2020-07-20 |
1200.0000 |
None |
1 |
800000 |
None |
None |
2019-10-04 |
None |
1 |
Ferring Pharmaceuticals Inc. acquired the Rights to Distribute Ortikos in the US from SUN on October 4, 2019 |
Sources
1. ORTIKOS [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc. 2. Crohn’s & Colitis Foundation. The Facts About Inflammatory Bowel Diseases. November 2014. 3. Crohn’s & Colitis Foundation. Living with Crohn’s Disease. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/living-with-crohnsdisease.pdf. Last accessed: May 2020. 4. Crohn’s & Colitis Foundation. Overview of Crohn’s Disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Last accessed: May 2020. |
None |
| Fresenius Kabi USA LLC |
63323082520 |
Decitabine for Injection 50 mg/vial |
2020-04-20 |
394.0000 |
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 Fresenius Kabi USA believes is otherwise in the public domain or publicly available, as of the date of this submission. (2) Fresenius Kabi USA’s marketing and pricing plans for this product are not in the public domain or otherwise publicly available. Consistent with the relevant statutes and regulations, Fresenius Kabi USA has left the “marketing and pricing plan description” data field blank. (3) Fresenius Kabi USA does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. Further, Fresenius Kabi USA does not know this information and has not put this information in the public domain. As a result, Fresenius Kabi USA has left the “estimated number of patients” data field blank. (4) The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed. |
None |
| Fresenius Kabi USA LLC |
63323072910 |
Micafungin Sodium Inj. Lyophilized 100 mg 10mL |
2020-05-08 |
1870.0000 |
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 Fresenius Kabi USA believes is otherwise in the public domain or publicly available, as of the date of this submission. (2) Fresenius Kabi USA’s marketing and pricing plans for this product are not in the public domain or otherwise publicly available. Consistent with the relevant statutes and regulations, Fresenius Kabi USA has left the “marketing and pricing plan description” data field blank. (3) Fresenius Kabi USA does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. Further, Fresenius Kabi USA does not know this information and has not put this information in the public domain. As a result, Fresenius Kabi USA has left the “estimated number of patients” data field blank. (4) The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed. |
None |
| Fresenius Kabi USA LLC |
63323072810 |
Micafungin Sodium Inj. Lyophilized 50 mg 10mL |
2020-05-08 |
935.0000 |
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 Fresenius Kabi USA believes is otherwise in the public domain or publicly available, as of the date of this submission. (2) Fresenius Kabi USA’s marketing and pricing plans for this product are not in the public domain or otherwise publicly available. Consistent with the relevant statutes and regulations, Fresenius Kabi USA has left the “marketing and pricing plan description” data field blank. (3) Fresenius Kabi USA does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. Further, Fresenius Kabi USA does not know this information and has not put this information in the public domain. As a result, Fresenius Kabi USA has left the “estimated number of patients” data field blank. (4) The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed. |
None |
| Fresenius Kabi USA LLC |
63323057486 |
Icatibant Injection 30 mg per 3 mL pack of 1 |
2020-10-21 |
5083.2600 |
None |
1 |
1 |
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 Fresenius Kabi USA believes is otherwise in the public domain or publicly available, as of the date of this submission. (2) Fresenius Kabi USA’s marketing and pricing plans for this product are not in the public domain or otherwise publicly available. Consistent with the relevant statutes and regulations, Fresenius Kabi USA has left the “marketing and pricing plan description” data field blank. (3) Fresenius Kabi USA does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. Further, Fresenius Kabi USA does not know this information and has not put this information in the public domain. As a result, Fresenius Kabi USA has left the “estimated number of patients” data field blank. (4) The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed. |
None |
| Fresenius Kabi USA LLC |
63323057493 |
Icatibant Injection 30 mg per 3 mL pack of 3 |
2020-10-21 |
15249.7800 |
None |
1 |
1 |
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 Fresenius Kabi USA believes is otherwise in the public domain or publicly available, as of the date of this submission. (2) Fresenius Kabi USA’s marketing and pricing plans for this product are not in the public domain or otherwise publicly available. Consistent with the relevant statutes and regulations, Fresenius Kabi USA has left the “marketing and pricing plan description” data field blank. (3) Fresenius Kabi USA does not believe the estimated number of patients with a condition for which this product may be prescribed in the United States, consistent with its label, is in the public domain. Further, Fresenius Kabi USA does not know this information and has not put this information in the public domain. As a result, Fresenius Kabi USA has left the “estimated number of patients” data field blank. (4) The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed. |
None |
| Genentech USA |
50242024501 |
PHESGO SC - 1200mg/600mg (15mL) Inject Solution |
2020-07-07 |
12707.0000 |
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 |
38600 |
None |
None |
None |
None |
None |
None |
It is estimated that there are approximately 38,600 patients in the US diagnosed with HER2+ breast cancer. Physicians treating patients with this condition make the determinations on therapeutic options.
PHESGO SC - 1200mg/600mg (15mL) Inject Solution was developed by Genentech USA Inc and was not acquired from a third party. |
None |
| Genentech USA |
50242026001 |
PHESGO SC - 600mg/600mg (10mL) Inject Solution |
2020-07-07 |
8471.0000 |
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 |
38600 |
None |
None |
None |
None |
None |
None |
It is estimated that there are approximately 38,600 patients in the US diagnosed with HER2+ breast cancer. Physicians treating patients with this condition make the determinations on therapeutic options.
PHESGO SC - 600mg/600mg (10mL) Inject Solution was developed by Genentech USA Inc and was not acquired from a third party. |
None |
| Genentech USA |
50242017507 |
Evrysdi 60mg/80mL oral powder (constituted to 0.75 mg/mL) |
2020-08-17 |
11170.4300 |
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 |
7200 |
1 |
1 |
None |
None |
None |
None |
Evrysdi 60mg/80mL oral powder (constituted to 0.75 mg/mL) was developed by Genentech USA Inc. and was not acquired from a third party. |
None |
| Genentech USA |
50242000701 |
Enspryng – 120mg/mL Prefilled Syringe |
2020-08-24 |
14615.3900 |
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 |
25400 |
1 |
1 |
None |
None |
None |
None |
Enspryng – 120mg/mL Prefilled Syringe was developed by Genentech USA Inc and was not acquired from a third party. |
None |
| Gilead Sciences, Inc. |
61958180501 |
HARVONI® (ledipasvir 33.75mg/sofosbuvir 150mg) oral pellets, 28 packets |
2020-05-26 |
31500.0000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Gilead believes is in the public domain or otherwise publicly available.
HARVONI oral pellets were granted orphan drug status by the FDA since it is estimated that, for the product, less than 200,000 patients in the U.S. are affected by a condition that it may be used to treat. However, Gilead is not aware of publicly available information related to the estimated number of patients that may be treated with HARVONI oral pellets. Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is unable to provide an estimated number of patients in its report.
Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product. |
None |
| Gilead Sciences, Inc. |
61958180401 |
HARVONI® (ledipasvir 45mg/sofosbuvir 200mg) oral pellets, 28 packets |
2020-05-26 |
31500.0000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Gilead believes is in the public domain or otherwise publicly available.
HARVONI oral pellets were granted orphan drug status by the FDA since it is estimated that, for the product, less than 200,000 patients in the U.S. are affected by a condition that it may be used to treat. However, Gilead is not aware of publicly available information related to the estimated number of patients that may be treated with HARVONI oral pellets. Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is unable to provide an estimated number of patients in its report.
Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product. |
None |
| Gilead Sciences, Inc. |
61958150401 |
SOVALDI® (sofosbuvir 150mg) oral pellets, 28 packets |
2020-05-26 |
28000.0000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Gilead believes is in the public domain or otherwise publicly available.
SOVALDI oral pellets were granted orphan drug status by the FDA since it is estimated that, for the product, less than 200,000 patients in the U.S. are affected by a condition that it may be used to treat. However, Gilead is not aware of publicly available information related to the estimated number of patients that may be treated with SOVALDI oral pellets. Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is unable to provide an estimated number of patients in its report.
Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product. |
None |
| Gilead Sciences, Inc. |
61958150501 |
SOVALDI® (sofosbuvir 200mg) oral pellets, 28 packets |
2020-05-26 |
28000.0000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Gilead believes is in the public domain or otherwise publicly available.
SOVALDI oral pellets were granted orphan drug status by the FDA since it is estimated that, for the product, less than 200,000 patients in the U.S. are affected by a condition that it may be used to treat. However, Gilead is not aware of publicly available information related to the estimated number of patients that may be treated with SOVALDI oral pellets. Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is unable to provide an estimated number of patients in its report.
Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product. |
None |
| GlaxoSmithKline |
00173089601 |
BLENREP INJ 100 MG |
2020-08-21 |
8277.0000 |
None |
1 |
3500 |
1 |
1 |
None |
None |
None |
None |
Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable, but not curable. In the US, more than 32,000 people are estimated to be diagnosed with multiple myeloma this year and nearly 13,000 people will die from the disease. Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments. GSK estimates that there are roughly 3,500 patients within the U.S. at a given time who suffer from multiple myeloma and would be potential candidates to use the product according to the current label. Diagnosed patients may or may not be prescribed BLENREP (NDC: 00173089601) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with BLENREP (NDC: 00173089601).
GSK has not released BLENREP's (NDC: 00173089601) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462049430 |
Deferasirox Tablets for Oral Suspension, 125 mg |
2020-01-17 |
675.8900 |
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 11,313 prescriptions for Deferasirox Tablets for Oral Suspension. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462049530 |
Deferasirox Tablets for Oral Suspension, 250 mg |
2020-01-17 |
1351.7600 |
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 11,313 prescriptions for Deferasirox Tablets for Oral Suspension. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462049630 |
Deferasirox Tablets for Oral Suspension, 500 mg |
2020-01-17 |
2703.4600 |
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 11,313 prescriptions for Deferasirox Tablets for Oral Suspension. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462072401 |
Chlorzoxazone Tablets USP, 375 mg |
2020-05-27 |
744.2900 |
None |
1 |
6570 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending April 2020 is 6,570 prescriptions for 375 mg , and 27,635 prescriptions for 750 mg. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462072501 |
Chlorzoxazone Tablets USP, 750 mg |
2020-05-27 |
832.2500 |
None |
1 |
27635 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending April 2020 is 6,570 prescriptions for 375 mg , and 27,635 prescriptions for 750 mg. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462042169 |
Atovaquone Oral Suspension USP,750 mg'5ml 42X5 |
2020-07-31 |
1239.0000 |
None |
1 |
120846 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, however IQVIA MAT data for the 12 months ending June 2020 is 120,846 prescriptions for the total market. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462068201 |
Sirolimus Tablets, .5 mg |
2020-10-23 |
694.3800 |
None |
1 |
213589 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending September 2020 is 213,589 prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462068301 |
Sirolimus Tablets, 1 mg |
2020-10-23 |
1388.7700 |
None |
1 |
213589 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending September 2020 is 213,589 prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Granules Pharmaceuticals Inc. |
70010005401 |
Butalbital and Acetaminophen Capsules, 50 mg/300 mg, 100 Count |
2020-02-19 |
1028.3300 |
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. |
70010004401 |
Butalbital, Acetaminophen and Caffeine Capsules, 50 mg/300 mg/40 mg, 100 Count |
2020-05-05 |
88.4200 |
None |
1 |
100 |
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. |
70010000201 |
COLCHICINE 0.6MG Tablets, 100count |
2020-05-13 |
107.5500 |
None |
1 |
100 |
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. |
70010000203 |
COLCHICINE 0.6MG Tablets, 30count |
2020-05-13 |
39.2700 |
None |
1 |
100 |
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 |
| Heritage Pharmacueticals Inc. D/B/A Avet Pharmacueticals Inc |
23155064941 |
Carmustine for Injection |
2020-02-26 |
2637.3900 |
None |
1 |
466000 |
None |
None |
2012-11-28 |
None |
1 |
None |
Estimated Number of Patients is based on information obtained from Cancer.org and represents total patients diagnosed with cancers that could be treated by this product |
None |
| Hikma Pharmaceuticals USA Inc |
00054047121 |
Everolimus Tabs 0.5 mg, 60 |
2020-03-10 |
951.4300 |
These drugs are generic products; therefore no marketing and pricing plans are available. These products are sold in the United States only. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma has not evaluated the volume of patients in the USA, as of January 2020 MAT IQVIA states a unit market size of 176,25. Hikma did not acquire this product. |
None |
| Hikma Pharmaceuticals USA Inc |
00054047221 |
Everolimus Tabs 0.75 mg, 60 |
2020-03-10 |
1427.1300 |
These drugs are generic products; therefore no marketing and pricing plans are available. These products are sold in the United States only. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma has not evaluated the volume of patients in the USA, as of January 2020 MAT IQVIA states a unit market size of 176,25. Hikma did not acquire this product. |
None |
| Hikma Pharmaceuticals USA Inc |
00143963410 |
Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection 20mg/200mL |
2020-04-22 |
1016.5000 |
These drugs are generic products; therefore no marketing and pricing plans are available. These products are sold in the United States only. |
None |
None |
None |
None |
2011-04-13 |
None |
1 |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma has not evaluated the volume of patients in the USA. According to CDC.gov, the estimated number of patients with hypertension is 108,000,000.
The Nicardipine products referenced herein were transferred from Exela to Hikma in connection with a License Development, Supply, and Marketing Agreement executed on April 13, 2011. This agreement is not in the public domain and thus the acquisition price cannot be disclosed. |
None |
| Hikma Pharmaceuticals USA Inc |
00143963310 |
Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection 40mg/200mL |
2020-04-22 |
2033.0000 |
These drugs are generic products; therefore no marketing and pricing plans are available. These products are sold in the United States only. |
None |
None |
None |
None |
2011-04-13 |
None |
1 |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma has not evaluated the volume of patients in the USA. According to CDC.gov, the estimated number of patients with hypertension is 108,000,000.
The Nicardipine products referenced herein were transferred from Exela to Hikma in connection with a License Development, Supply, and Marketing Agreement executed on April 13, 2011. This agreement is not in the public domain and thus the acquisition price cannot be disclosed. |
None |
| Hikma Pharmaceuticals USA Inc |
00054048014 |
Everolimus Tablets 2.5mg, Blister Pack of 28 |
2020-06-08 |
12012.9800 |
These drugs are generic products; therefore no marketing and pricing plans are available. These products are sold in the United States only. |
None |
73750 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2020 approximately 73,750 people will be diagnosed with advanced renal cell carcinoma. |
None |
| Hikma Pharmaceuticals USA Inc |
00054048114 |
Everolimus Tablets 5mg, Blister Pack of 28 |
2020-06-08 |
12565.3700 |
These drugs are generic products; therefore no marketing and pricing plans are available. These products are sold in the United States only. |
None |
73750 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2020 approximately 73,750 people will be diagnosed with advanced renal cell carcinoma. |
None |
| Hikma Pharmaceuticals USA Inc |
00054049714 |
Everolimus Tablets 7.5mg, Blister Pack of 28 |
2020-06-08 |
12565.3700 |
These drugs are generic products; therefore no marketing and pricing plans are available. These products are sold in the United States only. |
None |
73750 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2020 approximately 73,750 people will be diagnosed with advanced renal cell carcinoma. |
None |
| Hikma Pharmaceuticals USA Inc |
00054070219 |
Vigabatrin Oral Solution 500mg |
2020-09-25 |
1337.0600 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
3400000 |
None |
None |
None |
None |
None |
None |
Hikma has not evaluated the volume of patients in the USA. Vigabatrin Oral Solution is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures. According to CDC.gov, there are approximately 3.4 million people including children with epilepsy or seizure disorders nationwide. Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. |
None |
| Hikma Pharmaceuticals USA Inc |
00054052863 |
Rufinamide Oral Solution 40mg/mL, bottle of 460mL |
2020-11-01 |
1540.3700 |
None |
1 |
86060 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Rufinamide Oral Solution is indicated as adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome ("LGS") in pediatric patients 1 year of age and older and in adults. The incidence of LGS is estimated at approximately 26 per 100,000 people. Therefore, there are approximately 86,060 patients in the United States. |
None |
| Hikma Pharmaceuticals USA Inc |
00054039925 |
Bexarotene Capsules 75mg |
2020-11-25 |
5885.0000 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
77240 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Bexarotene capsules are a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. The American Cancer Society estimates that approximately 77,240 people will be diagnosed with T-cell lymphoma. |
None |
| Horizon Therapeutics USA, Inc. |
75987013015 |
Tepezza Intravenous Solution Reconstituted 500 MG, Single-Dose Vial |
2020-02-03 |
14900.0000 |
TEPEZZA is the first and only FDA-approved medicine for the treatment of Thyroid Eye Disease (TED), a serious, progressive and vision-threatening rare autoimmune disease that is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain, inflammation and facial disfigurement. Horizon's approach will focus on educating physicians about the disease state and TEPEZZA, providing education and support that simplifies the patient journey, and helping to facilitate access to TEPEZZA. TEPEZZA is a targeted biologic that addresses the underlying disease process, and its potential to significantly change the lives of people living with this rare and vision-threatening disease underscores the compelling value it offers. In addition to the value TEPEZZA brings to patients who previously had no meaningful options other than multiple eye surgeries, the pricing decision also reflects the significant investment made to develop and make an approved treatment available to a rare disease patient population. Horizon engaged in meaningful conversations with payors, as well as key members of the Thyroid Eye Disease community regarding this value in relation to pricing. |
None |
15000 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Horizon Therapeutics USA, Inc. |
75987014514 |
PROCYSBI (cysteamine bitartrate) delayed-release oral granules 300 MG, 120 Packets |
2020-04-23 |
48633.6000 |
The PROCYSBI Delayed-Release Oral Granules in Packets product provides another administration option for patients, in addition to PROCYSBI capsules. The new tear-open packets offer a convenient option for cystinosis patients who may have difficulty swallowing, need to sprinkle the granules on certain foods or mix with select liquids, or administer medication through a gastrostomy tube (G-tube). Additionally, the ability to access PROCYSBI granules in tear-open packets may help reduce the burden families living with cystinosis often face with managing multiple medications every day. Price remains consistent between 75mg capsules and 75mg and 300mg packets at the mg level. Horizon’s approach will continue to focus on educating physicians about the disease state and PROCYSBI, providing education and support that simplifies the patient journey, and helping to facilitate access to PROCYSBI. |
None |
15 |
None |
None |
None |
None |
None |
None |
Acquisition fields left blank as Horizon did not acquire PROCYSBI Delayed-Release Oral Granules in Packets. Horizon expects there to be 60 patients on treatment this year across all four NDC’s, which is approximately 15 patients per NDC. MediSpan is showing market availability of 3/17/2020 as PROCYSBI was added to MediSpan earlier than the product was available for ordering. Actual market availability was 4/23/2020 as reflected in this report. |
None |
| Horizon Therapeutics USA, Inc. |
75987014513 |
PROCYSBI (cysteamine bitartrate) delayed-release oral granules 300 MG, 60 Packets |
2020-04-23 |
24316.8000 |
The PROCYSBI Delayed-Release Oral Granules in Packets product provides another administration option for patients, in addition to PROCYSBI capsules. The new tear-open packets offer a convenient option for cystinosis patients who may have difficulty swallowing, need to sprinkle the granules on certain foods or mix with select liquids, or administer medication through a gastrostomy tube (G-tube). Additionally, the ability to access PROCYSBI granules in tear-open packets may help reduce the burden families living with cystinosis often face with managing multiple medications every day. Price remains consistent between 75mg capsules and 75mg and 300mg packets at the mg level. Horizon’s approach will continue to focus on educating physicians about the disease state and PROCYSBI, providing education and support that simplifies the patient journey, and helping to facilitate access to PROCYSBI. |
None |
15 |
None |
None |
None |
None |
None |
None |
Acquisition fields left blank as Horizon did not acquire PROCYSBI Delayed-Release Oral Granules in Packets. Horizon expects there to be 60 patients on treatment this year across all four NDC’s, which is approximately 15 patients per NDC. MediSpan is showing market availability of 3/17/2020 as PROCYSBI was added to MediSpan earlier than the product was available for ordering. Actual market availability was 4/23/2020 as reflected in this report. |
None |
| Horizon Therapeutics USA, Inc. |
75987014014 |
PROCYSBI (cysteamine bitartrate) delayed-release oral granules 75 MG, 120 Packets |
2020-04-23 |
12158.4000 |
The PROCYSBI Delayed-Release Oral Granules in Packets product provides another administration option for patients, in addition to PROCYSBI capsules. The new tear-open packets offer a convenient option for cystinosis patients who may have difficulty swallowing, need to sprinkle the granules on certain foods or mix with select liquids, or administer medication through a gastrostomy tube (G-tube). Additionally, the ability to access PROCYSBI granules in tear-open packets may help reduce the burden families living with cystinosis often face with managing multiple medications every day. Price remains consistent between 75mg capsules and 75mg and 300mg packets at the mg level. Horizon’s approach will continue to focus on educating physicians about the disease state and PROCYSBI, providing education and support that simplifies the patient journey, and helping to facilitate access to PROCYSBI. |
None |
15 |
None |
None |
None |
None |
None |
None |
Acquisition fields left blank as Horizon did not acquire PROCYSBI Delayed-Release Oral Granules in Packets. Horizon expects there to be 60 patients on treatment this year across all four NDC’s, which is approximately 15 patients per NDC. MediSpan is showing market availability of 3/17/2020 as PROCYSBI was added to MediSpan earlier than the product was available for ordering. Actual market availability was 4/23/2020 as reflected in this report. |
None |
| Horizon Therapeutics USA, Inc. |
75987014013 |
PROCYSBI (cysteamine bitartrate) delayed-release oral granules 75 MG, 60 Packets |
2020-04-23 |
6079.2000 |
The PROCYSBI Delayed-Release Oral Granules in Packets product provides another administration option for patients, in addition to PROCYSBI capsules. The new tear-open packets offer a convenient option for cystinosis patients who may have difficulty swallowing, need to sprinkle the granules on certain foods or mix with select liquids, or administer medication through a gastrostomy tube (G-tube). Additionally, the ability to access PROCYSBI granules in tear-open packets may help reduce the burden families living with cystinosis often face with managing multiple medications every day. Price remains consistent between 75mg capsules and 75mg and 300mg packets at the mg level. Horizon’s approach will continue to focus on educating physicians about the disease state and PROCYSBI, providing education and support that simplifies the patient journey, and helping to facilitate access to PROCYSBI. |
None |
15 |
None |
None |
None |
None |
None |
None |
Acquisition fields left blank as Horizon did not acquire PROCYSBI Delayed-Release Oral Granules in Packets. Horizon expects there to be 60 patients on treatment this year across all four NDC’s, which is approximately 15 patients per NDC. MediSpan is showing market availability of 3/17/2020 as PROCYSBI was added to MediSpan earlier than the product was available for ordering. Actual market availability was 4/23/2020 as reflected in this report. |
None |
| Immunomedics, Inc. |
55135013201 |
TRODELVY (sacituzumab govitecan-hziy) 180 mg vial |
2020-04-28 |
2012.5000 |
None |
1 |
9000 |
1 |
1 |
None |
None |
None |
None |
Specific to Introduced to Market Date (4/28/2020) TRODELVY was FDA approved on 4/22/2020, which is the date provided to Medispan. However, the date of product availability (or Product Launch Date) into the U.S. market was 4/28/2020.
Specific to Estimated Number of Patients Immunomedics is providing the following additional information that is publicly available:
Breast cancer is the most commonly diagnosed cancer in women in the US.
Source: Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019;69(1):7-34.
Based on data from the NCI’s SEER program, approximately 260,000 new cases of breast cancer were diagnosed in women in the US in 2019.
Source: National Cancer Institute. Cancer Stat Facts: Female Breast Cancer 2019; https://seer.cancer.gov/statfacts/html/breast.html. Accessed December 17, 2019
Of all new cases of breast cancer, approximately 10-15% are diagnosed with TNBC.
Source: American Cancer Society. Triple-negative breast cancer. https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/types-of-breast-cancer/triple-negative.html
Approximately 6-10% of new breast cancer cases are initially Stage 4 or metastatic. This is sometimes called “de novo” metastatic disease, meaning from the beginning.
Source: Metastatic Breast Cancer Network. Incidence and incidence rates. http://mbcn.org/education/category/incidence-and-incidence-rates
Approximately 30-40% of new breast cancer cases (Stage 1, Stage 2, and Stage 3) will progress to Stage 4 or metastatic stage.
Source: Zeichner SB, et al. Breast Cancer Bas Clin Res. 2016;10:25-36
Combining the two data points (de novo metastatic and those who progress to Stage 4) arrives at approximately 10,000 to 11,000 patients. Applying descending treatment rates sequentially from 1L to 2L to 3L you arrive at approximately 8,000 - 9,000 addressable patients. It is important to note that the initial indication for Trodelvy is for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Due to various external factors and dynamics, Immunomedics does not reasonably know how many patients will actually be prescribed TRODELVY.
Immunomedics does not publicly disclose the Marketing/Pricing Plan of TRODELVY. Thus, consistent with 22 C.C.R. §96076(c), Immunomedics has left that field blank.
Because this drug was not acquired, the fields "acquisition date," "acquisition price" and "acquisition price comment" have been left blank. |
None |
| Incyte Corporation |
50881002801 |
Pemazyre 13.5mg 14 count bottle |
2020-04-20 |
17000.0000 |
To market PEMAZYRE, Incyte designed activities to increase awareness and understanding with healthcare providers about the first FDA-approved product for these patients. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers. There is a consumer-directed website to educate patients on the disease state and PEMAZYRE, and Incyte intends to limit other direct-to-consumer advertising activities given the limited patient population.
At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations.
- Cholangiocarcinoma (CCA) is an orphan disease with limited treatment options.
- PEMAZYRE is the first treatment innovation for patients with cholangiocarcinoma since chemotherapy was approved 25 years ago
- It is a targeted treatment approved in the United States for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test. |
None |
None |
1 |
1 |
None |
None |
None |
None |
Comment regarding Field 7:
While Incyte's estimated volume of patients who may be prescribed PEMAZYRE is not available in the public domain, Cholangiocarcinoma (CCA) is a rare disease with a poor prognosis. Epidemiology studies suggest that the incidence rate of CCA ranges between 2.2 to 2.8 per 100,000 lives. CCA is a molecular target-rich disease with FGFR2 fusions and rearrangements representing 10-16% of intrahepatic CCA patients. FGFR2 fusions and rearrangements are rare in extrahepatic CCA. Patients with unresectable, previously treated iCCA with an FGFR2 fusion or rearrangement translate to ~1 per 1 million lives.
Comment regarding Field 8: Acquisition date - n/a
Comment regarding Field 9: Acquisition price - n/a
General Comment:
In the event 2017 California Senate Bill 17 (“SB-17”) and the laws it implements, including Cal. Health & Safety Code § 127677, are found unconstitutional or otherwise unlawful, Incyte reserves all of its legal rights. In issuing this report in an attempt to comply with Cal. Health & Safety Code § 127677, Incyte does not waive any legal claims or legal rights related to SB-17.
Please note that portions of this report and its contents may be exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes Incyte’s proprietary commercial information and otherwise would not be in the public interest to disclose. We ask that you please contact the Incyte legal department at 1801 Augustine Cut-Off, Wilmington, DE 19803 if you receive any PRA requests so that we may take appropriate steps to work with you to protect such information. |
None |
| Incyte Corporation |
50881002601 |
Pemazyre 4.5mg 14 count bottle |
2020-04-20 |
17000.0000 |
To market PEMAZYRE, Incyte designed activities to increase awareness and understanding with healthcare providers about the first FDA-approved product for these patients. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers. There is a consumer-directed website to educate patients on the disease state and PEMAZYRE, and Incyte intends to limit other direct-to-consumer advertising activities given the limited patient population.
At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations.
- Cholangiocarcinoma (CCA) is an orphan disease with limited treatment options.
- PEMAZYRE is the first treatment innovation for patients with cholangiocarcinoma since chemotherapy was approved 25 years ago
- It is a targeted treatment approved in the United States for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test. |
None |
None |
1 |
1 |
None |
None |
None |
None |
Comment regarding Field 7:
While Incyte's estimated volume of patients who may be prescribed PEMAZYRE is not available in the public domain, Cholangiocarcinoma (CCA) is a rare disease with a poor prognosis. Epidemiology studies suggest that the incidence rate of CCA ranges between 2.2 to 2.8 per 100,000 lives. CCA is a molecular target-rich disease with FGFR2 fusions and rearrangements representing 10-16% of intrahepatic CCA patients. FGFR2 fusions and rearrangements are rare in extrahepatic CCA. Patients with unresectable, previously treated iCCA with an FGFR2 fusion or rearrangement translate to ~1 per 1 million lives.
Comment regarding Field 8: Acquisition date - n/a
Comment regarding Field 9: Acquisition price - n/a
General Comment:
In the event 2017 California Senate Bill 17 (“SB-17”) and the laws it implements, including Cal. Health & Safety Code § 127677, are found unconstitutional or otherwise unlawful, Incyte reserves all of its legal rights. In issuing this report in an attempt to comply with Cal. Health & Safety Code § 127677, Incyte does not waive any legal claims or legal rights related to SB-17.
Please note that portions of this report and its contents may be exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes Incyte’s proprietary commercial information and otherwise would not be in the public interest to disclose. We ask that you please contact the Incyte legal department at 1801 Augustine Cut-Off, Wilmington, DE 19803 if you receive any PRA requests so that we may take appropriate steps to work with you to protect such information. |
None |
| Incyte Corporation |
50881002701 |
Pemazyre 9.0mg 14 count bottle |
2020-04-20 |
17000.0000 |
To market PEMAZYRE, Incyte designed activities to increase awareness and understanding with healthcare providers about the first FDA-approved product for these patients. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers. There is a consumer-directed website to educate patients on the disease state and PEMAZYRE, and Incyte intends to limit other direct-to-consumer advertising activities given the limited patient population.
At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations.
- Cholangiocarcinoma (CCA) is an orphan disease with limited treatment options.
- PEMAZYRE is the first treatment innovation for patients with cholangiocarcinoma since chemotherapy was approved 25 years ago
- It is a targeted treatment approved in the United States for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test. |
None |
None |
1 |
1 |
None |
None |
None |
None |
Comment regarding Field 7:
While Incyte's estimated volume of patients who may be prescribed PEMAZYRE is not available in the public domain, Cholangiocarcinoma (CCA) is a rare disease with a poor prognosis. Epidemiology studies suggest that the incidence rate of CCA ranges between 2.2 to 2.8 per 100,000 lives. CCA is a molecular target-rich disease with FGFR2 fusions and rearrangements representing 10-16% of intrahepatic CCA patients. FGFR2 fusions and rearrangements are rare in extrahepatic CCA. Patients with unresectable, previously treated iCCA with an FGFR2 fusion or rearrangement translate to ~1 per 1 million lives.
Comment regarding Field 8: Acquisition date - n/a
Comment regarding Field 9: Acquisition price - n/a
General Comment:
In the event 2017 California Senate Bill 17 (“SB-17”) and the laws it implements, including Cal. Health & Safety Code § 127677, are found unconstitutional or otherwise unlawful, Incyte reserves all of its legal rights. In issuing this report in an attempt to comply with Cal. Health & Safety Code § 127677, Incyte does not waive any legal claims or legal rights related to SB-17.
Please note that portions of this report and its contents may be exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes Incyte’s proprietary commercial information and otherwise would not be in the public interest to disclose. We ask that you please contact the Incyte legal department at 1801 Augustine Cut-Off, Wilmington, DE 19803 if you receive any PRA requests so that we may take appropriate steps to work with you to protect such information. |
None |
| Ingenus Pharmaceuticals, LLC |
50742052005 |
Cyclophosphamide Injection 1gm/5ml |
2020-07-31 |
732.5000 |
Ingenus prices their products based on the current market conditions along with a number of variables. All of these product specific variables are entered into a pricing model and pricing is determined. Some examples ( not all ) are cost of goods, profit share, freight costs, product volume, customer specific volumes, the COT/channels the specific product is sold in, rebates, chargebacks, contractual obligations. These factors vary product by product and aren’t all applicable in every case. |
None |
218623 |
None |
None |
None |
None |
None |
None |
As a manufacturer, Ingenus does not estimate the number of patients that may be prescribed our products. We manufacturer volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. Acquisition is not applicable. The total therapeutic WAC for this both SKUs of this product reaches the specified $670.00 amount |
None |
| Ingenus Pharmaceuticals, LLC |
50742051902 |
Cyclophosphamide Injection 500mg/2.5ml |
2020-07-31 |
366.2500 |
Ingenus prices their products based on the current market conditions along with a number of variables. All of these product specific variables are entered into a pricing model and pricing is determined. Some examples ( not all ) are cost of goods, profit share, freight costs, product volume, customer specific volumes, the COT/channels the specific product is sold in, rebates, chargebacks, contractual obligations. These factors vary product by product and aren’t all applicable in every case. |
None |
36174 |
None |
None |
None |
None |
None |
None |
As a manufacturer, Ingenus does not estimate the number of patients that may be prescribed our products. We manufacturer volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. Acquisition is not applicable. The total therapeutic WAC for this both SKUs of this product reaches the specified $670.00 amount |
None |
| Intra-Cellular Therapies, Inc. |
72060014230 |
Caplyta, 42 mg, capsule, 30 pack |
2020-03-18 |
1320.0000 |
None |
1 |
2400000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Janssen Biotech, Inc. |
57894050301 |
DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) Strength:1800mg / 15 mL Form:1 Single Vial |
2020-05-04 |
7574.0000 |
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 diagnosed with multiple myeloma. The pricing plan has WAC set for 1800mg / 15 mL subcutaneous injections at $7,574.00. The list price of DARZALEX FASPRO™ is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. DARZALEX FASPRO™ will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. On June 3, 2020, approval was received in the EU. |
None |
None |
None |
None |
None |
None |
None |
None |
The estimated number of patients in the United States with a condition for which DARZALEX FASPRO™ may be prescribed is not in the public domain or publicly available. DARZALEX FASPRO™ was developed by Janssen Biotech, Inc. |
None |
| Jazz Pharmaceuticals, Inc. |
68727071201 |
Zepzelca (lurbinectedin) 4mg lyophilized powder single dose vial |
2020-07-07 |
6633.0000 |
None |
1 |
8500 |
None |
1 |
2019-12-19 |
200000000.0000 |
None |
Lurbinectedin was licensed on December 19, 2019 through an exclusive license agreement between PharmaMar and Jazz Pharmaceuticals. Under the terms of the agreement, PharmaMar receives an upfront payment of $200 million with potential regulatory milestone payments of up to $250 million upon the achievement of accelerated and/or full regulatory approval of lurbinectedin by FDA within certain timelines. PharmaMar is also eligible to receive additional commercial milestone payments tied to future net sales of lurbinectedin. |
None |
None |
| Jazz Pharmaceuticals, Inc. |
68727015001 |
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution |
2020-11-02 |
5110.1200 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
| Karyopharm Therapeutics Inc. |
72237010106 |
XPOVIO (selinexor) 40mg (16 Tablets) |
2020-06-22 |
22000.0000 |
None |
1 |
9000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Karyopharm Therapeutics Inc. |
72237010107 |
XPOVIO (selinexor) 40mg (8 Tablets) |
2020-06-22 |
22000.0000 |
None |
1 |
9000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Karyopharm Therapeutics Inc. |
72237010103 |
XPOVIO (selinexor) 60mg (24 Tablets) |
2020-06-22 |
22000.0000 |
None |
1 |
9000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Kite Pharma, Inc. |
71287021901 |
TECARTUS™ (brexucabtagene autoleucel) 2 × 106CAR-positive viable T cells per kg of body weight, with a maximum of 2 × 108 CAR-positive viable T cells in approximately 68 mL of cell suspension for infusion |
2020-07-30 |
373000.0000 |
None |
1 |
None |
1 |
1 |
None |
None |
None |
None |
The information provided in this report is subject to general limitations and assumptions Kite has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Kite believes is in the public domain or otherwise publicly available.
Kite is not aware of publicly available information related to the estimated number of patients that may be treated with TECARTUS cell therapy. Consistent with Section 127681(c) of the California Health and Safety Code, Kite is unable to provide an estimated number of patients in its report.
Kite has not provided a response to the drug acquisition related data fields for this drug product because Kite developed this drug product. |
None |
| Mayne Pharma Inc |
51862029043 |
Triamcinolone Acetonide External Ointment 0.05% 430GM |
2020-05-18 |
779.3300 |
None |
1 |
13435 |
None |
None |
None |
None |
None |
None |
Estimated number of patients is an annualized number based on IQVIA average last 8 weeks of weekly scripts.
Introduced to Market Date (when product is commercially available) is expected end of May 2020. |
None |
| Mayne Pharma Inc |
51862033801 |
Chlorzoxazone 375mg Tabs 100 |
2020-07-28 |
744.2900 |
None |
1 |
8694 |
None |
None |
None |
None |
None |
None |
None |
None |
| Mayne Pharma Inc |
51862034001 |
Chlorzoxazone 750mg Tabs 100 |
2020-07-28 |
832.2500 |
None |
1 |
23769 |
None |
None |
None |
None |
None |
None |
None |
None |
| Mayne Pharma Inc |
51862057130 |
Doryx (Doxycycline Hyclate) Oral Tablet Delayed Release 80 MG |
2020-10-12 |
950.0000 |
None |
1 |
2000000 |
None |
None |
2015-02-25 |
50000000.0000 |
None |
None |
Doxycyline Hyclate is used to treat a wide variety of infections. The estimated number of patients is purely a guess as Mayne Pharma has no visibility into the prescribing habits of HCPs sufficient to provide a reliable number. Please refer to https://www.cdc.gov/ for additional information. |
None |
| Meitheal Pharmaceuticals, Inc. |
71288055586 |
Fulvestrant Injection 250mg 5mL SD Syringe 1 Pk of 2 Syringes |
2020-04-22 |
700.0000 |
This is a generic product and is not marketed. *(See Comments) |
None |
239431 |
None |
None |
None |
None |
None |
None |
Meitheal markets generic Fulvestrant as a therapeutic equivalent to the innovator (brand) drug. As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. Because its Fulvestrant product is a generic product and there are a number of alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed Fulvestrant. As such, given Fulvestrant's primary use for the treatment of breast cancer, Meitheal's best estimate regarding a patient population can be derived from the Centers for Disease Control and Prevention's ("CDC") tracking of breast cancer diagnoses within the United States. According to the CDC's most recent data (in 2017), approximately 239,431 women over the age of 40 were diagnosed with breast cancer. (https://gis.cdc.gov/Cancer/USCS/DataViz.html). |
None |
| Merck & Co., Inc. |
00006385602 |
RECARBRIO™ 1.25 grams (imipenem 500mg, cilastatin 500mg, relebactam 250mg)/Vial, powder |
2020-01-06 |
6687.5000 |
Marketing: At the time of introduction of RECARBRIO to the market, Merck will inform customers of its availability, accompanied by limited promotion to healthcare professionals.
Pricing: Merck prices our products, including RECARBRIO, to support access for patients today while also funding the critical investments that will empower our team of more than 12,000 Merck researchers to invent the cures and treatments of tomorrow. Our Company has a long history of responsibly pricing our medicines based on various factors, including the value provided to patients and the health care system, unmet medical need, access and ability to pay, R&D sustainability, and the competitive environment. Merck does not maintain records that reflect how these factors are applied in the context of any particular product. |
None |
None |
None |
1 |
None |
None |
None |
None |
Estimated Patients: The estimated volume of patients who may be prescribed the drug. RECARBRIO is indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
RECARBRIO is also indicated in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible Gram-negative microorganisms: Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Fusobacterium nucleatum, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Parabacteroides distasonis and Pseudomonas aeruginosa.
Acquisition Date / Acquisition Price: Acquisition fields are not applicable as Merck has not acquired this product.
Marketing/Pricing Plan (Non Public): Consistent with SB 17, Merck has limited its response to information publicly available or otherwise in the public domain.
Drug Product Description: RECARBRIO is delivered by intravenous (IV) infusion over 30 minutes every 6 hours in patients 18 years of age and older. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=338, https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=339 |
| Merck & Co., Inc. |
00006503302 |
ONTRUZANT® (trastuzumab-dttb) for injection, for intravenous use, 150 mg of lyophilized trastuzumab-dttb, 15 mL single-dose vial, Package of one 15 mL single-dose vial |
2020-04-15 |
1324.6600 |
Marketing: Promotional activities for ONTRUZANT will primarily include detailing of the product by Merck sales representatives to health care professionals working in various care settings, including infusion centers and hospitals. ONTRUZANT will also be marketed in the US with limited print distribution and digital resources to health care professionals. However, there will be no direct-to-consumer marketing for ONTRUZANT such as TV, magazine or journal ads.
Pricing: We believe that biosimilars provide a market-based solution to health care spending with significant promise to deliver cost savings. Increasing choice in treatment options and decreasing out-of-pocket costs for HER-2 positive breast cancer patients is a primary focus in our pricing strategy for ONTRUZANT. As such, the price of ONTRUZANT, a biosimilar to Herceptin, will be established in the U.S. at a list price (wholesaler acquisition cost) of $1,324.66 for the 150 mg single-dose vial and $3,709.04 for the 420 mg multiple-dose vial, representing a 15% discount to the current list price of Herceptin. Additionally, it’s important to note that the WAC does not include discounts that may be paid on this product to payers, providers, distributors and other purchasing organizations. |
None |
88833 |
None |
None |
2013-02-18 |
None |
1 |
None |
Marketing/Pricing Plan (Non Public): Consistent with SB 17, Merck has limited its response to information publicly available or otherwise in the public domain.
Estimated Patients: Ontruzant has the same indications as Herceptin and is indicated for the treatment of HER2-overexpressing breast cancer and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction. According to the American Cancer Society, approximately 268,600 women are diagnosed with breast cancer and 27,510 diagnosed with gastric cancer yearly. Of the 296,110 annual breast and gastric cancer diagnoses, collectively, approximately 15% - 30% of these patients are HER2 positive (sources: American Cancer Society Breast Cancer Statistics, ESMO Her2+ Gastric Cancer). Assuming the higher limit of the estimated range of 30%, the estimated annual patient population for ONTRUZANT is approximately 88,833. However, it is important to note there are several other products on the market that are indicated to treat these disease states, including the originator and several other biosimilars that would likely be used to treat a portion of the 88,833 annual cases.
Breakthrough Therapy Indicator / Priority Review Indicator: ONTRUZANT was not granted breakthrough therapy designation or priority review.
Acquisition Date / Acquisition Price: It is important to note that by completing the acquisition-related fields, Merck is not representing that Merck has acquired all rights and obligations associated with ONTRUZANT. Rather, in 2013, Merck entered into an agreement with Samsung Bioepis wherein Merck acquired responsibilities for commercialization of the product in the U.S. Samsung Bioepis, as the manufacturer of ONTRUZUANT and BLA holder, remains responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration. As part of this agreement with respect to ONTRUZANT, Merck has paid an upfront payment, pre-specified clinical and regulatory milestones and product supply payment. To the best of Merck’s knowledge, the amount of these payments has not been publicly disclosed. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=436 |
| Merck & Co., Inc. |
00006503402 |
ONTRUZANT® (trastuzumab-dttb) for injection, for intravenous use, 420 mg of lyophilized trastuzumab-dttb, 40 mL multi-dose vial with diluent, Package of one 40 mL multi-dose vial with diluent |
2020-04-15 |
3709.0400 |
Marketing: Promotional activities for ONTRUZANT will primarily include detailing of the product by Merck sales representatives to health care professionals working in various care settings, including infusion centers and hospitals. ONTRUZANT will also be marketed in the US with limited print distribution and digital resources to health care professionals. However, there will be no direct-to-consumer marketing for ONTRUZANT such as TV, magazine or journal ads.
Pricing: We believe that biosimilars provide a market-based solution to health care spending with significant promise to deliver cost savings. Increasing choice in treatment options and decreasing out-of-pocket costs for HER-2 positive breast cancer patients is a primary focus in our pricing strategy for ONTRUZANT. As such, the price of ONTRUZANT, a biosimilar to Herceptin, will be established in the U.S. at a list price (wholesaler acquisition cost) of $1,324.66 for the 150 mg single-dose vial and $3,709.04 for the 420 mg multiple-dose vial, representing a 15% discount to the current list price of Herceptin. Additionally, it’s important to note that the WAC does not include discounts that may be paid on this product to payers, providers, distributors and other purchasing organizations. |
None |
88833 |
None |
None |
2013-02-18 |
None |
1 |
None |
Marketing/Pricing Plan (Non Public): Consistent with SB 17, Merck has limited its response to information publicly available or otherwise in the public domain.
Estimated Patients: Ontruzant has the same indications as Herceptin and is indicated for the treatment of HER2-overexpressing breast cancer and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction. According to the American Cancer Society, approximately 268,600 women are diagnosed with breast cancer and 27,510 diagnosed with gastric cancer yearly. Of the 296,110 annual breast and gastric cancer diagnoses, collectively, approximately 15% - 30% of these patients are HER2 positive (sources: American Cancer Society Breast Cancer Statistics, ESMO Her2+ Gastric Cancer). Assuming the higher limit of the estimated range of 30%, the estimated annual patient population for ONTRUZANT is approximately 88,833. However, it is important to note there are several other products on the market that are indicated to treat these disease states, including the originator and several other biosimilars that would likely be used to treat a portion of the 88,833 annual cases.
Breakthrough Therapy Indicator / Priority Review Indicator: ONTRUZANT was not granted breakthrough therapy designation or priority review.
Acquisition Date / Acquisition Price: It is important to note that by completing the acquisition-related fields, Merck is not representing that Merck has acquired all rights and obligations associated with ONTRUZANT. Rather, in 2013, Merck entered into an agreement with Samsung Bioepis wherein Merck acquired responsibilities for commercialization of the product in the U.S. Samsung Bioepis, as the manufacturer of ONTRUZUANT and BLA holder, remains responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration. As part of this agreement with respect to ONTRUZANT, Merck has paid an upfront payment, pre-specified clinical and regulatory milestones and product supply payment. To the best of Merck’s knowledge, the amount of these payments has not been publicly disclosed. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=437 |
| MorphoSys |
73535020801 |
Monjuvi (tatasitamab-cxix) |
2020-08-05 |
1200.0000 |
Tafasitamab-cxix is approved in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). Accordingly, MorphoSys and our co-promotion partner plan to engage in a marketing plan for tafasitamab-cxix directed to educate providers and patient groups about this potential treatment option for DLBCL. In general, we plan marketing initiatives for tafasitamab-cxix that include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), materials to be used by our oncology sales managers to share information on tafasitamab with prescribers, materials to be used by our access and policy team with payers and other coverage decision makers regarding medical policy inclusion for tafasitamab and materials to educate patients about relapsed or refractory diffuse large B-cell lymphoma in the United States.
The list price of tafasitamab-cxix does not reflect discounts and rebates, which may be available through the Medicaid Drug Rebate Program (MDRP), Medicare, and/or the commercial insurance market. Tafasitamab-cxix also will be discounted, as required, under the 340B Drug Pricing Program, the Federal Supply Schedule (FSS), and any other applicable government programs. For these reasons, the actual cost of tafasitamab-cxix to individual patients, providers, and health insurers is expected to be lower than WAC, and, in the case of patients, the actual cost likely will vary from patient to patient based on individual insurance coverage. We have implemented pricing for tafasitamab-cxix considering appropriate access for patients, while taking into account costs undertaken in research, development, manufacturing, and marketing of the drug, as well as the companys' business operations and internal evaluations of the market for this new treatment. At MorphoSys, we strive to discover, develop, and deliver breakthrough cancer therapies to patients who need them. Society relies on research-driven companies like MorphoSys to provide new medicines to address unmet medical needs, and we take seriously the trust that patients, caregivers, and healthcare professionals (HCPs) place in us. We believe our commitment does not end until our treatments are accessible for the patients who are prescribed them. We thoughtfully price our drugs by balancing the value of the outcomes and innovation they bring to patients and the healthcare system, with market and societal expectations. More detailed marketing and pricing plans are not in the public domain or otherwise publicly available. |
None |
10000 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mylan Institutional Inc |
42292005505 |
Paliperidone ER 9mg UD20 |
2020-03-13 |
763.2100 |
None |
1 |
4200000 |
None |
None |
None |
None |
None |
None |
Paliperidone is indicated for (1) Schizophrenia: The efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults; (2) Schizoaffective Disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy. According to the National Alliance on Mental Illness (NAMI), it was estimated that Schizophrenia affects approximately 1% of the population (approximately 3.2M of the 328M US Population), and Schizoaffective Disorder is prevalent in approximately affects roughly 0.3% of the population (approximately 984,000 of the 328M US Population) (https://www.nami.org/learn-more/mental-health-conditions/schizoaffective-disorder). Therefore, an estimated 4.2M patients in the United States may be prescribed this product.
The Product was not a result of an acquisition. |
None |
| Mylan Institutional Inc |
42292005703 |
Abiraterone Acetate 250mg Tabs UD30 |
2020-06-08 |
425.0000 |
None |
1 |
89482 |
None |
None |
None |
None |
None |
None |
Abiraterone acetate tablets are indicated for the treatment of patients with metastatic castration-resistant prostate cancer. In 2020, an estimated 191,930 new cases of prostate cancer are expected to be diagnosed in men in the U.S. From them, 21,112 (11%) may have metastatic CRPC (mCRPC), plus 68,370 patients diagnosed in prior years (prevalence) and becoming mCRPC. In total, potentially 89,482 may require the use of abiraterone as part of their treatment during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378461501 |
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release Tablets, 10mg/10mg, 100s |
2020-07-21 |
592.0500 |
None |
1 |
2996432 |
None |
None |
None |
None |
None |
None |
Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Based on the literature, up to 80% of women experienced nausea and vomiting during pregnancy (NVP) in the U.S. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3990370/) The provisional number of births for the United States in 2019 was 3,745,540. (https://www.cdc.gov/nchs/data/vsrr/vsrr-8-508.pdf). Therefore, an estimated (using available data) 2,996,432 patients in the United States could potentially use this product as part of their pregnancy during the current year.
Please note that, although not all courses of treatment of the Product trigger the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program (the “threshold”), this notice is being submitted because the Product triggers the threshold only when taking into account the maximum recommended dose as listed in the Product Prescribing Information. |
None |
| Mylan Pharmaceuticals Inc |
00378039614 |
Dimethyl Fumarate Delayed-Release Capsules, 120mg, 14 count |
2020-08-18 |
1666.6200 |
None |
1 |
776836 |
None |
1 |
None |
None |
None |
None |
Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Based on the literature, approximately 85% of patients with MS are initially diagnosed with RRMS (https://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS) A 2017 study confirmed approximately 913,925 adult patients have MS in the United States. (https://www.nationalmssociety.org/About-the-Society/News/Landmark-Study-Estimates-Nearly%C2%A01-Million-in-the-U#:~:text=The%20estimated%20prevalence%20of%20MS,or%20913%2C925%20adults%20with%20MS). Therefore, an estimated (using available data) 776,836 patients in the United States could potentially use this product as part of their MS treatment during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378039991 |
Dimethyl Fumarate Delayed-Release Capsules, 240mg, 60 count |
2020-08-18 |
7142.4300 |
None |
1 |
776836 |
None |
1 |
None |
None |
None |
None |
Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Based on the literature, approximately 85% of patients with MS are initially diagnosed with RRMS (https://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS) A 2017 study confirmed approximately 913,925 adult patients have MS in the United States. (https://www.nationalmssociety.org/About-the-Society/News/Landmark-Study-Estimates-Nearly%C2%A01-Million-in-the-U#:~:text=The%20estimated%20prevalence%20of%20MS,or%20913%2C925%20adults%20with%20MS). Therefore, an estimated (using available data) 776,836 patients in the United States could potentially use this product as part of their MS treatment during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378309685 |
Everolimus Tablets, 2.5mg, 28 count |
2020-09-10 |
6419.4300 |
None |
1 |
272125 |
None |
None |
None |
None |
None |
None |
Everolimus Tablets (label and PI) are indicated for the treatment of hormone receptor-positive HER2-negative breast cancer, tuberous sclerosis complex-associated renal angiomyolipoma, and tuberous sclerosis complex-associated subependymal giant cell astrocytoma. Based on the literature in 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. (https://www.cancer.gov/types/breast/patient/breast-screening-pdq#section/all) According to the National Institute of Cancer the total percentage of breast cancer that is the subtype HR+/HER2- is 67%. (https://seer.cancer.gov/statfacts/html/breast-subtypes.html) Therefore, an estimated 222,125 (67% of 331,530) women in the United States may be prescribed the product for the first indication.
Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 80% of patients with TSC may develop renal angiomyolipomas (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4080684/). Therefore, an estimated 40,000 patients may be prescribed this product for the second indication.
Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 20% of patients with TSC general develop subependymal giant cell astrocytomas (SEGAs) during the first two decades of their life (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5707039/). Therefore, an estimated 10,000 patients in the United States may be prescribed this product for the third indication.
Therefore, considering all approved indications, a total of 272,125 patients in the United States may be prescribed the product. |
None |
| Mylan Pharmaceuticals Inc |
00378309785 |
Everolimus Tablets, 5mg, 28 count |
2020-09-10 |
6714.6200 |
None |
1 |
272125 |
None |
None |
None |
None |
None |
None |
Everolimus Tablets (label and PI) are indicated for the treatment of hormone receptor-positive HER2-negative breast cancer, tuberous sclerosis complex-associated renal angiomyolipoma, and tuberous sclerosis complex-associated subependymal giant cell astrocytoma. Based on the literature in 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. (https://www.cancer.gov/types/breast/patient/breast-screening-pdq#section/all) According to the National Institute of Cancer the total percentage of breast cancer that is the subtype HR+/HER2- is 67%. (https://seer.cancer.gov/statfacts/html/breast-subtypes.html) Therefore, an estimated 222,125 (67% of 331,530) women in the United States may be prescribed the product for the first indication.
Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 80% of patients with TSC may develop renal angiomyolipomas (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4080684/). Therefore, an estimated 40,000 patients may be prescribed this product for the second indication.
Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 20% of patients with TSC general develop subependymal giant cell astrocytomas (SEGAs) during the first two decades of their life (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5707039/). Therefore, an estimated 10,000 patients in the United States may be prescribed this product for the third indication.
Therefore, considering all approved indications, a total of 272,125 patients in the United States may be prescribed the product. |
None |
| Mylan Pharmaceuticals Inc |
00378309885 |
Everolimus Tablets, 7.5mg, 28 count |
2020-09-10 |
6714.6200 |
None |
1 |
272125 |
None |
None |
None |
None |
None |
None |
Everolimus Tablets (label and PI) are indicated for the treatment of hormone receptor-positive HER2-negative breast cancer, tuberous sclerosis complex-associated renal angiomyolipoma, and tuberous sclerosis complex-associated subependymal giant cell astrocytoma. Based on the literature in 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. (https://www.cancer.gov/types/breast/patient/breast-screening-pdq#section/all) According to the National Institute of Cancer the total percentage of breast cancer that is the subtype HR+/HER2- is 67%. (https://seer.cancer.gov/statfacts/html/breast-subtypes.html) Therefore, an estimated 222,125 (67% of 331,530) women in the United States may be prescribed the product for the first indication.
Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 80% of patients with TSC may develop renal angiomyolipomas (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4080684/). Therefore, an estimated 40,000 patients may be prescribed this product for the second indication.
Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 20% of patients with TSC general develop subependymal giant cell astrocytomas (SEGAs) during the first two decades of their life (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5707039/). Therefore, an estimated 10,000 patients in the United States may be prescribed this product for the third indication.
Therefore, considering all approved indications, a total of 272,125 patients in the United States may be prescribed the product. |
None |
| Mylan Pharmaceuticals Inc |
00378450093 |
Budesonide ER Tablets, 9mg, 30 count |
2020-10-20 |
1549.0200 |
None |
1 |
907000 |
None |
1 |
None |
None |
None |
None |
Budesonide extended-release tablets are indicated for the treatment of active, mild to moderate ulcerative colitis. Based on the literature, an estimated 907,000 Americans currently have ulcerative colitis. (https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf, page 10) |
None |
| Novadoz Pharmaceuticals, LLC |
72205004601 |
Thiotepa for Injection 100mg, 1 per pack |
2020-04-10 |
4250.0000 |
None |
1 |
451 |
None |
None |
2020-03-04 |
0.0000 |
1 |
This product was not acquired. MSN is the contract manufacturer for Novadoz. MSN owns the ANDA but the labeler code is owned by Novadoz. |
None |
None |
| Novadoz Pharmaceuticals, LLC |
72205004501 |
Thiotepa for Injection 15mg, 1 per pack |
2020-04-10 |
700.0000 |
None |
1 |
3100 |
None |
None |
2020-03-04 |
0.0000 |
1 |
This product was not acquired. MSN is the contract manufacturer for Novadoz. MSN owns the ANDA but the labeler code is owned by Novadoz. |
None |
None |
| Novadoz Pharmaceuticals, LLC |
72205005030 |
Toremifene Citrate Tablets 60mg |
2020-10-19 |
1144.5000 |
None |
1 |
6089 |
None |
None |
None |
None |
None |
None |
This product was not acquired. MSN is the contract manufacturer for Novadoz. MSN owns the ANDA but the labeler code is owned by Novadoz. |
None |
| Novartis |
00078070956 |
Tabrecta (Capmatinib) 56 tabs of 150mg |
2020-05-06 |
8975.0000 |
Novartis considered many factors in determining the price of Tabrecta. Tabrecta is the treatment specifically for patients with advanced or metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation with disease progression on or after platinum-based chemotherapy. We priced in parity to other treatments in this class and are focused on access to Tabrecta for this patient population. |
None |
192200 |
1 |
1 |
None |
None |
None |
None |
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 |
00078071656 |
Tabrecta (Capmatinib) 56 tabs of 200mg |
2020-05-06 |
8975.0000 |
Novartis considered many factors in determining the price of Tabrecta. Tabrecta is the treatment specifically for patients with advanced or metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation with disease progression on or after platinum-based chemotherapy. We priced in parity to other treatments in this class and are focused on access to Tabrecta for this patient population. |
None |
192200 |
1 |
1 |
None |
None |
None |
None |
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 |
00078100768 |
Kesimpta (Ofatumumab) 20mg/0.4mL (auto injector) |
2020-08-21 |
6916.6700 |
The marketing for Kesimpta includes education and promotion to physicians, direct to consumer promotions, other types of marketing (e.g., online platforms and education). KESIMPTA is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Kesimpta is the first B-cell therapy for patients with relapsing forms of multiple sclerosis or RMS that can be self-administered at home using an autoinjector pen. We priced in parity to other treatments in this class and are focused on access to Kesimpta for this patient population. |
None |
500000 |
None |
1 |
None |
None |
None |
None |
Novartis estimates there are 500,000 Multiple sclerosis patients in the United States. Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| Noven Therapeutics, LLC |
68968017203 |
Asenapine 3.8 mg/ 24 hours transdermal system |
2020-03-02 |
1200.0000 |
None |
1 |
2000 |
None |
None |
None |
None |
None |
None |
Product was not acquired |
None |
| Noven Therapeutics, LLC |
68968017303 |
Asenapine 5.7 mg/ 24 hours transdermal system |
2020-03-02 |
1200.0000 |
None |
1 |
2000 |
None |
None |
None |
None |
None |
None |
Product was not acquired |
None |
| Noven Therapeutics, LLC |
68968017403 |
Asenapine 7.6 mg/ 24 hours transdermal system |
2020-03-02 |
1200.0000 |
None |
1 |
2000 |
None |
None |
None |
None |
None |
None |
Product was not acquired |
None |
| Novo |
00169810001 |
Esperoct® 1000 IU |
2020-02-03 |
2.2300 |
None |
1 |
8000 |
None |
None |
None |
None |
None |
None |
Regarding the reported wholesale acquisition cost (WAC), NNI reports the WAC of Esperoct® on a per International Unit (IU) basis, including in the primary public pricing databases (e.g., MediSpan Price Pro). Accordingly, the WAC for the Esperoct® NDC-11s at issue also will be publicly listed as $2.23. The amount of IUs prescribed is based on patient bodyweight. Based on dosages set forth in the FDA-approved labeling, we expect that, for all patients, a course of therapy will exceed the $670 threshold for a Medicare Part D Specialty Drug. The Prescribing Information for Esperoct®, which includes the FDA-approved dosages, is available here: https://www.novo-pi.com/esperoct.pdf.
Regarding the reported patient estimate, Esperoct® is a coagulation Factor VIII concentrate indicated for use in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Per the Hemophilia Foundation of America, Hemophilia A affects nearly 20,000 people in the U.S. For the estimated patients requirement, market data indicates there are approximately 8,000 Hemophilia A patients on factor replacement therapy that could potentially use Esperoct® in the United States. It is not an estimate of prescriptions that might be written for Esperoct®.
Esperoct® was developed by Novo Nordisk. |
None |
| Novo |
00169815001 |
Esperoct® 1500 IU |
2020-02-03 |
2.2300 |
None |
1 |
8000 |
None |
None |
None |
None |
None |
None |
Regarding the reported wholesale acquisition cost (WAC), NNI reports the WAC of Esperoct® on a per International Unit (IU) basis, including in the primary public pricing databases (e.g., MediSpan Price Pro). Accordingly, the WAC for the Esperoct® NDC-11s at issue also will be publicly listed as $2.23. The amount of IUs prescribed is based on patient bodyweight. Based on dosages set forth in the FDA-approved labeling, we expect that, for all patients, a course of therapy will exceed the $670 threshold for a Medicare Part D Specialty Drug. The Prescribing Information for Esperoct®, which includes the FDA-approved dosages, is available here: https://www.novo-pi.com/esperoct.pdf.
Regarding the reported patient estimate, Esperoct® is a coagulation Factor VIII concentrate indicated for use in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Per the Hemophilia Foundation of America, Hemophilia A affects nearly 20,000 people in the U.S. For the estimated patients requirement, market data indicates there are approximately 8,000 Hemophilia A patients on factor replacement therapy that could potentially use Esperoct® in the United States. It is not an estimate of prescriptions that might be written for Esperoct®.
Esperoct® was developed by Novo Nordisk. |
None |
| Novo |
00169820001 |
Esperoct® 2000 IU |
2020-02-03 |
2.2300 |
None |
1 |
8000 |
None |
None |
None |
None |
None |
None |
Regarding the reported wholesale acquisition cost (WAC), NNI reports the WAC of Esperoct® on a per International Unit (IU) basis, including in the primary public pricing databases (e.g., MediSpan Price Pro). Accordingly, the WAC for the Esperoct® NDC-11s at issue also will be publicly listed as $2.23. The amount of IUs prescribed is based on patient bodyweight. Based on dosages set forth in the FDA-approved labeling, we expect that, for all patients, a course of therapy will exceed the $670 threshold for a Medicare Part D Specialty Drug. The Prescribing Information for Esperoct®, which includes the FDA-approved dosages, is available here: https://www.novo-pi.com/esperoct.pdf.
Regarding the reported patient estimate, Esperoct® is a coagulation Factor VIII concentrate indicated for use in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Per the Hemophilia Foundation of America, Hemophilia A affects nearly 20,000 people in the U.S. For the estimated patients requirement, market data indicates there are approximately 8,000 Hemophilia A patients on factor replacement therapy that could potentially use Esperoct® in the United States. It is not an estimate of prescriptions that might be written for Esperoct®.
Esperoct® was developed by Novo Nordisk. |
None |
| Novo |
00169830001 |
Esperoct® 3000 IU |
2020-02-03 |
2.2300 |
None |
1 |
8000 |
None |
None |
None |
None |
None |
None |
Regarding the reported wholesale acquisition cost (WAC), NNI reports the WAC of Esperoct® on a per International Unit (IU) basis, including in the primary public pricing databases (e.g., MediSpan Price Pro). Accordingly, the WAC for the Esperoct® NDC-11s at issue also will be publicly listed as $2.23. The amount of IUs prescribed is based on patient bodyweight. Based on dosages set forth in the FDA-approved labeling, we expect that, for all patients, a course of therapy will exceed the $670 threshold for a Medicare Part D Specialty Drug. The Prescribing Information for Esperoct®, which includes the FDA-approved dosages, is available here: https://www.novo-pi.com/esperoct.pdf.
Regarding the reported patient estimate, Esperoct® is a coagulation Factor VIII concentrate indicated for use in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Per the Hemophilia Foundation of America, Hemophilia A affects nearly 20,000 people in the U.S. For the estimated patients requirement, market data indicates there are approximately 8,000 Hemophilia A patients on factor replacement therapy that could potentially use Esperoct® in the United States. It is not an estimate of prescriptions that might be written for Esperoct®.
Esperoct® was developed by Novo Nordisk. |
None |
| Novo |
00169850001 |
Esperoct® 500 IU |
2020-02-03 |
2.2300 |
None |
1 |
8000 |
None |
None |
None |
None |
None |
None |
Regarding the reported wholesale acquisition cost (WAC), NNI reports the WAC of Esperoct® on a per International Unit (IU) basis, including in the primary public pricing databases (e.g., MediSpan Price Pro). Accordingly, the WAC for the Esperoct® NDC-11s at issue also will be publicly listed as $2.23. The amount of IUs prescribed is based on patient bodyweight. Based on dosages set forth in the FDA-approved labeling, we expect that, for all patients, a course of therapy will exceed the $670 threshold for a Medicare Part D Specialty Drug. The Prescribing Information for Esperoct®, which includes the FDA-approved dosages, is available here: https://www.novo-pi.com/esperoct.pdf.
Regarding the reported patient estimate, Esperoct® is a coagulation Factor VIII concentrate indicated for use in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Per the Hemophilia Foundation of America, Hemophilia A affects nearly 20,000 people in the U.S. For the estimated patients requirement, market data indicates there are approximately 8,000 Hemophilia A patients on factor replacement therapy that could potentially use Esperoct® in the United States. It is not an estimate of prescriptions that might be written for Esperoct®.
Esperoct® was developed by Novo Nordisk. |
None |
| NS Pharma, Inc. |
73292001101 |
Viltepso |
2020-08-21 |
1410.0000 |
None |
1 |
328 |
None |
None |
2020-04-01 |
None |
1 |
the “per vial” cost it is not a set dollar amount - the acquisition is set at 29,763 yen for this fiscal year (April 2020 – March 2021) and average exchange rate of the prior month of the shipment is used to calculate US$ amount. Thus the acquisition price fluctuates. |
Duchenne Muscular Dystrophy (DMD), is an ultra-orphan disease with a very small patient population, estimates put the patient volume at an estimated 0.000001% of US population, or 328 patients nationally. |
None |
| Par Pharmaceutical |
49884014601 |
Penicillamine Capsules 250mg 100s |
2020-01-02 |
20950.9100 |
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 did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is indicated for Wilson Disease, National Organization for Rare Disorders (“NORD”) indicates between 2,000 – 3,000 cases have been diagnosed in the United States. See https://rarediseases.org/rare-diseases/wilson-disease/. However, NORD indicates as many as 9,000 people in the United States may be actually affected by Wilson Disease. Further, NORD did not specify the number of patients diagnosed each month or year with Wilson Disease. Penicillamine is also indicated for excess cysteine excretion and severe rheumatoid arthritis unresponsive to other treatments. It is estimated that 1 in 10,000 people are affected by excess cysteine excretion in the United States. See https://ghr.nlm.nih.gov/condition/cystinuria#statistics. An estimated 1.3 million Americans suffer from rheumatoid arthritis. See https://www.rheumatoidarthritis.org/ra/facts-and-statistics/.
Because of the multiple indications of Penicillamine, and the absence of precise data about the various patient populations that have diseases for which Penicillamine is indicated, Par is unable to provide an estimate of the average number of patients who may be treated by this product.
Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that will be prescribed this product each month.
As a result, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
00254200001 |
Penicillamine Tablets 250mg 100s |
2020-01-02 |
4652.9200 |
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 did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is indicated for Wilson Disease, National Organization for Rare Disorders (“NORD”) indicates between 2,000 – 3,000 cases have been diagnosed in the United States. See https://rarediseases.org/rare-diseases/wilson-disease/. However, NORD indicates as many as 9,000 people in the United States may be actually affected by Wilson Disease. Further, NORD did not specify the number of patients diagnosed each month or year with Wilson Disease. Penicillamine is also indicated for excess cysteine excretion and severe rheumatoid arthritis unresponsive to other treatments. It is estimated that 1 in 10,000 people are affected by excess cysteine excretion in the United States. See https://ghr.nlm.nih.gov/condition/cystinuria#statistics. An estimated 1.3 million Americans suffer from rheumatoid arthritis. See https://www.rheumatoidarthritis.org/ra/facts-and-statistics/.
Because of the multiple indications of Penicillamine, and the absence of precise data about the various patient populations that have diseases for which Penicillamine is indicated, Par is unable to provide an estimate of the average number of patients who may be treated by this product.
Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that will be prescribed this product each month.
As a result, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
00254101019 |
Diazoxide Oral Suspension 50mg/mL 30mL bottle |
2020-08-04 |
275.5200 |
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) This product is indicated for management hypoglycemia due to hyperinsulinism associated with numerous different conditions. Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Because of the product’s widespread indications, and because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to provide an estimated number of patients who will be prescribed the products in the “estimated number of patients” data field. As a result, Par has left the estimated number of patients data field blank.
Because of the multiple indications of Diazoxide, and the absence of precise data about the various patient populations that have diseases for which Diazoxide is indicated, Par is unable to provide an estimate of the average number of patients who may be treated by this product.
Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that will be prescribed this product each month.
As a result, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
42023016410 |
Vasostrict® 1 mL x 10 Single Dose Vials |
2020-08-10 |
1975.6000 |
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) This product indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product.
Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the number of patients who may be prescribed this product.
As a result, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884094872 |
Sapropterin Dihydrochloride Powder for OS 100mg 30s |
2020-08-28 |
967.2000 |
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 did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is a phenylalanine hydroxylase activator indicated to for hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). National Organization for Rare Disorders (“NORD”) indicates approximately 1 in 1,000,000 individuals may Tetrahydrobiopterin deficiencies in the general population. See https://rarediseases.org/rare-diseases/tetrahydrobiopterin-deficiency/. Further, NORD did not specify the number of patients diagnosed each month or year with Tetrahydrobiopterin deficiencies.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that may be prescribed this product.
As a result, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=448 |
| Par Pharmaceutical |
49884087372 |
Sapropterin Dihydrochloride Powder for OS 500mg 30s |
2020-08-28 |
4836.0000 |
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 did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is a phenylalanine hydroxylase activator indicated to for hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). National Organization for Rare Disorders (“NORD”) indicates approximately 1 in 1,000,000 individuals may Tetrahydrobiopterin deficiencies in the general population. See https://rarediseases.org/rare-diseases/tetrahydrobiopterin-deficiency/. Further, NORD did not specify the number of patients diagnosed each month or year with Tetrahydrobiopterin deficiencies.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that may be prescribed this product.
As a result, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=449 |
| Par Pharmaceutical |
49884072008 |
Sapropterin Dihydrochloride Tablets 100mg 120s |
2020-08-28 |
3868.8000 |
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 did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is a phenylalanine hydroxylase activator indicated to for hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). National Organization for Rare Disorders (“NORD”) indicates approximately 1 in 1,000,000 individuals may Tetrahydrobiopterin deficiencies in the general population. See https://rarediseases.org/rare-diseases/tetrahydrobiopterin-deficiency/. Further, NORD did not specify the number of patients diagnosed each month or year with Tetrahydrobiopterin deficiencies.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that may be prescribed this product.
As a result, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=447 |
| Perrigo Pharmaceuticals |
45802088918 |
Calcipotriene-Betamethasone Dipropionate Topical Susp 0.005%/0.064% |
2020-10-09 |
1001.9500 |
We plan to market the product as a generic to the Brand reference drug primarily to regional and national wholesalers, warehousing retail chains, and hospital and LTC group purchasing organizations.
Product will be price to deliver value to the market as compared to the Brand reference drug. |
None |
8000000 |
None |
None |
None |
None |
None |
None |
Drug Product was not acquired by Perrigo so blank fields in 10 and 11 are intentional. |
None |
| Pfizer |
00069023801 |
RUXIENCE 10mg/ml SSOL 1x10mLGVL US |
2020-01-23 |
716.8000 |
None |
1 |
204000 |
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 rituximab market based on Rituxan's usage across therapeutic areas, we estimate 240,000 patients currently being treated on Avastin. Note this includes Rheumatoid Arthritis; please note that Ruxience is not indicated for use in that patient population (15% of patients). Comment regarding Fields 10-13: Ruxience was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069024901 |
RUXIENCE 10mg/ml SSOL 1x50mLGVL US |
2020-01-23 |
3584.0000 |
None |
1 |
204000 |
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 rituximab market based on Rituxan's usage across therapeutic areas, we estimate 240,000 patients currently being treated on Avastin. Note this includes Rheumatoid Arthritis; please note that Ruxience is not indicated for use in that patient population (15% of patients). Comment regarding Fields 10-13: Ruxience was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069030501 |
TRAZIMERA 420mg/30ml SFDPO 1x1 GVL US |
2020-02-18 |
3391.0800 |
None |
1 |
64000 |
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 trastuzumab market based on Herceptin's usage across therapeutic areas, we estimate 64,000 patients currently being treated on Herceptin. Comment regarding Fields 10-13: Trazimera was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069024810 |
PROPOFOL EDTA 10mg/ml INJ 10x100ml VL US |
2020-09-17 |
213.8000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
Pfizer Inc. is the reporting manufacturer for this product launch based on the following information. Pfizer acquired InnoPharma in September 2014. The ANDA for Propofol EDTA was transferred to InnoPharma subsequent to the acquisition. There is no licensing agreement between InnoPharma and Pfizer Inc. for Propofol EDTA; Pfizer Inc. is the NDC holder. Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - The estimated number of patients who may be prescribed Propofol EDTA is unknown. Comment regarding Fields 10-13: Propofol EDTA was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069020910 |
PROPOFOL EDTA 10mg/ml INJ 10x20ml VL US |
2020-09-17 |
42.8000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
Pfizer Inc. is the reporting manufacturer for this product launch based on the following information. Pfizer acquired InnoPharma in September 2014. The ANDA for Propofol EDTA was transferred to InnoPharma subsequent to the acquisition. There is no licensing agreement between InnoPharma and Pfizer Inc. for Propofol EDTA; Pfizer Inc. is the NDC holder. Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - The estimated number of patients who may be prescribed Propofol EDTA is unknown. Comment regarding Fields 10-13: Propofol EDTA was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069023420 |
PROPOFOL EDTA 10mg/ml INJ 20x50ml VL US |
2020-09-17 |
213.8000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
Pfizer Inc. is the reporting manufacturer for this product launch based on the following information. Pfizer acquired InnoPharma in September 2014. The ANDA for Propofol EDTA was transferred to InnoPharma subsequent to the acquisition. There is no licensing agreement between InnoPharma and Pfizer Inc. for Propofol EDTA; Pfizer Inc. is the NDC holder. Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - The estimated number of patients who may be prescribed Propofol EDTA is unknown. Comment regarding Fields 10-13: Propofol EDTA was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409351022 |
ERTAPENEM 1gm SPO 1x10 GVIAL US |
2020-09-29 |
1170.0000 |
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 who may be prescribed Ertapenem is unknown. Per 2020 IMS data, annual UoU is 3,584,259 (represents rolling 12 months). Comment regarding Fields 10-13: Ertapenem is licensed as part of a contract manufacturer relationship; Pfizer is not the ANDA holder. Because the product was not acquired, Fields 10 – 13 are intentionally left blank. |
None |
| QBioMed Inc. |
72928008901 |
STRONTIUM CHLORIDE Sr-89 INJECTION, USP |
2020-05-01 |
15000.0000 |
None |
1 |
2000 |
None |
None |
2020-09-06 |
2252913.0000 |
None |
Acquisition price includes global license and additional acquisition-related expenses. |
None |
None |
| Sanofi |
00024065601 |
SARCLISA (isatuximab-irfc) |
2020-03-09 |
3250.0000 |
Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by Healthcare Providers most likely to manage patients with relapsed and refractory multiple myeloma, materials to be used by sales representatives to share information on SARCLISA with prescribers, and materials to educate patients about relapsed and refractory multiple myeloma and SARCLISA. Direct to Consumer (DTC) outreach for SARCLISA will include search, website, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising.
Sanofi’s commitment to pricing rests on three principles: a holistic assessment of value when setting launch prices, year-over-year price increases that are limited to National Health Expenditure projections, and disclosure of our aggregate gross and net prices changes to provide greater transparency about the pricing of our medicines.
These comprehensive principles were drafted to address questions around the price of medicines in the United States. Our goal is to make our medicines accessible and affordable to all patients.
We share concerns about the affordability of medicines, and we believe deeply in the important role we play in providing treatments for serious illnesses. We are determined to do our part in pricing our medicines with greater transparency and according to their value, while continuing to advance scientific knowledge and bringing life-saving treatments to patients worldwide. |
None |
30000 |
None |
None |
None |
None |
None |
None |
In the United States, it is estimated that there are 131,392 people living with multiple myeloma (MM). In 2019, according to the American Cancer Society, MM was the third most common hematologic malignancy with 32,110 new cases. The national Surveillance Epidemiology and End Results (SEER), reported an annual age-standardized rate of 6.9 per 100,000 person for MM. MM remains an incurable disease with many patients relapsing multiple times throughout the course of the disease. It is estimated that 48%-66% of all treated patients are relapsed refractory multiple myeloma patients. Patients with relapsed refractory multiple myeloma who have received two prior therapies including lenalidomide and a proteasome inhibitor may be prescribed SARCLISA. Based upon the US prevalence of MM and the information above, sanofi-aventis US LLC reasonably estimates that the number of patients in the United States with a condition for which the new prescription drug may be prescribed is approximately 30,000.
Regarding the request for acquisition data (items 10-13) there is No Data to Report - Not Acquired. |
None |
| Seattle Genetics, Inc. |
51144000212 |
TUKYSA (tucatinib) 150 mg x 120 |
2020-04-17 |
18500.0000 |
With regard to marketing plans, efforts to ensure that healthcare providers with appropriate patients are aware of TUKYSA™ include customary digital and print media campaigns, oncology account managers sharing information with healthcare providers, and engagement of healthcare providers at congresses.
With regard to pricing plans, Seattle Genetics has a passion for helping patients, and that passion includes ensuring that we reach as many of the patients with cancers that our products treat as we can. Our pricing considerations are informed by that passion, and we incorporate diverse perspectives of stakeholders in the healthcare system. We also consistently seek to balance rewarding innovation while providing appropriate access for patients. Finally, we consider the clinical value our products deliver to patients, the severity of the cancers we treat, availability of alternative treatments, market dynamics, our continued ability to deliver new state-of-the-art innovations in response to other deadly cancers, and the meaningful impact we make on patient’s lives. |
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.
Pursuant to discussions with OSHPD, cancer.net lists that an estimated 276,480 women in the United States will be diagnosed with invasive breast cancer. Additional, it lists that About 6% of women have metastatic cancer when they are first diagnosed with breast cancer. The issue with these two sources of data is that they do not reflect the actual pool of patients that are eligible to use TUKYSA. TUKYSA is indicated for use with HER2+ Metastatic Breast Cancer patients. The first statistic lists ALL breast cancer patients, and the second only relates to patients who are diagnosed as metastatic upon FIRST diagnosis with their doctor. Over time, more of the breast cancer population will develop mestases. As such, both of these numbers, even combined, do not represent the TUKYSA patient population.
Additionally, Seattle Genetics notes this product is indicated for metastatic HER2+ breast cancer after receiving one or more prior anti-HER2-based regimens in the metastatic setting, and we are able to provide the following additional publicly available information on breast cancer more generally. Specifically, in 2019, it is estimated that there will be 268,600 people diagnosed with breast cancer. However, this data does not include patients who progress to metastatic stage or recur. According to SEER statistics from 2009-2015, 6% of breast cancers were metastatic (distant). Please note that this data is out of date. According to a retrospective analysis of 159,334 breast cancer patients diagnosed between 2010 to 2013, 26% of metastatic breast cancers are HER2+. There is no public information Seattle Genetics is aware of regarding the number of HER2+ metastatic breast cancer patients receive anti-HER2-based regimens. |
None |
| Seattle Genetics, Inc. |
51144000260 |
TUKYSA (tucatinib) 150 mg x 60 |
2020-04-17 |
9250.0000 |
With regard to marketing plans, efforts to ensure that healthcare providers with appropriate patients are aware of TUKYSA™ include customary digital and print media campaigns, oncology account managers sharing information with healthcare providers, and engagement of healthcare providers at congresses.
With regard to pricing plans, Seattle Genetics has a passion for helping patients, and that passion includes ensuring that we reach as many of the patients with cancers that our products treat as we can. Our pricing considerations are informed by that passion, and we incorporate diverse perspectives of stakeholders in the healthcare system. We also consistently seek to balance rewarding innovation while providing appropriate access for patients. Finally, we consider the clinical value our products deliver to patients, the severity of the cancers we treat, availability of alternative treatments, market dynamics, our continued ability to deliver new state-of-the-art innovations in response to other deadly cancers, and the meaningful impact we make on patient’s lives. |
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.
Pursuant to discussions with OSHPD, cancer.net lists that an estimated 276,480 women in the United States will be diagnosed with invasive breast cancer. Additional, it lists that About 6% of women have metastatic cancer when they are first diagnosed with breast cancer. The issue with these two sources of data is that they do not reflect the actual pool of patients that are eligible to use TUKYSA. TUKYSA is indicated for use with HER2+ Metastatic Breast Cancer patients. The first statistic lists ALL breast cancer patients, and the second only relates to patients who are diagnosed as metastatic upon FIRST diagnosis with their doctor. Over time, more of the breast cancer population will develop mestases. As such, both of these numbers, even combined, do not represent the TUKYSA patient population.
Additionally, Seattle Genetics notes this product is indicated for metastatic HER2+ breast cancer after receiving one or more prior anti-HER2-based regimens in the metastatic setting, and we are able to provide the following additional publicly available information on breast cancer more generally. Specifically, in 2019, it is estimated that there will be 268,600 people diagnosed with breast cancer. However, this data does not include patients who progress to metastatic stage or recur. According to SEER statistics from 2009-2015, 6% of breast cancers were metastatic (distant). Please note that this data is out of date. According to a retrospective analysis of 159,334 breast cancer patients diagnosed between 2010 to 2013, 26% of metastatic breast cancers are HER2+. There is no public information Seattle Genetics is aware of regarding the number of HER2+ metastatic breast cancer patients receive anti-HER2-based regimens. |
None |
| Seattle Genetics, Inc. |
51144000160 |
TUKYSA (tucatinib) 50 mg x 60 |
2020-04-17 |
4600.0000 |
With regard to marketing plans, efforts to ensure that healthcare providers with appropriate patients are aware of TUKYSA™ include customary digital and print media campaigns, oncology account managers sharing information with healthcare providers, and engagement of healthcare providers at congresses.
With regard to pricing plans, Seattle Genetics has a passion for helping patients, and that passion includes ensuring that we reach as many of the patients with cancers that our products treat as we can. Our pricing considerations are informed by that passion, and we incorporate diverse perspectives of stakeholders in the healthcare system. We also consistently seek to balance rewarding innovation while providing appropriate access for patients. Finally, we consider the clinical value our products deliver to patients, the severity of the cancers we treat, availability of alternative treatments, market dynamics, our continued ability to deliver new state-of-the-art innovations in response to other deadly cancers, and the meaningful impact we make on patient’s lives. |
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.
Pursuant to discussions with OSHPD, cancer.net lists that an estimated 276,480 women in the United States will be diagnosed with invasive breast cancer. Additional, it lists that About 6% of women have metastatic cancer when they are first diagnosed with breast cancer. The issue with these two sources of data is that they do not reflect the actual pool of patients that are eligible to use TUKYSA. TUKYSA is indicated for use with HER2+ Metastatic Breast Cancer patients. The first statistic lists ALL breast cancer patients, and the second only relates to patients who are diagnosed as metastatic upon FIRST diagnosis with their doctor. Over time, more of the breast cancer population will develop mestases. As such, both of these numbers, even combined, do not represent the TUKYSA patient population.
Additionally, Seattle Genetics notes this product is indicated for metastatic HER2+ breast cancer after receiving one or more prior anti-HER2-based regimens in the metastatic setting, and we are able to provide the following additional publicly available information on breast cancer more generally. Specifically, in 2019, it is estimated that there will be 268,600 people diagnosed with breast cancer. However, this data does not include patients who progress to metastatic stage or recur. According to SEER statistics from 2009-2015, 6% of breast cancers were metastatic (distant). Please note that this data is out of date. According to a retrospective analysis of 159,334 breast cancer patients diagnosed between 2010 to 2013, 26% of metastatic breast cancers are HER2+. There is no public information Seattle Genetics is aware of regarding the number of HER2+ metastatic breast cancer patients receive anti-HER2-based regimens. |
None |
| Shionogi Inc. |
59630026610 |
FETROJA, for injection, 1 gram of cefiderocol, 2 grams of FETROJA for injection every 8 hours, 10 single-dose vials per pack |
2020-02-24 |
1833.3300 |
None |
1 |
142000 |
None |
1 |
None |
None |
None |
None |
Pursuant to Cal. Health & Safety Code § 127681(c), the information provided in this report is limited to that which is otherwise in the public domain or publicly available.
The marketing/pricing plan for Fetroja® is not in the public domain or publicly available.
The estimated volume of patients who might be prescribed Fetroja® is not in the public domain or publicly available.
Fetroja® was developed by Shionogi & Co., Ltd. and its affiliates; therefore, there is no acquisition price to report. |
None |
| SK Life Science, Inc. |
71699010030 |
XCOPRI® Cenobamate Tablets 100mg |
2020-05-07 |
985.0000 |
While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US. |
None |
1800000 |
None |
None |
None |
None |
None |
None |
While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.” |
None |
| SK Life Science, Inc. |
71699020128 |
XCOPRI® Cenobamate Tablets 12.5mg(14)+25mg(14) |
2020-05-07 |
90.0000 |
While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US. |
None |
1800000 |
None |
None |
None |
None |
None |
None |
While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.” |
None |
| SK Life Science, Inc. |
71699015030 |
XCOPRI® Cenobamate Tablets 150mg |
2020-05-07 |
985.0000 |
While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US. |
None |
1800000 |
None |
None |
None |
None |
None |
None |
While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.” |
None |
| SK Life Science, Inc. |
71699020328 |
XCOPRI® Cenobamate Tablets 150mg(14)+200mg(14) |
2020-05-07 |
985.0000 |
While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US. |
None |
1800000 |
None |
None |
None |
None |
None |
None |
While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.” |
None |
| SK Life Science, Inc. |
71699020030 |
XCOPRI® Cenobamate Tablets 200mg |
2020-05-07 |
985.0000 |
While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US. |
None |
1800000 |
None |
None |
None |
None |
None |
None |
While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.” |
None |
| SK Life Science, Inc. |
71699010356 |
XCOPRI® Cenobamate Tablets 200mg(28)+150mg(28) |
2020-05-07 |
1970.0000 |
While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US. |
None |
1800000 |
None |
None |
None |
None |
None |
None |
While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.” |
None |
| SK Life Science, Inc. |
71699010256 |
XCOPRI® Cenobamate Tablets 200mg(28)+50mg(28) |
2020-05-07 |
985.0000 |
While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US. |
None |
1800000 |
None |
None |
None |
None |
None |
None |
While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.” |
None |
| SK Life Science, Inc. |
71699005030 |
XCOPRI® Cenobamate Tablets 50mg |
2020-05-07 |
985.0000 |
While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US. |
None |
1800000 |
None |
None |
None |
None |
None |
None |
While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.” |
None |
| SK Life Science, Inc. |
71699020228 |
XCOPRI® Cenobamate Tablets 50mg(14)+100mg(14) |
2020-05-07 |
985.0000 |
While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US. |
None |
1800000 |
None |
None |
None |
None |
None |
None |
While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.” |
None |
| SpecGx |
00406222401 |
Levorphanol Tartrate Tablets 2mg |
2020-01-10 |
4450.0000 |
This is a generic product, not marketed directly to consumers or healthcare professionals. WAC price is based upon an analysis of existing generic and brand WAC prices. The details of this analysis are considered proprietary information. |
None |
19600000 |
None |
None |
None |
None |
None |
None |
While the Centers for Disease Control and Prevention estimates that 19.6M individuals across the United States suffer from high-impact chronic pain, this product is appropriate for an extremely limited subset of patients with that condition. Physician guidance and the drug product labeling serve to identify the appropriate patient subset, which may result in approximately 1,000 prescriptions for this product per month across the United States.
This is a new product developed/manufactured by SpecGx and not acquired. |
None |
| Strides Pharma, Inc. |
42543096104 |
Cinacalcet Tablets 30mg, 30 (Singapore) |
2020-06-01 |
685.7000 |
Cinacalcet Tablets 30mg, 60mg, and 90mg are marketed in the generic multisource space, and therefore marketing of these product are not based on any aspects of the products themselves, but their prices and availability. For these reasons, Strides Pharma Inc.("Strides") does not interact with healthcare providers including physicians, hospital groups, group purchasing organizations, or other entities to promote Strides' products. The methodology that Strides uses to set the wholesale acquisition price("WAC") was to discount the reference drug price or match the lowest generic WACs available at the time of the product launch. Strides uses a subscription-based service, Medi-Span Price Rx, in obtaining this information to reflect a discount off of the Reference Drug listed by the FDA. Therefore, Cost-based, quality-adjusted, or value-based pricing were not used to establish WAC for this product. |
None |
100000 |
None |
None |
None |
None |
None |
None |
The reason for leaving the acquisition-related fields blank was because Strides developed the drugs. The source for the estimated patients is National Organization for Rare Disorders. |
None |
| Strides Pharma, Inc. |
42543096204 |
Cinacalcet Tablets 60mg, 30 (Singapore) |
2020-06-01 |
1371.3900 |
Cinacalcet Tablets 30mg, 60mg, and 90mg are marketed in the generic multisource space, and therefore marketing of these product are not based on any aspects of the products themselves, but their prices and availability. For these reasons, Strides Pharma Inc.("Strides") does not interact with healthcare providers including physicians, hospital groups, group purchasing organizations, or other entities to promote Strides' products. The methodology that Strides uses to set the wholesale acquisition price("WAC") was to discount the reference drug price or match the lowest generic WACs available at the time of the product launch. Strides uses a subscription-based service, Medi-Span Price Rx, in obtaining this information to reflect a discount off of the Reference Drug listed by the FDA. Therefore, Cost-based, quality-adjusted, or value-based pricing were not used to establish WAC for this product. |
None |
100000 |
None |
None |
None |
None |
None |
None |
The reason for leaving the acquisition-related fields blank was because Strides developed the drugs. The source for the estimated patients is National Organization for Rare Disorders. |
None |
| Strides Pharma, Inc. |
42543096304 |
Cinacalcet Tablets 90mg, 30 (Singapore) |
2020-06-01 |
2057.0900 |
Cinacalcet Tablets 30mg, 60mg, and 90mg are marketed in the generic multisource space, and therefore marketing of these product are not based on any aspects of the products themselves, but their prices and availability. For these reasons, Strides Pharma Inc.("Strides") does not interact with healthcare providers including physicians, hospital groups, group purchasing organizations, or other entities to promote Strides' products. The methodology that Strides uses to set the wholesale acquisition price("WAC") was to discount the reference drug price or match the lowest generic WACs available at the time of the product launch. Strides uses a subscription-based service, Medi-Span Price Rx, in obtaining this information to reflect a discount off of the Reference Drug listed by the FDA. Therefore, Cost-based, quality-adjusted, or value-based pricing were not used to establish WAC for this product. |
None |
100000 |
None |
None |
None |
None |
None |
None |
The reason for leaving the acquisition-related fields blank was because Strides developed the drugs. The source for the estimated patients is National Organization for Rare Disorders. |
None |
| Strides Pharma, Inc. |
64380090190 |
Triamcinolone Acetonide Ointment .05% 430G, 1 |
2020-06-08 |
779.3000 |
Triamcinolone Acetonide .05% 430G is marketed in the generic multisource space, and therefore marketing of the product is not based on any aspects of the product itself, but its price and availability. For these reasons, Strides Pharma Inc.("Strides")does not interact with healthcare providers including physicians, hospital groups, group purchasing organizations, or other entities to promote Strides' products. The methodology that Strides uses to set the wholesale acquisition price("WAC") was to discount the reference drug price or match the lowest generic WACs available at the time of the product launch. Strides uses a subscription-based service, Medi-Span Price Rx, in obtaining this information to reflect a discount off of the Reference Drug listed by the FDA. Therefore, Cost-based, quality-adjusted, or value-based pricing were not used to establish WAC for this product. |
None |
39600000 |
None |
None |
None |
None |
None |
None |
The reason for leaving the acquisition-related fields blank was because Strides developed the drugs.The source for the estimated number of patients is the National Psoriasis Foundation and the National Eczema Association. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=442 |
| SUN PHARMACEUTICALS |
10631000331 |
Absorica LD™ (isotretinoin) capsules 16mg |
2020-01-27 |
1063.1700 |
• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable
• ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin. |
None |
10000000 |
None |
None |
None |
None |
None |
None |
1. This product was developed by Sun Pharmaceutical Industries, Ltd.("Sun") 2.The reason for leaving the acquisition-related fields blank was because Sun developed the drugs |
None |
| SUN PHARMACEUTICALS |
10631000531 |
Absorica LD™ (isotretinoin) capsules 24mg |
2020-01-27 |
1143.9100 |
• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable
• ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin. |
None |
10000000 |
None |
None |
None |
None |
None |
None |
1. This product was developed by Sun Pharmaceutical Industries, Ltd.("Sun") 2.The reason for leaving the acquisition-related fields blank was because Sun developed the drugs |
None |
| SUN PHARMACEUTICALS |
10631000731 |
Absorica LD™ (isotretinoin) capsules 32mg |
2020-01-27 |
1143.9100 |
• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable
• ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin. |
None |
10000000 |
None |
None |
None |
None |
None |
None |
1. This product was developed by Sun Pharmaceutical Industries, Ltd.("Sun") 2.The reason for leaving the acquisition-related fields blank was because Sun developed the drugs |
None |
| SUN PHARMACEUTICALS |
10631000231 |
Absorica LD™ (isotretinoin) capsules 8mg |
2020-01-27 |
1063.1700 |
• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable
• ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin. |
None |
10000000 |
None |
None |
None |
None |
None |
None |
1. This product was developed by Sun Pharmaceutical Industries, Ltd.("Sun") 2.The reason for leaving the acquisition-related fields blank was because Sun developed the drugs |
None |
| SUN PHARMACEUTICALS |
63304072105 |
DILTIAZEM ER HCL 300MG 500 Capsules |
2020-03-05 |
795.1700 |
This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers. This product also offers the convenience and economy of bulk packaging. |
None |
10000000 |
None |
None |
None |
None |
None |
None |
1. This product was developed by Sun Pharmaceutical Industries, Ltd.("Sun") 2.The reason for leaving the acquisition-related fields blank was because Sun developed the drugs 3. This product (ANDA approval) is being marketed in the generic, multisource space |
None |
| SUN PHARMACEUTICALS |
47335017149 |
Tobramycin Inhalation Solution 300mg/ 5ml |
2020-04-21 |
1880.0500 |
This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Cost-based, quality-adjusted, or value-based pricings were not used to establish Wholesale Acquisition Cost for this product. This product is being marketed in the generic, multisource space. Sun representatives, who are responsible for generic sales, do not promote to health care providers. |
None |
6000 |
None |
None |
None |
None |
None |
None |
1) This product (ANDA approval) is being marketed in the generic, multisource space; 2) The reason for leaving the acquisition-related fields blank was because Sun developed the drugs |
None |
| SUN PHARMACEUTICALS |
63304058360 |
Fosamprenavir Oral Tablet 700mg |
2020-06-05 |
999.8900 |
This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers.
This product (ANDA approval) is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. |
None |
1200000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
10631009510 |
HALOG SOLUTION USP 0.1% 5ML 120ML |
2020-07-27 |
770.0600 |
This product is priced to reflect the clinical value of the drug and is priced on par with two other Halog formulations on the market - Halog Ointment and Halog Cream. The prevalence of corticosteroid-responsive dermatoses is unknown. However psoriasis and atopic dermatitis which fall within the category of corticosteroid-responsive dermatoses together represent a good proxy for the number of patients. in the United States, approximately 4.6% of
the population is affected with psoriasis1 and nearly 18 million people have AD2. |
None |
18000000 |
None |
None |
2015-03-25 |
None |
1 |
Product was acquired by Sun Pharmaceuticals Ind. (SPIL) as part of the Ranbaxy acquisition estimated total acquisition of over $4 billion on 25th March 2015. There was no acquisition price directly associated with the Halog Solution product as the product was not launched at the time of company acquisition. |
None |
None |
| Sunovion Pharmaceuticals Inc. |
63402001030 |
KYNMOBI 10 MG (Apomorphine Sublingual Film) |
2020-06-09 |
787.5000 |
"KYNMOBI™ (apomorphine hydrochloride) Sublingual Film was approved by the FDA in May 2020. It is the first and only sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD). The WAC for a trade box of 30 films is slightly higher than the Medicare Part D Specialty Tier Threshold. KYNMOBI is available in 5 strengths (10mg, 15mg, 20mg, 25mg and 30mg). To market KYNMOBI™ (apomorphine hydrochloride) Sublingual Film, Sunovion designed activities to increase awareness and understanding with healthcare providers about this new product and its clinical efficacy, safety, and tolerability. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers (HCPs) in peer-to-peer forums. There will be a Direct-to-Patient advertising campaign to educate patients about KYNMOBI and the treatment of OFF episodes. Sunovion will offer copayment assistance to commercially insured patients through a copay card program. Sunovion has also signed a national agreement with Walgreen’s retail pharmacies to provide easy access to a $0 titration kit and other support services.
Pricing:
Sunovion is focused on the innovative application of science and medicine to help people living with serious psychiatric, neurological and respiratory conditions. Our philosophy around the pricing of our medications is grounded in three key pillars: providing value; facilitating broad and sustainable access; and supporting patients.
Sunovion’s scientific advancements and breakthrough medical innovations help drive improvement in individual patient care and outcomes and the overall healthcare system. Our treatment options provide significant clinical value for patients. We are committed to working with health care providers, policy makers, and public and private payers, to ensure patients have broad and sustainable access to our innovative therapies. We offer rebates, discounts and co-pay cards. We also maintain a prescription assistance program to help patients who require financial assistance. Eligible patients are able to access Sunovion’s life-changing therapies at no cost.
The price of Kynmobi was guided by our key pillars. We believe that Kynmobi’s strong safety and efficacy profile, as demonstrated in clinical trials, and unique route of administration exemplify scientific innovation and deliver significant benefits to patients living with Parkinson’s disease. We sought to balance the need to sustain current business operations and fuel future innovation with the interests of ensuring broad and open access for patients. We considered feedback from patients, physicians and payers, unmet medical needs, patient affordability, and the medication’s likely coverage and formulary placement. We also evaluated competitor products within the Parkinson’s disease space and strove to deliver the benefits of Kynmobi to patients, physicians and payers at a lower list price than its branded competitors.
Except as otherwise described, we did not use any cost-based pricing, quality-adjusted pricing, value-based pricing, or other specific pricing models or strategies in setting the price for Kynmobi." |
None |
558000 |
None |
None |
2016-10-21 |
635000000.0000 |
None |
None |
patient estimate based on internal calculation using public data. |
None |
| Sunovion Pharmaceuticals Inc. |
63402001530 |
KYNMOBI 15 MG (Apomorphine Sublingual Film) |
2020-06-09 |
787.5000 |
"KYNMOBI™ (apomorphine hydrochloride) Sublingual Film was approved by the FDA in May 2020. It is the first and only sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD). The WAC for a trade box of 30 films is slightly higher than the Medicare Part D Specialty Tier Threshold. KYNMOBI is available in 5 strengths (10mg, 15mg, 20mg, 25mg and 30mg). To market KYNMOBI™ (apomorphine hydrochloride) Sublingual Film, Sunovion designed activities to increase awareness and understanding with healthcare providers about this new product and its clinical efficacy, safety, and tolerability. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers (HCPs) in peer-to-peer forums. There will be a Direct-to-Patient advertising campaign to educate patients about KYNMOBI and the treatment of OFF episodes. Sunovion will offer copayment assistance to commercially insured patients through a copay card program. Sunovion has also signed a national agreement with Walgreen’s retail pharmacies to provide easy access to a $0 titration kit and other support services.
Pricing:
Sunovion is focused on the innovative application of science and medicine to help people living with serious psychiatric, neurological and respiratory conditions. Our philosophy around the pricing of our medications is grounded in three key pillars: providing value; facilitating broad and sustainable access; and supporting patients.
Sunovion’s scientific advancements and breakthrough medical innovations help drive improvement in individual patient care and outcomes and the overall healthcare system. Our treatment options provide significant clinical value for patients. We are committed to working with health care providers, policy makers, and public and private payers, to ensure patients have broad and sustainable access to our innovative therapies. We offer rebates, discounts and co-pay cards. We also maintain a prescription assistance program to help patients who require financial assistance. Eligible patients are able to access Sunovion’s life-changing therapies at no cost.
The price of Kynmobi was guided by our key pillars. We believe that Kynmobi’s strong safety and efficacy profile, as demonstrated in clinical trials, and unique route of administration exemplify scientific innovation and deliver significant benefits to patients living with Parkinson’s disease. We sought to balance the need to sustain current business operations and fuel future innovation with the interests of ensuring broad and open access for patients. We considered feedback from patients, physicians and payers, unmet medical needs, patient affordability, and the medication’s likely coverage and formulary placement. We also evaluated competitor products within the Parkinson’s disease space and strove to deliver the benefits of Kynmobi to patients, physicians and payers at a lower list price than its branded competitors.
Except as otherwise described, we did not use any cost-based pricing, quality-adjusted pricing, value-based pricing, or other specific pricing models or strategies in setting the price for Kynmobi." |
None |
558000 |
None |
None |
2016-10-21 |
635000000.0000 |
None |
None |
patient estimate based on internal calculation using public data. |
None |
| Sunovion Pharmaceuticals Inc. |
63402002030 |
KYNMOBI 20 MG (Apomorphine Sublingual Film) |
2020-06-09 |
787.5000 |
"KYNMOBI™ (apomorphine hydrochloride) Sublingual Film was approved by the FDA in May 2020. It is the first and only sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD). The WAC for a trade box of 30 films is slightly higher than the Medicare Part D Specialty Tier Threshold. KYNMOBI is available in 5 strengths (10mg, 15mg, 20mg, 25mg and 30mg). To market KYNMOBI™ (apomorphine hydrochloride) Sublingual Film, Sunovion designed activities to increase awareness and understanding with healthcare providers about this new product and its clinical efficacy, safety, and tolerability. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers (HCPs) in peer-to-peer forums. There will be a Direct-to-Patient advertising campaign to educate patients about KYNMOBI and the treatment of OFF episodes. Sunovion will offer copayment assistance to commercially insured patients through a copay card program. Sunovion has also signed a national agreement with Walgreen’s retail pharmacies to provide easy access to a $0 titration kit and other support services.
Pricing:
Sunovion is focused on the innovative application of science and medicine to help people living with serious psychiatric, neurological and respiratory conditions. Our philosophy around the pricing of our medications is grounded in three key pillars: providing value; facilitating broad and sustainable access; and supporting patients.
Sunovion’s scientific advancements and breakthrough medical innovations help drive improvement in individual patient care and outcomes and the overall healthcare system. Our treatment options provide significant clinical value for patients. We are committed to working with health care providers, policy makers, and public and private payers, to ensure patients have broad and sustainable access to our innovative therapies. We offer rebates, discounts and co-pay cards. We also maintain a prescription assistance program to help patients who require financial assistance. Eligible patients are able to access Sunovion’s life-changing therapies at no cost.
The price of Kynmobi was guided by our key pillars. We believe that Kynmobi’s strong safety and efficacy profile, as demonstrated in clinical trials, and unique route of administration exemplify scientific innovation and deliver significant benefits to patients living with Parkinson’s disease. We sought to balance the need to sustain current business operations and fuel future innovation with the interests of ensuring broad and open access for patients. We considered feedback from patients, physicians and payers, unmet medical needs, patient affordability, and the medication’s likely coverage and formulary placement. We also evaluated competitor products within the Parkinson’s disease space and strove to deliver the benefits of Kynmobi to patients, physicians and payers at a lower list price than its branded competitors.
Except as otherwise described, we did not use any cost-based pricing, quality-adjusted pricing, value-based pricing, or other specific pricing models or strategies in setting the price for Kynmobi." |
None |
558000 |
None |
None |
2016-10-21 |
635000000.0000 |
None |
None |
patient estimate based on internal calculation using public data. |
None |
| Sunovion Pharmaceuticals Inc. |
63402002530 |
KYNMOBI 25 MG (Apomorphine Sublingual Film) |
2020-06-09 |
787.5000 |
"KYNMOBI™ (apomorphine hydrochloride) Sublingual Film was approved by the FDA in May 2020. It is the first and only sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD). The WAC for a trade box of 30 films is slightly higher than the Medicare Part D Specialty Tier Threshold. KYNMOBI is available in 5 strengths (10mg, 15mg, 20mg, 25mg and 30mg). To market KYNMOBI™ (apomorphine hydrochloride) Sublingual Film, Sunovion designed activities to increase awareness and understanding with healthcare providers about this new product and its clinical efficacy, safety, and tolerability. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers (HCPs) in peer-to-peer forums. There will be a Direct-to-Patient advertising campaign to educate patients about KYNMOBI and the treatment of OFF episodes. Sunovion will offer copayment assistance to commercially insured patients through a copay card program. Sunovion has also signed a national agreement with Walgreen’s retail pharmacies to provide easy access to a $0 titration kit and other support services.
Pricing:
Sunovion is focused on the innovative application of science and medicine to help people living with serious psychiatric, neurological and respiratory conditions. Our philosophy around the pricing of our medications is grounded in three key pillars: providing value; facilitating broad and sustainable access; and supporting patients.
Sunovion’s scientific advancements and breakthrough medical innovations help drive improvement in individual patient care and outcomes and the overall healthcare system. Our treatment options provide significant clinical value for patients. We are committed to working with health care providers, policy makers, and public and private payers, to ensure patients have broad and sustainable access to our innovative therapies. We offer rebates, discounts and co-pay cards. We also maintain a prescription assistance program to help patients who require financial assistance. Eligible patients are able to access Sunovion’s life-changing therapies at no cost.
The price of Kynmobi was guided by our key pillars. We believe that Kynmobi’s strong safety and efficacy profile, as demonstrated in clinical trials, and unique route of administration exemplify scientific innovation and deliver significant benefits to patients living with Parkinson’s disease. We sought to balance the need to sustain current business operations and fuel future innovation with the interests of ensuring broad and open access for patients. We considered feedback from patients, physicians and payers, unmet medical needs, patient affordability, and the medication’s likely coverage and formulary placement. We also evaluated competitor products within the Parkinson’s disease space and strove to deliver the benefits of Kynmobi to patients, physicians and payers at a lower list price than its branded competitors.
Except as otherwise described, we did not use any cost-based pricing, quality-adjusted pricing, value-based pricing, or other specific pricing models or strategies in setting the price for Kynmobi." |
None |
558000 |
None |
None |
2016-10-21 |
635000000.0000 |
None |
None |
patient estimate based on internal calculation using public data. |
None |
| Sunovion Pharmaceuticals Inc. |
63402003030 |
KYNMOBI 30 MG (Apomorphine Sublingual Film) |
2020-06-09 |
787.5000 |
"KYNMOBI™ (apomorphine hydrochloride) Sublingual Film was approved by the FDA in May 2020. It is the first and only sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD). The WAC for a trade box of 30 films is slightly higher than the Medicare Part D Specialty Tier Threshold. KYNMOBI is available in 5 strengths (10mg, 15mg, 20mg, 25mg and 30mg). To market KYNMOBI™ (apomorphine hydrochloride) Sublingual Film, Sunovion designed activities to increase awareness and understanding with healthcare providers about this new product and its clinical efficacy, safety, and tolerability. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers (HCPs) in peer-to-peer forums. There will be a Direct-to-Patient advertising campaign to educate patients about KYNMOBI and the treatment of OFF episodes. Sunovion will offer copayment assistance to commercially insured patients through a copay card program. Sunovion has also signed a national agreement with Walgreen’s retail pharmacies to provide easy access to a $0 titration kit and other support services.
Pricing:
Sunovion is focused on the innovative application of science and medicine to help people living with serious psychiatric, neurological and respiratory conditions. Our philosophy around the pricing of our medications is grounded in three key pillars: providing value; facilitating broad and sustainable access; and supporting patients.
Sunovion’s scientific advancements and breakthrough medical innovations help drive improvement in individual patient care and outcomes and the overall healthcare system. Our treatment options provide significant clinical value for patients. We are committed to working with health care providers, policy makers, and public and private payers, to ensure patients have broad and sustainable access to our innovative therapies. We offer rebates, discounts and co-pay cards. We also maintain a prescription assistance program to help patients who require financial assistance. Eligible patients are able to access Sunovion’s life-changing therapies at no cost.
The price of Kynmobi was guided by our key pillars. We believe that Kynmobi’s strong safety and efficacy profile, as demonstrated in clinical trials, and unique route of administration exemplify scientific innovation and deliver significant benefits to patients living with Parkinson’s disease. We sought to balance the need to sustain current business operations and fuel future innovation with the interests of ensuring broad and open access for patients. We considered feedback from patients, physicians and payers, unmet medical needs, patient affordability, and the medication’s likely coverage and formulary placement. We also evaluated competitor products within the Parkinson’s disease space and strove to deliver the benefits of Kynmobi to patients, physicians and payers at a lower list price than its branded competitors.
Except as otherwise described, we did not use any cost-based pricing, quality-adjusted pricing, value-based pricing, or other specific pricing models or strategies in setting the price for Kynmobi." |
None |
558000 |
None |
None |
2016-10-21 |
635000000.0000 |
None |
None |
patient estimate based on internal calculation using public data. |
None |
| Sunrise Pharmaceutical Inc. |
11534019701 |
chlordiazePOXIDE-Clidinium Oral Capsule 5-2.5 MG 100 ct |
2020-08-03 |
1395.0000 |
o Our plan is to offer this product for sale to wholesale, and retail customers |
None |
5000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Taiho Oncology, Inc. |
64842072709 |
INQOVI Tablets, 35 mg. 5's |
2020-08-31 |
7495.0000 |
The price is $7,495.00 per pack. Marketing plans will consist of print ads; journal ads, direct mail, and in-person calls to HCPs. |
None |
10000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| TARO PHARMACEUTICALS |
51672530708 |
Dapsone Topical Gel 7.5% Pump 90GM |
2020-01-02 |
707.8500 |
This product (NDA Approval) is being marketed in the generic, multisource space. Dapsone 7.5% gel is considered to be an Authorized Generic (AG) . This product is priced in the market to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives who are responsible for generic sales do not promote the promote to health care providers. |
None |
None |
None |
None |
None |
None |
None |
None |
Taro Pharmaceutical USA . is a licensee for this Authorized Generic. This product is being marketed in the generic space. The product is priced to reflect a discount off of the Reference Drug listed by the FDA.
The estimated average of patients per month is unknown to Taro.
The product was not acquired. |
None |
| Teva Parenteral Medicines, Inc. |
00703400401 |
ROMIDEPSIN RTU INJ 27.5 MG/5.5ML 5.5ML |
2020-04-14 |
8796.1500 |
None |
1 |
20000 |
None |
None |
None |
None |
None |
None |
Estimated average of up to 20,000 prescriptions per year, based on historic IQVIA data on sales of romidepsin vials. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
63459030343 |
HERZUMA® (trastuzumab-pkrb) 150 MG / 50 ML - 1 Vial |
2020-03-16 |
1402.5000 |
None |
1 |
135 |
None |
None |
2016-10-04 |
1.0000 |
None |
Teva acquired rights on October 4, 2016 from Celltrion to commercialize HERZUMA and another biosimilar product for $160M in up-front payments plus additional payments dependent on product sales. The acquisition price for the HERZUMA rights was incorporated into the broader deal's overall purchase price, and thus, there was no one particular price that Teva paid to acquire those rights. We were, nonetheless, required to enter a non-zero value in the "Acquisition Cost" field, and so we entered "1.00." |
Average of approximately 250 patients per month anticipated (in total, across both NDC's). |
None |
| Teva Pharmaceuticals USA |
63459030547 |
HERZUMA® (trastuzumab-pkrb) 420 MG / 10 ML - 1 Vial |
2020-03-16 |
3927.0000 |
None |
1 |
112 |
None |
None |
2016-10-04 |
1.0000 |
None |
Teva acquired rights on October 4, 2016 from Celltrion to commercialize HERZUMA and another biosimilar product for $160M in up-front payments plus additional payments dependent on product sales. The acquisition price for the HERZUMA rights was incorporated into the broader deal's overall purchase price, and thus, there was no one particular price that Teva paid to acquire those rights. We were, nonetheless, required to enter a non-zero value in the "Acquisition Cost" field, and so we entered "1.00." |
Average of approximately 250 patients per month anticipated (in total, across both NDC's). |
None |
| Teva Pharmaceuticals USA |
00093351656 |
DEFERASIROX 180MG TABLETS 30 (launched under ANDA 209223) |
2020-04-24 |
2189.0700 |
None |
1 |
6770 |
None |
None |
None |
None |
None |
None |
Average of approximately 6,770 prescriptions per year, based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00591395550 |
VIGABATRIN 500MG POWDER FOR SOL 50 |
2020-05-14 |
1665.7400 |
None |
1 |
23450 |
None |
None |
None |
None |
None |
None |
Average of approximately 23,450 prescriptions per year, based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00093776624 |
EVEROLIMUS TABLETS 2.5MG 28 (7X4) |
2020-06-10 |
6419.4300 |
None |
1 |
2950 |
None |
None |
None |
None |
None |
None |
Average of approximately 2,950 prescriptions per year, based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00093776724 |
EVEROLIMUS TABLETS 5MG 28 (7X4) |
2020-06-10 |
6714.6200 |
None |
1 |
12550 |
None |
None |
None |
None |
None |
None |
Average of approximately 12,550 prescriptions per year, based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00093776824 |
EVEROLIMUS TABLETS 7.5MG 28 (7X4) |
2020-06-10 |
6714.6200 |
None |
1 |
4850 |
None |
None |
None |
None |
None |
None |
Average of approximately 4,850 prescriptions per year, based on historic IQVIA data. Acquisition questions not applicable (and acquisition fields therefore left blank); Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00093313331 |
IMIQUIMOD CREAM 3.75 PUMP %/ MG 1 |
2020-07-29 |
1064.5800 |
None |
1 |
1650 |
None |
None |
2016-08-02 |
33430000000.0000 |
None |
This product (the "Product") is an authorized generic version of Zyclara® Cream. Actavis Mid Atlantic LLC (“Actavis”) had certain rights to sell the Product, and on August 2, 2016, Teva acquired those rights, along with Actavis itself, as part of a broader deal involving other assets. The acquisition price for those rights was incorporated into that broader deal’s overall purchase price and, thus, there was no one particular price that Teva paid to acquire those rights. We were, nonetheless, required to enter a non-zero value in the "Acquisition Price" field, and so we entered $33,430,000,000, which is the total amount that Teva paid (along with roughly 100 million shares of Teva stock) in connection with the broader deal referenced above. Once again, and to be clear, this total is not representative of the amount that Teva paid for the rights to the Product in particular. |
Estimated average of approximately 1,650 prescriptions per year, based on historic IQVIA data. |
None |
| Teva Pharmaceuticals USA |
00093537601 |
Clozapine ODT 150mg/100 count |
2020-07-30 |
1726.3200 |
None |
1 |
1800000 |
None |
None |
None |
None |
None |
None |
Estimated average of approximately 25,400 prescriptions per year (across these three particular NDCs), based on historic IQVIA data, although research suggests that as many as 1.8 million Americans have been diagnosed with schizophrenia and/or schizoaffective disorder, the primary indications for this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093537701 |
Clozapine ODT 200mg/100 count |
2020-07-30 |
2301.7700 |
None |
1 |
1800000 |
None |
None |
None |
None |
None |
None |
Estimated average of approximately 25,400 prescriptions per year (across these three particular NDCs), based on historic IQVIA data, although research suggests that as many as 1.8 million Americans have been diagnosed with schizophrenia and/or schizoaffective disorder, the primary indications for this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093537784 |
Clozapine ODT 200mg/48 count |
2020-07-30 |
1104.8300 |
None |
1 |
1800000 |
None |
None |
None |
None |
None |
None |
Estimated average of approximately 25,400 prescriptions per year (across these three particular NDCs), based on historic IQVIA data, although research suggests that as many as 1.8 million Americans have been diagnosed with schizophrenia and/or schizoaffective disorder, the primary indications for this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00591405094 |
SILDENAFIL CITRATE 10MG/ML PWD ORSU 1 |
2020-08-17 |
984.9700 |
None |
1 |
17000 |
None |
None |
None |
None |
None |
None |
Estimated average of approximately 16,800 prescriptions per year, based on historic IQVIA data. Research similarly suggests that as many as 17,000 Americans have been diagnosed with pulmonary arterial hypertension, the primary indication for this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093375028 |
TOBRAMYCIN SOL 300/4 MG/ML 28 |
2020-09-15 |
2672.2100 |
None |
1 |
24000 |
None |
None |
None |
None |
None |
None |
Estimated average of approximately 9,200 prescriptions per year (across these two particular NDCs), based on historic IQVIA data, although research suggests that as many as 24,000 Americans have been diagnosed with cystic fibrosis with Pseudomonas aeruginosa, the primary indication for this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093375063 |
TOBRAMYCIN SOL 300/4 MG/ML 56 |
2020-09-15 |
5344.4200 |
None |
1 |
24000 |
None |
None |
None |
None |
None |
None |
Estimated average of approximately 9,200 prescriptions per year (across these two particular NDCs), based on historic IQVIA data, although research suggests that as many as 24,000 Americans have been diagnosed with cystic fibrosis with Pseudomonas aeruginosa, the primary indication for this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093921906 |
DIMETHYL FUMARATE DR CAPSULES 240MG 60 |
2020-09-28 |
943.4500 |
None |
1 |
728000 |
None |
None |
2020-08-25 |
None |
1 |
None |
Estimated average of approximately 430,000 prescriptions per year, based on historic IQVIA data, although research suggests that as many as 728,000 Americans have been diagnosed with multiple sclerosis.
The product is an authorized generic version of TECFIDERA®, manufactured by Biogen Swiss Manufacturing GmbH (“Biogen”). Teva sells the product as Biogen’s distributor in the US market, pursuant to an agreement between the parties dated August 25, 2020. The economic terms of that agreement, including any payments by Teva to acquire the rights to sell the product from Biogen, are confidential and non-public. |
None |
| Teva Pharmaceuticals USA |
00093523456 |
EFAVIRENZ/EMTRICITABINE/TENOFOVIR TAB 600MG/200MG/300MG 30 |
2020-09-30 |
2365.8200 |
None |
1 |
1100000 |
None |
None |
None |
None |
None |
None |
Estimated average of approximately 168,000 prescriptions per year, based on historic IQVIA data. Research suggests that as many 1.1 million Americans have been diagnosed with HIV. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093760756 |
EMTRICITABINE/TENOFOVIR TAB 200/300MG 30 |
2020-09-30 |
1455.4000 |
None |
1 |
1100000 |
None |
None |
None |
None |
None |
None |
Estimated average of approximately 1.4 million prescriptions per year, based on historic IQVIA data. Research suggests that as many 1.1 million Americans have been diagnosed with HIV. Acquisition fields left blank; Teva developed this product. |
None |
| The PharmaNetwork LLC |
53097056860 |
Marinol 2.5 mg, 60 capsules in 1 bottle |
2020-04-01 |
694.4300 |
None |
1 |
804500 |
1 |
None |
None |
None |
None |
None |
Marinol is indicated for anorexia associated with weight loss in patients with AIDS and for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. There are approximately 1.2 million people in the U.S. living with HIV and it is estimated that 20% to 34% of those patients will experince some degree of wasting or anorexia. There are approximately 650,000 people per year receiving chemotherapy treatments in the U.S. in outpatient settings and it is estimated that 45 to 61% of patients with cancer experience chemotherapy-induced nausea and vomiting. ThePharmaNetwork's estimated volume of patients who may be prescribed Marinol is not available in the public domain nor is the estimated number of patients for this drug known to ThePharmaNetwork. The estimated number of patients provided is a combination of 34% of 1.2 million HIV patients and 61% of 650,000 chemotherapy patients.
ThePharmaNetwork did not acquire this product. Patheon Softgels Inc. is the supplier of this product and Alkem Laboratories Ltd. is the parent company of ThePharmaNetwork. |
None |
| Tolmar Inc |
63646004012 |
Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Topical Suspension, 2x60g |
2020-06-01 |
1669.9200 |
None |
1 |
8000000 |
None |
None |
None |
None |
None |
None |
8,000,000 patients estimated based on the National Psoriasis Foundation.
While specific marketing and pricing plans are not available in the public domain, this is a generic drug that is not marketed. Tolmar has a long history of responsible pricing based on several factors including value provided to the patient and the healthcare system, unmet medical need, research and development sustainability, and the competitive environment. |
None |
| Tolmar Inc |
63646004060 |
Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Topical Suspension, 60g |
2020-06-01 |
834.9600 |
None |
1 |
8000000 |
None |
None |
None |
None |
None |
None |
8,000,000 patients estimated based on the National Psoriasis Foundation.
While specific marketing and pricing plans are not available in the public domain, this is a generic drug that is not marketed. Tolmar has a long history of responsible pricing based on several factors including value provided to the patient and the healthcare system, unmet medical need, research and development sustainability, and the competitive environment. |
None |
| Tolmar Pharmaceuticals, Inc. |
62935015350 |
Fensolvi (leuprolide acetate) |
2020-06-05 |
22578.0000 |
None |
1 |
13700 |
None |
None |
None |
None |
None |
None |
None |
None |
| Ultragenyx Pharmaceuticals Inc. |
69794005050 |
Dojolvi; 500mL; Bottle |
2020-07-01 |
4875.0000 |
Ultragenyx does not have patented marketing information. Any marketing information related to this product is know only to Ultragenyx's Commercial team. Marketing information has potential commercial value and allowing this information to remain non-public and confidential, allows Ultragenyx to obtain a business advantage over its competitors who do not have or know Ultragenyx’s marketing information. Making the marketing information public would not serve the public interest and therefore disclosure is not required. |
None |
1500 |
None |
None |
None |
None |
None |
None |
The estimated prevalence of LC-FAOD is2,000-3,500 LC-FAOD in the US. However this is not the addressable population as many patients with different variants of LC-FAOD may not even know they have the disease. LC-FAOD is a general classification of many genetic mutations that vary in population size and severity. 1,500 patients is the estimation of patients that experience symptoms and seek medical attention due to LC-FAOD.
Dojolvi was developed internally by Ultragenyx. Therefore there was no acquisition price. |
None |
| UroGen Pharma, Inc. |
72493010303 |
None |
2020-06-01 |
21376.0000 |
UroGen currently only sells Jelmyto in the U.S. UroGen's commercialization team has sales resources in the field detailing this product to healthcare providers. The drug (Jelmyto) is priced at WAC, with limited discounting. |
None |
6500 |
1 |
1 |
None |
None |
None |
None |
We did not acquire the drug. This explains why the acquisition-related fields were left blank. |
None |
| Viela Bio, Inc. |
72677055101 |
UPLIZNA™ (inebilizumab-cdon), Carton containing three 100 mg /10 mL single-dose vials |
2020-07-13 |
131000.0000 |
Uplizna is the first and only B-cell depleter approved for the treatment adult patients with AQP4+ neuromyelitis optica spectrum disorder (NMOSD). Viela’s approach to marketing includes a focus on educating healthcare professionals, primarily neurologists, about the devastating effects of this rare disease and providing information about the efficacy, safety and dosing of Uplizna. Marketing includes dissemination of print materials, digital advertising, in-person presentations and virtual engagements. In addition to healthcare professionals, Viela also provides educational resources and support to the patient community in collaboration with advocacy organizations.
Viela’s approach to pricing innovative therapies is driven by the value a drug brings to customers. Leading up to FDA approval, the company engaged with key stakeholders—including patients, payers and physicians—to better understand the value this medicine could bring to people affected by NMOSD, who despite recent innovation, have limited treatment options. |
None |
10000 |
1 |
None |
None |
None |
None |
None |
None |
None |
| ViiV Healthcare |
49702025018 |
RUKOBIA (fostemsavir) 600mg extended-release tablets |
2020-07-22 |
7650.0000 |
None |
1 |
9300 |
1 |
1 |
None |
None |
None |
None |
Regarding Marketing/Pricing Plan Description, ViiV has not released RUKOBIA's marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
RUKOBIA is a novel attachment inhibitor for the treatment of HIV-1 infection indicated for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection, failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The estimated HTE population who are unable to form a suppressive regimen and potentially eligible for treatment with RUKOBIA is approximately 9,300 for the US. This is based on the number of people living with HIV according to the Centers for Disease Control and Prevention (CDC) and a projection for the heavily treatment-experienced adult population who are unable to form a suppressive regimen.
RUKOBIA was granted breakthrough therapy designation and priority review by the Food And Drug Administration.
Note on Acquisition Fields: ViiV acquired fostemsavir as an investigational asset from Bristol Myers Squibb and completed development of the product. Accordingly, Rukobia was not an approved prescription drug at the time ViiV acquired it. Therefore the following fields related to drug acquisition have been left blank: ACQUISITION_DATE, ACQUISITION_PRICE, ACQUISITION_PRICE_NONPUBLIC, ACQUISITION_PRICE_COMMENT. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710151709 |
Fondaparinux Inj 10mg/0.8ml (2x0.8ml) |
2020-01-13 |
950.6000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Please note that the WAC represented is WAC for a 30 day course of treatment based on Zydus dosing assumption. Zydus dosing assumption is 10mg per day for 9 days. This is an AP rated generic product. Zydus is not the ANDA holder for this product but is the sales and marketing partner. Acquisition date and price are not applicable as the drug was not acquired. Additionally, as Zydus manufactures/sells generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710151406 |
Fondaparinux Inj 2.5mg/0.5ml (10x0.5ml) |
2020-01-13 |
705.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Please note that the WAC represented is WAC for a 30 day course of treatment based on Zydus dosing assumption. Zydus dosing assumption is 2.5mg per day for 32 days. This is an AP rated generic product. Zydus is not the ANDA holder for this product but is the sales and marketing partner. Acquisition date and price are not applicable as the drug was not acquired. Additionally, as Zydus manufactures/sells generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710151409 |
Fondaparinux Inj 2.5mg/0.5ml (2x0.5ml) |
2020-01-13 |
1211.7000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Please note that the WAC represented is WAC for a 30 day course of treatment based on Zydus dosing assumption. Zydus dosing assumption is 2.5mg per day for 32 days. This is an AP rated generic product. Zydus is not the ANDA holder for this product but is the sales and marketing partner. Acquisition date and price are not applicable as the drug was not acquired. Additionally, as Zydus manufactures/sells generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710151509 |
Fondaparinux Inj 5mg/0.4ml (2x0.4ml) |
2020-01-13 |
950.6000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Please note that the WAC represented is WAC for a 30 day course of treatment based on Zydus dosing assumption. Zydus dosing assumption is 5mg per day for 9 days. This is an AP rated generic product. Zydus is not the ANDA holder for this product but is the sales and marketing partner. Acquisition date and price are not applicable as the drug was not acquired. Additionally, as Zydus manufactures/sells generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710151609 |
Fondaparinux Inj 7.5mg/0.6ml (2x0.6ml) |
2020-01-13 |
950.6000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Please note that the WAC represented is WAC for a 30 day course of treatment based on Zydus dosing assumption. Zydus dosing assumption is 7.5mg per day for 9 days. This is an AP rated generic product. Zydus is not the ANDA holder for this product but is the sales and marketing partner. Acquisition date and price are not applicable as the drug was not acquired. Additionally, as Zydus manufactures/sells generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710113301 |
Chlorpromazine HCl 200mg Tab |
2020-02-11 |
989.3500 |
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. |
70710153001 |
Doxorubicin Hydrochloride 20mg/10mL Liposomal Injection |
2020-09-29 |
969.0000 |
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/sells generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally, nor do we have access to any information which would indicate the number of patients in the United States with the condition(s) for which our products may be prescribed. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710153101 |
Doxorubicin Hydrochloride 50mg/25mL Liposomal Injection |
2020-09-29 |
2422.5500 |
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/sells generic products, we do not estimate the number of patients that may be prescribed our products neither by state or nationally. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. |
None |