| Aadi Bioscience, Inc. |
80803015350 |
FYARRO™ (sirolimus protein-bound particles for injectable suspension) (albumin-bound) 100 MG per Vial {1 Vial per Pack} |
2022-02-22 |
6785.0000 |
None |
1 |
300 |
1 |
1 |
None |
None |
None |
None |
"Aadi has listed Fyarro with a WAC price effective date of 11/22/2021 within the pricing compendiums (i.e., Medispan); however, the product was not made available for purchase in California until February 21, 2022.
Specific to Estimated Number of Patients: It is estimated there are 100-300 new patients per year in the US with advanced / malignant PEComa. (Note: There is no formal published epidemiology information; Aadi analysis based on multiple sources including Aadi internal data and external research)
Specific to the Acquisition Fields: Aadi owns the FDA regulatory approval for FYARRO and the drug is and has always been sold under an Aadi labeler code. The FDA-approved drug was not “acquired” and Aadi was extensively involved in the research and development of the drug, including conducting clinical trials and submitting the application for FDA approval. We note that Aadi licensed from Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation, now Bristol-Myers Squibb Company the exclusive rights for certain patents and a non-exclusive license for certain technology and know-how pertaining to ABI-009 (which ultimately became FYARRO). Those license rights enabled Aadi to pursue the clinical trials and related development work necessary to seek and obtain FDA approval of the product.
" |
None |
| AbbVie |
00074231030 |
RINVOQ (upadacitinib) 30MG 30 Day Bottle |
2022-01-24 |
5671.2600 |
RINVOQ is marketed for the treatment of refractory, moderate to severe Atopic Dermatitis in adults and pediatrics 12 and above. The Wholesale Acquisition Cost (WAC) of RINVOQ is $5,671.26 for a month supply of 30 mg (30 count). To date, RINVOQ has been approved in >50 jurisdictions outside the United States. |
None |
12000 |
1 |
1 |
None |
None |
None |
None |
Response on estimated volume of patients: RINVOQ is marketed for the treatment of refractory, moderate to severe atopic dermatitis in adults and children 12 years and older. Based upon published analysis, atopic dermatitis affects approximately 16.5 million adults and 9.6 million children under the age of 18 in the United States. See Shaw TE, Currie GP, Koudelka CW, Simpson EL. Eczema prevalence in the United States: data from the 2003 National Survey of Children’s Health. J Invest Dermatol. 2011;131(1):67-73, Silverberg JI, Simpson EL. Association between severe eczema in children and multiple comorbid conditions and increased healthcare utilization. Pediatr Allergy Immunol. 2013;24(5):476-486, Silverberg JI, Simpson EL. Associations of childhood eczema severity: a US population-based study. Dermatitis. 2014;25(3):107-114, Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J Invest Dermatol. 2019;139(3):583-590. RINVOQ may be prescribed for a fraction of those patients for whom a physician and patient in consultation may consider this treatment appropriate. |
None |
| AbbVie |
00074104328 |
RINVOQ (upadacitinib) 45MG 30 Day Bottle |
2022-03-23 |
10586.2400 |
RINVOQ is marketed to treat adults with moderately to severely active ulcerative colitis (UC) . The Wholesale Acquisition Cost (WAC) of RINVOQ 45mg tablets is $10,586.35 per bottle of 28 tablets. To date, RINVOQ has been approved in jurisdictions outside the United States. |
None |
7200 |
None |
1 |
None |
None |
None |
None |
None |
None |
| AbbVie |
00074501501 |
RISA 600mg / 10mL VIAL |
2022-06-28 |
9136.4000 |
SKYRIZI is marketed for the treatment of moderately to severely active Crohn's disease in adults. The Wholesale Acquisition Cost (WAC) of SKYRIZI is $9,136.40. To date, SKYRIZI has been approved in >50 jurisdictions outside the United States. |
None |
1000 |
None |
1 |
None |
None |
None |
None |
Response on estimated volume of patients (1,000 per month): Inflammatory bowel disease (IBD) is a family of chronic inflammatory diseases that affect different regions of the GI tract and includes both ulcerative colitis (UC and Crohn’s disease (CD). In the United State, nearly 1.5 million Americans are affected by this chronic disease.
CD is a chronic inflammatory disease characterized by discontinuous areas of transmural inflammation (skip lesions) that occur anywhere along the GI tract, from the mouth to the anus. CD is an unpredictable, progressive disease that impacts patients’ daily lives and when inadequately controlled, CD can lead to irreversible damage to the intestines.
In North America, the incidence of CD ranges from 3.1 to 14.6 cases per 100,000 person-years, with a prevalence of 26 to 199 cases per 100,000 person-years. CD affects males slightly more than females. The peak age at onset for IBD is between 15 and 30 years, with a second peak occurring between 60 and 80 years. |
None |
| AbbVie |
00074107001 |
SKYRIZI (risankizumab-rzaa) |
2022-08-23 |
18272.7900 |
SKYRIZI is marketed for the treatment of moderately to severely active Crohn's disease in adults. The Wholesale Acquisition Cost (WAC) of SKYRIZI is $18,272.79 |
None |
1000 |
None |
1 |
None |
None |
None |
None |
Response on estimated volume of patients (1,000 per month) - Inflammatory bowel disease (IBD) is a family of chronic inflammatory diseases that affect different regions of the GI tract and includes both ulcerative colitis (UC and Crohn’s disease (CD). In the United State, nearly 1.5 million Americans are affected by this chronic disease.
CD is a chronic inflammatory disease characterized by discontinuous areas of transmural inflammation (skip lesions) that occur anywhere along the GI tract, from the mouth to the anus. CD is an unpredictable, progressive disease that impacts patients’ daily lives and when inadequately controlled, CD can lead to irreversible damage to the intestines.
In North America, the incidence of CD ranges from 3.1 to 14.6 cases per 100,000 person-years, with a prevalence of 26 to 199 cases per 100,000 person-years. CD affects males slightly more than females. The peak age at onset for IBD is between 15 and 30 years, with a second peak occurring between 60 and 80 years. |
None |
| AbbVie |
00074106501 |
risankizumab-rzaa 180mg/1.2ml OBI |
2022-12-28 |
18272.7900 |
SKYRIZI is marketed for the treatment of moderately to severely active Crohn's disease in adults. The Wholesale Acquisition Cost (WAC) of SKYRIZI is $18,272.79. To date, SKYRIZI has been approved in >50 jurisdictions outside the United States. |
None |
1000 |
None |
1 |
None |
None |
None |
None |
Response on estimated volume of patients (1,000 per month): Inflammatory bowel disease (IBD) is a family of chronic inflammatory diseases that affect different regions of the GI tract and includes both ulcerative colitis (UC and Crohn’s disease (CD). In the United State, nearly 1.5 million Americans are affected by this chronic disease.
CD is a chronic inflammatory disease characterized by discontinuous areas of transmural inflammation (skip lesions) that occur anywhere along the GI tract, from the mouth to the anus. CD is an unpredictable, progressive disease that impacts patients’ daily lives and when inadequately controlled, CD can lead to irreversible damage to the intestines.
In North America, the incidence of CD ranges from 3.1 to 14.6 cases per 100,000 person-years, with a prevalence of 26 to 199 cases per 100,000 person-years. CD affects males slightly more than females. The peak age at onset for IBD is between 15 and 30 years, with a second peak occurring between 60 and 80 years. |
None |
| Accord BioPharma, Inc. |
69448001463 |
1 SYRINGE in 1 CARTON (69448-014-63) > .37 g in 1 SYRINGE |
2022-04-05 |
3900.0000 |
None |
1 |
74000 |
None |
None |
2022-01-28 |
None |
1 |
None |
None |
None |
| Accord Healthcare, Inc. |
16729024438 |
Pemetrexed Disodium Intravaneous Sol Reconstituted 1000MG 1 pack |
2022-05-25 |
1044.5000 |
None |
1 |
0 |
None |
None |
None |
None |
None |
None |
Accord did not acquire the NDC for Pemetrexed, the generic product was developed in house.
Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information.
Accord does not have internal methods or procedures to estimate a reasonable number of patients with a disease state and therefore, cannot answer this question with any level of accuracy that is needed in order to comply with the requirement. |
None |
| Accord Healthcare, Inc. |
16729046785 |
Pirfenidone 267 mg tablet 3 pack |
2022-05-27 |
7147.4100 |
None |
1 |
0 |
None |
None |
None |
None |
None |
None |
"Accord did not acquire the NDC for Pemetrexed, the generic product was developed in house.
Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information.
Accord does not have internal methods or procedures to estimate a reasonable number of patients with a disease state and therefore, cannot answer this question with any level of accuracy that is needed in order to comply with the requirement." |
None |
| Accord Healthcare, Inc. |
16729046815 |
Pirfenidone 801 mg tablet 1 pack |
2022-05-27 |
7147.4100 |
None |
1 |
0 |
None |
None |
None |
None |
None |
None |
"Accord did not acquire the NDC for Pemetrexed, the generic product was developed in house.
Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information.
Accord does not have internal methods or procedures to estimate a reasonable number of patients with a disease state and therefore, cannot answer this question with any level of accuracy that is needed in order to comply with the requirement." |
None |
| Accord Healthcare, Inc. |
16729052235 |
Pemetrexed Injection 1000mg/40mL (25mg/mL) SDV |
2022-09-08 |
1044.5000 |
None |
1 |
28500 |
None |
None |
None |
None |
None |
None |
None |
None |
| Accord Healthcare, Inc. |
16729034210 |
Fingolimod 0.5mg Caps 30 Pack |
2022-10-18 |
4870.5600 |
None |
1 |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
| Accord Healthcare, Inc. |
16729025105 |
Bendamustine HCl for Injection, USP 100mg/vial |
2022-12-07 |
1600.0000 |
None |
1 |
1240 |
None |
None |
None |
None |
None |
None |
Accord Healthcare is a generic drug manufacturer, and this drug is a generic product with many other generics products available within this therapeutic class. Bendamustine Hydrochloride for Injection is an alkylating drug indicated for treatment of patients with Chronic lymphocytic leukemia and Indolent B-cell non-Hodgkin lymphoma. |
None |
| Advagen Pharma Limited |
72888008630 |
Diclofenac Potassium Tablet 25mg 30ct |
2022-07-07 |
861.2900 |
None |
1 |
24000 |
None |
None |
None |
None |
None |
None |
This is a new presentation to be added in the next few weeks. Advagen already markets 2 other presentations in 50mg tablet from. This product was not acquired. Marketing right were granted to Advagen by the approval owner. |
None |
| Advanced Accelerator Applications |
66948001061 |
PLUVICTO (Single dose vial, 7.5 ml to 12.5 ml) |
2022-03-23 |
42500.0000 |
The marketing for PLUVICTO (Lutetium Lu 177 vipivotide tetraxetan) includes education and promotion to physicians, direct to consumer promotions, other types of marketing (e.g., online platforms and education). |
None |
1300 |
1 |
1 |
None |
None |
None |
None |
Advanced Accelerator Applications considered many factors in determining the price of PLUVICTO and the financial and non-financial factors are considered as a whole when establishing the WAC price. We priced in parity to other branded treatments in this therapeutic area. Factors in our pricing methodology included consideration of value delivered to the patient, healthcare system, and society, as well as existing market dynamics, and aggregate company-wide costs for research and development; manufacturing and distribution; to undertake quality measures; and ensure safety and effectiveness with ongoing pharmacovigilance for patients. |
None |
| Agios Pharmaceuticals |
71334021020 |
PYRUKYND 20mg Monthly Pack (20mg 14ct blister card x 4) |
2022-02-25 |
25760.0000 |
None |
1 |
13 |
None |
1 |
None |
None |
None |
None |
The exact prevalence of Pyruvate Kinase Deficiency is unknown. Diagnosed prevalence is estimated at 3.2 to 8.5 per one million people. Secrest MH et al. Eur J Haematol. 2020;105:173-184. doi:10.1111/ejh.13424 |
None |
| Agios Pharmaceuticals |
71334022512 |
PYRUKYND 20mg/5mg Taper Pack |
2022-02-25 |
6440.0000 |
None |
1 |
13 |
None |
1 |
None |
None |
None |
None |
The exact prevalence of Pyruvate Kinase Deficiency is unknown. Diagnosed prevalence is estimated at 3.2 to 8.5 per one million people. Secrest MH et al. Eur J Haematol. 2020;105:173-184. doi:10.1111/ejh.13424 |
None |
| Agios Pharmaceuticals |
71334021550 |
PYRUKYND 50mg Monthly Pack (50mg 14ct blister card x 4) |
2022-02-25 |
25760.0000 |
None |
1 |
13 |
None |
1 |
None |
None |
None |
None |
The exact prevalence of Pyruvate Kinase Deficiency is unknown. Diagnosed prevalence is estimated at 3.2 to 8.5 per one million people. Secrest MH et al. Eur J Haematol. 2020;105:173-184. doi:10.1111/ejh.13424 |
None |
| Agios Pharmaceuticals |
71334023013 |
PYRUKYND 50mg/20mg Taper Pack |
2022-02-25 |
6440.0000 |
None |
1 |
13 |
None |
1 |
None |
None |
None |
None |
The exact prevalence of Pyruvate Kinase Deficiency is unknown. Diagnosed prevalence is estimated at 3.2 to 8.5 per one million people. Secrest MH et al. Eur J Haematol. 2020;105:173-184. doi:10.1111/ejh.13424 |
None |
| Agios Pharmaceuticals |
71334020505 |
PYRUKYND 5mg Monthly Pack (5mg 14ct blister card x 4) |
2022-02-25 |
25760.0000 |
None |
1 |
13 |
None |
1 |
None |
None |
None |
None |
The exact prevalence of Pyruvate Kinase Deficiency is unknown. Diagnosed prevalence is estimated at 3.2 to 8.5 per one million people. Secrest MH et al. Eur J Haematol. 2020;105:173-184. doi:10.1111/ejh.13424 |
None |
| Agios Pharmaceuticals |
71334022011 |
PYRUKYND 5mg Taper Pack (5mg 7ct blister card x 1) |
2022-02-25 |
3220.0000 |
None |
1 |
13 |
None |
1 |
None |
None |
None |
None |
The exact prevalence of Pyruvate Kinase Deficiency is unknown. Diagnosed prevalence is estimated at 3.2 to 8.5 per one million people. Secrest MH et al. Eur J Haematol. 2020;105:173-184. doi:10.1111/ejh.13424 |
None |
| Akorn Inc |
17478079312 |
Cetrorelix Acetate for Injection 0.25mg |
2022-10-24 |
187.1500 |
None |
1 |
40000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Alembic Pharmaceuticals, Inc. |
62332065530 |
Formoterol Fumarate Inhalation Solution, 20mcg, 30mL |
2022-04-06 |
481.8900 |
We plan to launch the product as a generic drug and compete on price with other manufacturers. |
None |
32000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Alembic Pharmaceuticals, Inc. |
62332065560 |
Formoterol Fumarate Inhalation Solution, 20mcg, 60mL |
2022-04-06 |
963.7800 |
We plan to launch the product as a generic drug and compete on price with other manufacturers. |
None |
32000 |
None |
None |
None |
None |
None |
None |
None |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=659 |
| Alembic Pharmaceuticals, Inc. |
62332047964 |
Pirfenidone Tablet, 267mg |
2022-06-30 |
5360.5500 |
None |
1 |
100000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Alembic Pharmaceuticals, Inc. |
62332048090 |
Pirfenidone Tablet, 801mg |
2022-06-30 |
5360.5500 |
None |
1 |
100000 |
None |
None |
None |
None |
None |
None |
None |
None |
| American Regent |
00517102025 |
Vasopressin 20unit/mL 1mL Vial |
2022-02-03 |
3951.0000 |
We do not intend to engage in, nor have we engaged in to date, any substantial marketing activities relating to the Vasopressin Product in the U.S. or internationally. Our marketing efforts to promote the new drug are generally limited to marketing on our website as well as digital announcements (including those at professional society events) to announce the availability of the new Vasopressin Product. Our pricing plans are not in the public domain. |
None |
1000 |
None |
None |
None |
None |
None |
None |
We provide the following comment regarding the patient estimate: Vasopressin is approved by the FDA to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. It is estimated that 3.8MM vials are used annually. If we then assume that an estimated 3.8 vials per patient are used on average by each patient then this total is 1,000,000 unique patients annually or 83,333 per month for the entire market. We do not know how many of those potential patients may take this product.
We provide the following comment regarding the acquisition fields: This product was not acquired and the acquisition fields are not applicable.
We provide the following general comment: We have limited the information included in this submission to that which is otherwise in the public domain or publicly available, as the California requirements permit. |
None |
| American Regent |
00517038105 |
PROVAYBLUE ® (methylene blue) injection USP, 0.5% 50 mg/10 mL (5 mg/mL) |
2022-05-09 |
1823.0000 |
We do intend to engage in domestic only marketing activities relating to the ProvayBlue launch to create market awareness of this new vial presentation. Our marketing efforts to promote the new drug are generally through digital media, American Regent website, ProvayBlue website and eblasts. Printed marketing materials are only for the use of the sales force and are used to facilitate a conversation. Our pricing plans are not in the public domain. |
None |
None |
None |
None |
None |
None |
None |
None |
We provide the following comment regarding the patient estimate: ProvayBlue (Methylene Blue) is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. This product is also an orphan drug, which is a drug that is used for rare diseases. The number of patients that use ProvayBlue (Methylene Blue) on label is unknown. However, we do know that ProvayBlue (Methylene Blue) is used off label as a marker dye. American Regent sells 439,060 number of units a year in a 10ml ampule and now it is available in a 10ml vial. The number of patients of it being used as a marker dye is unknown.
We provide the following comment regarding the Priority Review Field: This product did not receive a priority review; however, it did receive an accelerated approval.
We provide the following comment regarding the acquisition fields: ProvayBlue is not an acquired product. The partner from whom we license the drug, (which is not affiliated with American Regent) is the NDA holder of this NDC.
We provide the following general comment: We have limited the information included in this submission to that which is otherwise in the public domain or publicly available, as the California requirements permit. |
None |
| American Regent |
00517060201 |
INJECTAFER 100 mg/2 mL (50 mg/mL) |
2022-08-03 |
166.0500 |
We do intend to engage in domestic only marketing activities relating to the Injectafer launch to create market awareness of this new presentation. Our marketing efforts to promote the new drug are generally through digital media, Daiichi Sankyo website, Injectafer websites and eblasts. Printed marketing materials are only for the use of the sales force and are used to facilitate a conversation. Our pricing plans are not in the public domain. |
None |
None |
None |
None |
None |
None |
None |
None |
We provide the following comment regarding the patient estimate: Injectafer (Ferric Carboxymaltose) is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in adults and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron and adult patients who have non-dialysis dependent chronic kidney disease. The total number of patients that use Injectafer annually is unknown, however over a twelve-month period ending June 2022 [*IMS MAT June 2022], the total number of Injectafer milligrams that were reported to be sold to the market was 511,516,500, thus based on a 1500mg regiment of 750mg for each infusion, the minimum number of patients is about 341,000.
*IMS SMART-US EDITION NSP DATABASE
We provide the following comment regarding the acquisition fields: Injectafer is not an acquired product. The licensor has granted American Regent the right to develop, manufacture, distribute and sell the product in the United States. American Regent is the NDA holder of this NDC but markets the drug through our parent company, Daiichi Sankyo, Inc.
We provide the following general comment: We have limited the information included in this submission to that which is otherwise in the public domain or publicly available, as the California requirements permit. |
None |
| Amgen |
55513011201 |
TEZSPIRE (210 mg/1.91 mL (110 mg/mL) prefilled syringe, 1 pk) |
2022-01-07 |
3633.0000 |
There is a direct-to-consumer marketing plan for Tezspire. Efforts in the public domain currently consist of: (1) patient website www.tezspire.com, search and banner advertising (2) patient educational brochure and (3) social media. The purpose of the website is to educate patients about the definition of severe asthma and Tezspire aligned to the Tezspire USPI, including Important Safety Information. It also provides information about the Tezspire Together hub for access services.
Promotional activities to HCPs include the HCP website, www.tezspirehcp.com, search, banner advertising, and other digital educational programs in line with the Tezspire USPI. The purpose of these tools is for education that Tezspire is the first and only biologic approved for severe asthma without phenotypic or biomarker limitations. Tezspire offers multiple free goods program in the form of a bridge program called FastStart for commercially insured eligible patients and a sample program.
Amgen understands that the cost of prescription drugs is a concern for many people, and we are committed to the responsible pricing of our medicines.
Our approach to pricing across the globe is underpinned by two simple core principles:
I. Pricing our products according to the value they deliver
II. Employs flexible pricing approaches to ensure patient access
TEZSPIRE is available at a WAC of $3,633.00 per 30-day supply. |
None |
None |
1 |
1 |
None |
None |
None |
None |
Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available. |
None |
| Amneal Pharmaceuticals |
70121168007 |
Carboprost Tromethamine Injection, USP 250 mcg/mL |
2022-02-08 |
3189.9000 |
This is a generic product that is not marketed. |
None |
27383 |
None |
None |
None |
None |
None |
None |
Estimated average of patients per month is unknown to Amneal Pharmaceuticals LLC. This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
70121156807 |
Releuko (filgrastim-ayow) 300 mcg/0.5 mL Injection 10 Single-dose Prefilled Syringes |
2022-02-28 |
2280.0000 |
This is a generic product that is not marketed. |
None |
2867 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
70121156907 |
Releuko (filgrastim-ayow) 300 mcg/mL Injection 10 x 1 mL Single-dose Vials |
2022-02-28 |
2280.0000 |
This is a generic product that is not marketed. |
None |
8667 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
70121157007 |
Releuko (filgrastim-ayow) 480 mcg/0.8 mL Injection 10 Single-dose Prefilled Syringes |
2022-02-28 |
3648.0000 |
This is a generic product that is not marketed. |
None |
3641 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
70121157107 |
Releuko (filgrastim-ayow) 480 mcg/1.6 mL (300 mcg/mL) Injection 10 x 1.6mL Single-dose Vials |
2022-02-28 |
3648.0000 |
This is a generic product that is not marketed. |
None |
29560 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
69238229801 |
Oxycodone ER 40mg Tablet 100 |
2022-04-01 |
1284.2500 |
This is a generic product that is not marketed. |
None |
1574 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
69238230001 |
Oxycodone ER 80mg Tablet 100 |
2022-04-01 |
2240.9600 |
This is a generic product that is not marketed. |
None |
893 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
70257041687 |
Lyvispah (Baclofen) Oral Granules 20mg, 90ct |
2022-05-16 |
1650.0000 |
When pricing our medicines, Amneal considers not only the market dynamics that may impact access for patients, but also looks at overall benefits to help maintain continuous supply to patients, sponsorship of patient assistance programs, and reinvestment into Amneal to support new therapies, supply chain, and R&D to bring drugs to market and help improve the value our therapies bring to the healthcare system. |
None |
50 |
None |
None |
2022-02-09 |
83000500.0000 |
None |
Under the terms of the transaction, Amneal will pay approximately $83.5 million of cash at close, and certain royalties (low double-digits) based on annual net sales for certain acquired products. The transaction will be financed with cash on hand and is expected to close in the first quarter of 2022, subject to the satisfaction of customary closing conditions, including clearance under the Hart-Scott Rodino Antitrust Improvements Act. |
Lyvispah was part of a larger acquisition involving multiple products and as such an acquisition cost specific to Lyvispah is not available |
None |
| Amneal Pharmaceuticals |
69238208806 |
Bexarotene 1% Topical Gel 60g |
2022-05-23 |
23268.9300 |
This is a generic product that is not marketed. |
None |
66 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
60219164008 |
Pirfenidone 267mg |
2022-05-25 |
5360.5600 |
This is a generic product that is not marketed. |
None |
193906 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
60219164109 |
Pirfenidone 801mg |
2022-05-25 |
5360.5600 |
This is a generic product that is not marketed. |
None |
58746 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
70121175407 |
Alymsys (bevacizumab-maly) Injection 100mg/4ml |
2022-05-26 |
7186.0000 |
This is a generic product that is not marketed. |
None |
24950 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
70121175501 |
Alymsys (bevacizumab-maly) Injection 400mg/16ml |
2022-05-26 |
2874.4000 |
This is a generic product that is not marketed. |
None |
25050 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
70121175507 |
Alymsys (bevacizumab-maly) Injection 400mg/16ml 10 x 16mL single-dose vial |
2022-05-26 |
28744.0000 |
This is a generic product that is not marketed. |
None |
25050 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
69238142401 |
Vigabatrin Tabs 500mg |
2022-06-30 |
10511.8900 |
This is a generic product that is not marketed. |
None |
1602 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
70121164205 |
Vasopressin Injection, 20 Units/mL x 25 SDV |
2022-08-10 |
2627.6300 |
This is a generic product that is not marketed. |
None |
4466 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
70121164207 |
Vasopressin Injection, 20 Units/mL x 10 SDV |
2022-09-02 |
1051.0500 |
This is a generic product that is not marketed. |
None |
3020 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
65162068312 |
Diclofenac Sodium 2% Topical Solution |
2022-11-15 |
1616.8200 |
This is a generic product that is not marketed. |
None |
448815 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amylyx Pharmaceuticals, Inc. |
73063003503 |
Relyvrio- Sodium phenylbutyrate 3g and taurursodiol 1g - 56ct |
2022-10-06 |
12504.2400 |
None |
1 |
29000 |
None |
1 |
None |
None |
None |
None |
For column 7 "Estimated Number of Patients" 29,000 adults living with ALS in the United States. |
None |
| Amylyx Pharmaceuticals, Inc. |
73063003504 |
Relyvrio- Sodium phenylbutyrate 3g and taurursodiol 1g - 7ct |
2022-10-06 |
1563.0300 |
None |
1 |
29000 |
None |
1 |
None |
None |
None |
None |
For column 7 "Estimated Number of Patients" 29,000 adults living with ALS in the United States. |
None |
| Analog Pharma |
70505021060 |
NITISINONE capsules, for oral use 10 mg. |
2022-07-07 |
21797.0000 |
Orphan drug, extremely rare disease with less than 300 patients and 25% less than the brand. |
None |
300 |
None |
None |
None |
None |
None |
None |
None |
None |
| Analog Pharma |
70505020260 |
NITISINONE capsules, for oral use 2 mg. |
2022-07-07 |
4360.0000 |
Orphan drug, extremely rare disease with less than 300 patients and 25% less than the brand. |
None |
300 |
None |
None |
None |
None |
None |
None |
None |
None |
| Analog Pharma |
70505020560 |
NITISINONE capsules, for oral use 5 mg. |
2022-07-07 |
10899.0000 |
Orphan drug, extremely rare disease with less than 300 patients and 25% less than the brand. |
None |
300 |
None |
None |
None |
None |
None |
None |
None |
None |
| ANIP |
70954025510 |
Methyltestosterone Capsules, USP 10mg 100ct |
2022-04-25 |
6213.8800 |
Novitium did some market research with customers to understand the generic pricing. At this time, Novitium is focused on selling Methyltestosterone in the United States. |
None |
15 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505623004 |
Paclitaxel Injection |
2022-04-12 |
1441.0100 |
None |
1 |
62000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505605004 |
Bortezomib for Injection |
2022-05-02 |
913.7100 |
None |
1 |
34940 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505040603 |
Diclofenac Sodium Solution |
2022-05-09 |
1616.8200 |
None |
1 |
3000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505431800 |
TOLVAPTAN |
2022-05-20 |
4687.1900 |
None |
1 |
2985 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505606700 |
Pemetrexed for Injection 1000 mg |
2022-05-25 |
4280.7800 |
None |
1 |
198862 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505606600 |
Pemetrexed for Injection 500 mg |
2022-05-25 |
2140.3900 |
None |
1 |
198862 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505606800 |
Pemetrexed for Injection 750 mg |
2022-05-25 |
3210.5900 |
None |
1 |
198862 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505455303 |
Ambrisentan Tabs 10mg |
2022-07-13 |
5533.6100 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505455203 |
Ambrisentan Tabs 5mg |
2022-07-13 |
5533.6100 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505453402 |
Lenalidomide Capsules 10mg |
2022-09-06 |
20157.3600 |
None |
1 |
11065 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505453502 |
Lenalidomide Capsules 15mg |
2022-09-06 |
15118.0400 |
None |
1 |
11065 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505453702 |
Lenalidomide Capsules 25mg |
2022-09-06 |
15118.0400 |
None |
1 |
11065 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505453302 |
Lenalidomide Capsules 5mg |
2022-09-06 |
20157.3600 |
None |
1 |
11065 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505431700 |
TOLVAPTAN 15MG |
2022-09-06 |
3671.1000 |
None |
1 |
2985 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505433203 |
Fingolimod Capsules 0.5mg |
2022-10-18 |
4870.5600 |
None |
1 |
15000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Ardelyx, Inc. |
73154005060 |
IBSRELA 50 mg |
2022-03-18 |
1500.0000 |
"• Marketing messaging will emphasize the unique, first-in-class mechanism of action of IBSRELA (tenapanor), and the clinical data that demonstrates significant improvement in abdominal pain, bloating and constipation with a quick onset of action and sustained efficacy.
• IBSRELA will be positioned as a first-in-class NHE3 inhibitor that provides a new therapeutic option for adults with IBS-C.
• This positioning and messaging focus will establish IBSRELA, with its new mechanistic approach, and triple-acting effect, as a meaningful new medicine in the treatment toolkit for HCPs who treat adult patients with IBS-C. Sales force focus is on the HCPs who treat patients with IBS-C.
Ardelyx is a biopharmaceutical company founded with a mission to discover, develop, and commercialize innovative first in class medicines that meet significant unmet medical needs. Pricing for IBSRELA (tenapanor) was determined based on a consideration of therapeutic area dynamics and the clinical value proposition of IBSRELA. Therapeutic area dynamics include the multifactorial pathophysiology of IBS-C, the limited number of therapies available, and the unmet medical needs of adult patients. Considerations of the clinical value proposition of IBSRELA include its first-in-class, novel mechanism of action and demonstrated safety and efficacy profile from the Phase 3 clinical trial program. The WAC price of IBSRELA of $1500 for a 30-day supply of treatment is within the range of currently marketed IBS therapies." |
None |
11000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Ascend Laboratories, LLC |
67877063502 |
TOLVAPTAN 15MG TABLETS Size 10 |
2022-09-07 |
4630.1000 |
None |
1 |
1 |
None |
None |
None |
None |
None |
None |
The "1" is a place holder as the estimated number of patients is unknown to Ascend Laboratories. Ascend is a generic manufacturer, and the drug is used for Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease affecting over 12 million people worldwide. It's estimated that between 1 in every 400 to 2,500 people has the disease. It can affect women and men, across all ethnic groups. |
None |
| Ascend Laboratories, LLC |
67877063533 |
TOLVAPTAN 15MG TABLETS Size 1X10 |
2022-09-07 |
4630.1000 |
None |
1 |
1 |
None |
None |
None |
None |
None |
None |
The "1" is a place holder as the estimated number of patients is unknown to Ascend Laboratories. Ascend is a generic manufacturer, and the drug is used for Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease affecting over 12 million people worldwide. It's estimated that between 1 in every 400 to 2,500 people has the disease. It can affect women and men, across all ethnic groups. |
None |
| Ascend Laboratories, LLC |
67877047630 |
FINGOLIMOD 0.5MG CAPSULE |
2022-09-26 |
8279.9400 |
None |
1 |
1 |
None |
None |
None |
None |
None |
None |
Fingolimod capsule is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older. As Ascend's product is a generic, it is unknown how many patients will take it. |
None |
| AstraZeneca |
00310351260 |
CALQUENCE® (acalabrutinib) |
2022-08-16 |
14485.9200 |
"AstraZeneca will engage 9 sales representatives to cover the state of California. Patient brochures as well as therapy management guides, may be left behind in offices for informational purposes. AstraZeneca provides online resources via CALQUENCE US healthcare professionals and patient websites. Patients may register for the CALQUENCE support program via the website which will enroll them in a digital relationship marketing program to receive materials such as welcome letters, patient brochures, etc. The CALQUENCE patient savings program for eligible commercially insured patients will be available for patients in California and can be found via AstraZeneca’s Product website.
When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s
pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers." |
None |
11500 |
None |
None |
None |
None |
None |
None |
CALQUENCE is a targeted alternative to traditional chemotherapy. CALQUENCE is a kinase inhibitor that affects the growth of MCL cancer cells. Kinases are part of the chemical pathways within cells, some of which can start the growth of new cells. Kinase inhibitors help stop growth signals and reduce the number of new cancer cells being made. CALQUENCE works by blocking a protein called Bruton tyrosine kinase (BROO-tuhn TY-ruh-seen KY-nays), or BTK, in B cells. |
None |
| AstraZeneca |
00310450525 |
IMJUDO LQD 25MG VI 1X1.25ML US |
2022-11-17 |
3250.0000 |
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 |
10000 |
None |
1 |
None |
None |
None |
None |
Imjudo is indicated in combination with durvalumab, for treatment of adult patients with unresectable hepatocellular carcinoma. |
None |
| AstraZeneca |
00310453530 |
IMJUDO LQD 300MG VI 1X15ML US |
2022-11-17 |
39000.0000 |
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 |
10000 |
None |
1 |
None |
None |
None |
None |
Imjudo is indicated in combination with durvalumab, for treatment of adult patients with unresectable hepatocellular carcinoma. |
None |
| AstraZeneca |
00310621039 |
FARXIGA TAB 10MG HUD BL 3X10 EA US |
2022-12-02 |
548.8300 |
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 |
None |
None |
None |
None |
None |
None |
None |
This is the HUD (or Hospital Unit Dose) of Farxiga. |
None |
| Aurobindo Pharma USA, Inc. |
59651043601 |
Digoxin Tablets USP 62.5 mcg (0.0625mg) - 100/Bottle |
2022-02-15 |
1152.0000 |
None |
1 |
60 |
None |
None |
None |
None |
None |
None |
None |
None |
| Aurobindo Pharma USA, Inc. |
59651035308 |
Diclofenac Potassium Capsules 25 mg - 120/Bottle |
2022-03-24 |
1054.5000 |
None |
1 |
60 |
None |
None |
None |
None |
None |
None |
None |
None |
| AuroMedics Pharma LLC |
55150036610 |
Arsenic Trioxide Injection, 12mg/6ml SDV - 10s |
2022-04-04 |
5253.5000 |
We plan to market the drug to clinics and hospitals |
None |
1000 |
None |
None |
None |
None |
None |
None |
None |
None |
| AuroMedics Pharma LLC |
55150038301 |
Pemetrexed for injection, USP SDV, 1000mg/vial - 1s |
2022-05-27 |
1000.0000 |
We plan to market the drug to clinics and hospitals |
None |
1000 |
None |
None |
None |
None |
None |
None |
None |
None |
| AuroMedics Pharma LLC |
55150037125 |
Vasopressin Injection USP, SDV 20 units/1mL - 25s |
2022-06-30 |
3753.6400 |
we plan to market the drug to clinics and hospitals |
None |
10000 |
None |
None |
None |
None |
None |
None |
None |
None |
| AuroMedics Pharma LLC |
55150042110 |
Esmolol Hydrochloride in Sodium Chloride Injection SD Bags 2000mg/100mL - 10's |
2022-08-10 |
1595.0000 |
We plan to market the drug to clinics and hospitals |
None |
10000 |
None |
None |
None |
None |
None |
None |
None |
None |
| AuroMedics Pharma LLC |
55150042010 |
Esmolol Hydrochloride in Sodium Chloride Injection SD Bags 2500mg/250mL - 10's |
2022-08-10 |
1398.0000 |
We plan to market the drug to clinics and hospitals |
None |
10000 |
None |
None |
None |
None |
None |
None |
None |
None |
| AuroMedics Pharma LLC |
55150032925 |
Medroxyprogesterone Acetate Injectable Suspension USP, SDV 150mg/mL - 25s |
2022-12-31 |
915.9200 |
We plan to market the drug to clinics, pharmacies and hospitals |
None |
10000 |
None |
None |
None |
None |
None |
None |
None |
None |
| AvKare |
42291087001 |
Tretinoin 10mg Cap - 100ct |
2022-06-15 |
2523.3500 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
Drug has been previously submitted to compendia, but not previously launched or marketed by the manufacturer |
None |
| AvKare |
50268068312 |
POSACONAZOLE DR TAB 100MG 2X10 CT |
2022-08-07 |
850.0000 |
None |
1 |
29000 |
None |
None |
None |
None |
None |
None |
Drug not acquired |
None |
| AvKare |
42291047312 |
Etravirine 100mg 120ct |
2022-12-07 |
929.3600 |
None |
1 |
1200000 |
None |
None |
None |
None |
None |
None |
None |
None |
| AvKare |
42291047460 |
Etravirine 200mg 60ct |
2022-12-07 |
929.3600 |
None |
1 |
1200000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Axsome Therapeutics, Inc. |
81968004530 |
Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) 105MG; 45MG 30 Tablets |
2022-10-17 |
524.0000 |
None |
1 |
6217 |
1 |
None |
None |
None |
None |
None |
Axsome Therapeutics, Inc. considers the process of assessing and developing a marketing and pricing plan to be a trade secret using confidential information and cannot release this data into the public domain. |
None |
| Azurity Pharmaceuticals |
52652600102 |
Fleqsuvy 300ml 25mg per 5ml |
2022-03-18 |
1650.0000 |
Azurity Institutional Sales Force promoting Fleqsuvy to in- and out-patient pharmacies in the hospital setting. The sales force provided with marketing materials highlighting the profile and benefits of Fleqsuvy, including its oral suspension liquid nature, concentrated formulation and advantages as compared to Ozobax. After in-depth research, recommendation was to Price Fleqsuvy less vs Ozobax to gain favorable payer coverage relative to Ozobax |
None |
250 |
None |
None |
None |
None |
None |
None |
None |
None |