| 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 |
| Biocon Limited |
70377010411 |
Aminocaproic Acid Oral Solution |
2022-10-24 |
1100.0000 |
Launch of a generic pharmaceutical. Pricing and supply offers made to large GPOs with purchasing decision authority for retail, wholesale, and specialty outlets. GPOs include Red Oak Sourcing, Walgreens Boots Alliance Development, ClarusONE Sourcing Services, and Econdisc. This product is priced at a discount of ~60% off the brand WAC. |
None |
69000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Limited |
70377010311 |
Aminocaproic Acid Tablets |
2022-10-24 |
1008.1100 |
Launch of a generic pharmaceutical. Pricing and supply offers made to large GPOs with purchasing decision authority for retail, wholesale, and specialty outlets. GPOs include Red Oak Sourcing, Walgreens Boots Alliance Development, ClarusONE Sourcing Services, and Econdisc. This product is priced at a discount of ~20% off the brand WAC. |
None |
20000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biogen |
64406001901 |
Byooviz 0.5 mg (0.05 mL of 10 mg/mL solution) |
2022-07-01 |
1130.0000 |
BYOOVIZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences.
Further information can be found at:
https://www.biogen.com/content/dam/corporate/en_us/pdfs/BIOGEN_PricingPrinciplesInfographic_4-26-19.pdf |
None |
1000000 |
None |
None |
None |
None |
None |
None |
BYOOVIZ™ (ranibizumab-nuna), a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Myopic Choroidal Neovascularization (mCNV). The estimated number of patients provided in this report is based on 2021 prevalence estimates resulting from analyses of several data sources and publications. |
None |
| BioXcel Therapeutics, Inc. |
81092112001 |
Igalmi Sublingual Film 120 MCG 10 |
2022-07-01 |
1050.0000 |
BioXcel Therapeutics, Inc.consider multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). Igalmi is an FDA approved treatment for Schizophrenia or bipolar I or II disorder in adults. which affects a number of patients in the US annually. BioXcel Therapeutics, Inc. approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment with BioXcel Therapeutics, Inc. products. |
None |
20625 |
1 |
None |
None |
None |
None |
None |
None |
None |
| BioXcel Therapeutics, Inc. |
81092118001 |
Igalmi Sublingual Film 180 MCG 10 |
2022-07-01 |
1050.0000 |
BioXcel Therapeutics, Inc.consider multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply). Igalmi is an FDA approved treatment for Schizophrenia or bipolar I or II disorder in adults. which affects a number of patients in the US annually. BioXcel Therapeutics, Inc. approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment with BioXcel Therapeutics, Inc. products. |
None |
8839 |
1 |
None |
None |
None |
None |
None |
None |
None |
| bluebird bio, Inc. |
73554311101 |
ZYNTEGLO (betibeglogene autotemcel) |
2022-10-01 |
2800000.0000 |
None |
1 |
1500 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| bluebird bio, Inc. |
73554211101 |
SKYSONA is a cell suspension for intravenous infusion; a single dose of SKYSONA contains a minimum of 5.0 × 10^6 CD34+ cells/kg of body weight, suspended in a solution containing 5% dimethyl sulfoxide (DMSO) |
2022-12-01 |
3000000.0000 |
SKYSONA is an autologous hematopoietic stem cell-based gene therapy indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD). CALD is a rare, progressive, neurodegenerative disease that primarily affects young boys and causes irreversible, devastating neurologic decline, including major functional disabilities such as loss of communication, cortical blindness, requirement for tube feeding, total incontinence, wheelchair dependence, or complete loss of voluntary movement. Nearly half of patients who do not receive treatment die within five years of symptom onset. bluebird took this profound impact into consideration when pricing the therapy—weighing the therapy’s robust and sustained clinical benefit, quality of life improvements for patients and their families, cost savings to the system, and the overall impact on society. We are focused on timely access to this therapy for this patient population. |
None |
40 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Boehringer Ingelheim |
00597003510 |
SPEVIGO Vial 450mg/7.5mL (60mg/mL) 2ct |
2022-09-01 |
51133.0000 |
Specific Marketing and Pricing Plans for Spevigo® are not in the public domain or publicly available. Boehringer Ingelheim considers several factors in determining the price of our medicines. These factors include: the value of innovative medicines; cost effectiveness (meaning the economic value to patients given the effectiveness of the drug, compared to other drugs in the same class); investments made (including in research and development), manufacturing and other costs and the risks undertaken. Boehringer Ingelheim invests 20% of its net sales into research and development. |
None |
22816 |
1 |
1 |
None |
None |
None |
None |
Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available.
Note to Estimated Number of Patients: SPEVIGO® is the first approved treatment option for generalized pustular psoriasis (GPP) flares in adults. It is estimated that 1 out of every 10,000 people have GPP. In the US, 22,816 patients are diagnosed with GPP, a fraction of which experience a GPP flare in a given year. |
None |
| Bristol Myers Squibb |
00003712511 |
OPDUALAG™ (240 mg and 80 mg/20 mL (12 mg and 4 mg/mL) Injection |
2022-03-18 |
13694.2700 |
We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply. |
None |
180 |
None |
1 |
None |
None |
None |
None |
Comment regarding "Estimated Number of Patients" : 180 patients per month (forecast) |
None |
| Bristol Myers Squibb |
73625011311 |
Camzyos 10mg capsule, bottle of 30 |
2022-04-28 |
7356.1600 |
We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 25% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply. |
None |
200 |
1 |
None |
2020-11-17 |
1310000000.0000 |
None |
Mavacamten is a heritage Myokardia investigational medication that BMS acquired in 2020 for $13.1 billion. Acquisition price of the individual drug is not publicly available |
Comment regarding "Estimated Number of Patients" : This is a first in class medication and the expectation is about 200 per month, subject to change. |
None |
| Bristol Myers Squibb |
73625011411 |
Camzyos 15mg capsule, bottle of 30 |
2022-04-28 |
7356.1600 |
We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 25% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply. |
None |
200 |
1 |
None |
2020-11-17 |
1310000000.0000 |
None |
Mavacamten is a heritage Myokardia investigational medication that BMS acquired in 2020 for $13.1 billion. Acquisition price of the individual drug is not publicly available |
Comment regarding "Estimated Number of Patients" : This is a first in class medication and the expectation is about 200 per month, subject to change. |
None |
| Bristol Myers Squibb |
73625011111 |
Camzyos 2.5mg capsule, bottle of 30 |
2022-04-28 |
7356.1600 |
We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 25% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply. |
None |
200 |
1 |
None |
2020-11-17 |
1310000000.0000 |
None |
Mavacamten is a heritage Myokardia investigational medication that BMS acquired in 2020 for $13.1 billion. Acquisition price of the individual drug is not publicly available |
Comment regarding "Estimated Number of Patients" : This is a first in class medication and the expectation is about 200 per month, subject to change. |
None |
| Bristol Myers Squibb |
73625011211 |
Camzyos 5mg capsule, bottle of 30 |
2022-04-28 |
7356.1600 |
We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 25% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply. |
None |
200 |
1 |
None |
2020-11-17 |
1310000000.0000 |
None |
Mavacamten is a heritage Myokardia investigational medication that BMS acquired in 2020 for $13.1 billion. Acquisition price of the individual drug is not publicly available |
Comment regarding "Estimated Number of Patients" : This is a first in class medication and the expectation is about 200 per month, subject to change. |
None |
| Bristol Myers Squibb |
00003089511 |
SOTYKTU™ (deucravacitinib) for oral use, 6mg tablets; pink, round, biconvex, laser printed with “BMS 895” and “6 mg” on one side with no content on the other side |
2022-09-12 |
6164.3800 |
We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 25% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply. |
None |
900 |
None |
None |
None |
None |
None |
None |
Comment regarding "Estimated Number of Patients" : Estimated 900 patients per month (forecast). However, BMS is unable to provide an exact number of patients who will be prescribed Sotyktu each month. |
None |
| Calliditas Therapeutics US Inc. |
81749000401 |
TARPEYO™ (budesonide) delayed release capsules |
2022-01-27 |
14160.0000 |
None |
1 |
4000 |
None |
1 |
None |
None |
None |
None |
Estimated Number of Patients: There is no ICD-10 code for IgA Nephropathy and no IgA Nephropathy patient registry in the state. The estimated IgAN incidence in the US based on native biopsy is 4000 - 4500 IgAN patients. |
None |
| Camber Pharmaceuticals, Inc. |
31722057960 |
Maraviroc 150mg 60ct |
2022-02-07 |
1410.8200 |
None |
1 |
1200000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Camber Pharmaceuticals, Inc. |
31722058060 |
Maraviroc 300mg 60ct |
2022-02-07 |
1410.8200 |
None |
1 |
1200000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Camber Pharmaceuticals, Inc. |
31722087227 |
Pirfenidone 267mg 270ct |
2022-10-01 |
1800.0000 |
None |
1 |
100000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Camber Pharmaceuticals, Inc. |
31722087390 |
Pirfenidone 801mg 90ct |
2022-10-01 |
1800.0000 |
None |
1 |
100000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Camber Pharmaceuticals, Inc. |
31722088930 |
Fingolimod 0.5mg 30ct |
2022-10-17 |
3681.7300 |
None |
1 |
1000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Celltrion USA, Inc. |
72606057301 |
Abiraterone Acetate 500mg |
2022-01-21 |
4219.5400 |
This product is a generic equivalent of an existing innovator product. Celltrion USA, Inc. does not engage in direct-to-consumer marketing and paid advertising to consumers, physicians, or other healthcare professionals for its generic products. |
None |
4500 |
None |
None |
None |
None |
None |
None |
None |
None |
| Cerona Therapeutics, Inc. |
81643927001 |
Floxuridine; for injection; sterile,nonpyrogenic, lyophilized powder for reconstitution; Each vial (packaged individually) contains 500 mg of floxuridine to be reconstituted with 5 mL of sterile water for injection |
2022-06-27 |
3350.0000 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Chiesi USA |
10122050201 |
Revcovi® (elapegademase-IvIr 1.6mg/ml) Injection |
2022-04-18 |
11245.5900 |
None |
1 |
47 |
None |
1 |
2020-11-24 |
None |
1 |
Private company deal. Price not released. |
New NDC reflecting manufacturer's labeler code. |
None |
| Cipla USA, Inc. |
69097087067 |
Lanreotide Injection 120mg/0.5ml Syringe 1ct |
2022-01-31 |
8892.6600 |
None |
1 |
175000 |
None |
None |
None |
None |
None |
None |
Product was not acquired |
None |
| Cipla USA, Inc. |
69097093698 |
Lanthanum Carbonate Chew Tabs 1000mg 90's |
2022-02-25 |
971.4800 |
None |
1 |
558060 |
None |
1 |
None |
None |
None |
None |
Pricing for this product was submitted to data compendia on 2/2/2022, however the product was not commercially available until 2/25/2022. This product was not acquired. |
None |
| Cipla USA, Inc. |
69097093498 |
Lanthanum Carbonate Chew Tabs 500 mg 90's |
2022-02-25 |
971.4800 |
None |
1 |
558060 |
None |
1 |
None |
None |
None |
None |
Pricing for this product was submitted to data compendia on 2/2/2022, however the product was not commercially available until 2/25/2022. This product was not acquired. |
None |
| Cipla USA, Inc. |
69097093598 |
Lanthanum Carbonate Chew Tabs 750mg 90's |
2022-02-25 |
971.4800 |
None |
1 |
558060 |
None |
1 |
None |
None |
None |
None |
Pricing for this product was submitted to data compendia on 2/2/2022, however the product was not commercially available until 2/25/2022. This product was not acquired. |
None |
| Cipla USA, Inc. |
69097098793 |
Pirfenidone Tabs 267mg 270ct |
2022-08-16 |
1800.0000 |
None |
1 |
100000 |
1 |
None |
2022-05-11 |
None |
1 |
Drug is licensed from another manufacturer, acquisition price represents licensing cost |
None |
None |
| Cipla USA, Inc. |
69097098805 |
Pirfenidone Tabs 801mg 90ct |
2022-08-16 |
1800.0000 |
None |
1 |
100000 |
1 |
None |
2022-05-11 |
None |
1 |
Drug is licensed from another manufacturer, acquisition price represents licensing cost |
None |
None |
| Cipla USA, Inc. |
69097038273 |
Lenalidomide Capsules 10mg 28 count |
2022-09-08 |
20157.3600 |
None |
1 |
34000 |
1 |
None |
None |
None |
None |
None |
None |
None |
| Cipla USA, Inc. |
69097038381 |
Lenalidomide Capsules 15 mg 21 count |
2022-09-08 |
15118.0400 |
None |
1 |
34000 |
1 |
None |
None |
None |
None |
None |
None |
None |
| Cipla USA, Inc. |
69097038581 |
Lenalidomide Capsules 25mg 21 count |
2022-09-08 |
15118.0400 |
None |
1 |
34000 |
1 |
None |
None |
None |
None |
None |
None |
None |
| Cipla USA, Inc. |
69097038173 |
Lenalidomide Capsules 5mg 28’s |
2022-09-08 |
20157.3600 |
None |
1 |
34000 |
1 |
None |
None |
None |
None |
None |
None |
None |
| Cipla USA, Inc. |
69097090950 |
Leuprolide acetate suspension 22.5mg/2ml syringe |
2022-11-22 |
1355.0700 |
None |
1 |
270000 |
None |
None |
None |
None |
None |
None |
drug not acquired |
None |
| CMP Pharma |
46287004515 |
Tadalafil oral suspension, 20mg.5 mL, 150 mL bottle |
2022-10-12 |
1895.0000 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Coherus BioSciences, Inc. |
70114044001 |
Each CIMERLI 0.3 mg carton contains a single-dose, 2-mL glass vial with a WHITE CAP designed to deliver 0.05 mL of 6 mg/mL ranibizumab-eqrn solution |
2022-10-03 |
816.0000 |
None |
1 |
1621598 |
None |
None |
None |
None |
None |
None |
None |
None |
| Coherus BioSciences, Inc. |
70114044101 |
Each CIMERLI 0.5 mg carton contains a single-dose, 2-mL glass vial with a BLUE CAP designed to deliver 0.05 mL of 10 mg/mL ranibizumab-eqrn solution. |
2022-10-03 |
1360.0000 |
None |
1 |
1621598 |
None |
None |
None |
None |
None |
None |
None |
None |
| CTI BioPharma Corp. |
72482010012 |
VONJO 100 mg capsule, 120 capsules |
2022-03-10 |
19500.0000 |
VONJO will be promoted by our commercial field team to healthcare professionals to educate them on our product. We will use various means of promotion including in-office visits, virtual meetings, ad campaigns, and digital marketing. Pricing was established by CTI BioPharma Corp. after conducting extensive market research and analysis, which included the research and development investment made, forecasted operational costs, and the overall competitive landscape to reach our determination of launch WAC price. Our launch WAC price is intended to reflect the drug’s specific value to patients within our indicated population and the healthcare providers who treat them. |
None |
7000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Dash Pharmaceuticals, LLC |
69339015917 |
Itraconazole Oral Solution 100mg/10mL 1x40 10mL Unit Dose Cups |
2022-04-29 |
979.3000 |
Pricing is consistent with WAC pricing for generic 150mL bottle with a premium added for the unit dose packaging components |
None |
1260 |
None |
None |
None |
None |
None |
None |
None |
None |
| Dermavant Sciences, Inc. |
81672505101 |
VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Each gram of VTAMA cream contains 10 mg of tapinarof in a white to off-white cream. |
2022-05-26 |
1325.0000 |
Dermavant Sciences, Inc. (“Dermavant”) will market VTAMA (tapinarof) cream, 1% in the United States through national and regional wholesalers/distributors as well as independent retail pharmacies. Dermavant has a national sales force in place to inform and educate healthcare professionals (HCPs) about VTAMA cream and it will also engage in non-personal promotion through print and online medical/general media. A website www.VTAMA.com provides further information about VTAMA cream. HCPs and Patients can call 1-8-DERMAVANT / 1-833-762-8268 for assistance. The list price for VTAMA cream in the United States is $1,325. VTAMA cream is not marketed by Dermavant in any other country outside the United States. |
None |
460000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Dr. Reddy's Laboratories, Inc. |
43598008525 |
Vasopressin Injection, USP 20u/mL 1mL SDV 25s |
2022-02-08 |
3951.2000 |
None |
1 |
230000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy's Laboratories, Inc. does not estimate the number of patients for this drug. Number provided is the number of cases of septic shock in the US each year; 2) Dr. Reddy’s did not acquire the product; 3) Product is an authorized generic of Vasostrict® |
None |
| Dr. Reddy's Laboratories, Inc. |
43598013074 |
Methylprednisolone Sodium Succinate Injection 1 gm, 1 vial |
2022-04-04 |
32.5000 |
None |
1 |
6600000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number indicated is the number of adults reporting moderate-to-severe symptoms of atopic dermatitis which is one of the drug's indications. 2) Dr. Reddy's did not acquire the product; 3) The WAC price, when accounting for a 30-day supply, exceeds the reporting threshold. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598047060 |
Posaconazole DR Tabs 100mg US 60s |
2022-04-19 |
970.0000 |
None |
1 |
23000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is the number instances of invasive fungal candidiasis infections in the US per year. 2) Dr. Reddy's did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598038662 |
Pemetrexed for Injection 100mg, 1 Vial |
2022-05-25 |
159.0000 |
None |
1 |
541000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with lung cancer in the US. 2) Dr. Reddy’s did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598038711 |
Pemetrexed for Injection 500mg, 1 Vial |
2022-05-25 |
793.0000 |
None |
1 |
541000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with lung cancer in the US. 2) Dr. Reddy’s did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598045804 |
Sorafenib Tablets 200mg 120s HDPE US |
2022-06-13 |
15534.9600 |
None |
1 |
70000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimated number of patients is the number of diagnosed patients of kidney and renal pelvic cancers in the US. 2) Dr. Reddy’s did not acquire the product |
None |
| Dr. Reddy's Laboratories, Inc. |
43598014362 |
Azacitidine for Injection 100mg/vial |
2022-07-07 |
100.0000 |
None |
1 |
20000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number of patients provided is based on the incidence of myelodysplastic syndrome per year in the US. 2) Dr. Reddy's did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598042660 |
Bortezomib 3.5mg IV/SC Inj 1's USA |
2022-07-26 |
250.0000 |
None |
1 |
35000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate of 35000 is the number of patients with multiple myeloma in the US.
2) Dr. Reddy's did not acquire the product. 3) Although WAC is only $250.00, it exceeds the threshold for a 30-day supply. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598016001 |
Potassium Chloride Solution 10% 40MEQ/30ML 100CT |
2022-08-16 |
1260.0000 |
None |
1 |
44000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of patients with severe hypokalemia in the US. 2) Dr. Reddy's did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598051263 |
Lenalidomide Capsules 10 mg, 28 ct |
2022-09-07 |
20157.3600 |
None |
1 |
200000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of patients with mantle cell lymphoma in the US. 2) Dr. Reddy's did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598051321 |
Lenalidomide Capsules 15 mg, 21 ct |
2022-09-07 |
15118.0400 |
None |
1 |
200000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of patients with mantle cell lymphoma in the US. 2) Dr. Reddy's did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598051663 |
Lenalidomide Capsules 2.5 mg, 28 ct |
2022-09-07 |
20157.3600 |
None |
1 |
200000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of patients with mantle cell lymphoma in the US. 2) Dr. Reddy's did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598051421 |
Lenalidomide Capsules 20 mg, 21 ct |
2022-09-07 |
15118.0400 |
None |
1 |
200000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of patients with mantle cell lymphoma in the US. 2) Dr. Reddy's did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598051521 |
Lenalidomide Capsules 25 mg, 21 ct |
2022-09-07 |
15118.0400 |
None |
1 |
200000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of patients with mantle cell lymphoma in the US. 2) Dr. Reddy's did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598051163 |
Lenalidomide Capsules 5 mg, 28 ct |
2022-09-07 |
20157.3600 |
None |
1 |
200000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of patients with mantle cell lymphoma in the US. 2) Dr. Reddy's did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598009730 |
Sapropterin Dihydrochloride Sachet 100mg (Javygtor), 30s |
2022-09-19 |
1260.0000 |
None |
1 |
19000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s did not acquire the product 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Organization for Rare Disorders, the reported incidence of Phenylketonuria (PKU) from newborn screening programs ranges from one in 13,500 to 19,000 newborns in the United States However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Sapropterin dihydrochloride sachets 100mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598037074 |
Pemetrexed for Injection 1000mg/Vial USA 1's |
2022-09-26 |
1586.0000 |
None |
1 |
541000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with lung cancer in the US. 2) Dr. Reddy’s did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598005311 |
Desmopressin 4mcg/ml Soln for Inj(MDV), 10ml |
2022-10-03 |
525.0000 |
None |
1 |
60600 |
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. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598009604 |
Sapropterin DiHCL Tablets (Javygtor) 100 mg, 120s |
2022-10-04 |
5040.0000 |
None |
1 |
19000 |
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 Organization for Rare Disorders, the reported incidence of Phenylketonuria (PKU) from newborn screening programs ranges from one in 13,500 to 19,000 newborns in the United States However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Sapropterin dihydrochloride tablets 100mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Penicillamine in rheumatoid arthritis patients should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. 2) This is currently being marketing by Cycle Pharma. 3) 2) Dr. Reddy's did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598028530 |
Fingolimod 0.5mg 30s capsules |
2022-10-20 |
4140.0000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with MS in the US. 2) Dr. Reddy’s did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598017111 |
Thiotepa for injection, 100mg/Vial, 1 vial |
2022-10-27 |
2995.0000 |
None |
1 |
300000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with breast and ovarian cancer in the US. 2) Dr. Reddy’s did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598016230 |
Sapropterin Dihydrochloride Sachets, 500 mg (Javygtor), 30s |
2022-12-22 |
6300.0000 |
None |
1 |
19000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s did not acquire the product 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Organization for Rare Disorders, the reported incidence of Phenylketonuria (PKU) from newborn screening programs ranges from one in 13,500 to 19,000 newborns in the United States However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Sapropterin dihydrochloride sachets 500mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598004763 |
Sunitinib Malate Caps 37.5mg 28s |
2022-12-27 |
12453.3100 |
None |
1 |
6000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s did not acquire the product. 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with gastrointestinal stromal tumors (GIST) per year. |
None |
| Eckson Labs, LLC |
44118070010 |
Plexion Cleanser Strength: Sodium Sulfacetimide, sulfer 9.8%, 4.8% 285g Tube |
2022-04-01 |
693.0000 |
None |
1 |
12000 |
None |
None |
None |
None |
None |
None |
This product has an anticipated launch of April 1, 2022. |
None |
| Eckson Labs, LLC |
44118070260 |
Plexion Cloths Sodium Sulfacetamide, Sulfur 9.8%4.8% 60ct 4g per packet in 1 carton |
2022-05-03 |
752.0000 |
None |
1 |
6000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Eckson Labs, LLC |
44118070302 |
Plexion Lotion Sulfur and Sulfacetamide Sodium 48mg98mg/g 57g in 1 bottle |
2022-05-03 |
699.0000 |
None |
1 |
9000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Eckson Labs, LLC |
44118070430 |
Vytone Cream Hydrocortizone Acetate and Iodoquinol 19mg10mg/g 30ct 2gm packets in 1 carton |
2022-05-03 |
854.0000 |
None |
1 |
6000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Edenbridge Pharmaceuticals, LLC |
42799095001 |
Vigabatrin Tablets USP 500mg 100CT |
2022-12-12 |
10511.8900 |
None |
1 |
12 |
None |
None |
None |
None |
None |
None |
The first shipments of this presentation of Vigabatrin are scheduled to ship on or around 12/22/22. This product was not acquired. Edenbridge is not the ANDA holder. |
None |
| Eli Lilly and Company |
00002147180 |
MOUNJARO 10 mg/0.5 mL 4 single-dose pens |
2022-06-02 |
974.3300 |
None |
1 |
34500000 |
None |
1 |
None |
None |
None |
None |
MOUNJAROTM (tirzepatide) injection is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MOUNJARO was approved by the FDA in May 2022.
Based on diabetes prevalence data from CDC’s diabetes statistics report [https://www.cdc.gov/diabetes/data/statistics-report/index.html], approximately 33.6 to 35.4 million people have type 2 diabetes. The average of that range (34.5 million) is reflected in the Estimated Patients field. People with type 2 diabetes may or may not use MOUNJARO to manage their diabetes.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and. |
None |
| Eli Lilly and Company |
00002146080 |
MOUNJARO 12.5 mg/0.5 mL 4 single-dose pens |
2022-06-02 |
974.3300 |
None |
1 |
34500000 |
None |
1 |
None |
None |
None |
None |
MOUNJAROTM (tirzepatide) injection is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MOUNJARO was approved by the FDA in May 2022.
Based on diabetes prevalence data from CDC’s diabetes statistics report [https://www.cdc.gov/diabetes/data/statistics-report/index.html], approximately 33.6 to 35.4 million people have type 2 diabetes. The average of that range (34.5 million) is reflected in the Estimated Patients field. People with type 2 diabetes may or may not use MOUNJARO to manage their diabetes.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and. |
None |
| Eli Lilly and Company |
00002145780 |
MOUNJARO 15 mg/0.5 mL 4 single-dose pens |
2022-06-02 |
974.3300 |
None |
1 |
34500000 |
None |
1 |
None |
None |
None |
None |
MOUNJAROTM (tirzepatide) injection is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MOUNJARO was approved by the FDA in May 2022.
Based on diabetes prevalence data from CDC’s diabetes statistics report [https://www.cdc.gov/diabetes/data/statistics-report/index.html], approximately 33.6 to 35.4 million people have type 2 diabetes. The average of that range (34.5 million) is reflected in the Estimated Patients field. People with type 2 diabetes may or may not use MOUNJARO to manage their diabetes.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and. |
None |
| Eli Lilly and Company |
00002150680 |
MOUNJARO 2.5 mg/0.5 mL 4 single-dose pens |
2022-06-02 |
974.3300 |
None |
1 |
34500000 |
None |
1 |
None |
None |
None |
None |
MOUNJAROTM (tirzepatide) injection is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MOUNJARO was approved by the FDA in May 2022.
Based on diabetes prevalence data from CDC’s diabetes statistics report [https://www.cdc.gov/diabetes/data/statistics-report/index.html], approximately 33.6 to 35.4 million people have type 2 diabetes. The average of that range (34.5 million) is reflected in the Estimated Patients field. People with type 2 diabetes may or may not use MOUNJARO to manage their diabetes.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and. |
None |
| Eli Lilly and Company |
00002149580 |
MOUNJARO 5 mg/0.5 mL 4 single-dose pens |
2022-06-02 |
974.3300 |
None |
1 |
34500000 |
None |
1 |
None |
None |
None |
None |
MOUNJAROTM (tirzepatide) injection is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MOUNJARO was approved by the FDA in May 2022.
Based on diabetes prevalence data from CDC’s diabetes statistics report [https://www.cdc.gov/diabetes/data/statistics-report/index.html], approximately 33.6 to 35.4 million people have type 2 diabetes. The average of that range (34.5 million) is reflected in the Estimated Patients field. People with type 2 diabetes may or may not use MOUNJARO to manage their diabetes.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and. |
None |
| Eli Lilly and Company |
00002148480 |
MOUNJARO 7.5 mg/0.5 mL 4 single-dose pens |
2022-06-02 |
974.3300 |
None |
1 |
34500000 |
None |
1 |
None |
None |
None |
None |
MOUNJAROTM (tirzepatide) injection is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MOUNJARO was approved by the FDA in May 2022.
Based on diabetes prevalence data from CDC’s diabetes statistics report [https://www.cdc.gov/diabetes/data/statistics-report/index.html], approximately 33.6 to 35.4 million people have type 2 diabetes. The average of that range (34.5 million) is reflected in the Estimated Patients field. People with type 2 diabetes may or may not use MOUNJARO to manage their diabetes.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and. |
None |
| Exelan Pharmaceuticals, Inc. |
76282071727 |
Pirfenidone Tablets 267mg 270ct |
2022-08-02 |
6292.7000 |
None |
1 |
100000 |
None |
None |
None |
None |
None |
None |
product not acquired |
None |
| Exelan Pharmaceuticals, Inc. |
76282071690 |
Pirfenidone Tablets 801mg 90ct |
2022-08-02 |
6281.0500 |
None |
1 |
100000 |
None |
None |
None |
None |
None |
None |
product not acquired |
None |
| Fennec Pharmaceuticals, Inc. |
73077001001 |
PEDMARK (sodium thiosulfate injection), 12.5 g/100 mL, 100 mL vial |
2022-10-11 |
11417.0900 |
None |
1 |
3480 |
1 |
1 |
None |
None |
None |
None |
PEDMARK was not aquired. Comment regarding to patient estimate - Cisplatin carries the highest risk of ototoxicity among all FDA-approved platinum compounds1. About 5000 children (=18 years) are diagnosed with a solid tumor and treated with platinum-based chemotherapy every year in the United States.2,3 About 70% of these patients (~3500) are diagnosed with localized, non-metastatic disease.4 (1. Langer T et al. Trends Pharmacol Sci. 2013;34(8):458-469. 2. Ward E et al. CA Cancer J Clin. 2014;64(2):83-103. 3. National Cancer Institute. Standard populations – 19 age groups. Accessed June 10, 2022. https://seer.cancer.gov/stdpopulations/stdpop.19ages.html 4. Perkins SM et al. PLoS One. 2014;9(7):e100396. 5. Camet ML et al. Front Oncol. 2021;11:673080. FDA, US Food and Drug Administration). We estimate approximately 290 patients on a monthly based in the United States. |
None |
| Fresenius Kabi USA LLC |
63323092688 |
romiDEPsin Intravenous Solution Reconstituted 10 MG |
2022-02-07 |
3168.6500 |
None |
1 |
216 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219038030 |
Allopurinol Sodium Intravenous Solution Reconstituted 500 MG |
2022-05-17 |
2900.0000 |
None |
1 |
2000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
63323013410 |
PEMEtrexed Disodium Intravenous Solution Reconstituted 100 MG |
2022-05-24 |
125.0000 |
None |
1 |
788000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
63323045050 |
PEMEtrexed Disodium Intravenous Solution Reconstituted 500 MG |
2022-05-24 |
625.0000 |
None |
1 |
788000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219038110 |
Iodixanol Inj 270 MG/ML (Iodine Equivalent), 100 ML, Unit-Dose, Bottle Qty 10 |
2022-07-15 |
1021.3000 |
None |
1 |
479000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219038150 |
Iodixanol Inj 270 MG/ML (Iodine Equivalent), 150 ML, Unit-Dose, Bottle Qty 10 |
2022-07-15 |
1489.6000 |
None |
1 |
479000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219038310 |
Iodixanol Inj 320 MG/ML (Iodine Equivalent), 100 ML, Unit-Dose, Bottle Qty 10 |
2022-07-15 |
1134.9000 |
None |
1 |
479000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219038350 |
Iodixanol Inj 320 MG/ML (Iodine Equivalent), 150 ML, Unit-Dose, Bottle Qty 10 |
2022-07-15 |
1566.7000 |
None |
1 |
479000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219038370 |
Iodixanol Inj 320 MG/ML (Iodine Equivalent), 200 ML, Unit-Dose, Bottle Qty 10 |
2022-07-15 |
1930.0000 |
None |
1 |
479000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219002920 |
Thiotepa For Inj 100 MG, 1 Each, Unit-Dose, Vial |
2022-07-20 |
3000.0000 |
None |
1 |
415000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219008850 |
Gadoterate Meglumine Intravenous Solution 50 MMOL/100ML |
2022-10-27 |
1084.9800 |
None |
1 |
4165 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219055001 |
PRALAtrexate Intravenous Solution 20 MG/ML |
2022-11-29 |
4981.9700 |
None |
1 |
1420 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219055202 |
PRALAtrexate Intravenous Solution 40 MG/2ML |
2022-11-29 |
9963.9400 |
None |
1 |
713 |
None |
None |
None |
None |
None |
None |
None |
None |
| Genentech USA |
50242009601 |
Vabysmo 6mg/0.05ml Vial |
2022-02-08 |
2190.0000 |
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 |
80000 |
None |
None |
None |
None |
None |
None |
Estimated number of patients for Vabysmo is per year. Vabysmoo was not acquired from a 3rd party |
None |
| GlaxoSmithKline |
00173090442 |
NUCALA, Injection, 40 mg/0.4mL, 1 Syringe in 1 Carton |
2022-06-22 |
1330.1400 |
None |
1 |
300000 |
None |
None |
None |
None |
None |
None |
NUCALA (NDC: 001730090442) is a 40 mg prefilled syringe approved for appropriate children aged 6 to 11 years old who have severe eosinophilic asthma (SEA). Asthma is the most common chronic disease in children. It is estimated that 6 million children in the US are living with asthma. Approximately 2.5-5% (150,000-300,000) of these cases are characterized as severe. Diagnosed patients may or may not be prescribed NUCALA (NDC: 00173090442) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with NUCALA (NDC: 00173090442).
GSK has not released NUCALA's (NDC: 00173090442) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). |
None |
| GlaxoSmithKline |
58160082415 |
PRIORIX, Single dose vial, 0.5mL, package size: 10 |
2022-08-02 |
873.1400 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
GSK has not released PRIORIX's (NDC: 58160-0824-15) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
GSK is limiting its response to information that which is otherwise in the public domain or publicly available per California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). We are unable to identify specific and accurate information in the public domain regarding the estimated volume of patients who may be prescribed Priorix (NDC:58160082415) for Measles, Mumps, Rubella. According to the CDC, roughly 90% of children under 24 months are vaccinated against mumps, measles, rubella (MMR), and there are roughly 3.6 million births per year. PRIORIX is approved for administration at 12 through 15 months of age for the first dose and at 4 through 6 years of age for the second dose.
https://www.cdc.gov/nchs/data/vsrr/vsrr012-508.pdf
https://www.cdc.gov/nchs/fastats/measles.htm |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462088260 |
Abiraterone Acetate oral tablets 500 mg, 120 count |
2022-06-22 |
4219.5400 |
None |
1 |
45309 |
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 May 2022 is 45,309 prescriptions for 500 mg. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462016630 |
Fingolimod Capsules 0.5 mg, 30 |
2022-10-31 |
1000.0000 |
None |
1 |
182150 |
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 September 2022 is 182,150 prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462085320 |
Sodium Phenylbutyrate Tablets 500mg, 250 |
2022-11-22 |
3000.0000 |
None |
1 |
1760 |
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 September 2022 is 1,760 prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Global Blood Therapeutics, Inc. |
72786011102 |
Oxbryta 300mg Tablets for Oral Suspension 60-Count Bottle |
2022-01-10 |
10417.0000 |
(a)Description of the marketing used in the introduction of the new prescription drug:
Marketing efforts used by Global Blood Therapeutics, Inc. (GBT) in the introduction of OXBRYTA currently include direct-to-consumer advertising through print materials, web-based mediums, in-person patient ambassador programs and radio. In addition, GBT participates in patient-focused conferences and events. GBT does not currently plan to conduct direct-to-consumer advertising of OXBRYTA through television.
GBT will offer a free drug program for qualifying patients. Aside from such program, GBT does not plan to provide direct-to-consumer promotional incentives that are different from GBT’s “patient assistance programs”
GBT will educate health care providers about OXBRYTA through in-office visits by GBT representatives, direct mailings, educational speaker programs, promotion at large conferences and conventions as well as web-based mediums. GBT will distribute educational materials to health care providers regarding OXBRYTA, including medical journal articles about the drug.
GBT does not plan to offer product samples for OXBRYTA, and will not provide any “gifts” to health care providers. (b) Methodology used to establish the price of the new prescription drug:
Global Blood Therapeutics, Inc. (GBT) does not conceptualize its pricing decisions by considering a specific set of financial and/or non-financial factors. A range of considerations impacted its decision to set the wholesale acquisition cost for OXBRYTA. The following list of financial and nonfinancial factors reflects its good faith effort to articulate the considerations that impacted its pricing decision:
• The direct and indirect cost and burden of sickle cell disease in the patient population for which OXBRYTA is indicated and the prevalence of the disease.
• The value and impact of OXBRYTA for patients, their families and society, including its clinical benefit relative to existing treatments for sickle cell disease, and the anticipated cost savings GBT’s believes OXBRYTA will bring to the health care system.
• The impact on net revenues, and the need to fund operations, which includes production, supply, and other operational and administrative costs.
• GBT’s commitment to and investment in developing medicines for sickle cell disease, including costs associated with developing OXBRYTA, as well as anticipated future investments in research and development.
• The results of GBT’s extensive research with patients, physicians and payers, including regarding stakeholder perceptions and potential government and commercial payer coverage for OXBRYTA.
• The price of OXBRYTA as compared to treatments for other orphan drugs, which require a significant investment for a smaller eligible patient population. |
None |
16000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Global Blood Therapeutics, Inc. |
72786011103 |
Oxbryta 300mg Tablets for Oral Suspension 90-Count Bottle |
2022-01-10 |
10417.0000 |
(a)Description of the marketing used in the introduction of the new prescription drug:
Marketing efforts used by Global Blood Therapeutics, Inc. (GBT) in the introduction of OXBRYTA currently include direct-to-consumer advertising through print materials, web-based mediums, in-person patient ambassador programs and radio. In addition, GBT participates in patient-focused conferences and events. GBT does not currently plan to conduct direct-to-consumer advertising of OXBRYTA through television.
GBT will offer a free drug program for qualifying patients. Aside from such program, GBT does not plan to provide direct-to-consumer promotional incentives that are different from GBT’s “patient assistance programs”.
GBT will educate health care providers about OXBRYTA through in-office visits by GBT representatives, direct mailings, educational speaker programs, promotion at large conferences and conventions as well as web-based mediums. GBT will distribute educational materials to health care providers regarding OXBRYTA, including medical journal articles about the drug.
GBT does not plan to offer product samples for OXBRYTA, and will not provide any “gifts” to health care providers. (b) Methodology used to establish the price of the new prescription drug:
Global Blood Therapeutics, Inc. (GBT) does not conceptualize its pricing decisions by considering a specific set of financial and/or non-financial factors. A range of considerations impacted its decision to set the wholesale acquisition cost for OXBRYTA. The following list of financial and nonfinancial factors reflects its good faith effort to articulate the considerations that impacted its pricing decision:
• The direct and indirect cost and burden of sickle cell disease in the patient population for which OXBRYTA is indicated and the prevalence of the disease.
• The value and impact of OXBRYTA for patients, their families and society, including its clinical benefit relative to existing treatments for sickle cell disease, and the anticipated cost savings GBT’s believes OXBRYTA will bring to the health care system.
• The impact on net revenues, and the need to fund operations, which includes production, supply, and other operational and administrative costs.
• GBT’s commitment to and investment in developing medicines for sickle cell disease, including costs associated with developing OXBRYTA, as well as anticipated future investments in research and development.
• The results of GBT’s extensive research with patients, physicians and payers, including regarding stakeholder perceptions and potential government and commercial payer coverage for OXBRYTA.
• The price of OXBRYTA as compared to treatments for other orphan drugs, which require a significant investment for a smaller eligible patient population. |
None |
16000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Heritage Pharmacueticals Inc. D/B/A Avet Pharmacueticals Inc |
23155084012 |
DICLOFENAC POTASSIUM 25MG 120CT CAPSULES |
2022-12-19 |
1609.1100 |
None |
1 |
10000 |
None |
None |
None |
None |
None |
None |
10000 patients on an annual basis. Estimate based on customer volumes. |
None |
| Hikma Pharmaceuticals USA Inc |
00143939210 |
Remifentanil HCl for Injection, 2mg/5mL |
2022-01-04 |
1225.0000 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
36241815 |
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. Remifentanil Hydrochloride for injection is an opioid agonist indicated for intravenous administration: (1) as an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. According to the American Hospital Association, there were approximately 36,241,815 admissions to U.S. Hospitals. |
None |
| Hikma Pharmaceuticals USA Inc |
00054071119 |
Deferiprone Tablets, 1000mg, bottle of 50 |
2022-02-11 |
6975.5800 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
125000 |
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.
Deferiprone is indicated for the treatment of patients with trans-fusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate, as well as sickle cell anemia disorders. |
None |
| Hikma Pharmaceuticals USA Inc |
00143939310 |
Remifentanil HCl for Injection, 5mg, 10 vials |
2022-06-02 |
2600.0000 |
This drug is a generic product, therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
36241815 |
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. Remifentanil Hydrochloride for injection is an opioid agonist indicated for intravenous administration: (1) as an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. According to the American Hospital Association, there were approximately 36,241,815 admissions to U.S. Hospitals. |
None |
| Horizon Therapeutics USA, Inc. |
75987015003 |
Injection 100 MG/10 ML |
2022-05-30 |
131000.0000 |
Uplizna is the first and only B-cell depleter approved for the treatment adult patients with AQP4+ neuromyelitis optica spectrum disorder (NMOSD). Horizon’s approach to marketing includes a focus on educating healthcare professionals, primarily neurologists, about the devastating effects of this rare disease and providing information about the efficacy, safety and dosing of Uplizna. Marketing includes dissemination of print materials, digital advertising, in-person presentations and virtual engagements. In addition to healthcare professionals, Horizon also provides educational resources and support to the patient community in collaboration with advocacy organizations.
Horizon’s approach to pricing innovative therapies is driven by the value a drug brings to customers. Leading up to FDA approval, the company engaged with key stakeholders—including patients, payers and physicians—to better understand the value this medicine could bring to people affected by NMOSD, who despite recent innovation, have limited treatment options. |
None |
10000 |
1 |
None |
2021-03-15 |
3000000000.0000 |
None |
In March 2021, Horizon completed the acquisition of Viela, in which Horizon acquired all of the issued and outstanding shares of Viela’s common stock for $53.00 per share in cash. The total consideration for the acquisition was approximately $3.0 billion, including cash acquired of $342.3 million. |
None |
None |
| Immunocore Commercial LLC |
80446040101 |
Injection: 100 mcg/0.5 mL solution in a single-dose vial |
2022-02-11 |
18760.0000 |
KIMMTRAK will be promoted by our commercial field teams to healthcare professionals and payers to educate them on our product. We will use various means of promotion including in-office visits, virtual meetings, ad campaigns, and digital marketing. Pricing was established by a comprehensive analysis to reflect the drug’s value to patients within our indicated population and the healthcare providers who treat them. |
None |
400 |
1 |
1 |
None |
None |
None |
None |
There are roughly 800-1000 metastatic uveal melanoma patients diagnosed and living in the U.S. Approximately half of these patient are HLA-A-0201 positive making them eligible for KIMMTRAK |
None |
| ImmunoGen, Inc. |
72903085301 |
ELAHERE 100 mg/20 mL |
2022-11-28 |
6220.0000 |
None |
1 |
5200 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Ingenus Pharmaceuticals, LLC |
50742048401 |
Bortezomib Injection 3.5mg/vial |
2022-05-02 |
800.0000 |
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 |
32500 |
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. |
None |
| Ingenus Pharmaceuticals, LLC |
50742034001 |
Pemetrexed 100mg Injection |
2022-05-25 |
160.0000 |
Ingenus does not plan to promote Pemetrexed Injection to physicians or other health professionals. The product will be sold to wholesalers and specialty distributors.
Ingenus prices their products based on the current market conditions along with a number of variables. All of these product specific variables are entered into a pricing model and pricing is determined. Some examples ( not all ) are cost of goods, profit share, freight costs, product volume, customer specific volumes, the COT/channels the specific product is sold in, rebates, chargebacks, contractual obligations. These factors vary product by product and aren’t all applicable in every case. |
None |
25000 |
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. The patient number provided is a based on the number of patients covered by the drug indication. Acquisition is not applicable. The WAC per vial price is below the threshold, however when course of therapy is considered, the total WAC would be above the threshold. |
None |
| Ingenus Pharmaceuticals, LLC |
50742034101 |
Pemetrexed 500mg Injection |
2022-05-25 |
800.0000 |
Ingenus does not plan to promote Pemetrexed Injection to physicians or other health professionals. The product will be sold to wholesalers and specialty distributors.
Ingenus prices their products based on the current market conditions along with a number of variables. All of these product specific variables are entered into a pricing model and pricing is determined. Some examples ( not all ) are cost of goods, profit share, freight costs, product volume, customer specific volumes, the COT/channels the specific product is sold in, rebates, chargebacks, contractual obligations. These factors vary product by product and aren’t all applicable in every case. |
None |
25000 |
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. The patient number provided is a based on the number of patients covered by the drug indication. Acquisition is not applicable. |
None |
| Janssen Biotech, Inc. |
57894011102 |
CARVYKTI™ Strength: 0.5-1.0×10^6 CAR+ viable T-cells per kg of body wt, with a ma dose of 1×10^8 CAR+ viable T-cells, 5% DMSO, Form: Suspension for intravenous infusion, ,Package Size 30mL |
2022-03-03 |
465000.0000 |
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 relapsed/refractory multiple myeloma who have received a proteosome inhibitor, immunomodulatory agent and anti-CD 38 therapy. The WAC is set at $465,000. The list price of CARVYKTI™ does not include discounts which may be available through Medicaid, Medicare, and commercial insurance. CARVYKTI™ will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. International approvals are pending. |
None |
34920 |
1 |
1 |
None |
None |
None |
None |
There are 34,920 newly diagnosed patients with multiple myeloma each year. CARVYKTI™ is indicated for patients with relapsed refractory disease. Exact information for the CARVYKTI™ indicated patient population is not available in the public domain. |
None |
| Janssen Biotech, Inc. |
57894011101 |
CARVYKTI™ Strength: 0.5-1.0×10^6 CAR+ viable T-cells per kg of body wt, with a ma dose of 1×10^8 CAR+ viable T-cells, 5% DMSO, Form: Suspension for intravenous infusion, Package Size 70mL, |
2022-03-03 |
465000.0000 |
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 relapsed/refractory multiple myeloma who have received a proteosome inhibitor, immunomodulatory agent and anti-CD 38 therapy. The WAC is set at $465,000. The list price of CARVYKTI™ does not include discounts which may be available through Medicaid, Medicare, and commercial insurance. CARVYKTI™ will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. International approvals are pending. |
None |
34920 |
1 |
1 |
None |
None |
None |
None |
There are 34,920 newly diagnosed patients with multiple myeloma each year. CARVYKTI™ is indicated for patients with relapsed refractory disease. Exact information for the CARVYKTI™ indicated patient population is not available in the public domain. |
None |
| Janssen Biotech, Inc. |
57894045001 |
TECVAYLI™ (teclistamab) Strength: 153 mg Form: 1 single vial Package Size: 1 |
2022-10-26 |
9027.0000 |
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 relapsed/refractory multiple myeloma who have received a proteosome inhibitor, immunomodulatory agent, and CD-38 therapy. The pricing plan has WAC set for the 153 mg/1.7 mL vial at $9,027.00. The list price of TECVAYLI will also be discounted as required under the 340 B program, Federal Supply Schedule, and other government programs. In August 2022, the European Commission (EC) granted conditional marketing authorisation (CMA) of TECVAYLI® (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. European approval allows Janssen to market TECVAYLI in all member states of the European Union and the European Economic Area. International pricing plans are based on ensuring compliance with local laws and processes. Member states pricing and reimbursement negotiations are ongoing and are based upon local funding choices. |
None |
34920 |
1 |
1 |
None |
None |
None |
None |
There are 34,920 newly diagnosed patients with multiple myeloma each year. TECVAYLI is indicated for patients with relapsed refractory disease. Exact information for the TECVAYLI indicated population is not available in the public domain. |
None |
| Janssen Biotech, Inc. |
57894044901 |
TECVAYLI™ (teclistamab) Strength: 30 mg Form: 1 single vial Package Size: 1 |
2022-10-26 |
1770.0000 |
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 relapsed/refractory multiple myeloma who have received a proteosome inhibitor, immunomodulatory agent, and CD-38 therapy. The pricing plan has WAC set for the 30 mg/3 mL vial at $1,770.00. The list price of TECVAYLI will also be discounted as required under the 340 B program, Federal Supply Schedule, and other government programs. In August 2022, the European Commission (EC) granted conditional marketing authorisation (CMA) of TECVAYLI® (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. European approval allows Janssen to market TECVAYLI in all member states of the European Union and the European Economic Area. International pricing plans are based on ensuring compliance with local laws and processes. Member states pricing and reimbursement negotiations are ongoing and are based upon local funding choices. |
None |
34920 |
1 |
1 |
None |
None |
None |
None |
There are 34,920 newly diagnosed patients with multiple myeloma each year. TECVAYLI is indicated for patients with relapsed refractory disease. Exact information for the TECVAYLI indicated population is not available in the public domain. |
None |
| Kedrion Biopharma Inc. |
70573009902 |
Ryplazim 68.8 mg vial /1 vial per box |
2022-01-19 |
2064.0000 |
The manifestations of cPLGD in patients are very variable resulting in widely varying treatment regimen. Real world data with 12 patients on Expanded Access showed that except for 1 patient all other patients are treated with the PI recommended dosage of 6.6 mg/kg BW. In contrast, the frequency of treatment is handled more flexible and most patients are on an extended regimen outside of the PI recommended frequency of 2,3 or 4 days. The majority of patients is on a 7 day treatment regimen. Based on the real world data of these 12 patients, the mean weekly treatment costs are $15,410.54. The treatment is a long-term replacement therapy that reduces or eliminates the number/size of the lesions in a patient. In the clinical trial 78% of external and 75% of internal lesions were resolved at the end of week 48. No recurrent or new lesions developed during the 48 weeks. |
None |
500 |
1 |
1 |
2021-10-20 |
1.0000 |
None |
Acquisition part of a package for the purchase of the company Prometic; price for product cannot be singled out. |
None |
None |
| KMM Pharmaceuticals, LLC |
52187055510 |
Ergotamine Tartrate and Caffeine Tablets, USP |
2022-03-21 |
1110.2200 |
None |
1 |
6000 |
None |
None |
None |
None |
None |
None |
This drug is drug listed with the FDA and has also been listed with such data reporting services as MediSpan, but is yet to go into production and be launched. |
None |
| Laurus Generics Inc. |
42385093412 |
Lopinavir and Ritonavir Tablets 200mg/50mg 120ct |
2022-12-09 |
884.7600 |
None |
1 |
25000 |
None |
None |
None |
None |
None |
None |
This product was not acquired. Product shipments to begin in the next two weeks. Estimated number of patients may change as the FDA is reviewing the efficacy of this drug for treatment in covid patients. |
None |
| Laurus Generics Inc. |
42385092499 |
Pirfenidone Tablets, 267mg (3) 90ct bottles in one carton |
2022-12-24 |
2680.2800 |
None |
1 |
5000 |
None |
None |
None |
None |
None |
None |
This product was not acquired. Laurus is the ANDA approval owner. The number of patients to be served is unknown at this time and is estimated. |
None |
| Laurus Generics Inc. |
42385092590 |
Pirfenidone Tablets, 534mg 90CT |
2022-12-24 |
2680.2800 |
None |
1 |
5000 |
None |
None |
None |
None |
None |
None |
This product was not acquired. Laurus is the ANDA approval owner. The number of patients to be served is unknown at this time and is estimated. |
None |
| Laurus Generics Inc. |
42385092690 |
Pirfenidone Tablets, 801mg 90CT |
2022-12-24 |
2680.2800 |
None |
1 |
5000 |
None |
None |
None |
None |
None |
None |
This product was not acquired. Laurus is the ANDA approval owner. The number of patients to be served is unknown at this time and is estimated. |
None |
| LEO Pharma Inc. |
50222034602 |
Adbry (tralokinumab-ldrm); 150 mg/mL solution injection in a single-dose prefilled syringe with needle guard; one carton containing 2 prefilled syringes |
2022-02-01 |
1674.4000 |
Adbry (tralokinumab-ldrm) will be marketed to appropriate healthcare professionals (HCPs) and adult patients in the U.S.* with moderate-to-severe atopic dermatitis who are candidates for the treatment. Generally, marketing activities that support the launch of a new treatment are designed to raise awareness and understanding among HCPs and patients about the approved indication, efficacy, and safety data contained within the treatment’s FDA-approved label.
Specific marketing materials and activities used in the launch of the drug in the U.S. include: marketing materials, sales materials, digital advertisements through mobile and web-based platforms, digital patient brochures, third-party media channels and paid search, product-specific websites (www.AdbryHCP.com and www.Adbry.com), social media ads, banner ads, videos and video banners, professional congresses (including exhibit booths), and product speaker programs.
LEO Pharma does not expect to launch any direct-to-consumer marketing advertisements on television in 2022.
Consistent with industry practice relating to biologics and other specialty medicines, LEO Pharma also offers (including through third party service providers) patient support programs that are intended to facilitate a patient’s access to his/her/their medication as prescribed by the patient’s doctor. LEO Pharma does not consider those programs to be marketing or promotional activities.
*Adbry is only marketed by LEO Pharma in the U.S.; however the drug is marketed and sold by affiliates of LEO Pharma in countries outside the U.S. under a different brand name in accordance with the laws and regulations of the corresponding jurisdiction.
With respect to pricing plans, LEO Pharma is guided by a commitment to help advance the standard of care for people with skin diseases. Pricing decisions are intended to balance the need to continue to innovate and help patients who may be facing limited treatment options, while facilitating access to products for eligible patients. When establishing the wholesale acquisition cost of Adbry, LEO Pharma considered a range of financial and non-financial factors. These factors included, without limitation, the unique clinical value that Adbry offers as the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms[1], [2], [3]; the safety and efficacy profile of the drug; availability and accessibility of alternative therapies for the approved indication; patient access considerations, including the introduction of the Adbry Advocate Program to support U.S. patients at diagnosis and throughout treatment with Adbry; preclinical and ongoing clinical trials for the drug; anticipated rebates, discounts and other fees to be negotiated with supply chain partners, including wholesalers, distributors, and payers; manufacturing and marketing costs; available and resourced competitive market data, including market pricing and sales data; past and ongoing investments in R&D (including resources, infrastructure and organization) to support and build on the existing product portfolio while developing new and innovative therapies via a robust product pipeline; and licensing fees and royalty payments to its licensor.
[1] LEO Pharma Inc. (2022). Adbry (tralokinumab-ldrm): Prescribing Information. Retrieved from: https://www.leo-pharma.us/Files/Billeder/US%20Website%20Product%20PIs/AdbryPI.pdf
[2] Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
[3] Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Ra1 and IL-13Ra2. J Mol Biol. 2017; 429:208–19. |
None |
1 |
None |
None |
2016-06-30 |
115000000.0000 |
None |
LEO Pharma A/S, an affiliate of LEO Pharma Inc., entered into a license agreement with AstraZeneca on June 30, 2016 for the exclusive, global rights to tralokinumab in atopic dermatitis and any future dermatology indications. Per the terms of the agreement, the company was required to pay AstraZeneca an upfront payment of $115 million, plus up to $1 billion in commercially-related milestones and tiered percentage royalties on product sales. |
With respect to column 7 (Estimated Number of Patients), Adbry (tralokinumab-ldrm) is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. [1] According to the National Eczema Association, approximately 16.5 million adults in the United States have AD, with nearly 6.6 million adults, or approximately 40%, affected by moderate or severe disease. [2], [3] LEO Pharma Inc. (LEO Pharma) does not know the specific number of patients who might meet the anticipated prescribing criteria for Adbry, or the volume of relevant patients who might be prescribed the product.
[1] LEO Pharma Inc. (2022). Adbry (tralokinumab-ldrm): Prescribing Information. Retrieved from: https://www.leo-pharma.us/Files/Billeder/US%20Website%20Product%20PIs/AdbryPI.pdf
[2] National Eczema Association. (2022, March 1). Eczema Stats. https://nationaleczema.org/research/eczema-facts/
[3] Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J Invest Dermatol. 2019;139(3):583-590.
The wholesale acquisition cost (WAC) reflects the undiscounted list price to wholesalers without regard to prompt pay or other discounts, rebates, or other price reductions. The WAC may not represent actual costs to patients, payers and health systems and should not be considered a reflection of the actual transaction prices. The price paid by patients is often different than the WAC price, and most patients will not pay the WAC price. How much a patient will pay will depend on several factors, including the patient’s insurance coverage and any discount or other programs that the patient may be eligible to participate in.
LEO Pharma provides this report consistent with its good faith understanding and interpretation of Cal. Health & Safety Code § 127681. In providing this report, LEO Pharma does not waive, but expressly reserves, any and all rights, claims or legal challenges with respect to Cal. Health & Safety Code § 127681, and related legislation, and any implementing regulations thereto, LEO Pharma’s interpretation thereof and/or the application thereof to LEO Pharma and/or any other entity affiliated with LEO Pharma. |
None |
| LEO Pharma Inc. |
50222034604 |
Adbry (tralokinumab-ldrm); 150 mg/mL solution injection in a single-dose prefilled syringe with needle guard; two cartons (multipack) containing 4 prefilled syringes |
2022-02-01 |
3348.8000 |
Adbry (tralokinumab-ldrm) will be marketed to appropriate healthcare professionals (HCPs) and adult patients in the U.S.* with moderate-to-severe atopic dermatitis who are candidates for the treatment. Generally, marketing activities that support the launch of a new treatment are designed to raise awareness and understanding among HCPs and patients about the approved indication, efficacy, and safety data contained within the treatment’s FDA-approved label.
Specific marketing materials and activities used in the launch of the drug in the U.S. include: marketing materials, sales materials, digital advertisements through mobile and web-based platforms, digital patient brochures, third-party media channels and paid search, product-specific websites (www.AdbryHCP.com and www.Adbry.com), social media ads, banner ads, videos and video banners, professional congresses (including exhibit booths), and product speaker programs.
LEO Pharma does not expect to launch any direct-to-consumer marketing advertisements on television in 2022.
Consistent with industry practice relating to biologics and other specialty medicines, LEO Pharma also offers (including through third party service providers) patient support programs that are intended to facilitate a patient’s access to his/her/their medication as prescribed by the patient’s doctor. LEO Pharma does not consider those programs to be marketing or promotional activities.
*Adbry is only marketed by LEO Pharma in the U.S.; however the drug is marketed and sold by affiliates of LEO Pharma in countries outside the U.S. under a different brand name in accordance with the laws and regulations of the corresponding jurisdiction.
With respect to pricing plans, LEO Pharma is guided by a commitment to help advance the standard of care for people with skin diseases. Pricing decisions are intended to balance the need to continue to innovate and help patients who may be facing limited treatment options, while facilitating access to products for eligible patients. When establishing the wholesale acquisition cost of Adbry, LEO Pharma considered a range of financial and non-financial factors. These factors included, without limitation, the unique clinical value that Adbry offers as the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms[1], [2], [3]; the safety and efficacy profile of the drug; availability and accessibility of alternative therapies for the approved indication; patient access considerations, including the introduction of the Adbry Advocate Program to support U.S. patients at diagnosis and throughout treatment with Adbry; preclinical and ongoing clinical trials for the drug; anticipated rebates, discounts and other fees to be negotiated with supply chain partners, including wholesalers, distributors, and payers; manufacturing and marketing costs; available and resourced competitive market data, including market pricing and sales data; past and ongoing investments in R&D (including resources, infrastructure and organization) to support and build on the existing product portfolio while developing new and innovative therapies via a robust product pipeline; and licensing fees and royalty payments to its licensor.
[1] LEO Pharma Inc. (2022). Adbry (tralokinumab-ldrm): Prescribing Information. Retrieved from: https://www.leo-pharma.us/Files/Billeder/US%20Website%20Product%20PIs/AdbryPI.pdf
[2] Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
[3] Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Ra1 and IL-13Ra2. J Mol Biol. 2017; 429:208–19. |
None |
1 |
None |
None |
2016-06-30 |
115000000.0000 |
None |
LEO Pharma A/S, an affiliate of LEO Pharma Inc., entered into a license agreement with AstraZeneca on June 30, 2016 for the exclusive, global rights to tralokinumab in atopic dermatitis and any future dermatology indications. Per the terms of the agreement, the company was required to pay AstraZeneca an upfront payment of $115 million, plus up to $1 billion in commercially-related milestones and tiered percentage royalties on product sales. |
With respect to column 7 (Estimated Number of Patients), Adbry (tralokinumab-ldrm) is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. [1] According to the National Eczema Association, approximately 16.5 million adults in the United States have AD, with nearly 6.6 million adults, or approximately 40%, affected by moderate or severe disease. [2], [3] LEO Pharma Inc. (LEO Pharma) does not know the specific number of patients who might meet the anticipated prescribing criteria for Adbry, or the volume of relevant patients who might be prescribed the product.
[1] LEO Pharma Inc. (2022). Adbry (tralokinumab-ldrm): Prescribing Information. Retrieved from: https://www.leo-pharma.us/Files/Billeder/US%20Website%20Product%20PIs/AdbryPI.pdf
[2] National Eczema Association. (2022, March 1). Eczema Stats. https://nationaleczema.org/research/eczema-facts/
[3] Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J Invest Dermatol. 2019;139(3):583-590.
The wholesale acquisition cost (WAC) reflects the undiscounted list price to wholesalers without regard to prompt pay or other discounts, rebates, or other price reductions. The WAC may not represent actual costs to patients, payers and health systems and should not be considered a reflection of the actual transaction prices. The price paid by patients is often different than the WAC price, and most patients will not pay the WAC price. How much a patient will pay will depend on several factors, including the patient’s insurance coverage and any discount or other programs that the patient may be eligible to participate in.
LEO Pharma provides this report consistent with its good faith understanding and interpretation of Cal. Health & Safety Code § 127681. In providing this report, LEO Pharma does not waive, but expressly reserves, any and all rights, claims or legal challenges with respect to Cal. Health & Safety Code § 127681, and related legislation, and any implementing regulations thereto, LEO Pharma’s interpretation thereof and/or the application thereof to LEO Pharma and/or any other entity affiliated with LEO Pharma. |
None |
| Lifestar Pharma LLC |
70756061756 |
Tobramycin Inhalation Solution, USP 300mg/4ml |
2022-09-22 |
2350.0000 |
None |
1 |
40000 |
None |
None |
None |
None |
None |
None |
Not Acquired |
None |
| Mallinckrodt Hospital Products Inc. |
43825020001 |
Terlivaz; For injection: 0.85 mg terlipressin as a white to off-white lyophilized powder in a single-dose vial for reconstitution |
2022-10-13 |
950.0000 |
TERLIVAZ is a vasopressin receptor agonist indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Hepatorenal syndrome is an acute and rare disease, occurring in a small patient population. Treatment is delivered by a highly specialized team of providers (typically hepatology, nephrology, critical care, or transplant specialty) in the hospital inpatient care setting. TERLIVAZ is marketed only to physicians and hospitals and not directly to patients. Mallinckrodt is committed to pricing our innovative products responsibly based on the value they represent to patients and the healthcare system while providing broad patient access. In so doing, we continue to invest in innovation that brings value to patients, providers, and the U.S. healthcare system through research and development, quality manufacturing, as well as through patient education and disease awareness. |
None |
35000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Marinus Pharmaceuticals, Inc. |
81583010005 |
ZTALMY® (ganaxolone) oral suspension (50 mg/mL). Cherry flavored white to off white suspension in a 4 fl. oz (135 mL) round natural high density polyethylene bottle with a propylene child resistant cap containing 110 mL of ZTALMY. Carton with 5 bottles. |
2022-08-22 |
12125.0000 |
Marinus has created patient-facing and provider-facing websites and educational materials which are available in print format from our sales representatives or as digital downloads from the websites. Marinus also provides reprints of medical publications to providers upon request. This amount also includes promotional meals between sales representatives and HCPs to discuss the product. |
None |
2000 |
None |
1 |
None |
None |
None |
None |
CDD occurs in approximately 1 in 40,000 live births, or 90-100 newborns per year in the United States. We estimate there are currently about 2,000 addressable pediatric patients. References: 1. Symonds et al. 2019;142(8):2303-2318. The number provided for each NDC is reflective of total patients and represents an average over the next 18 years. |
None |
| Marinus Pharmaceuticals, Inc. |
81583010001 |
ZTALMY® (ganaxolone) oral suspension (50 mg/mL). Cherry flavored white to off white suspension in a 4 fl. oz (135 mL) round natural high density polyethylene bottle with a propylene child resistant cap containing 110 mL of ZTALMY. Carton with one bottle. |
2022-08-22 |
2425.0000 |
Marinus has created patient-facing and provider-facing websites and educational materials which are available in print format from our sales representatives or as digital downloads from the websites. Marinus also provides reprints of medical publications to providers upon request. This amount also includes promotional meals between sales representatives and HCPs to discuss the product. |
None |
2000 |
None |
1 |
None |
None |
None |
None |
CDD occurs in approximately 1 in 40,000 live births, or 90-100 newborns per year in the United States. We estimate there are currently about 2,000 addressable pediatric patients. References: 1. Symonds et al. 2019;142(8):2303-2318. The number provided for each NDC is reflective of total patients and represents an average over the next 18 years. |
None |
| Mayne Pharma Inc |
68308034290 |
Dapsone External Gel 7.5 % |
2022-02-15 |
801.5300 |
None |
1 |
40627 |
None |
None |
None |
None |
None |
None |
The estimated number of patients is purely an estimate based on IMS TRx data. Mayne Pharma has no visibility into the prescribing habits of HCPs sufficient to provide a reliable number. Please refer to https://www.cdc.gov/ for additional information. |
None |
| Medunik USA, Inc. |
71770020010 |
PHEBURANE® (sodium phenylbutyrate) oral pellets |
2022-09-01 |
4375.0000 |
Orphan drug, extremely rare disease and offered a at a similar cost to other NaPB products. |
None |
7 |
None |
None |
None |
None |
None |
None |
None |
None |
| Merck Sharp & Dohme LLC |
00085222402 |
posaconazole, oral suspension, eight (8) single-use packets each containing 300 mg unit dose of powder for suspension |
2022-11-07 |
1644.7200 |
Marketing: At the time of introduction of NOXAFIL PowderMix for delayed-release oral suspension to the market, Merck will send a communication to announce the availability of NOXAFIL PowderMix to payers and purchasers. There is no direct to consumer campaign currently planned.
Pricing: Merck considers several factors in determining the price of our medications. These factors are listed below and are largely based on the value of the product, as well as the competitive landscape, and market for the medication.
•Value provided to patients: To what extent does a new medicine or vaccine establish a new standard of care that has the potential to significantly extend and improve patient lives?
•Value provided to healthcare systems: To what extent does a new medicine or vaccine reduce the costs associated with hospitalization and other costly complications of disease if not appropriately (or optimally) treated?
•Unmet need: Does a new medicine or vaccine address a critical unmet medical need for large numbers of people,
where few or no treatments exist?
•Access and Affordability: How can we assure that various customers-including national, regional or local institutional payers, physicians, employers and patients-can afford to pay for our products?
•R&D sustainability: Given the long-term risk and cost of capital, are we appropriately compensating our investors to ensure that we can continue the risky and capital-intensive biopharmaceutical research and development that will bring forward medically-important breakthroughs?
•Competition: What are the costs of other treatments and interventions currently on the market relative to the value provided by Merck's products? |
None |
200 |
None |
None |
None |
None |
None |
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.
Breakthrough Therapy Designation and Priority Review Indicators: NOXAFIL PowderMix was not granted breakthrough therapy designation or priority review.
Estimated Patients: Noxafil is an azole antifungal indicated as follows:
Noxafil injection and Noxafil delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older.
Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graftversus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows:
- Noxafil injection: adults and pediatric patients 2 years of age and older
- Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg
- Noxafil oral suspension: adults and pediatric patients 13 years of age and older
- Noxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 40 kg or less
Noxafil oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adult and pediatric patients aged 13 years and older.
To estimate the average number of patients, data from The Center for International Blood and Marrow Transplant Research (CIBMTR), US Health Resources and Services Administration HRSA) and US Centers for Disease Control and Prevention (CDC) was examined. Stem cell transplants were identified in the US between 2016 and 2020 for patients age 0-10. The occurrence rate for pediatrics patients, with GVHD, was applied to determine the number of potential patients per year. Estimated average number of patients who will be prescribed Noxafil PowderMix for delayed-release oral suspension annually in the U.S is approximately 200, or approximately 16-17 patients monthly.
Acquisition Date / Acquisition Price: Acquisition fields are not applicable as Merck has not acquired this product. |
None |
| Mirati Therapeutics, Inc. |
80739081218 |
KRAZATI (adagrasib) tablets, 200 mg,180 count |
2022-12-21 |
19750.0000 |
There is no direct-to-consumer marketing for Krazati via TV or magazine ads. Promotional activities in support of patients include a patient specific website www.Krazati.com, search and standard patient educational materials. The intent of the website is to support patient education around KRASG12C testing, Krazati’s clinical profile, Krazati’s approved label and USPI, including important safety information.
Promotional activities to HCPs include sales representative detailing, speaker programs, congresses and non-personal promotion such as HCP website, www.krazatihcp.com, search, banner advertising, and other digital educational programming in line with the Krazati USPI. Mirati in support of Lung Cancer patients is providing patient support services as described on www.miratiandme.com website. Mirati appreciates that the cost of prescription drugs is a concern for many people. Thus, Mirait is committed to responsible pricing of our cancer therapies. We factored in pre-launch research, post launch-sales and operational costs. Mirati believes in pricing our therapies in line with similar therapies and according to the value they provide. Mirati's global pricing focus is to ensure patient access. Krazati is available at a 30-day WAC of $19,750 and priced in line with comparable targeted cancer therapies. |
None |
5000 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mitsubishi Tanabe Pharma America, Inc. |
70510232201 |
Radicava ORS Kit Oral Suspension 105mg/5mL dose 1 bottle x 50mL |
2022-06-15 |
12719.3000 |
None |
1 |
16000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Mitsubishi Tanabe Pharma America, Inc. |
70510232102 |
Radicava ORS Starter Kit Oral Suspension 105mg/5mL dose 2 bottles x 35mL |
2022-06-15 |
17807.0200 |
None |
1 |
16000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Mycovia Pharmaceuticals, Inc. |
74695082318 |
VIVJOA, 150mg, capsule, carton of 18 |
2022-07-18 |
2700.0000 |
VIVJOA will be promoted by our sales force to healthcare professionals to educate them on our product. We will use various means of promotion including in-office visits, ad campaigns, and multimedia marketing.
VIVJOA's pricing was established following comprehensive analysis and reflects the competitive marketplace, product development investments, and various operational costs. |
None |
7000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Mylan Pharmaceuticals Inc |
00378667828 |
Sunitinib Malate 12.5mg Oral Capsule |
2022-01-04 |
4883.6400 |
None |
1 |
83020 |
None |
None |
None |
None |
None |
None |
Sunitinib Malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, adult patients with advanced renal cell carcinoma (RCC), adult patients at high risk of recurrent RCC following nephrectomy, and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. Based on the literature, approximately 4,000 to about 6,000 GIST cases are diagnosed each year in the United States (https://www.cancer.org/cancer/gastrointestinal-stromal-tumor/about/key-statistics.html); approximately 73,820 new cases of renal cell carcinoma will be diagnosed in the United States (https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21551) ; and approximately 4,200 patients will be diagnosed with pancreatic NET in the United States (https://www.cancer.org/cancer/pancreatic-neuroendocrine-tumor/about/key-statistics.html#:~:text=Pancreatic%20neuroendocrine%20tumors%20(NETs)%20are,with%20pancreatic%20NET%20in%202021). Therefore, an estimated (using available data) 83,020 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378667928 |
Sunitinib Malate 25mg Oral Capsule |
2022-01-04 |
9767.3000 |
None |
1 |
83020 |
None |
None |
None |
None |
None |
None |
Sunitinib Malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, adult patients with advanced renal cell carcinoma (RCC), adult patients at high risk of recurrent RCC following nephrectomy, and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. Based on the literature, approximately 4,000 to about 6,000 GIST cases are diagnosed each year in the United States (https://www.cancer.org/cancer/gastrointestinal-stromal-tumor/about/key-statistics.html); approximately 73,820 new cases of renal cell carcinoma will be diagnosed in the United States (https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21551) ; and approximately 4,200 patients will be diagnosed with pancreatic NET in the United States (https://www.cancer.org/cancer/pancreatic-neuroendocrine-tumor/about/key-statistics.html#:~:text=Pancreatic%20neuroendocrine%20tumors%20(NETs)%20are,with%20pancreatic%20NET%20in%202021). Therefore, an estimated (using available data) 83,020 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378668128 |
Sunitinib Malate 37.5mg Oral Capsule |
2022-01-04 |
14650.9500 |
None |
1 |
83020 |
None |
None |
None |
None |
None |
None |
Sunitinib Malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, adult patients with advanced renal cell carcinoma (RCC), adult patients at high risk of recurrent RCC following nephrectomy, and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. Based on the literature, approximately 4,000 to about 6,000 GIST cases are diagnosed each year in the United States (https://www.cancer.org/cancer/gastrointestinal-stromal-tumor/about/key-statistics.html); approximately 73,820 new cases of renal cell carcinoma will be diagnosed in the United States (https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21551) ; and approximately 4,200 patients will be diagnosed with pancreatic NET in the United States (https://www.cancer.org/cancer/pancreatic-neuroendocrine-tumor/about/key-statistics.html#:~:text=Pancreatic%20neuroendocrine%20tumors%20(NETs)%20are,with%20pancreatic%20NET%20in%202021). Therefore, an estimated (using available data) 83,020 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378668028 |
Sunitinib Malate 50mg Oral Capsule |
2022-01-04 |
17003.4800 |
None |
1 |
83020 |
None |
None |
None |
None |
None |
None |
Sunitinib Malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, adult patients with advanced renal cell carcinoma (RCC), adult patients at high risk of recurrent RCC following nephrectomy, and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. Based on the literature, approximately 4,000 to about 6,000 GIST cases are diagnosed each year in the United States (https://www.cancer.org/cancer/gastrointestinal-stromal-tumor/about/key-statistics.html); approximately 73,820 new cases of renal cell carcinoma will be diagnosed in the United States (https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21551) ; and approximately 4,200 patients will be diagnosed with pancreatic NET in the United States (https://www.cancer.org/cancer/pancreatic-neuroendocrine-tumor/about/key-statistics.html#:~:text=Pancreatic%20neuroendocrine%20tumors%20(NETs)%20are,with%20pancreatic%20NET%20in%202021). Therefore, an estimated (using available data) 83,020 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378120178 |
Sorafenib Tosylate Tablets, 200mg |
2022-06-01 |
20239.8300 |
None |
1 |
159934 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Sorafenib tosylate tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC), patients with advanced renal cell carcinoma (RCC), and patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment. Based on the literature, Hepatocellular carcinoma (HCC) accounts for 90% of primary liver cancer(https://www.nature.com/articles/s12276-020-00527-1), and about 41,260 new cases of liver cancer will be diagnosed (https://www.cancer.org/cancer/liver-cancer/about/what-is-key-statistics.html). About 79,000 new cases of kidney cancer will be diagnosed in the US (https://www.cancer.org/cancer/kidney-cancer/about/key-statistics.html), and there will be about 43,800 new cases of thyroid cancer this year in the US (https://www.cancer.org/cancer/thyroid-cancer/about/key-statistics.html). Therefore, an estimated (using available data) 159,934 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378193701 |
Lenalidomide 10mg Oral capsule, 100 |
2022-09-06 |
71990.6200 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378193728 |
Lenalidomide 10mg Oral capsule, 28 |
2022-09-06 |
20157.3600 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378194101 |
Lenalidomide 15mg Oral capsule, 100 |
2022-09-06 |
71990.6200 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378194121 |
Lenalidomide 15mg Oral capsule, 21 |
2022-09-06 |
15118.0400 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378194001 |
Lenalidomide 25mg Oral capsule, 100 |
2022-09-06 |
71990.6200 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378194021 |
Lenalidomide 25mg Oral capsule, 21 |
2022-09-06 |
15118.0400 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378193601 |
Lenalidomide 5mg Oral capsule, 100 |
2022-09-06 |
71990.6200 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378193628 |
Lenalidomide 5mg Oral capsule, 28 |
2022-09-06 |
20157.3600 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378452593 |
Fingolimod Capsules, 0.5mg, 30 |
2022-09-22 |
8883.8900 |
None |
1 |
830000 |
None |
1 |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Fingolimod Capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older. Based on the literature, nearly one million people are living with MS in the United States (https://www.nationalmssociety.org/About-the-Society/MS-Prevalence). Relapsing–remitting MS (RRMS) is the most common type of MS, affecting approximately 80–85% of all patients with MS (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3916439/). Therefore, an estimated (using available data) 830,000 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378309985 |
Everolimus Tablets, 10mg |
2022-12-15 |
1678.6600 |
None |
1 |
274523 |
None |
1 |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Everolimus Tabs is indicated for oral suspension for adult and pediatric patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer and Tuberous Sclerosis Complex. Based on the literature, approximately 50,000 patients in the United States have Tuberous Sclerosis Complex (https://www.tscalliance.org/about-tsc/what-is-tsc/). According to the National Cancer Institute (NCI), an estimated 78 percent of breast cancers are HER2-negative (https://seer.cancer.gov/statfacts/html/breast-subtypes.html ), and about 70-80 percent of newly diagnosed breast cancers are hormone receptor-positive (https://www.komen.org/breast-cancer/diagnosis/factors-that-affect-prognosis/tumor-characteristics ). The American Cancer Society's estimates 287,850 new cases of invasive breast cancer will be diagnosed in women (https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html ). Therefore, an estimated (using available data) 274,523 patients in the United States could potentially use this product during the current year. |
None |
| NextWave Pharmaceuticals, Inc. |
24478010201 |
Dyanavel XR (amphetamine) Suspension 2.5gm/mL 464mL Bottle |
2022-09-07 |
1341.9900 |
None |
1 |
26000 |
None |
None |
None |
None |
None |
None |
The NDA approval is in the name of TRIS Pharma, parent of Nextwave Pharma. This is not an acquisition. |
None |
| Nobelpharma America, LLC |
73683010110 |
HYFTOR (sirolimus topical gel) 0.2% |
2022-08-22 |
1750.0000 |
None |
1 |
30000 |
None |
1 |
None |
None |
None |
None |
Nobelpharma America, LLC considers the process of assessing and developing a marketing and pricing plan to be a trade secret using confidential information and cannot release this data into the public domain. |
None |
| Novartis |
00078102884 |
Vijoice (alpelisib) 125 mg 28 tablets |
2022-04-05 |
32500.0000 |
Novartis considered many factors in determining the price of Vijoice. Vijoice is a treatment for adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies impacting an estimated 14 people per million. We priced in parity to other branded treatments in this therapeutic area and are focused on access to Vijoice for this patient population. |
None |
4800 |
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. 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 |
00078103502 |
Vijoice (alpelisib) 250 mg 56 tablets |
2022-04-05 |
32500.0000 |
Novartis considered many factors in determining the price of Vijoice. Vijoice is a treatment for adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies impacting an estimated 14 people per million. We priced in parity to other branded treatments in this therapeutic area and are focused on access to Vijoice for this patient population. |
None |
4800 |
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. 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 |
00078102184 |
Vijoice (alpelisib) 50 mg 28 tablets |
2022-04-05 |
32500.0000 |
Novartis considered many factors in determining the price of Vijoice. Vijoice is a treatment for adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies impacting an estimated 14 people per million. We priced in parity to other branded treatments in this therapeutic area and are focused on access to Vijoice for this patient population. |
None |
4800 |
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. 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 |
| Novugen Pharma USA LLC |
82293000210 |
ABIRATERONE ACETATE |
2022-08-15 |
4219.5400 |
This is a generic drug that will be distributed through typical generic channels such as wholesalers, distributors and retail pharmacy chains. Pricing was established by reviewing competitive generic products and aligning WAC prices with the lowest available price for the product. |
None |
350 |
None |
None |
None |
None |
None |
None |
None |
None |
| Padagis US LLC |
00574016712 |
Diclofenac Sodium Topical Solution 2% w/w 3.8 FL. OZ (112 grams) |
2022-11-22 |
1616.8200 |
Product is be priced to deliver value to the market as compared to the Brand referenced drug. |
None |
32500000 |
None |
None |
None |
None |
None |
None |
Diclofenac 2% Topical Solution is indicated for treatment of the pain of osteoarthritis of the knee. According to the CDC, osteoarthritis affects 32.5 million US Adults.
As a generic manufacturer, Padagis does not have information available to accurately determinate the number of patients that could potentially have a condition for which the drug may be prescribed. Padagis neither collects nor uses estimated patient information and does not believe there is publicly available data that accurately represents the number of patients for all indications.
Based on IQVIA NPA data available to Padagis, Padagis estimates that approximately 268,000 prescriptions were filled for the product in the past 12 months, but number of prescriptions filled should not be misinterpreted as an accurate estimate of the number of patients with a condition for which the new drug may be prescribed, as dosage and therapy may vary across individual patients. |
None |
| Par Pharmaceutical |
49884004233 |
Glycopyrrolate Oral Solution 1 mg/5 mL (0.2 mg/mL) |
2022-01-04 |
399.6000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data.
Par notes that this product is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).
The forum on Child and Family Statistics estimates as of 2022 there are approximately 74.3 million children in the United States ( https://www.childstats.gov/americaschildren/tables/pop1.asp).
The Centers for Disease Control state that 1 in 345 children have been identified with Cerebral Palsy. (https://www.cdc.gov/ncbddd/cp/features/cerebral-palsy-11-things.html ).
The National Institutes of Health reported in 2016 between 10% and 58% of children with Cerebral Palsy have excess drooling, with estimates that 10% of children with excessive drooling have embarrassing drooling (
https://pubmed.ncbi.nlm.nih.gov/27281791/ , https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2827743/ ).
Par has not independently verified this information.
Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884028302 |
Everolimus Tablets 1mg 60s |
2022-01-25 |
1780.4500 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
1. Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data.
Par notes this product indicated for the prophylaxis of organ rejection in adult patients who have had kidney or liver transplants.
The Centers for Disease Control and Prevention (“CDC”) states that 20,167 patients had a kidney transplant in the United States in 2017. ( https://nccd.cdc.gov/ckd/detail.aspx?Qnum=Q234 )
The National Institutes of Health (“NIH”) states that about 7,100 liver transplants were performed in the United States in 2015. ( https://www.niddk.nih.gov/health-information/liver-disease/liver-transplant/definition-facts )
Par has not independently verified this information.
Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
42023023710 |
Vasostrict (Vasopressin Inj., USP) 10 units/100mL (0.2 units/mL) |
2022-02-03 |
2123.7700 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
1) The information contained in this report is subject to the following limitations and assumptions.
Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.
Par has not been able to identify an estimate of the average number of patients in the U.S. who may experience vasodilatory shock. Additionally Vasostrict is indicated as a secondary treatment for vasodilatory shock for patients who remain hypotensive despite fluids and catecholamines. Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
42023021910 |
Vasostrict (Vasopressin Inj., USP) 40 units/100mL (0.4 units/mL) |
2022-02-03 |
4247.5400 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
1) The information contained in this report is subject to the following limitations and assumptions.
Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.
Par has not been able to identify an estimate of the average number of patients in the U.S. who may experience vasodilatory shock. Additionally Vasostrict is indicated as a secondary treatment for vasodilatory shock for patients who remain hypotensive despite fluids and catecholamines. Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884076854 |
Tolvaptan Tablets 15mg 10s |
2022-03-10 |
3302.0400 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data.
Par notes this product indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia.
The National Center for Biotechnology Information (“NCBI”) states that hyponatremia has a 20 to 35% prevalence in hospitalized patients. ( https://www.ncbi.nlm.nih.gov/books/NBK470386/#_article-23274_s4_ )
Par has not independently verified this information.
Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884077054 |
Tolvaptan Tablets 30mg 10s |
2022-03-10 |
3496.5000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data.
Par notes this product indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia.
The National Center for Biotechnology Information (“NCBI”) states that hyponatremia has a 20 to 35% prevalence in hospitalized patients. ( https://www.ncbi.nlm.nih.gov/books/NBK470386/#_article-23274_s4_ )
Par has not independently verified this information.
Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884012891 |
Everolimus Tablets 10mg 28s |
2022-11-29 |
1272.1700 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
1. Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Par notes this product indicated for the treatment of numerous diseases including Hormone Receptor-Positive, HER2-Negative Breast Cancer, Neuroendocrine Tumors (NET), Renal Cell Carcinoma (RCC), Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma, and Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA).
Because of the product’s widespread indications, and because
Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884016002 |
Everolimus Tablets 0.75mg 60s |
2022-12-13 |
1335.3400 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data.
Par notes this product indicated for the prophylaxis of organ rejection in adult patients who have had kidney or liver transplants.
The Centers for Disease Control and Prevention (“CDC”) states that 20,167 patients had a kidney transplant in the United States in 2017. ( https://nccd.cdc.gov/ckd/detail.aspx?Qnum=Q234 )
The National Institutes of Health (“NIH”) states that about 7,100 liver transplants were performed in the United States in 2015. ( https://www.niddk.nih.gov/health-information/liver-disease/liver-transplant/definition-facts )
Par has not independently verified this information.
Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Pfizer |
00409082901 |
AZTREONAM 1gm SFDPO 1x10 VL US |
2022-01-24 |
330.0000 |
None |
1 |
21528 |
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 - Pfizer estimates that in total, approximately 21,528 patients across the United States, could potentially receive aztreonam. Comment regarding Fields 10-13: Aztreonam was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409083001 |
AZTREONAM 2gm SFDPO 1x10 VL US |
2022-01-24 |
650.0000 |
None |
1 |
21528 |
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 - Pfizer estimates that in total, approximately 21,528 patients across the United States, could potentially receive aztreonam. Comment regarding Fields 10-13: Aztreonam was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069150130 |
TALZENNA (Talazoparib) 0.5MG CAP 1X30 40CC BTL US |
2022-01-31 |
16231.7600 |
None |
1 |
3500 |
None |
1 |
2016-09-28 |
14300000000.0000 |
None |
On September 28, 2016, Pfizer Inc. acquired Medivation for approximately $14.3 billion in cash ($13.9 billion, net of cash acquired). |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 3500 patients in the U.S. could potentially receive a TALZENNA prescription. (Total pool of gBRCA-mutated metastatic breast cancer patients tested and eligible for treatment with a PARP inhibitor) |
None |
| Pfizer |
00069175130 |
TALZENNA (Talazoparib) 0.75MG CAP 1X30 40CC BTL US |
2022-01-31 |
16231.7600 |
None |
1 |
3500 |
None |
1 |
2016-09-28 |
14300000000.0000 |
None |
On September 28, 2016, Pfizer Inc. acquired Medivation for approximately $14.3 billion in cash ($13.9 billion, net of cash acquired). |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 3500 patients in the U.S. could potentially receive a TALZENNA prescription. (Total pool of gBRCA-mutated metastatic breast cancer patients tested and eligible for treatment with a PARP inhibitor) |
None |
| Pfizer |
00069033530 |
CIBINQO 100mg TAB 1x30 BTL US |
2022-02-08 |
4914.0000 |
None |
1 |
1200000 |
1 |
1 |
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 - Pfizer estimates that there are approximately 1.2M patients in the United States that could potentially receive CIBINQO® for the treatment of moderate-to-severe atopic dermatitis. Comment regarding Fields 10-13: CIBINQO® was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069043530 |
CIBINQO 200mg TAB 1x30 BTL US |
2022-02-08 |
4914.0000 |
None |
1 |
1200000 |
1 |
1 |
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 - Pfizer estimates that there are approximately 1.2M patients in the United States that could potentially receive CIBINQO® for the treatment of moderate-to-severe atopic dermatitis. Comment regarding Fields 10-13: CIBINQO® was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069023530 |
CIBINQO 50mg TAB 1x30 BTL US |
2022-02-08 |
4914.0000 |
None |
1 |
1200000 |
1 |
1 |
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 - Pfizer estimates that there are approximately 1.2M patients in the United States that could potentially receive CIBINQO® for the treatment of moderate-to-severe atopic dermatitis. Comment regarding Fields 10-13: CIBINQO® was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409170401 |
BORTEZOMIB 1mg SFDPO 1x1 VL US |
2022-05-16 |
81.1700 |
None |
1 |
481000 |
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 - Pfizer estimates that in total, approximately 481,000 patients across the United States, could potentially receive bortezomib. Comment regarding Fields 10-13: Bortezomib was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409170301 |
BORTEZOMIB 2.5mg SFDPO 1x1 VL US |
2022-05-16 |
192.0100 |
None |
1 |
481000 |
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 - Pfizer estimates that in total, approximately 481,000 patients across the United States, could potentially receive bortezomib. Comment regarding Fields 10-13: Bortezomib was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409106001 |
PEMETREXED 100mg SPO 1x1 VL |
2022-06-21 |
110.0000 |
None |
1 |
130000 |
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 - Pemetrexed is a secondary treatment for locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Pfizer estimates that in total, approximately 130,000 patients across the United States, could potentially receive pemetrexed. Comment regarding Fields 10-13: Pemetrexed was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409106101 |
PEMETREXED 500mg SPO 1x1 VL |
2022-06-21 |
497.8400 |
None |
1 |
130000 |
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 - Pemetrexed is a secondary treatment for locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Pfizer estimates that in total, approximately 130,000 patients across the United States, could potentially receive pemetrexed. Comment regarding Fields 10-13: Pemetrexed was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409104501 |
PEMETREXED 100mg/4ml SLIQ 1x1 FTGVIAL US |
2022-06-27 |
110.0000 |
None |
1 |
130000 |
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 - Pemetrexed is a secondary treatment for locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Pfizer estimates that in total, approximately 130,000 patients across the United States, could potentially receive pemetrexed. Comment regarding Fields 10-13: Pemetrexed was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409353201 |
PEMETREXED 1gm/40ml SLIQ 1x1 FTGVIAL US |
2022-06-27 |
900.0000 |
None |
1 |
130000 |
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 - Pemetrexed is a secondary treatment for locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Pfizer estimates that in total, approximately 130,000 patients across the United States, could potentially receive pemetrexed. Comment regarding Fields 10-13: Pemetrexed was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409218801 |
PEMETREXED 500mg/20ml SLIQ 1x1 FTGVIAL US |
2022-06-27 |
497.8400 |
None |
1 |
130000 |
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 - Pemetrexed is a secondary treatment for locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Pfizer estimates that in total, approximately 130,000 patients across the United States, could potentially receive pemetrexed. Comment regarding Fields 10-13: Pemetrexed was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409170001 |
BORTEZOMIB 3.5mg SFDPO 1x1 VL US |
2022-07-27 |
250.0000 |
None |
1 |
481000 |
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 - Pfizer estimates that in total, approximately 481,000 patients across the United States, could potentially receive bortezomib. Comment regarding Fields 10-13: Bortezomib was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069025310 |
FRAGMIN 2500IU SSOL 10x4ml GVL US |
2022-10-17 |
279.6000 |
None |
1 |
3 |
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 - Pfizer is the sole market manufacture for Fragmin®. Since a pediatric dosing has never been available before, we cannot confirm usage. The pediatric formulation launch was developed at the request from the FDA for pediatric dosing. Therefore, Pfizer estimates the number of patients to range from 0-3 annually. Comment regarding Fields 10-13: Fragmin was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pharmaceutical Associates, Inc |
00121097400 |
SUCRALFATE ORAL SUSPENSION - 1g/10mL - 10mL - 100/cs |
2022-09-15 |
899.7000 |
PAI will utilize its sales team to market this product to customers across the country. PAI will offer market competitive pricing to retail chains, independent pharmacies, hospitals, long-term care facilities and government agencies in order to provide value for our customers |
None |
15000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Pharmacyclics an AbbVie Company |
57962000712 |
Imbruvica® (ibrutinib) Oral Suspension 70mg/mL |
2022-09-12 |
9614.6300 |
None |
1 |
20 |
None |
None |
None |
None |
None |
None |
Pharmacyclcis is providing information for pediatrics only as there is very limited market intelligence available as to whether the suspension will be utilized by adults with trouble swallowing pills, or only pediatric patients as studied in the clinical setting. The pediatric market only of 15-20 patients annually. |
None |
| Piramal Critical Care |
66794023942 |
Zinc Sulfate injection 25mg/5mL 1 box of 25 vials |
2022-06-27 |
950.0000 |
Piramal considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply)
Piramal's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment with Zinc Sulfate. |
None |
303036 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Piramal is limiting its response to that which is otherwise in the public domain or publicly available. As a manufacturer, Piramal does not estimate the number of patients that may be prescribed our products. We manufacture volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. This product was not acquired; however, Piramal distributes on a non-exclusive basis. Piramal does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Piramal Critical Care |
66794024042 |
Zinc Sulfate injection 30mg/10mL 1 box of 25 vials |
2022-06-27 |
1100.0000 |
Piramal considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply)
Piramal's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment with Zinc Sulfate. |
None |
8800 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Piramal is limiting its response to that which is otherwise in the public domain or publicly available. As a manufacturer, Piramal does not estimate the number of patients that may be prescribed our products. We manufacture volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. This product was not acquired; however, Piramal distributes on a non-exclusive basis. Piramal does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Primus Pharmaceuticals Inc |
68040071338 |
IMPOYZ® External Cream; Clobetasol propionate 0.025%; Cream; 100g |
2022-01-24 |
1235.0000 |
None |
1 |
25000 |
None |
None |
2021-03-01 |
None |
1 |
The manufacturer believes that this information should be protected as trade secret. The acquisition cost information is not patented. Since the manufacturer is a private company, the acquisition cost is not publicly available and is only known to certain individuals within its organization or consultants subject to confidentiality obligations. The information is also subject to confidentiality agreements with the selling entity. If this information were disclosed, it could negatively impact the manufacturer's negotiation power in future acquisitions and allow competitors to gain insight into the manufacturer's costs and margins for the product. This information is not necessary for consumers (HCPs or patients) to make a decision whether to use the manufacturer's product, as that decision would be made on publicly available information like clinical data, price for the product and its competition and insurance coverage. |
None |
None |
| Provention Bio, Inc. |
73650031610 |
TZIELD (teplizumab injection 2mg/2ml) 10 Vial Carton |
2022-12-02 |
138500.0000 |
Provention conducted extensive market research and analysis on appropriate pricing, taking into account a variety of factors, including, without limitation, the unmet need, the competitive landscape, and the potential value that treatment could provide |
None |
1000 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Provention Bio, Inc. |
73650031614 |
TZIELD (teplizumab injection 2mg/2ml) 14 Vial Carton |
2022-12-02 |
193900.0000 |
Provention conducted extensive market research and analysis on appropriate pricing, taking into account a variety of factors, including, without limitation, the unmet need, the competitive landscape, and the potential value that treatment could provide. |
None |
1000 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Provention Bio, Inc. |
73650031601 |
TZIELD (teplizumab injection 2mg/2ml) Single Vial |
2022-12-02 |
13850.0000 |
Provention conducted extensive market research and analysis on appropriate pricing, taking into account a variety of factors, including, without limitation, the unmet need, the competitive landscape, and the potential value that treatment could provide |
None |
1000 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088052454 |
Dotremin (30ct), Folate (as folic acid) 1700mcg DFE (1000mcg folic acid) + Vitamin D3 (cholecalciferol) 250mcg (1000IU) |
2022-01-17 |
1704.0000 |
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.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
250000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088052554 |
Multitam Multivitamin (30ct) |
2022-01-17 |
1800.0000 |
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.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
275000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088078500 |
Diclotrex II, Diclofenac Sodium Topical Solution 1.5% w/w 5floz (150ml), Camphotrex 3oz (85g) |
2022-03-02 |
3275.0000 |
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.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
300000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088078400 |
Lexitral Pharmapak II, Diclofenac SodiumTopical Solution 1.5%w/w 5floz (150mL), Penetral Cream Capsaicin 8fl. oz. |
2022-03-02 |
3748.9300 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
185000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088042907 |
Lydexa 4.12% Cream, Lidocaine HCI 4.12%, (3oz) |
2022-03-02 |
1398.4000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
275000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088078300 |
Xrylix II, Diclofenac Sodium Topical Solution 1.5% w/w 5floz (150ml),Xrylix sheets (30ct) |
2022-03-02 |
3969.5700 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
225000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088048916 |
Urea 41% Cream, Urea 41%, (8oz) |
2022-06-01 |
3162.0000 |
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.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
300000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088069554 |
Davimet Multivitamin, Vitamin A 83%, Vitamin C 67%, Vitamin D3 50%, Vitamin E 67%, Thiamin 88%, Riboflavin 92%, Niacin 84%, Vitamin B6 62%, Folate 417%, Vitamin B12 18%, Chewable tablets, grape flavor, (30ct) |
2022-09-19 |
1800.0000 |
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.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
250000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088048307 |
Lidotran Cream, Lidocaine 3.88%, cream, (3oz) |
2022-09-19 |
1123.8100 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
325000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088063000 |
Naprotin, Naproxen tablets, USP, 500mg, (100 ct)_Penetral Cream (Capsaicin 0.025%, 8fl oz/ 237ml) |
2022-09-27 |
3510.0000 |
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.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
175000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| QOL Medical LLC |
67871011107 |
Sucraid (Sacrosidase) Oral Solution 8500IU/mL, 6ct, 2mL Vials |
2022-09-13 |
10535.0000 |
None |
1 |
2000 |
None |
None |
None |
None |
None |
None |
QOL anticipates the first shipments of this product in the next few weeks. |
None |
| Rigel Pharmaceuticals, Inc. |
71332000501 |
Rezlidhia Capsules 150mg, 30 caps. |
2022-12-21 |
16100.0000 |
Rezlidhia (Olutasidenib) 150 mg capsules is an FDA approved treatment for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Rigel’s approach for a new product launch is to develop marketing materials for our sales teams to educate healthcare professionals on the appropriate utilization of REZLIDHIA consistent with the US FDA approved indication. Rigel utilizes printed materials, websites, and other digital media to communicate this information to relevant healthcare professionals. We provide patient assistance programs, including a copay assistance program which can be found at www.rezlidhia.com, and our Rigel OneCare program which aids in patient support services, benefit verifications, prior authorizations, temporary and long term free drug supply, and adherence support. Additional company and product information is included on Rigel’s website at www.rigel.com. Rigel gives careful consideration to a number of interdependent factors when setting the price of the Company’s pharmaceutical products, some of which include the clinical and economic value that a particular therapy provides to the patients and the nation’s healthcare system overall (e.g. objective and subjective measures of individual health outcomes and overall costs of therapy in both inpatient and outpatient settings, for public and private facilities and payors). Fundamentally, Rigel gives serious consideration to a number of factors impacting the final price determined for each of its products, including Rezlidhia, including but not limited to; (1) clinical and economic value of a particular therapy, (2) the therapeutic category, its market dynamics, and competitor pricing, (3) discounts provided to customers in both the commercial and government channels, (4) patient support provided by Rigel to ensure patient access to life-saving and life-changing medications, (5) ongoing capital investments, and (6) overall research and development or product acquisition costs. This consideration into pricing is based on an overall assessment of the particular circumstances of these and other interdependencies and the judgement and expertise of Rigel’s leadersip team, and does not follow a fixed algorithm. Related to the product pricing is the discounted pricing available in certain circumstances, generally a fixed percent off the wholesale acquisition cost, which is set by contract or regulation, and is based on assessment of market dynamics, product access, and overall commercial economics. |
None |
20380 |
None |
None |
2022-07-27 |
2000000.0000 |
None |
Under the terms of the agreement, Forma will receive an upfront payment of $2.0 million, and is eligible to receive an additional $17.5 million upon the achievement of certain near-term regulatory, approval, and first commercial sale milestones. In addition, Forma is eligible to receive a total of up to an additional $215.5 million in connection with the achievement of certain development and commercial milestones. Forma is also eligible to receive tiered royalties in the low-teens to mid-thirties. Moving forward, Rigel will be responsible for the potential launch and commercialization of olutasidenib in the U.S., and intends to work with potential partners to further develop and commercialize olutasidenib outside the U.S. |
The estimated number of patients is per year. See: https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html |
None |
| Sagent Pharmaceuticals |
25021019111 |
Micafungin Injection (100mg 1x10) |
2022-10-25 |
1870.0000 |
No amount spent on marketing |
None |
2083 |
None |
None |
None |
None |
None |
None |
None |
None |
| Sagent Pharmaceuticals |
25021019011 |
Micafungin Injection (50mg 1x10) |
2022-10-25 |
935.0000 |
No amount spent on marketing |
None |
2083 |
None |
None |
None |
None |
None |
None |
None |
None |
| Sandoz Inc. |
00781808532 |
PIRFENIDONE 267MG 270FCT BO US |
2022-05-02 |
9130.5700 |
This launch is specific to the U.S. Sandoz Inc. is contracting within the wholesaler and/or specialty pharmacy space. The WAC is priced lower than the WAC of the reference product. |
None |
100000 |
None |
None |
None |
None |
None |
None |
According to Cortellis data from July 2021, IPF is rare disease, with an estimated prevalence of 44,000 to 135,000 cases and an incidence of 21,000 new cases per year in the U.S.
Source: https://insights.decisionresourcesgroup.com/disease/idiopathic-pulmonary-fibrosis.
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product.
Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
00781808692 |
PIRFENIDONE 801MG 90FCT BO US |
2022-05-02 |
9130.5700 |
This launch is specific to the U.S. Sandoz Inc. is contracting within the wholesaler and/or specialty pharmacy space. The WAC is priced lower than the WAC of the reference product. |
None |
100000 |
None |
None |
None |
None |
None |
None |
According to Cortellis data from July 2021, IPF is rare disease, with an estimated prevalence of 44,000 to 135,000 cases and an incidence of 21,000 new cases per year in the U.S.
Source: https://insights.decisionresourcesgroup.com/disease/idiopathic-pulmonary-fibrosis.
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product.
Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
00781351990 |
PEMETREXED FOR INJ 500MG/20ML |
2022-06-07 |
3369.1700 |
This launch is specific to the U.S. Sandoz Inc. is contracting within the oncology and hospital space. The WAC is priced lower than the WAC of the reference product. |
None |
53482 |
None |
None |
None |
None |
None |
None |
According to Decision Resources Group, now part of Clarivate, an estimated 53,482 patients in 2022 are treated with pemetrexed, (all branded and generic prescriptions, not just Sandoz) for non-small cell lung cancer (NSCLC) in the United States.
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product.
Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
00781349895 |
ARSENIC TRIOXIDE 12MG/6ML 6ML 10LIVI |
2022-07-14 |
4784.4000 |
This launch is specific to the U.S. Sandoz Inc. is contracting within the oncology and hospital space. The WAC is priced lower than the WAC of the reference product. |
None |
39743 |
None |
None |
None |
None |
None |
None |
According to Decision Resources Group, now part of Clarivate, an estimated 39,743 patients in 2022 are treated for Acute Myeloid Leukemia.
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product.
Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sanofi |
80203034701 |
ENJAYMO® (Sutimlimab-jome) |
2022-02-21 |
1800.0000 |
In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with CAD, materials to be used by sales representatives to share information on Enjaymo with prescribers, and materials to educate patients about CAD and Enjaymo. Direct to Consumer (DTC) outreach for Enjaymo will include search, website and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising.
Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with CAD, materials to be used by sales representatives to share information on Enjaymo with prescribers, and materials to educate patients about CAD and Enjaymo.
Sanofi’s commitment to pricing rests on three pillars: a holistic assessment of value when setting launch prices, year-over-year price increases that are limited to National Health Expenditure projections, and disclosure of our aggregate gross and net prices changes to provide greater transparency about the pricing of our medicines.
Given the growing concerns over rising health care costs, our approach to pricing reflects our commitment to patient access while minimizing our contribution to health care inflation. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need
Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system. |
None |
4000 |
1 |
1 |
None |
None |
None |
None |
In the United States, it is estimated that there are ~5,000 people living with Cold Agglutinin Disease. While there are no US-specific population-based studies, national studies in European countries estimate a prevalence between 12-16 cases per million (Bylsma 2019, Berentsen 2006). CAD is a chronic autoimmune hemolytic anemia caused by an auto-antibody that targets red blood cells. The amount of autoimmune hemolytic anemia that a patient experiences will differ between patients and is in part determined by the temperature at which the cold agglutinin binds to the patients red blood cells. As a result, patients may experience mild, moderate or severe levels of anemia with intermittent exacerbations of symptoms and anemia. While Enjaymo is indicated for the treatment of all CAD patients regardless of severity, physicians may prefer to reserve pharmacologic treatment for symptomatic patients. In observational studies, the proportion of patients observed experiencing moderate to severe levels of anemia ranged from ~ 45% to 80% (Mullins 2017). Under the assumption that these patients are more likely to be symptomatic, the potential number of patients prescribed Enjaymo may range from 2,250 to 4,000. |
None |
| Sanofi |
58468005001 |
XENPOZYME™ (olipudase alfa-rpcp) for injection, for intravenous use |
2022-09-12 |
7142.0000 |
Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with acid sphingomyelinase deficiency (ASMD) disease, materials to be used by sales representatives to share information on XENOPZYME™ with prescribers, and materials to educate patients about ASMD and XENOPZYME™. Direct to Consumer (DTC) outreach for XENOPZYME™ will include search, website, online ad placements, email, and webinars. DTC initiatives are not expected to include any TV, radio, or national magazine advertising.
Sanofi’s commitment to pricing rests on three principles: a holistic assessment of value when setting launch prices, year-over-year price increases that are limited to National Health Expenditure projections, and disclosure of our aggregate gross and net prices changes to provide greater transparency about the pricing of our medicines. These comprehensive principles were drafted to address questions around the price of medicines in the United States. Our goal is to make our medicines accessible and affordable to all patients.
Given the growing concerns over rising health care costs, our approach to pricing reflects our commitment to patient access while minimizing our contribution to health care inflation. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need?.
Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system. |
None |
1339 |
1 |
1 |
None |
None |
None |
None |
Historically, referred to as Niemann-Pick disease (NPD) types A, A/B, and B, acid sphingomyelinase deficiency (ASMD) is a rare, progressive genetic disease with significant morbidity and mortality. XENPOZYME™ is the first therapy indicated specifically for the treatment of ASMD, and is currently the only approved treatment for this disease. www.rarediseases.org estimates ASMD prevalence at 1 in 250,000. Based on the US population in 2023, the estimated number of patients in the US with ASMD for which XENPOZYME™ may be prescribed is 1,339. However, because some cases go misdiagnosed or undiagnosed, determining the true frequency of ASMD in the general US population is difficult. It has been estimated that there are fewer than 120 patients diagnosed with ASMD in the U.S. Approximately two-thirds of patients with ASMD in the U.S. are pediatric. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=670 |
| Santen US |
65086000112 |
Verkazia .01% |
2022-05-02 |
1465.0000 |
This drug is addressing a rare disease within VRC market. There are estimated to be around 115k patients at any given time within the US. The WAC price is based upon modeling of this market within the US. product is the first drug specially indicated for this condition. |
None |
115000 |
1 |
None |
None |
None |
None |
None |
None |
None |
| Secura Bio, Inc. |
07311622556 |
Copiktra 25 mg oral capsule, 56 capsules per package, Secura labeler code |
2022-07-01 |
18074.3100 |
None |
1 |
200000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Slayback Pharma LLC |
71225012001 |
VIVIMUSTA- bendamustine hydrochloride injection 100mg/4mL, 4 mL in 1 VIAL |
2022-12-22 |
3209.5400 |
None |
1 |
8300 |
None |
None |
None |
None |
None |
None |
This product was not acquired. |
None |
| SpecGx |
00406771160 |
Noxafil (posaconazole) |
2022-07-18 |
970.0000 |
None |
1 |
2500 |
None |
None |
None |
None |
None |
None |
Consistent with Section 127681(c) of the California Health and Safety Code with respect to average number of patients, the information is not otherwise in the public domain or publicly available. Noxafil is used in the treatment of fungal infections, this number is an estimate of the number of patients that the product may be used for in the state. This is a generic product, not marketed directly to consumers or healthcare professionals. WAC price is based upon an analysis of existing generic and brand WAC prices. The details of this analysis are considered proprietary information. |
None |
| Spectrum Pharmaceuticals, Inc. |
76961010101 |
Rolvedon 13.2 mg/0.6 mL solution 1 prefilled syringe |
2022-10-18 |
4500.0000 |
Marketing: Rolvedon is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Educational materials will be provided to HCPs along with being available on the product website, and highlight access and affordability support for Rolvedon to ensure appropriate access to therapy.
Pricing: Rolvedon is an injectable drug administered subcutaneously after cytotoxic chemotherapy by healthcare professionals (i.e., a Part B drug), not a tablet, capsule, or similar self-administered drug covered by Part D. Rolvedon’s WAC is comparable to that of other drugs indicated for similar conditions, and is priced responsibly taking into account Rolvedon’s development costs; complex manufacturing (Rolvedon is a biologic); distribution and storage requirements (Rolvedon is a cold-chain product); and Spectrum’s ongoing operational costs (G&A, overhead) and patient assistance/support programs. |
None |
150000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Strides Pharma, Inc. |
64380015301 |
VALGANCICLOVIR 450MG TAB 60-STR |
2022-09-07 |
1009.5900 |
Marketed as a generic. WAC has been reduced considerably to match competition since launch |
None |
720 |
None |
None |
2022-06-01 |
133333.0000 |
None |
None |
None |
None |
| Strides Pharma, Inc. |
64380018901 |
Zileuton ER Tablets 600mg, 120ct |
2022-12-31 |
1500.0000 |
None |
1 |
1200 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
62756006483 |
Fingolimod Oral Capsule 0.5MG, 30 count |
2022-10-25 |
2220.9700 |
None |
1 |
296700 |
None |
None |
None |
None |
None |
None |
None |
None |
| Telix Pharmaceuticals (US) Inc |
74725010025 |
Illuccix (kit for the preparation of gallium Ga 68) - produced from a cyclotron and purified via GE FASTlab™ or Eckert & Ziegler GalliaPharm® Ge 68/Ga-68 generator gozetotide injection |
2022-04-08 |
4700.0000 |
Telix will market Illuccix® through a variety of channels, including sales conversations with health care professionals, digital banners, email marketing, patient education, professional associations, trade shows, and public relations.
Telix participates in Medicaid and agrees to provide outpatient drugs to 340B covered entities at significantly reduced prices. |
None |
170000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Telix Pharmaceuticals (US) Inc |
74725010064 |
Illuccix (kit for the preparation of gallium Ga 68) - produced from an IRE Galli Eo® Ge 68/Ga-68 generator gozetotide injection - |
2022-04-08 |
4700.0000 |
Telix will market Illuccix® through a variety of channels, including sales conversations with health care professionals, digital banners, email marketing, patient education, professional associations, trade shows, and public relations.
Telix participates in Medicaid and agrees to provide outpatient drugs to 340B covered entities at significantly reduced prices. |
None |
170000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Teva Pharmaceuticals USA |
00480124328 |
LENALIDOMIDE CAPSULE 10MG 28 |
2022-03-03 |
20157.3600 |
None |
1 |
70000 |
None |
None |
None |
None |
None |
None |
Estimated average of up to 10,310 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that there are as many as 70,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Natco Pharma. |
None |
| Teva Pharmaceuticals USA |
00480124421 |
LENALIDOMIDE CAPSULE 15MG 21 |
2022-03-03 |
15118.0400 |
None |
1 |
70000 |
None |
None |
None |
None |
None |
None |
Estimated average of up to 10,310 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that there are as many as 70,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Natco Pharma. |
None |
| Teva Pharmaceuticals USA |
00480124621 |
LENALIDOMIDE CAPSULE 25MG 21 |
2022-03-03 |
15118.0400 |
None |
1 |
70000 |
None |
None |
None |
None |
None |
None |
Estimated average of up to 10,310 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that there are as many as 70,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Natco Pharma. |
None |
| Teva Pharmaceuticals USA |
00480124228 |
LENALIDOMIDE CAPSULE 5MG 28 |
2022-03-03 |
20157.3600 |
None |
1 |
70000 |
None |
None |
None |
None |
None |
None |
Estimated average of up to 10,310 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that there are as many as 70,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Natco Pharma. |
None |
| Teva Pharmaceuticals USA |
00480943589 |
Diclofenac Potassium Caps 25mg 120 |
2022-03-24 |
1609.1100 |
None |
1 |
12000000 |
None |
None |
None |
None |
None |
None |
Estimated average of up to 1,243 prescriptions per month, based on historic IQVIA data, although research suggests that there are as many as 12,000,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Bionpharma Inc. |
None |
| Teva Pharmaceuticals USA |
00480361087 |
PIRFENIDONE TABLETS 267MG 270 |
2022-05-11 |
7147.4100 |
None |
1 |
140000 |
None |
1 |
None |
None |
None |
None |
Estimated average of up to 4,708 prescriptions per month (across both dosage strengths), based on historic IQVIA data, although research suggests that as many as 140,000 Americans suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480361198 |
PIRFENIDONE TABLETS 801MG 90 |
2022-05-11 |
7147.4100 |
None |
1 |
140000 |
None |
1 |
None |
None |
None |
None |
Estimated average of up to 4,708 prescriptions per month (across both dosage strengths), based on historic IQVIA data, although research suggests that as many as 140,000 Americans suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480451501 |
PEMETREXED INJECTION 1 G/40 ML 1 |
2022-05-31 |
6849.3300 |
None |
1 |
51000 |
None |
None |
None |
None |
None |
None |
Although Teva launched this NDC at a WAC of $6,849.33, it subsequently lowered the WAC to $1,882.77.
Estimated average of 116 prescriptions per month (across both dosage strengths), based on historic IQVIA data and related internal forecasting, although research suggests that as many as 51,000 Americans may be eligible to take this product, based on its approved indications. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480451401 |
PEMETREXED INJECTION 500 MG/20 ML 1 |
2022-05-31 |
3424.6700 |
None |
1 |
51000 |
None |
None |
None |
None |
None |
None |
Although Teva launched this NDC at a WAC of $3,424.67, it subsequently lowered the WAC to $990.93.
Estimated average of 116 prescriptions per month (across both dosage strengths), based on historic IQVIA data and related internal forecasting, although research suggests that as many as 51,000 Americans may be eligible to take this product, based on its approved indications. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480449056 |
TASIMELTEON CAPSULE 20MG 30 |
2022-12-29 |
20570.9600 |
None |
1 |
90000 |
None |
None |
None |
None |
None |
None |
Research suggests that there are as many as 90,000 patients in the US whose condition matches the product’s approved indication and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed the product. |
None |
| Tolmar Inc |
69087015812 |
Jatenza, 158 mg, 12 BOTTLES in 1 BOX, 120 Liquid Filled Capsules in 1 Bottle |
2022-10-28 |
962.6400 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers, patients, and caregivers about the approved indication, efficacy and safety data contained within the medicine's FDA approved label. Generally, Tolmar markets in the US at medical conferences in the urology, endocrinology, and general medicine community, as well as promoting to appropriate healthcare professionals, patients, and caregivers |
None |
2361 |
None |
None |
2022-10-27 |
7500000.0000 |
None |
None |
prices are for 120 tabs. |
None |
| Tolmar Inc |
69087019812 |
Jatenza, 198 mg, 12 BOTTLES in 1 BOX, 120 Liquid Filled Capsules in 1 Bottle |
2022-10-28 |
962.6400 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers, patients, and caregivers about the approved indication, efficacy and safety data contained within the medicine's FDA approved label. Generally, Tolmar markets in the US at medical conferences in the urology, endocrinology, and general medicine community, as well as promoting to appropriate healthcare professionals, patients, and caregivers |
None |
2361 |
None |
None |
2022-10-27 |
7500000.0000 |
None |
None |
prices are for 120 tabs. |
None |
| Tolmar Inc |
69087023712 |
Jatenza, 237 mg, 12 BOTTLES in 1 BOX, 120 Liquid Filled Capsules in 1 Bottle |
2022-10-28 |
1925.2600 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers, patients, and caregivers about the approved indication, efficacy and safety data contained within the medicine's FDA approved label. Generally, Tolmar markets in the US at medical conferences in the urology, endocrinology, and general medicine community, as well as promoting to appropriate healthcare professionals, patients, and caregivers |
None |
2361 |
None |
None |
2022-10-27 |
7500000.0000 |
None |
None |
prices are for 120 tabs. |
None |
| TruPharma, LLC |
52817072005 |
Apomorphine Hydrochloride Injection, 30mg/3mL (10mg/mL), 5-Count |
2022-03-01 |
5207.8500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
1500 |
None |
None |
None |
None |
None |
None |
None |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=588 |
| TWi Pharmaceuticals USA, Inc. |
24979071051 |
Paclitaxel Protein-Bound Particles for Injectable Suspension 100mg, vial |
2022-04-07 |
1422.0500 |
Selling to hospitals and clinics as they represent 98% of the market.
Generic product discounted between 10-15% of brand product list price. |
None |
32000 |
None |
None |
2022-04-01 |
None |
1 |
None |
None |
None |
| TWi Pharmaceuticals USA, Inc. |
24979071544 |
Sorafenib 200mg 120ct |
2022-12-28 |
15000.0000 |
Sold as a low volume generic in a limited competition environment. |
None |
552 |
None |
None |
None |
None |
None |
None |
None |
None |
| United Therapeutics |
66302063203 |
Tyvaso DPI Maintenance Kit Inhalation Powder 112 cartridges of 32 MCG with 5 inhalers per box |
2022-06-22 |
20906.0900 |
United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply).
Tyvaso DPI is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment. |
None |
75000 |
None |
None |
None |
None |
None |
None |
Estimated patients is confidential and proprietary, and not publicly available or within the public domain. |
None |
| United Therapeutics |
66302064803 |
Tyvaso DPI Maintenance Kit Inhalation Powder 112 cartridges of 48 MCG with 5 inhalers per box |
2022-06-22 |
20906.0900 |
United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply).
Tyvaso DPI is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment. |
None |
75000 |
None |
None |
None |
None |
None |
None |
Estimated patients is confidential and proprietary, and not publicly available or within the public domain. |
None |
| United Therapeutics |
66302066403 |
Tyvaso DPI Maintenance Kit Inhalation Powder 112 cartridges of 64 MCG with 5 inhalers per box |
2022-06-22 |
20906.0900 |
United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply).
Tyvaso DPI is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment. |
None |
75000 |
None |
None |
None |
None |
None |
None |
Estimated patients is confidential and proprietary, and not publicly available or within the public domain. |
None |
| United Therapeutics |
66302060002 |
TYVASO DPI Titration Kit Inhalation Powder 112 cartridges of 16 MCG and 84 cartridges of 32 MCG with 5 inhalers per box |
2022-07-27 |
20906.0900 |
"United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply).
Tyvaso DPI is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment." |
None |
75000 |
None |
1 |
None |
None |
None |
None |
None |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=664 |
| United Therapeutics |
66302061603 |
Tyvaso DPI Maintenance Kit Inhalation Powder 112 cartridges of 16 MCG with 5 inhalers per box |
2022-08-02 |
20906.0900 |
United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply).
Tyvaso DPI is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment. |
None |
75000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| United Therapeutics |
66302061002 |
Tyvaso DPI Titration Kit Inhalation Powder 112 cartridges of 16 MCG and 112 cartridges of 32 MCG and 28 cartridges of 48 MCG with 5 inhalers per box |
2022-08-04 |
20906.0900 |
United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply).
Tyvaso DPI is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment. |
None |
75000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| USWM, LLC |
78670014002 |
ZIMHI Injection 5 mg/.5mL |
2022-03-31 |
125.0000 |
To help reduce the number of deaths resulting from the opioid crisis by increasing access to higher dose naloxone. This will be achieved by educating public health entities (including State supported naloxone distribution programs, Harm Reduction, Law Enforcement and Emergency First Responders, Community Support programs) and all other channels including specialty distributors, specialty pharmacies, advocacy groups, physicians, patients, and health systems on the approved indication, efficacy, safety, and administration of the pre-filled naloxone device. ZIMHI will utilize a multitude of marketing resources including a Public Health & Advocacy relations team for the US, a small field sales force to educate HCP’s, digital education and ordering, a website, medical conferences, advocacy meetings, etc. to compliantly engage the aforementioned interest groups. |
None |
10000000 |
None |
1 |
None |
None |
None |
None |
USWM, LLC has a distribution and commercialization agreement with Adamis Pharmaceuticals Corp to distribute this product. USWM purchases the finished product from Adamis through terms specified in a supply agreement. |
None |
| Validus Pharmaceuticals |
30698022010 |
Anzemet 50mg tablets 10 count |
2022-05-24 |
295.6200 |
None |
1 |
1000000 |
None |
None |
2015-12-21 |
None |
1 |
The NDA # 20-623 was part of a portfolio purchased from Sanofi Aventis in 2015. |
Anzemet Tablets NDA #20-623 was approved by the FDA on 09/11/1997
NDC # 30698-0220-10 is a relaunch under a new packing size
There is a price decrease per pill. The prior WAC price was $72.05 per pill. The new WAC price is $29.56 under NDC # 30698-0220-10
Anzemet Tablets is a antiemetic used primarily (but not exclusively) by patients
receiving chemotherapy. This is only one of several options for antiemetics. |
None |
| Vifor (International) Inc. |
59353006512 |
KORSUVA (difelikefalin) injection Carton containing 12 single-dose vials |
2022-05-02 |
1800.0000 |
Vifor (International) Inc. plans to market Korsuva to appropriate healthcare professionals who treat moderate to severe CKD-aP adult patients on hemodialysis. Currently, Vifor does not plan to engage in television or radio advertising or promotional campaigns. The current WAC is set at $150.00 per single-dose vial, and at $1,800.00 for a standard 30-day supply. The list price of Korsuva is not reflective of discounts and rebates which may be available to various government and private payers and purchasers. |
None |
33000 |
1 |
1 |
None |
None |
None |
None |
Vifor did not acquire Korsuva and has therefore left acquisition-related data fields blank. |
None |
| Vifor (International) Inc. |
59353006501 |
KORSUVA (difelikefalin) injection 65 mcg/1.3 mL single-dose vial |
2022-05-02 |
150.0000 |
Vifor (International) Inc. plans to market Korsuva to appropriate healthcare professionals who treat moderate to severe CKD-aP adult patients on hemodialysis. Currently, Vifor does not plan to engage in television or radio advertising or promotional campaigns. The current WAC is set at $150.00 per single-dose vial, and at $1,800.00 for a standard 30-day supply. The list price of Korsuva is not reflective of discounts and rebates which may be available to various government and private payers and purchasers. |
None |
33000 |
1 |
1 |
None |
None |
None |
None |
The data entered in the “WAC at Intro to Market” data field is based on the WAC for a single therapeutic dose, however a normal course of therapy would have a monthly WAC price of 1800, therefore necessitating reporting. |
None |
| ViiV Healthcare |
49702026423 |
APRETUDE (cabotegravir 600mg/3 mL) |
2022-01-24 |
3700.0000 |
None |
1 |
1200000 |
1 |
1 |
None |
None |
None |
None |
Regarding Marketing/Pricing Plan Description, ViiV has not released APRETUDE's marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
The 1,200,000 patient number does not reflect the number of persons that are estimated to be prescribed Apretude; it represents the estimated number of persons in the US that had indications for PrEP (Pre-exposure Prophylaxis) in 2019. According to the CDC, an estimated 1.2 million persons in the US had indications for PrEP and approximately 284,000 were prescribed PrEP in 2019. The 2019 approximations for California were about 165,000 persons with PrEP indications and 44,000 persons prescribed PrEP. The 2019 US and California estimates are based on Centers for Disease Control and Prevention. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data—United States and 6 dependent areas, 2019. HIV Surveillance Supplemental Report 2021;26(No. 2), published May 2021. Apretude is indicated in at-risk adults and adolescents weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating Apretude (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
APRETUDE was granted a priority review and breakthrough therapy designation by the Food And Drug Administration.
Note on Acquisition Fields: APRETUDE was developed by ViiV Healthcare, therefore the following fields related to drug acquisition have been left blank: ACQUISITION_DATE, ACQUISITION_PRICE, ACQUISITION_PRICE_NONPUBLIC, ACQUISITION_PRICE_COMMENT. |
None |
| ViiV Healthcare |
49702025837 |
TRIUMEQ PD Tablets for Oral Suspension (abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg) |
2022-05-04 |
1001.7200 |
None |
1 |
1900 |
None |
1 |
None |
None |
None |
None |
Regarding Marketing/Pricing Plan Description, ViiV has not released TRIUMEQ PD's marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
The 1,900 patient number does not reflect the number of persons that are estimated to be prescribed TRIUMEQ PD; it represents the estimated number of children aged less than 13 years living with diagnosed HIV infection, Year-end 2018 - United States and 6 Dependent Areas. This 2018 estimate is based on the Centers for Disease Control and Prevention, HIV Surveillance Report, 2018 Updated Edition, Volume 31: Diagnoses of HIV Infection in the United States and Dependent Areas, 2018: Children Aged < 13 years. Data for the year 2018 are preliminary and based on deaths reported to CDC as of December 2019. This estimate does not reflect new infections for 2019-2021. TRIUMEQ PD is indicated for the treatment of pediatric patients weighing 10 kgs to < 25 kgs with human immunodeficiency virus type 1 (HIV-1).
TRIUMEQ PD was granted priority review by the Food And Drug Administration.
Note on Acquisition Fields: TRIUMEQ PD was developed by ViiV Healthcare, therefore the following fields related to drug acquisition have been left blank: ACQUISITION_DATE, ACQUISITION_PRICE, ACQUISITION_PRICE_NONPUBLIC, ACQUISITION_PRICE_COMMENT. |
None |
| Woodward Pharma Services LLC |
69784061025 |
Leukeran® Tablets, 2mg, 25ct |
2022-10-21 |
6009.1500 |
Product is priced at a discount to comparable therapies, and patient assistance programs have been made available. |
None |
10000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Woodward Pharma Services LLC |
69784062025 |
Myleran® Tablets, 2mg, 25ct |
2022-10-21 |
3125.0000 |
Product is priced at a discount to comparable therapies, and patient assistance programs have been made available. |
None |
9000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Woodward Pharma Services LLC |
69784063025 |
Tabloid® Tablets, 40mg, 25ct |
2022-10-21 |
5624.5000 |
Product is priced at a discount to comparable therapies, and patient assistance programs have been made available. |
None |
10000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Xeris Pharmaceuticals, INC. |
72065000301 |
RECORLEV™ (levoketoconazole) 150mg Tablets 50 in 1 Bottle |
2022-01-26 |
13500.0000 |
None |
1 |
25000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710128701 |
Vigabatrin 500mg Tablets 100 Count |
2022-02-10 |
10511.8900 |
None |
1 |
400000 |
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. Zydus has entered “400000” in the “Estimated Number of Patients” column, howvever: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Vigabatrin is indicated for the treatment of adults and childer 10 years of age and older with refractory complex partial seizures (CPS) who have not responded well enough to other treatments. It is noted that it should not be the first medication used to treat CPS. As per the UpToDate link (https://www.uptodate.com/contents/evaluation-and-management-of-drug-resistant-epilepsy) it estimates that as many as 20 to 40 percent of patients with epilepsy (roughly 400,000 people living in the United States) are likely to have refractory epilepsy. Zydus based its esimate on this number. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710167401 |
Pemetrexed Inj 1000mg/1ml (1x1ml) |
2022-05-26 |
1882.7700 |
None |
1 |
203599 |
None |
None |
None |
None |
None |
None |
This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “203,599” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Pemetrexed is a chemotherapy medication for the treatment of pleural mesothelioma and non-small cell lung cancer. As per the Pleural Mesothelioma link (https://www.pleuralmesothelioma.com/cancer/pleural/) of the 3,000 cases of mesothelioma diagnosed per year about 2,100 to 2,370 are pleural mesothelioma. Also, as per the Cancer.Net link (https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics) an estimated 236,740 adults in the United States will be diagnosed with lung cancer and approximately 80% - 85% of lung cancers are non-small cell lung cancer (https://www.cancer.org/cancer/lung-cancer/about/). Zydus has based its patient estimate by adding 2,370 of the possible pleural mesothelioma diagnoses with 201,229, 85% of the estimated potential lung cancer diagnoses. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710165501 |
Pemetrexed Inj 500mg/1ml (1x1ml) |
2022-05-26 |
990.9300 |
None |
1 |
203599 |
None |
None |
None |
None |
None |
None |
This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “203,599” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Pemetrexed is a chemotherapy medication for the treatment of pleural mesothelioma and non-small cell lung cancer. As per the Pleural Mesothelioma link (https://www.pleuralmesothelioma.com/cancer/pleural/) of the 3,000 cases of mesothelioma diagnosed per year about 2,100 to 2,370 are pleural mesothelioma. Also, as per the Cancer.Net link (https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics) an estimated 236,740 adults in the United States will be diagnosed with lung cancer and approximately 80% - 85% of lung cancers are non-small cell lung cancer (https://www.cancer.org/cancer/lung-cancer/about/). Zydus has based its patient estimate by adding 2,370 of the possible pleural mesothelioma diagnoses with 201,229, 85% of the estimated potential lung cancer diagnoses. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710183908 |
Nelarabine Inj Nova+ 250mg/50mL (6X50mL) |
2022-07-15 |
3966.0000 |
None |
1 |
8060 |
None |
None |
None |
None |
None |
None |
This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “8,060” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Nelarabine Injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. As per the Lymphoma Info link (https://www.lymphomainfo.net/articles/non-hodgkins/what-is-t-cell-lymphoblastic-lymphoma) of the 70,000 new lymphoma diagnoses in the United States each year, no more than 2% are lymphoblastic lymphoma. That comes out to around 1,400 new cases each year. Also, as per the Key Statistics for Acute Lymphocytic Leukemia (ALL) (https://www.cancer.org/cancer/acute-lymphocytic-leukemia/about/key-statistics.html) the American Cancer Society estimates about 6,660 new cases of ALL (including both children and adults). Zydus has based its patient estimate by adding 1,400 of the T-Cell Lymphoblastic lymphoma cases with 6,660 of the possible Acute Lymphocytic Leukemia cases (totaling 8,060). |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710103207 |
Lenalidomide 10mg Capsule (28 CAPS) |
2022-09-14 |
20157.3600 |
None |
1 |
60000 |
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. Zydus has entered “60,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Lenalidomide is indicated for the treatment of Multiple Myeloma. As per the University of California San Francisco link (https://www.ucsfhealth.org/conditions/multiple-myeloma#) about 60,000 people have this disease and 20,000 new cases are diagnosed each year in the United States. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710103308 |
Lenalidomide 15mg Capsule (21 CAPS) |
2022-09-14 |
15118.0400 |
None |
1 |
60000 |
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. Zydus has entered “60,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Lenalidomide is indicated for the treatment of Multiple Myeloma. As per the University of California San Francisco link (https://www.ucsfhealth.org/conditions/multiple-myeloma#) about 60,000 people have this disease and 20,000 new cases are diagnosed each year in the United States. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710103508 |
Lenalidomide 25mg Capsule (21 CAPS) |
2022-09-14 |
15118.0400 |
None |
1 |
60000 |
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. Zydus has entered “60,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Lenalidomide is indicated for the treatment of Multiple Myeloma. As per the University of California San Francisco link (https://www.ucsfhealth.org/conditions/multiple-myeloma#) about 60,000 people have this disease and 20,000 new cases are diagnosed each year in the United States. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710103107 |
Lenalidomide 5mg Capsule (28 CAPS) |
2022-09-14 |
20157.3600 |
None |
1 |
60000 |
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. Zydus has entered “60,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Lenalidomide is indicated for the treatment of Multiple Myeloma. As per the University of California San Francisco link (https://www.ucsfhealth.org/conditions/multiple-myeloma#) about 60,000 people have this disease and 20,000 new cases are diagnosed each year in the United States. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
68382091206 |
Fingolimod 0.5mg Capsule (30 Caps) |
2022-10-20 |
2220.9700 |
None |
1 |
913925 |
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. Zydus has entered “913,925” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Fingolimod is indicated for the treatment of Multiple Sclerosis. As per the National Multiple Sclerosis Society link (https://www.nationalmssociety.org/What-is-MS/Who-Gets-MS/How-Many-People) about 913,925 adults are living with MS in the United States. |
None |