| Mayne Pharma Inc |
51862029043 |
Triamcinolone Acetonide External Ointment 0.05% 430GM |
2020-05-18 |
779.3300 |
None |
1 |
13435 |
None |
None |
None |
None |
None |
None |
Estimated number of patients is an annualized number based on IQVIA average last 8 weeks of weekly scripts.
Introduced to Market Date (when product is commercially available) is expected end of May 2020. |
None |
| Mayne Pharma Inc |
51862033801 |
Chlorzoxazone 375mg Tabs 100 |
2020-07-28 |
744.2900 |
None |
1 |
8694 |
None |
None |
None |
None |
None |
None |
None |
None |
| Mayne Pharma Inc |
51862034001 |
Chlorzoxazone 750mg Tabs 100 |
2020-07-28 |
832.2500 |
None |
1 |
23769 |
None |
None |
None |
None |
None |
None |
None |
None |
| Mayne Pharma Inc |
51862057130 |
Doryx (Doxycycline Hyclate) Oral Tablet Delayed Release 80 MG |
2020-10-12 |
950.0000 |
None |
1 |
2000000 |
None |
None |
2015-02-25 |
50000000.0000 |
None |
None |
Doxycyline Hyclate is used to treat a wide variety of infections. The estimated number of patients is purely a guess as Mayne Pharma has no visibility into the prescribing habits of HCPs sufficient to provide a reliable number. Please refer to https://www.cdc.gov/ for additional information. |
None |
| Meitheal Pharmaceuticals, Inc. |
71288055586 |
Fulvestrant Injection 250mg 5mL SD Syringe 1 Pk of 2 Syringes |
2020-04-22 |
700.0000 |
This is a generic product and is not marketed. *(See Comments) |
None |
239431 |
None |
None |
None |
None |
None |
None |
Meitheal markets generic Fulvestrant as a therapeutic equivalent to the innovator (brand) drug. As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. Because its Fulvestrant product is a generic product and there are a number of alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed Fulvestrant. As such, given Fulvestrant's primary use for the treatment of breast cancer, Meitheal's best estimate regarding a patient population can be derived from the Centers for Disease Control and Prevention's ("CDC") tracking of breast cancer diagnoses within the United States. According to the CDC's most recent data (in 2017), approximately 239,431 women over the age of 40 were diagnosed with breast cancer. (https://gis.cdc.gov/Cancer/USCS/DataViz.html). |
None |
| Merck & Co., Inc. |
00006385602 |
RECARBRIO™ 1.25 grams (imipenem 500mg, cilastatin 500mg, relebactam 250mg)/Vial, powder |
2020-01-06 |
6687.5000 |
Marketing: At the time of introduction of RECARBRIO to the market, Merck will inform customers of its availability, accompanied by limited promotion to healthcare professionals.
Pricing: Merck prices our products, including RECARBRIO, to support access for patients today while also funding the critical investments that will empower our team of more than 12,000 Merck researchers to invent the cures and treatments of tomorrow. Our Company has a long history of responsibly pricing our medicines based on various factors, including the value provided to patients and the health care system, unmet medical need, access and ability to pay, R&D sustainability, and the competitive environment. Merck does not maintain records that reflect how these factors are applied in the context of any particular product. |
None |
None |
None |
1 |
None |
None |
None |
None |
Estimated Patients: The estimated volume of patients who may be prescribed the drug. RECARBRIO is indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
RECARBRIO is also indicated in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible Gram-negative microorganisms: Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Fusobacterium nucleatum, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Parabacteroides distasonis and Pseudomonas aeruginosa.
Acquisition Date / Acquisition Price: Acquisition fields are not applicable as Merck has not acquired this product.
Marketing/Pricing Plan (Non Public): Consistent with SB 17, Merck has limited its response to information publicly available or otherwise in the public domain.
Drug Product Description: RECARBRIO is delivered by intravenous (IV) infusion over 30 minutes every 6 hours in patients 18 years of age and older. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=338, https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=339 |
| Merck & Co., Inc. |
00006503302 |
ONTRUZANT® (trastuzumab-dttb) for injection, for intravenous use, 150 mg of lyophilized trastuzumab-dttb, 15 mL single-dose vial, Package of one 15 mL single-dose vial |
2020-04-15 |
1324.6600 |
Marketing: Promotional activities for ONTRUZANT will primarily include detailing of the product by Merck sales representatives to health care professionals working in various care settings, including infusion centers and hospitals. ONTRUZANT will also be marketed in the US with limited print distribution and digital resources to health care professionals. However, there will be no direct-to-consumer marketing for ONTRUZANT such as TV, magazine or journal ads.
Pricing: We believe that biosimilars provide a market-based solution to health care spending with significant promise to deliver cost savings. Increasing choice in treatment options and decreasing out-of-pocket costs for HER-2 positive breast cancer patients is a primary focus in our pricing strategy for ONTRUZANT. As such, the price of ONTRUZANT, a biosimilar to Herceptin, will be established in the U.S. at a list price (wholesaler acquisition cost) of $1,324.66 for the 150 mg single-dose vial and $3,709.04 for the 420 mg multiple-dose vial, representing a 15% discount to the current list price of Herceptin. Additionally, it’s important to note that the WAC does not include discounts that may be paid on this product to payers, providers, distributors and other purchasing organizations. |
None |
88833 |
None |
None |
2013-02-18 |
None |
1 |
None |
Marketing/Pricing Plan (Non Public): Consistent with SB 17, Merck has limited its response to information publicly available or otherwise in the public domain.
Estimated Patients: Ontruzant has the same indications as Herceptin and is indicated for the treatment of HER2-overexpressing breast cancer and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction. According to the American Cancer Society, approximately 268,600 women are diagnosed with breast cancer and 27,510 diagnosed with gastric cancer yearly. Of the 296,110 annual breast and gastric cancer diagnoses, collectively, approximately 15% - 30% of these patients are HER2 positive (sources: American Cancer Society Breast Cancer Statistics, ESMO Her2+ Gastric Cancer). Assuming the higher limit of the estimated range of 30%, the estimated annual patient population for ONTRUZANT is approximately 88,833. However, it is important to note there are several other products on the market that are indicated to treat these disease states, including the originator and several other biosimilars that would likely be used to treat a portion of the 88,833 annual cases.
Breakthrough Therapy Indicator / Priority Review Indicator: ONTRUZANT was not granted breakthrough therapy designation or priority review.
Acquisition Date / Acquisition Price: It is important to note that by completing the acquisition-related fields, Merck is not representing that Merck has acquired all rights and obligations associated with ONTRUZANT. Rather, in 2013, Merck entered into an agreement with Samsung Bioepis wherein Merck acquired responsibilities for commercialization of the product in the U.S. Samsung Bioepis, as the manufacturer of ONTRUZUANT and BLA holder, remains responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration. As part of this agreement with respect to ONTRUZANT, Merck has paid an upfront payment, pre-specified clinical and regulatory milestones and product supply payment. To the best of Merck’s knowledge, the amount of these payments has not been publicly disclosed. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=436 |
| Merck & Co., Inc. |
00006503402 |
ONTRUZANT® (trastuzumab-dttb) for injection, for intravenous use, 420 mg of lyophilized trastuzumab-dttb, 40 mL multi-dose vial with diluent, Package of one 40 mL multi-dose vial with diluent |
2020-04-15 |
3709.0400 |
Marketing: Promotional activities for ONTRUZANT will primarily include detailing of the product by Merck sales representatives to health care professionals working in various care settings, including infusion centers and hospitals. ONTRUZANT will also be marketed in the US with limited print distribution and digital resources to health care professionals. However, there will be no direct-to-consumer marketing for ONTRUZANT such as TV, magazine or journal ads.
Pricing: We believe that biosimilars provide a market-based solution to health care spending with significant promise to deliver cost savings. Increasing choice in treatment options and decreasing out-of-pocket costs for HER-2 positive breast cancer patients is a primary focus in our pricing strategy for ONTRUZANT. As such, the price of ONTRUZANT, a biosimilar to Herceptin, will be established in the U.S. at a list price (wholesaler acquisition cost) of $1,324.66 for the 150 mg single-dose vial and $3,709.04 for the 420 mg multiple-dose vial, representing a 15% discount to the current list price of Herceptin. Additionally, it’s important to note that the WAC does not include discounts that may be paid on this product to payers, providers, distributors and other purchasing organizations. |
None |
88833 |
None |
None |
2013-02-18 |
None |
1 |
None |
Marketing/Pricing Plan (Non Public): Consistent with SB 17, Merck has limited its response to information publicly available or otherwise in the public domain.
Estimated Patients: Ontruzant has the same indications as Herceptin and is indicated for the treatment of HER2-overexpressing breast cancer and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction. According to the American Cancer Society, approximately 268,600 women are diagnosed with breast cancer and 27,510 diagnosed with gastric cancer yearly. Of the 296,110 annual breast and gastric cancer diagnoses, collectively, approximately 15% - 30% of these patients are HER2 positive (sources: American Cancer Society Breast Cancer Statistics, ESMO Her2+ Gastric Cancer). Assuming the higher limit of the estimated range of 30%, the estimated annual patient population for ONTRUZANT is approximately 88,833. However, it is important to note there are several other products on the market that are indicated to treat these disease states, including the originator and several other biosimilars that would likely be used to treat a portion of the 88,833 annual cases.
Breakthrough Therapy Indicator / Priority Review Indicator: ONTRUZANT was not granted breakthrough therapy designation or priority review.
Acquisition Date / Acquisition Price: It is important to note that by completing the acquisition-related fields, Merck is not representing that Merck has acquired all rights and obligations associated with ONTRUZANT. Rather, in 2013, Merck entered into an agreement with Samsung Bioepis wherein Merck acquired responsibilities for commercialization of the product in the U.S. Samsung Bioepis, as the manufacturer of ONTRUZUANT and BLA holder, remains responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration. As part of this agreement with respect to ONTRUZANT, Merck has paid an upfront payment, pre-specified clinical and regulatory milestones and product supply payment. To the best of Merck’s knowledge, the amount of these payments has not been publicly disclosed. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=437 |
| MorphoSys |
73535020801 |
Monjuvi (tatasitamab-cxix) |
2020-08-05 |
1200.0000 |
Tafasitamab-cxix is approved in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). Accordingly, MorphoSys and our co-promotion partner plan to engage in a marketing plan for tafasitamab-cxix directed to educate providers and patient groups about this potential treatment option for DLBCL. In general, we plan marketing initiatives for tafasitamab-cxix that include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), materials to be used by our oncology sales managers to share information on tafasitamab with prescribers, materials to be used by our access and policy team with payers and other coverage decision makers regarding medical policy inclusion for tafasitamab and materials to educate patients about relapsed or refractory diffuse large B-cell lymphoma in the United States.
The list price of tafasitamab-cxix does not reflect discounts and rebates, which may be available through the Medicaid Drug Rebate Program (MDRP), Medicare, and/or the commercial insurance market. Tafasitamab-cxix also will be discounted, as required, under the 340B Drug Pricing Program, the Federal Supply Schedule (FSS), and any other applicable government programs. For these reasons, the actual cost of tafasitamab-cxix to individual patients, providers, and health insurers is expected to be lower than WAC, and, in the case of patients, the actual cost likely will vary from patient to patient based on individual insurance coverage. We have implemented pricing for tafasitamab-cxix considering appropriate access for patients, while taking into account costs undertaken in research, development, manufacturing, and marketing of the drug, as well as the companys' business operations and internal evaluations of the market for this new treatment. At MorphoSys, we strive to discover, develop, and deliver breakthrough cancer therapies to patients who need them. Society relies on research-driven companies like MorphoSys to provide new medicines to address unmet medical needs, and we take seriously the trust that patients, caregivers, and healthcare professionals (HCPs) place in us. We believe our commitment does not end until our treatments are accessible for the patients who are prescribed them. We thoughtfully price our drugs by balancing the value of the outcomes and innovation they bring to patients and the healthcare system, with market and societal expectations. More detailed marketing and pricing plans are not in the public domain or otherwise publicly available. |
None |
10000 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mylan Institutional Inc |
42292005505 |
Paliperidone ER 9mg UD20 |
2020-03-13 |
763.2100 |
None |
1 |
4200000 |
None |
None |
None |
None |
None |
None |
Paliperidone is indicated for (1) Schizophrenia: The efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults; (2) Schizoaffective Disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy. According to the National Alliance on Mental Illness (NAMI), it was estimated that Schizophrenia affects approximately 1% of the population (approximately 3.2M of the 328M US Population), and Schizoaffective Disorder is prevalent in approximately affects roughly 0.3% of the population (approximately 984,000 of the 328M US Population) (https://www.nami.org/learn-more/mental-health-conditions/schizoaffective-disorder). Therefore, an estimated 4.2M patients in the United States may be prescribed this product.
The Product was not a result of an acquisition. |
None |
| Mylan Institutional Inc |
42292005703 |
Abiraterone Acetate 250mg Tabs UD30 |
2020-06-08 |
425.0000 |
None |
1 |
89482 |
None |
None |
None |
None |
None |
None |
Abiraterone acetate tablets are indicated for the treatment of patients with metastatic castration-resistant prostate cancer. In 2020, an estimated 191,930 new cases of prostate cancer are expected to be diagnosed in men in the U.S. From them, 21,112 (11%) may have metastatic CRPC (mCRPC), plus 68,370 patients diagnosed in prior years (prevalence) and becoming mCRPC. In total, potentially 89,482 may require the use of abiraterone as part of their treatment during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378461501 |
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release Tablets, 10mg/10mg, 100s |
2020-07-21 |
592.0500 |
None |
1 |
2996432 |
None |
None |
None |
None |
None |
None |
Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Based on the literature, up to 80% of women experienced nausea and vomiting during pregnancy (NVP) in the U.S. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3990370/) The provisional number of births for the United States in 2019 was 3,745,540. (https://www.cdc.gov/nchs/data/vsrr/vsrr-8-508.pdf). Therefore, an estimated (using available data) 2,996,432 patients in the United States could potentially use this product as part of their pregnancy during the current year.
Please note that, although not all courses of treatment of the Product trigger the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program (the “threshold”), this notice is being submitted because the Product triggers the threshold only when taking into account the maximum recommended dose as listed in the Product Prescribing Information. |
None |
| Mylan Pharmaceuticals Inc |
00378039614 |
Dimethyl Fumarate Delayed-Release Capsules, 120mg, 14 count |
2020-08-18 |
1666.6200 |
None |
1 |
776836 |
None |
1 |
None |
None |
None |
None |
Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Based on the literature, approximately 85% of patients with MS are initially diagnosed with RRMS (https://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS) A 2017 study confirmed approximately 913,925 adult patients have MS in the United States. (https://www.nationalmssociety.org/About-the-Society/News/Landmark-Study-Estimates-Nearly%C2%A01-Million-in-the-U#:~:text=The%20estimated%20prevalence%20of%20MS,or%20913%2C925%20adults%20with%20MS). Therefore, an estimated (using available data) 776,836 patients in the United States could potentially use this product as part of their MS treatment during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378039991 |
Dimethyl Fumarate Delayed-Release Capsules, 240mg, 60 count |
2020-08-18 |
7142.4300 |
None |
1 |
776836 |
None |
1 |
None |
None |
None |
None |
Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Based on the literature, approximately 85% of patients with MS are initially diagnosed with RRMS (https://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS) A 2017 study confirmed approximately 913,925 adult patients have MS in the United States. (https://www.nationalmssociety.org/About-the-Society/News/Landmark-Study-Estimates-Nearly%C2%A01-Million-in-the-U#:~:text=The%20estimated%20prevalence%20of%20MS,or%20913%2C925%20adults%20with%20MS). Therefore, an estimated (using available data) 776,836 patients in the United States could potentially use this product as part of their MS treatment during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378309685 |
Everolimus Tablets, 2.5mg, 28 count |
2020-09-10 |
6419.4300 |
None |
1 |
272125 |
None |
None |
None |
None |
None |
None |
Everolimus Tablets (label and PI) are indicated for the treatment of hormone receptor-positive HER2-negative breast cancer, tuberous sclerosis complex-associated renal angiomyolipoma, and tuberous sclerosis complex-associated subependymal giant cell astrocytoma. Based on the literature in 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. (https://www.cancer.gov/types/breast/patient/breast-screening-pdq#section/all) According to the National Institute of Cancer the total percentage of breast cancer that is the subtype HR+/HER2- is 67%. (https://seer.cancer.gov/statfacts/html/breast-subtypes.html) Therefore, an estimated 222,125 (67% of 331,530) women in the United States may be prescribed the product for the first indication.
Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 80% of patients with TSC may develop renal angiomyolipomas (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4080684/). Therefore, an estimated 40,000 patients may be prescribed this product for the second indication.
Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 20% of patients with TSC general develop subependymal giant cell astrocytomas (SEGAs) during the first two decades of their life (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5707039/). Therefore, an estimated 10,000 patients in the United States may be prescribed this product for the third indication.
Therefore, considering all approved indications, a total of 272,125 patients in the United States may be prescribed the product. |
None |
| Mylan Pharmaceuticals Inc |
00378309785 |
Everolimus Tablets, 5mg, 28 count |
2020-09-10 |
6714.6200 |
None |
1 |
272125 |
None |
None |
None |
None |
None |
None |
Everolimus Tablets (label and PI) are indicated for the treatment of hormone receptor-positive HER2-negative breast cancer, tuberous sclerosis complex-associated renal angiomyolipoma, and tuberous sclerosis complex-associated subependymal giant cell astrocytoma. Based on the literature in 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. (https://www.cancer.gov/types/breast/patient/breast-screening-pdq#section/all) According to the National Institute of Cancer the total percentage of breast cancer that is the subtype HR+/HER2- is 67%. (https://seer.cancer.gov/statfacts/html/breast-subtypes.html) Therefore, an estimated 222,125 (67% of 331,530) women in the United States may be prescribed the product for the first indication.
Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 80% of patients with TSC may develop renal angiomyolipomas (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4080684/). Therefore, an estimated 40,000 patients may be prescribed this product for the second indication.
Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 20% of patients with TSC general develop subependymal giant cell astrocytomas (SEGAs) during the first two decades of their life (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5707039/). Therefore, an estimated 10,000 patients in the United States may be prescribed this product for the third indication.
Therefore, considering all approved indications, a total of 272,125 patients in the United States may be prescribed the product. |
None |
| Mylan Pharmaceuticals Inc |
00378309885 |
Everolimus Tablets, 7.5mg, 28 count |
2020-09-10 |
6714.6200 |
None |
1 |
272125 |
None |
None |
None |
None |
None |
None |
Everolimus Tablets (label and PI) are indicated for the treatment of hormone receptor-positive HER2-negative breast cancer, tuberous sclerosis complex-associated renal angiomyolipoma, and tuberous sclerosis complex-associated subependymal giant cell astrocytoma. Based on the literature in 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. (https://www.cancer.gov/types/breast/patient/breast-screening-pdq#section/all) According to the National Institute of Cancer the total percentage of breast cancer that is the subtype HR+/HER2- is 67%. (https://seer.cancer.gov/statfacts/html/breast-subtypes.html) Therefore, an estimated 222,125 (67% of 331,530) women in the United States may be prescribed the product for the first indication.
Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 80% of patients with TSC may develop renal angiomyolipomas (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4080684/). Therefore, an estimated 40,000 patients may be prescribed this product for the second indication.
Approximately, 50,000 people in the United States are affected by TSC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644963/). Up to 20% of patients with TSC general develop subependymal giant cell astrocytomas (SEGAs) during the first two decades of their life (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5707039/). Therefore, an estimated 10,000 patients in the United States may be prescribed this product for the third indication.
Therefore, considering all approved indications, a total of 272,125 patients in the United States may be prescribed the product. |
None |
| Mylan Pharmaceuticals Inc |
00378450093 |
Budesonide ER Tablets, 9mg, 30 count |
2020-10-20 |
1549.0200 |
None |
1 |
907000 |
None |
1 |
None |
None |
None |
None |
Budesonide extended-release tablets are indicated for the treatment of active, mild to moderate ulcerative colitis. Based on the literature, an estimated 907,000 Americans currently have ulcerative colitis. (https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf, page 10) |
None |