| 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 |