| 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 |