| Zydus Pharmaceuticals (USA) Inc. |
70710153406 |
Cisatracurium Besylate 200mg/20mL Solution for Injection |
2021-01-15 |
2670.0000 |
None |
1 |
1 |
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 put a “1” in the “Estimated Number of Patients” column for the following reasons:
• 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.
• 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.
• Cisatracurium Besylate Injection has multiple indications as listed in the Indications and Usage section in our Prescribing Information (as of January 22, 2021). Zydus neither collects nor uses estimated patient information in our normal course of business. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710139009 |
Droxidopa 200mg Capsules (90 Count) |
2021-02-19 |
1226.0500 |
None |
1 |
1 |
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 put a “1” in the “Estimated Number of Patients” column for the following reasons: (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. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710139109 |
Droxidopa 300mg Capsules (90 Count) |
2021-02-19 |
1839.0800 |
None |
1 |
1 |
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 put a “1” in the “Estimated Number of Patients” column for the following reasons: (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. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
68382012001 |
Azathioprine 100mg Tablets (100) |
2021-10-14 |
738.7600 |
None |
1 |
1 |
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 put a “1” in the “Estimated Number of Patients” column for the following reasons: (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. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
68382011901 |
Azathioprine 75mg Tablets (100) |
2021-10-14 |
1657.0500 |
None |
1 |
1 |
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 put a “1” in the “Estimated Number of Patients” column for the following reasons: (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. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710149105 |
Fluphenazine HCl 10mg Tablets (500) |
2021-10-26 |
1826.8000 |
None |
1 |
1 |
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 put a “1” in the “Estimated Number of Patients” column for the following reasons: (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. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710149005 |
Fluphenazine HCl 5mg Tablets (500) |
2021-10-26 |
1448.9000 |
None |
1 |
1 |
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 put a “1” in the “Estimated Number of Patients” column for the following reasons: (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. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710172608 |
Nelarabine Inj 250mg/50mL (6X5mL) |
2021-11-19 |
3966.0000 |
None |
1 |
186400 |
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 put a “186400” in the “Estimated Number of Patients” column. Approximately 1,519,907 people in the United States are living with or in remission from leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS) or myeloproliferative neoplasms (MPNs) and it is estimated that 186,400 people in the US will be diagnosed with leukemia, lymphoma or myeloma in 2021. *Information is from the Leukemia and Lymphoma Society website (https://www.lls.org/facts-and-statistics/facts-and-statistics-overview as of 11/30/2021
Zydus does 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. Zydus neither collects nor uses estimated patient information in our normal course of business. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710101403 |
Phytonadione (Vitamin K) 5mg Tablet 30 Count |
2021-12-13 |
1125.3700 |
None |
1 |
334 |
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 put a “334” in the “Estimated Number of Patients” column for the following reasons: (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). Phytonadione is indicated for the treatment of adults with coagulation disorders (hypoprothrombinemia). As per the Medscape article dated June 16, 2021, both acquired and inherited hypoprothrombinemia are exceedingly rare in the United States. Hypoprothrombinemia due to vitamin K deficiency is rarely seen since vitamin K injections are routinely given in the neonatal period. Per the Pubmed.gov (https://pubmed.ncbi.nlm.nih.gov/19141155/) online article dated November 14, 2008, Prothrombin (factor II) deficiency is a rare autosomal recessive coagulation disorder that occurs in approximately 1 in 1-2 million people. Zydus took this information by the estimated number of people in the USA as of December 20, 2021 (per https://www.worldometers.info/world-population/us-population/) and came up with our estimated patients number. |
None |