| Zydus Pharmaceuticals (USA) Inc. |
68382076906 |
Topiramate ER Capsules 100mg 30ct |
Generic |
FDA |
2023-01-04 |
822.2600 |
None |
1 |
42400000 |
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 “42,400,000” 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). Topiramate ER Capsules is indicated for the treatment of epileptic seizures and for the treatment of migraines. As per the CDC link "Frequently asked questions about Epilepsy" (https://www.cdc.gov/epilepsy/about/faq.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fepilepsy%2Fbasics%2Ffaq.htm) about 3.4 million people in the United States have active epilepsy. Also, as per the link "How Common is Migraine?" (https://migraine.com/migraine-statistics) roughly 39 million people in the United States have migraine. For this reason we have put in a number of 42.4 million in estimated number of patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710103007 |
Lenalidomide 2.5mg Capsule (28 CAPS) |
Generic |
FDA |
2023-03-06 |
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. |
70710103408 |
Lenalidomide 20mg Capsule (21 CAPS) |
Generic |
FDA |
2023-03-06 |
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. |
68382035201 |
Sirolimus 2mg Tablets (100 ct) |
Generic |
FDA |
2023-03-23 |
1186.3400 |
None |
1 |
25000 |
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 “25,000” 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). Sirolimus is indicated to prevent rejction of a kidney transplant. As per Organ Procurement & Transplantation Network (OPTN) link (https://optn.transplant.hrsa.gov/news/2022-organ-transplants-again-set-annual-records-organ-donation-from-deceased-donors-continues-12-year-record-setting-trend/) upwards of 25,000 people in the United States had first time kidney transplants in 2022. For this reason we are estimating approximately 25,000 patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710189506 |
Arsenic Trioxide Injection (NovaPlus N+) 10mg/10ml |
Generic |
FDA |
2023-04-24 |
3790.5000 |
None |
1 |
5000 |
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 “5,000” 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). Arsenic Trioxide is indicated for the treatment of acute promyelocytic leukemia (APL). As per NIH GARD (Genetic and Rare Diseases Information Center) link (https://rarediseases.info.nih.gov/diseases/538/acute-promyelocytic-leukemia) fewer than 5,000 people in the United States have this disease. For this reason we are estimating approximately 5,000 patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710189606 |
Arsenic Trioxide Injection (NovaPlus N+) 12mg/6ml |
Generic |
FDA |
2023-04-24 |
5388.7700 |
None |
1 |
5000 |
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 “5,000” 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). Arsenic Trioxide is indicated for the treatment of acute promyelocytic leukemia (APL). As per NIH GARD (Genetic and Rare Diseases Information Center) link (https://rarediseases.info.nih.gov/diseases/538/acute-promyelocytic-leukemia) fewer than 5,000 people in the United States have this disease. For this reason we are estimating approximately 5,000 patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710120801 |
Plerixafor Inj. 24mg/1.2mL (1X1.2mL) |
Generic |
FDA |
2023-07-26 |
1200.0000 |
None |
1 |
20000 |
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 “20,000” 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). Plerixafor is indicated for the peripheral mobilization of hematopoietic stem cells for those patients with certain types of cancer (non-Hodgkin's lymphoma-NHL, multiple myeloma-MM) to prepare them for stem cell transplant. As per NIH LIbrary of Medicine National Center for Biotechnology Information link regarding the Prevalence of Hemtopoietic Cell Transplant Survivors in the United States (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3779514/#) approximately 20,000 patients receive HCT (hematopoietic cell transplantation) each year in the USA. For this reason we are estimating approximately 20,000 patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710185207 |
Indomethacin Suppositories 50mg |
Generic |
FDA |
2023-08-03 |
10314.2900 |
None |
1 |
1300000 |
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 “1,300,000” 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). Indomethacin Suppository is indicated for for moderate to severe ankylosing spondylitis, osteoarthritis, rheumatoid arthritis or gouty arthritis in adults and children older than 14 years of age. As per NIH LIbrary of Medicine National Center for Biotechnology Information link regarding the Prevalence Trend and Disparities in Rheumatoid Arthritis amound US Adults 2005-2018 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8348893/#) approximately 1.3 million adults suffer from RA, representing 0.6% to 1% of the adult population. For this reason we are estimating approximately 1.3 million patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710192601 |
Sodium Phenylacetate and Sodium Benzoate 10%-10% Inj. 20ml (1 vial) |
Generic |
FDA |
2023-09-25 |
2500.0000 |
None |
1 |
2396 |
None |
None |
None |
None |
None |
None |
This is an AP rated generic product that is distributed by Zydus. Acquisition date and price are not applicable. Zydus has entered “2,396” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic distributor 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. Sales volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our 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). Sodium Phenylacetate and Sodium Benzoate is indicated for the treatment of acute hyperammonemia and associated encephalopathy in pediatric and adult patients with deficiences in enzymes of the urea cycle. As per NIH LIbrary of Medicine National Center for Biotechnology Information link regarding Hyperammonemia ( https://www.ncbi.nlm.nih.gov/books/NBK557504/#), its prevalence is estimated to be 1:140000. Based on the USA population counter clock dated September 27, 2023, the US population is 335,491,897 which was divided by 140,000 to arrive at the 2,396 patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
68382048116 |
Pitavastatin Calcium 1mg Tablets |
Generic |
FDA |
2023-11-02 |
828.7400 |
None |
1 |
93000000 |
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 “93,000,000” 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).Pitavastatin Calcium is indicated for hyperlipidemia (or high cholesterol). As per the Cleveland Clink link regarding Hyperlipidemia (https://my.clevelandclinic.org/health/diseases/21656-hyperlipidemia) approximately 93 million adults age 20 and older have a total cholesterol count above the recommended limit of 200mg/dL. For this reason we are estimating approximately 93 million patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
68382048216 |
Pitavastatin Calcium 2mg Tablets |
Generic |
FDA |
2023-11-02 |
828.7400 |
None |
1 |
93000000 |
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 “93,000,000” 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).Pitavastatin Calcium is indicated for hyperlipidemia (or high cholesterol). As per the Cleveland Clink link regarding Hyperlipidemia (https://my.clevelandclinic.org/health/diseases/21656-hyperlipidemia) approximately 93 million adults age 20 and older have a total cholesterol count above the recommended limit of 200mg/dL. For this reason we are estimating approximately 93 million patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
68382048316 |
Pitavastatin Calcium 4mg Tablets |
Generic |
FDA |
2023-11-02 |
828.7400 |
None |
1 |
93000000 |
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 “93,000,000” 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).Pitavastatin Calcium is indicated for hyperlipidemia (or high cholesterol). As per the Cleveland Clink link regarding Hyperlipidemia (https://my.clevelandclinic.org/health/diseases/21656-hyperlipidemia) approximately 93 million adults age 20 and older have a total cholesterol count above the recommended limit of 200mg/dL. For this reason we are estimating approximately 93 million patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710183805 |
Methylene Blue 50mg/10mL Solution for injection (5 x 10ml) |
Generic |
FDA |
2023-12-07 |
1171.9400 |
None |
1 |
3000 |
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 “3,000” 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).Methylene Blue Solution for Injection is indicated for methemoglobinemia. As per the Jama Network link regarding Risk of Topical Anesthetic Induced Methemoglobinemia (https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1673755#) as many as 3,000 cases of methemoglobinemia overall may occur annually in the United States. For this reason we are estimating approximately 3,000 patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
68382035806 |
Topiramate ER Capsules 200mg 30ct TK |
Generic |
FDA |
2023-12-12 |
1125.2400 |
None |
1 |
42400000 |
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 “42,400,000” 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). Topiramate ER Capsules is indicated for the treatment of epileptic seizures and for the treatment of migraines. As per the CDC link "Frequently asked questions about Epilepsy" (https://www.cdc.gov/epilepsy/about/faq.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fepilepsy%2Fbasics%2Ffaq.htm) about 3.4 million people in the United States have active epilepsy. Also, as per the link "How Common is Migraine?" (https://migraine.com/migraine-statistics) roughly 39 million people in the United States have migraine. For this reason we have put in a number of 42.4 million in estimated number of patients. |
None |