Glenmark Pharmaceuticals Inc., USA |
68462075825 |
Phytonadione Injectable Emulsion 10 mg/mL 25 Vials |
2025-01-17 |
1069.1700 |
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3610240 |
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The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Glenmark believes is in the public domain or publicly available. Acquisition fields left blank as drug was developed by Gland but being marketed by Glenmark. Marketing/Pricing Plan not in the public domain or publicly available. To provide its best estimate of U.S. patients who may be prescribed this drug product per year, Glenmark estimated patient populations for each indication of the drug. This product is indicated for coagulation disorders due to faulty formations of factors II, VII, IX and X. It is also given to newborns for prophylaxis treatment of hemorrhagic disease. We estimated potential patients that meet these criteria. For neonate estimated patients, we took the latest data on the number of births in the US (https://www.cdc.gov/nchs/products/databriefs/db507.htm) 3,596,017 for 2023 and rounded up to 3.6 MM. For coagulation disorders with Factor II,VII and X deficiencies, we used the incidents per person based on data from bleeding.org ( https://www.bleeding.org/bleeding-disorders-a-z) and applied to the latest US population data from the US census bureau (https://www.census.gov/library/stories/2024/12/new-year-population.html#:~:text=Population%20size%20(by%20single%20year,%2C%20Fertility%2C%20Mortality%20and%20Migration), Factor II - 1 in 2,000,000 when applied to total population of 341,150,000 (rounded) is 171 patients, Factor VII - 1 per 300,000 (low end of range) and applied to the population figure is 1,137 patients, Factor X - 1 per 500,000 (low end of range) and applied to the population figure is 682 patients. For coagulation disorder with Factor IX deficiency (Hemophilia B), we used the maximum number of persons with hemophilia based on data from bleeding.org ( https://www.bleeding.org/bleeding-disorders-a-z) 33,000 people and used their assumption that one quarter of this population has Hemophilia B or 8,250 patients. Total estimated patients who may be given this product is is 3,610,240. |
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