Icosapent Ethyl
Overview
Icosapent Ethyl is an ethyl ester of eicosapentaenoic acid (EPA), an omega-3 fatty acid that is used to lower triglyceride levels in adults with severe hypertriglyceridemia. It is a prescription medication that has been shown to reduce the risk of cardiovascular events.
API suppliers (6)
Suppliers of Icosapent Ethyl evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
Country recorded for 4 of 6 suppliers.
1 of 6 holds a GMP certificate on record in the EU or UK registers
- SICHUAN GOWELL PHARMACEUTICAL CO LTD2 active DMF
- FINORGA SASFrance1 active DMF GMP on record
- HUATAI PHARMA INCChina1 active DMF
- AK BIOPHARM CO., LTD.South1 active DMF
- KINOMEGA BIOPHARM INCChina1 active DMF
- SKUNY BIOSCIENCE CO LTD
Patent & exclusivity (US)
Per the FDA Orange Book (21 approved US products), the latest listed US patent on Icosapent Ethyl expires 28 Jun 2033. Generic API sourcing typically opens up once these lapse.
Therapeutic areas
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