Amarin Corporation plc announced this week that Vascepa (icosapent ethyl) has U.S. Food and Drug Administration (FDA) approval for new chemical entity (NCE) marketing exclusivity.
The five-year exclusivity runs from
July 26, 2012 to July 26, 2017. The statutory 30-month stay will expire on January
26, 2020.
"Amarin's goal is to protect the commercial potential of Vascepa to 2030," Amarin President and CEO John F. Thero said. "NCE regulatory exclusivity complements multiple patents covering Vascepa with expiration dates in 2030."
Vascepa, known in scientific literature as AMR101, is a prescription omega-3 fatty acid diet supplement used to reduce triglyceride (TG) levels in adult patients. It is not fish oil, although it contains 1 gram of a single molecule active ingredient that is derived from fish. The manufacturing process to isolate the molecule is regulated by the FDA to ensure impurities are eliminated in the product.
Vascepa is used in conjunction with a low-fat, low cholesterol diet to help patients reduce the amount of triglycerides, or fats, in the blood. While the body needs some triglycerides for energy, a high level can raise the risk of heart disease. It can also be a sign of metabolic syndrome, which is a condition characterized by high blood pressure, high blood sugar, low levels of HDL cholesterol and high triglycerides. Patients with metabolic syndrome are at risk of heart disease, diabetes and stroke.
Patients who are allergic to fish or shellfish should inform their health providers; Vascepa can cause an anaphylactic reaction.
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