Amarin calls on FDA to extend Vascepa exclusivity by five years

US biotech firm Amarin (Nasdaq: AMRN) has filed with a federal court requesting it to order the US Food and Drug Administration to extend its marketing exclusivity for Vascepa (icosapent ethyl), an adjunct to diet to reduce triglyceride, for five years, according to a report from Bloomberg.

Earlier this week, Amarin announced that the FDA had awarded three years of marketing exclusivity to Vascepa capsules in connection with the July 26, 2012 approval of the cardiovascular drug under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act, but stated that it is reviewing the FDA’s reasoning for granting three, rather than five years of exclusivity.

While the active ingredient in Vascepa, icosapent ethyl, a type of omega-3 fatty acid, is present in GlaxoSmithKline’s (LSE: GSK) Lovaza, its active ingredient of Lovaza is an undifferentiated fish-oil mixture, according to the complaint. “The mixture is not the same as Vascepa’s active ingredient (icosapent ethyl),” according to the complaint says Bloomberg.