FDA Awards Amarin 3-Yr Exclusivity For Vascepa Capsules

(RTTNews) - Amarin Corp. plc (AMRN) said Friday that the U.S. Food and Drug Administration has awarded three years of marketing exclusivity to Vascepa capsules in connection with the July 26, 2012 approval of Vascepa pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act.

Such exclusivity extends through July 25, 2015 and is expected to be supplemented by a 30-month stay under the Hatch-Waxman Amendments that would be triggered after patent infringement litigation initiated by Amarin following valid notice to Amarin of the acceptance of an application to the FDA seeking approval of a generic version of Vascepa.

FDA marketing exclusivity is separate from, and in addition to, patent protection, trade secrets and manufacturing barriers to entry which also help protect Vascepa against generic competition.

"Amarin is reviewing the FDA's reasoning for granting Vascepa three-year, rather than five-year, exclusivity, and evaluating whether to challenge the decision," said John Thero, President and Chief Executive Officer of Amarin.