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Amarin Corporation PLC announces FDA award of three-year exclusivity for Vascepa capsules


Friday, 21 Feb 2014 04:01pm EST 

Amarin Corporation PLC: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.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. 

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