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Expert Analysis

Amarin Decision Opens Door To Longer Exclusivity Periods

Law360, New York (June 12, 2015, 2:06 PM EDT) -- On May 28, 2015, the U.S. District Court for the District of Columbia vacated and remanded the U.S. Food and Drug Administration's administrative decision denying five years of new chemical entity exclusivity for Amarin Pharmaceuticals Ireland Ltd.'s recently approved drug, Vascepa.[1] With the caveat that the district court's holding is subject to a potential appeal, Amarin is an important case for innovator pharmaceutical companies that are developing drugs that contain, as their sole active ingredient, a single component of a previously FDA-approved active ingredient multicomponent drug mixture, especially if the mixture is not fully characterized....

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