Amarin Sues FDA Over Vascepa Market Exclusivity Denial

Law360, Washington (February 28, 2014, 3:51 PM EST) -- Amarin Corp. PLC sued the U.S. Food and Drug Administration in Washington, D.C., federal court Thursday, alleging the regulator wrongly denied its bid for a market exclusivity period for high blood fat treatment Vascepa, exposing it to possible patent litigation.

The FDA had mistakenly failed to designate Vascepa as a "pioneer drug," which would have protected it from generic competition for five years after introduction and stopped generic-drug makers from challenging the underlying patents for four years, despite its active ingredient never having been used in...
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