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...
To view the full article, register now.

Documents

Related

Sections

Case Information

Case Title

AMARIN PHARMACEUTICALS IRELAND LIMITED v. FOOD AND DRUG ADMINISTRATION et al


Case Number

1:14-cv-00324

Court

District Of Columbia

Nature of Suit

Other Statutory Actions

Judge

Randolph D. Moss

Date Filed

February 26, 2014

Law Firms

Companies

Government Agencies

Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.