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AMARIN PHARMACEUTICALS IRELAND LIMITED v. FOOD AND DRUG ADMINISTRATION et al
Case Number:
1:14-cv-00324
Court:
Nature of Suit:
Judge:
Firms
Government Agencies
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August 11, 2015
FDA, Amarin Bash Watson's Bid To Join Exclusivity Fight
The U.S. Food and Drug Administration and Amarin Pharmaceuticals Ireland Ltd. attacked efforts by Watson Laboratories Inc. to appeal a recent D.C. federal court decision on exclusivity for omega-3 drug Vascepa, arguing Monday that the company's proposed intervention is premature.
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July 22, 2015
Watson Moves To Undo Amarin's Exclusivity Win Over FDA
Watson Laboratories Inc. on Wednesday moved to eliminate extra exclusivity granted recently for Amarin Pharmaceuticals Ireland Ltd.'s omega-3 drug Vascepa, appealing to the D.C. Circuit and asking for permission to take over litigation from the U.S. Food and Drug Administration.
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May 29, 2015
FDA Botched Amarin's Vascepa Exclusivity, Judge Rules
A D.C. federal judge on Thursday vacated the U.S. Food and Drug Administration's decision to limit market exclusivity for Amarin Pharmaceuticals Ireland Ltd.'s fish oil drug Vascepa, finding that the agency exceeded its authority to interpret the Hatch-Waxman Act.
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March 17, 2015
Amarin Says FDA Changed Rules To Deny Market Exclusivity
The U.S. Food and Drug Administration improperly reversed course on how it defined an active ingredient when it denied market exclusivity to Amarin Pharmaceuticals Ireland Ltd.'s drug Vascepa, the company argued on Tuesday, asking a D.C. federal judge to grant that exclusivity.
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February 28, 2014
Amarin Sues FDA Over Vascepa Market Exclusivity Denial
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.