Legal Opinion
Amarin Pharmaceuticals Ireland Limited v. Food and Drug Administration
District Court, District of Columbia
Decided May 28, 2015No. Civil Action No. 2014-0324PublishedCited by 12 opinions
1Opinion of the Court
MEMORANDUM OPINION
RANDOLPH D. MOSS, United States District Judge
Amarin Pharmaceuticals Ireland Limited (“Amarin”) challenges the Food and Drug Administration’s determination that Amarin’s new drug, Vascepa (icosapent ethyl) Capsules (“Vascepa”), is not entitled to a five-year period of market exclusivity under the Federal Food, Drug, and Cosmetic Act (“FDCA”). That period of exclusivity is available for a new drug, if “no active ingredient (including any ester or salt of the active ingredient)” of the drug “has been approved in any other application” for new drug approval. Here, the Food and…
2Cases cited35 opinions
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- Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co.Supreme Court of the United States · 1983
- Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc.Supreme Court of the United States · 1975
- TRW Inc. v. AndrewsSupreme Court of the United States · 2001
- Barnhart v. WaltonSupreme Court of the United States · 2002
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3Cited by12 opinions
- Amarin Pharmaceuticals Ireland Limited v. Food and Drug AdministrationDistrict Court, District of Columbia · 2015
- Otsuka Pharm. Co. v. BurwellCourt of Appeals for the D.C. Circuit · 2016
- Amgen Inc. v. HarganCourt of Appeals for the D.C. Circuit · 2018
- Cigar Ass'n of Am. v. U.S. Food & Drug Admin.Court of Appeals for the D.C. Circuit · 2018
- Ferring Pharmaceuticals, Inc. v. BurwellDistrict Court, District of Columbia · 2016
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