Legal Opinion
Amarin Pharmaceuticals Ireland Limited v. Food and Drug Administration
District Court, District of Columbia
Decided October 15, 2015No. Civil Action No. 2014-0324PublishedCited by 16 opinions
1Opinion of the Court
MEMORANDUM OPINION AND ORDER
RANDOLPH D. MOSS, United States District Judge
In this action brought under the Administrative Procedure Act, 5 U.S.C. § 702 et seq., Plaintiff Amarin Pharmaceuticals Ireland Limited (“Amarin”) challenged the Food and Drug Administration’s determination that Amarin’s new drug, Vascepa (icosapent ethyl) Capsules (“Vascepa”) was not entitled to a five-year period of market exclusivity under the Drug Price Competition and Patent Term Restoration Act, Pub. L. No. 98^17, 98 Stat. 1585 (1984) (“Hatch-Waxman Amendments”). As the Court has previously explained, the…
2Cases cited30 opinions
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- Griggs v. Provident Consumer Discount Co.Supreme Court of the United States · 1982
- United Airlines, Inc. v. McDonaldSupreme Court of the United States · 1977
- Company Doe v. Public CitizenCourt of Appeals for the Fourth Circuit · 2014
- National Credit Union Administration v. First National Bank & Trust Co.Supreme Court of the United States · 1998
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3Cited by16 opinions
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- HRN Group, LLC v. Najarian Capital, LLCUnited States Bankruptcy Court, N.D. Georgia · 2019
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