Legal Opinion
Amneal Pharmaceuticals LLC v. Food and Drug Administration
District Court, District of Columbia
Decided January 24, 2018No. Civil Action No. 2017-0180Published
1Opinion of the Court
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA AMNEAL PHARMACEUTICALS LLC, Plaintijj”, v. :l()OD AND DRUG ADMINISTRATION, et Civil Action NO. 17_180 (RDM) Defendcmts, and LUPIN PHARMACEUTICALS, INC., et al., lntervenor-Defendants. MEMORANDUM OPINION The Federal Food, Drug, and Cosmetic Act (“FDCA”), as amended by the Drug Price Competition and Patent Restoration Act of 1984 (“Hatch-Waxman Act”) and the Medicare Prescription Drug Improvement and Modernization Act of 2003 (“Medicare Modemization Act”), grants 180 days of market exclusivity to the first generic manufacturer to file an…
2Cases cited28 opinions
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co.Supreme Court of the United States · 1983
- Citizens to Preserve Overton Park, Inc. v. VolpeSupreme Court of the United States · 1971
- Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc.Supreme Court of the United States · 1975
- University of Texas v. CamenischSupreme Court of the United States · 1981
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