Legal Opinion
Amneal Pharm. LLC v. Food & Drug Admin.
Court of Appeals for the D.C. Circuit
Decided January 23, 2018No. Civil Action No. 17–18(RDM)PublishedCited by 4 opinions
1Opinion of the Court
RANDOLPH D. MOSS, United States District Judge
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 Modernization Act"), grants 180 days of market exclusivity to the first generic manufacturer to file an abbreviated new drug application ("ANDA") that challenges a patent covering the brand-name version of the drug. But that right is not absolute and is subject to various statutorily defined "forfeiture events." As…
2Cases cited29 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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3Cited by4 opinions
- Teva Pharm. United States, Inc. v. AzarCourt of Appeals for the D.C. Circuit · 2019
- Norwich Pharmaceuticals, Inc. v. BecerraDistrict Court, District of Columbia · 2023
- Sti Pharma, LLC v. AzarDistrict Court, District of Columbia · 2020
- Teva Pharmaceuticals USA, Inc. v. Azar, IIDistrict Court, District of Columbia · 2019