Legal Opinion
Mylan Laboratories Limited v. Food and Drug Administration
District Court, District of Columbia
Decided December 27, 2012No. Civil Action No. 2012-1637PublishedCited by 19 opinions
1Opinion of the Court
MEMORANDUM OPINION
JOHN D. BATES, District Judge.
On September 28, 2012, the Food and Drug Administration (“FDA”) decided that Ranbaxy Laboratories Limited (“Ranbaxy”) had not forfeited its eligibility for 180-day exclusivity to market generic valsarían tablets. Because of this decision, plaintiffs Mylan Laboratories Limited and Mylan Pharmaceuticals, Inc. (“Mylan”) are blocked from marketing their generic valsarían tablets. Mylan brings this action challenging FDA’s decision under the Administrative Procedure Act (“APA”) and the Drug Price • Competition and Patent Term Restoration Act of 1984…
2Cases cited30 opinions
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- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Winter v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 2008
- Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co.Supreme Court of the United States · 1983
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3Cited by19 opinions
- Geo Specialty Chemicals, Incorporated v. HusisianDistrict Court, District of Columbia · 2013
- Seeger v. U.S. Dep't of Def.Court of Appeals for the D.C. Circuit · 2018
- Amgen Inc. v. HarganCourt of Appeals for the D.C. Circuit · 2018
- Ranbaxy Laboratories, Ltd. v. BurwellDistrict Court, District of Columbia · 2015
- Amneal Pharm. LLC v. Food & Drug Admin.Court of Appeals for the D.C. Circuit · 2018
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