Legal Opinion
Mylan Pharmaceuticals, Inc. v. Sebelius
District Court, District of Columbia
Decided April 23, 2012No. Civil Action No. 2012-0524PublishedCited by 8 opinions
1Opinion of the Court
MEMORANDUM OPINION
ELLEN SEGAL HUVELLE, District Judge.
On April 4, 2012, two days before Mylan Pharmaceuticals Inc.’s (“Mylan”) anticipated launch, the Food and Drug Administration (“FDA”) decided that Teva Pharmaceuticals U.S.A. Inc. (“Teva USA”) was entitled to a 180-day period of exclusivity to market modafinil, the generic version of Provigil. The FDA rejected Mylan’s request for final approval to sell modafinil and indicated that it would consider Mylan’s request at the conclusion of Teva USA’s period of exclusivity. Mylan brings this action pursuant to the Administrative Procedure Act…
2Cases cited61 opinions
- 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
- Auer v. RobbinsSupreme Court of the United States · 1997
- Amoco Production Co. v. Village of GambellSupreme Court of the United States · 1987
- National Cable & Telecommunications Assn. v. Brand X Internet ServicesSupreme Court of the United States · 2005
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3Cited by8 opinions
- Mylan Laboratories Limited v. Food and Drug AdministrationDistrict Court, District of Columbia · 2012
- Astrazeneca Pharmaceuticals Lp v. Food and Drug AdministrationDistrict Court, District of Columbia · 2012
- Amgen Inc. v. HarganCourt of Appeals for the D.C. Circuit · 2018
- Mylan Pharmaceuticals, Inc. v. United States Food & Drug AdministrationDistrict Court, N.D. West Virginia · 2014
- Amgen Inc. v. PriceDistrict Court, District of Columbia · 2018
3 more not listed; retrieve them via the Exa API.