Legal Opinion
Teva Pharmaceutical Industries Ltd. v. Crawford
Court of Appeals for the D.C. Circuit
Decided June 3, 2005No. 05-5004PublishedCited by 39 opinions
1Opinion of the Court
GINSBURG, Chief Judge.
Teva Pharmaceutical Industries has sued to overturn the Food and Drug Administration’s denial of its “citizen petition” requesting that the agency prohibit Pfizer, Inc., the holder of the approved New Drug Application (NDA) for gabapentin, from marketing that drug in “generic” form during the 180-day exclusivity period provided by the Drug Price Competition and Patent Term Restoration Act, also known as the “Hatch-Waxman Amendments” to the Food, Drug, & Cosmetic Act. Because the exclusivity provision does not apply to the holder of an approved NDA, the district court…
2Cases cited5 opinions
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Connecticut National Bank v. GermainSupreme Court of the United States · 1992
- MCI Telecommunications Corp. v. American Telephone & Telegraph Co.Supreme Court of the United States · 1994
- Mylan Laboratories, Inc. v. Tommy G. Thompson, Secretary, United States Department of Health and Human ServicesCourt of Appeals for the D.C. Circuit · 2005
- Teva Pharmaceuticals, Industries, Ltd. v. Food & Drug AdministrationDistrict Court, District of Columbia · 2004
3Cited by39 opinions
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- In re Niaspan Antitrust LitigationDistrict Court, E.D. Pennsylvania · 2014
- King Drug Co of Florence Inc v. Smithkline Beecham CorporationCourt of Appeals for the Third Circuit · 2015
- American Sales Co. v. Warner Chilcott Co.Court of Appeals for the First Circuit · 2016
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