Legal Opinion
Hi-Tech Pharmacal Co. v. United States Food & Drug Administration
District Court, District of Columbia
Decided October 10, 2008No. Civil Action 08-01495 (JDB)PublishedCited by 62 opinions
1Opinion of the Court
MEMORANDUM OPINION
JOHN D. BATES, District Judge.
Plaintiff Hi-Tech Pharmacal Co., Inc. (“Hi-Tech”) brings this action pursuant to the Administrative Procedures Act (“APA”) asserting a statutory right under the Drug Price Competition and Patent Term Restoration Act of 1984 (known as the “Hatch-Waxman Act”), as amended by the Medicare Modernization Act of 2003, to a 180-day period of marketing exclusivity for the generic version of the branded drug COSOPT®. Currently before the Court is Hi-Tech’s motion for a preliminary injunction to prevent defendant Food and Drug Administration (“FDA”) from…
2Cases cited26 opinions
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- Munaf v. GerenSupreme Court of the United States · 2008
- Norton v. Southern Utah Wilderness AllianceSupreme Court of the United States · 2004
- Mova Pharmaceutical Corp. v. ShalalaCourt of Appeals for the D.C. Circuit · 1998
- Serono Labs Inc v. Ferring Pharm. Inc.Court of Appeals for the D.C. Circuit · 1998
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3Cited by62 opinions
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- Mylan Laboratories Limited v. Food and Drug AdministrationDistrict Court, District of Columbia · 2012
- LG Electronics U.S.A., Inc. v. United States Department of EnergyDistrict Court, District of Columbia · 2010
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