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The Hatch-Waxman Act: Encouraging Innovation and Generic Drug Competition

[ Vol. 10 , Issue. 18 ]


Allen M. Sokal and Bart A. Gerstenblith   Pages 1950 - 1959 ( 10 )


Congress carefully crafted the Hatch-Waxman Act to address two competing goals: to spur new pharmaceutical development and to encourage greater public access to generic drugs. To that end, the Act contains important provisions directed to fulfilling each goal, including provisions favorable to either branded drug or generic drug manufacturers. This article addresses those provisions in the context of issues pertaining to patent rights and in light of the congressional goals.


Hatch-Waxman Act, patent term restoration, exclusivity, branded drugs, generic drugs, Generic Drug Competition, Drug Price Competition, Patent Term Restoration Act, Federal Food, Drug, and Cosmetic Act, New Drug Application, Federal Circuit, In-vestigational New Drug, United States Patent and Trade-mark Office, tacrine hydrochloride, 1-hydroxy-tacrine, Lipitor, cromolyn sodium drug, cefuroxime axetil, Scope of Rights, amlodipine besylate, amlodipine maleate, ANDA, new chemical entity, orphan” drugs, Orange Book Listing, Automatic Injunction, Medicare Prescription Drug, Improvement, and Modernization Act, FFDCA, AUC, Cmax, FDA Guidance, Regulatory Review Testing


Finnegan, Henderson,Farabow, Garrett&Dunner, LLP, 901 New York Ave., NW, Washington,DC 20001-4413.

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