The Complexities of Litigating Generic Drug Exclusion Claims in the Antitrust Class Action Context

Royall, M. Sean; Lipton, Joshua
March 2010
Antitrust Magazine;Spring2010, Vol. 24 Issue 2, p22
The article focuses on the complexities involved in litigating generic drug exclusion claims made by the branded pharmaceutical manufacturers under the U.S. antitrust law. It discusses the Hatch-Waxman Act which permits a generic manufacturer to file an Abbreviated New Drug Application, to be approved by the U.S. Food & Drug Administration. It discusses Noerr-Pennington doctrine and that the final approval of a generic drug may be postponed if branded drug manufacturer files a citizen petition.


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