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Authorized Generics: Antitrust Issues And The Hatch-Waxman Act

Law360 (March 31, 2006, 12:00 AM EST) -- An authorized generic (AG) is a pharmaceutical product that was originally marketed and sold by a brand company, but is relabeled and marketed under a generic product name. One problem with AGs is that they do not have to abide by the 180-day market exclusivity provision granted by the Hatch-Waxman Act to the first generic on the market. AGs could thus undercut the public policy rationale underlying the Hatch-Waxman Act, and have the potential of threatening the generic industry as a whole.

An AG, also known...
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