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Expert Analysis

Authorized Generics And Pay-For-Delay Settlements

Law360, New York (August 28, 2012, 1:10 PM EDT) -- The focus of this article is the role of authorized generics ("AGs") in pay-for-delay settlements. The Federal Trade Commission recently approved staff's filing an amicus curiae brief in the matter of Effexor XR, which explains that commitments by the incumbent branded drug manufacturer not to introduce an AG (hereafter, a "no-AG commitment") during the Hatch Waxman Act ("HWA") "exclusivity" period in competition with the independent generic constitutes an in-kind reverse payment and, as such, should be a basis for presuming an antitrust violation.[1]...

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