Much like the Hatch-Waxman Act created an abbreviated pathway for generic manufacturers of human drugs to enter the market, The Generic Animal Drug and Patent Term Restoration Act (“GADPTRA”) provides a framework for sponsors of pioneer veterinary drugs to enjoy a period of regulatory exclusivity before giving generic animal drug makers a chance for earlier market entry by filing an Abbreviated New Animal Drug Application (“ANADA”) and successfully challenging the pioneer’s “Green Book”-listed patents in district court litigation.
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