Issue Date: June 1, 1998
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural, Generic Drugs
Status: Final
180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act
This guidance is intended to provide industry with information on how the Food and Drug Administration (FDA) is applying the 180-day generic drug exclusivity provisions of the Federal Food, Drug, and Cosmetic Act (the Act) in light of recent court decisions. The guidance addresses the issue of the elimination of the “successful defense” requirement, which required an abbreviated new application (ANDA) applicant to be sued for patent infringement and to prevail in the litigation to receive the 180-day period of marketing exclusivity. This guidance will remain in effect until superseded by new regulations or new guidance.
Download the Guidance Document
