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 This guidance will remain in effect until superseded by new regulations or new guidance.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.