180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act June 1998
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
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 This guidance will remain in effect until superseded by new regulations or new guidance.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-1998-D-101c.