On January 13, 2017, the FDA published the draft guidance for industry entitled “180-Day Exclusivity: Questions and Answers.”
Certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), relate to generic drug exclusivity, commonly referred to as “180-day exclusivity.” Generally speaking, these provisions provide for a 180-day exclusivity period for generic applicants that are first to file a substantially complete abbreviated new drug application (ANDA) for a particular brand name drug product and challenge the listed patents that protect the brand name product.
This draft guidance summarizes many of the FDA’s past decisions on 180-day exclusivity under the MMA in a direct and user-friendly question-and-answer format. The content is organized by subject area, including: applicable statutory scheme, first applicants, 180-day exclusivity and patents, 180-day exclusivity trigger and scope, 180-day exclusivity relinquishment and waiver, forfeiture of 180-day exclusivity, and procedural questions regarding 180-day exclusivity determinations. The draft guidance is intended to enhance transparency for stakeholders on how the FDA has implemented these provisions, and the role those provisions play in the generic drug approval process.
The FDA plans to update this draft guidance to include additional questions and answers as appropriate.
To comment on the draft guidance, please visit the public docket, FDA-2016-D-4645.
Direct link to the guidance: http://www.fda.gov/downloads/
Drugs/ GuidanceComplianceRegulatoryIn formation/Guidances/UCM536725. pdf