FDA consulting on 180-day generic exclusivity guidelines

The US Food and Drug Administration (FDA) has published draft guidance relating to the 180-day exclusivity for generic drug product provisions as the agency seeks to establish its current approach to this topic.

This guidance seeks to answer questions about the sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), relating to generic drug exclusivity in an attempt to enhance transparency and facilitate the development, approval, and timely marketing of generics.

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.