The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, is a comprehensive legal framework enacted by Congress in 1984 to simplify the generic drug approval process and protect incentives for innovation.1
The Hatch-Waxman amendments include patent and proprietary provisions for new drug applications and 180-day exclusivity for certain abbreviated new drug applicants.2 In general, the Food and Drug Administration has implemented these legislative provisions within the context of application-specific decisions. 1
Creating a litigation precedent with a streamlined process and timetable where generic manufacturers can challenge brand manufacturers’ patents in federal court without risking patent infringement damages. Since Hatch-Waxman’s inception, generic pharmaceuticals have seen tremendous growth.1
The Hatch-Waxman Amendments established the approval pathway for generic drugs, under which applicants can submit an abbreviated new drug application under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).2
Almost 90% of prescriptions in the United States are filled with generics and more than 80% of approved pharmaceuticals have generic versions available.1
Generics are usually entered into the market immediately following patent expiration and some have been known to corner as 90% of the market within three months.1
WHAT IS HATCH-WAXMAN?. Phrma.org; 2018. https://www.phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/D-F/Fact-Sheet_What-is-Hatch-Waxman_June-2018.
Hatch-Waxman Letters. U.S. Food and Drug Administration. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/hatch-waxman-letters. Published 2021.