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Hatch-Waxman Act
Practical Law Glossary Item 9-543-2565 (Approx. 3 pages)
Glossary
Hatch-Waxman Act
The Hatch-Waxman Act is formally known as the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub.L. No. 98-417). It amended the Food, Drug, and Cosmetic Act to establish the Food and Drug Administration's (FDA) generic drug approval process and the patent litigation process for generic drugs. Key features include:
- An abbreviated approval process for generic drugs using an abbreviated new drug application (ANDA).
- Market and patent exclusivity periods for both branded and generic drugs.
- Patent term extensions to account for delays resulting from the FDA approval process for new drug applications.
- Patent litigation that may be triggered when a generic drug applicant files an ANDA with certain patent certifications concerning the relevant reference drug.
- An automatic 30-month stay of the FDA approval process for the generic drug if there is patent litigation.
For more information on the details of the Hatch-Waxman Act, see Practice Note, Hatch-Waxman Act: Overview.