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:
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.