Hatch-Waxman Act: Overview | Practical Law
This Practice Note provides an overview of the Hatch-Waxman Act, formally known as the Drug Price Competition and Patent Term Restoration Act of 1984, P.L. 98-417. This Note also summarizes the relevant regulatory provisions concerning branded and generic drugs, including the drug approval process, exclusivities for both branded and generic drugs, patent term extension, and patent litigation under the Hatch-Waxman Act.