← Legal Glossary
Hatch-Waxman Framework
Definition
The regulatory and statutory framework under the Drug Price Competition and Patent Term Restoration Act that allows generic drugs to be approved through an abbreviated pathway while preserving patent protections for branded drugs. It establishes procedures for patent disputes when generics seek approval.
Examples
- •A generic manufacturer may file an Abbreviated New Drug Application (ANDA) referencing an existing branded drug, triggering patent notification and dispute resolution procedures