Hatch-Waxman
The 1984 US law that created the modern generic-drug approval pathway and 30-month patent stay.
Definition
The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman) created the ANDA pathway for generic small-molecule approvals, the 30-month automatic stay on generic approval when a brand sponsor sues on Orange Book patents, the 180-day first-filer exclusivity, and the patent-term restoration to compensate brand sponsors for time lost to FDA review.
See also
- ANDA — The FDA pathway for approving a generic copy of a previously-approved small-molecule drug.
- Orange Book — The FDA-maintained list of approved drug products with patent and exclusivity information.
- Paragraph IV — A generic manufacturer's certification that a brand drug's patents are invalid or not infringed.