Definition
Hatch-Waxman Act
The Hatch-Waxman Act is the Drug Price Competition and Patent Term Restoration Act of 1984, the federal law that created the modern generic drug approval pathway while giving brand manufacturers patent term restoration and new periods of exclusivity.
2 min readReviewed September 14, 2026
Also known as: Drug Price Competition and Patent Term Restoration Act, Hatch-Waxman Amendments, Public Law 98-417
Key facts
- Official name
- Drug Price Competition and Patent Term Restoration Act of 1984
- Public law
- Pub. L. 98-417, enacted September 24, 1984
- Named after
- Senator Orrin Hatch and Representative Henry Waxman
- Major amendments
- Medicare Modernization Act of 2003 (MMA)
- Codified in
- FD&C Act Section 505 and Title 35 of the U.S. Code
What is the Hatch-Waxman Act?
Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the patent laws to strike a bargain. Generic manufacturers got a faster, cheaper route to market through the Abbreviated New Drug Application (ANDA). Brand manufacturers got back some of the patent life lost during clinical development and FDA review, plus new exclusivities.
The law also built a system for resolving patent disputes before generic launch, centered on patents listed in the Orange Book and certifications filed by generic applicants.
What the law created
Key provisions include:
- The ANDA pathway in Section 505(j) and the 505(b)(2) pathway for applications that rely on data the sponsor does not own.
- Patent term restoration under 35 U.S.C. 156, of up to five years, capped so remaining patent life after approval does not exceed 14 years.
- Patent listing in the Orange Book and four patent certifications, including Paragraph IV challenges.
- A 30-month stay of generic approval when a brand company sues within 45 days of Paragraph IV notice.
- 180-day exclusivity for the first generic applicant to file a Paragraph IV challenge.
- Five-year new chemical entity exclusivity and three-year exclusivity for new clinical investigations.
- A safe harbor under 35 U.S.C. 271(e)(1) that allows generic development work before patents expire.
Why Hatch-Waxman matters
Almost every date in a small-molecule loss of exclusivity forecast comes from a Hatch-Waxman mechanism: patent expiry after term restoration, exclusivity expiry, the 30-month stay and the 180-day generic exclusivity window.
The law has been amended and litigated. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) limited repeated 30-month stays and added forfeiture rules for 180-day exclusivity. In FTC v. Actavis (2013), the Supreme Court held that reverse payment settlements between brand and generic companies can violate antitrust law. Biologics fall outside Hatch-Waxman and follow the Biologics Price Competition and Innovation Act (BPCIA).