# Hatch-Waxman Act 1984

Source: https://onco.cc/terms/hatch-waxman/  
OnCo record `hatch-waxman` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The 1984 US law that created the modern generic drug: copies are approved on bioequivalence alone, brands get patent time restored for years lost in review, and the two sides fight it out through patent challenges with a 30-month pause.

## Summary

United States, federal statute. The Drug Price Competition and Patent Term Restoration Act, known by its sponsors' names as Hatch-Waxman, was signed on 24 September 1984 (Public Law 98-417). It amended section 505 of the Federal Food, Drug, and Cosmetic Act and Title 35 of the patent code. Primary text: the FDA's ANDA and exclusivity pages link the statute and regulations.

What it changed: a generic manufacturer files an abbreviated new drug application (ANDA) showing bioequivalence to the brand instead of repeating clinical trials; the brand lists its patents in the Orange Book and gets up to five years of patent term restored for time lost in development and review, capped at fourteen years of protection after approval, plus five years of new chemical entity data exclusivity and three years for new clinical studies. A generic that certifies the brand's patents are invalid or not infringed (a Paragraph IV certification) triggers litigation and an automatic 30-month stay of approval; the first successful challenger earns 180 days of generic exclusivity. The Bolar exemption lets generics do development work during the patent term.

What it means for cancer care: it is why imatinib, capecitabine, abiraterone, bortezomib and lenalidomide now cost a fraction of their launch prices in the United States, and it drives the exclusivity timeline on this site. The arguments concern 'pay for delay' settlements (curbed by the Supreme Court's Actavis decision in 2013), patent thickets and product hopping that stretch protection, and the fact that biologics fell outside it until the 2010 biosimilar law.

## Fields

- Kind: Term
- Last checked: 2026-09-17
- Also known as: Hatch-Waxman; Drug Price Competition and Patent Term Restoration Act; Paragraph IV; Paragraph IV certification; ANDA pathway; abbreviated new drug application; ANDA; 180-day exclusivity; 30-month stay; patent term restoration; Bolar exemption; Orange Book
- Tags: law; us

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Drug_Price_Competition_and_Patent_Term_Restoration_Act
- Wikipedia: https://en.wikipedia.org/wiki/Drug_Price_Competition_and_Patent_Term_Restoration_Act
- FDA: Hatch-Waxman letters and the ANDA pathway: https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/hatch-waxman-letters
- FDA: patents and exclusivity, frequently asked questions: https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity

## Connected records

- terms: [340B Drug Pricing Program](https://onco.cc/terms/340b-program/), [Biologics Price Competition and Innovation Act 2010](https://onco.cc/terms/bpcia/), [Biosimilar](https://onco.cc/terms/biosimilar/), [EU data and market protection (8+2+1)](https://onco.cc/terms/eu-data-exclusivity/), [Inflation Reduction Act 2022: Medicare drug price negotiation](https://onco.cc/terms/inflation-reduction-act/), [Nexavar compulsory licence (India, 2012)](https://onco.cc/terms/nexavar-compulsory-licence/), [Novartis v. Union of India (Glivec, 2013)](https://onco.cc/terms/novartis-glivec-ruling/), [Orphan Drug Act 1983](https://onco.cc/terms/orphan-drug-act/), [Paediatric drug laws: BPCA and PREA](https://onco.cc/terms/bpca-prea/), [Supplementary protection certificate (EU)](https://onco.cc/terms/spc/), [TRIPS Agreement and the Doha Declaration](https://onco.cc/terms/trips-doha/), [US regulatory exclusivity periods](https://onco.cc/terms/us-regulatory-exclusivity/)
- technologies: [Generic oncology drug supply and shortage mitigation](https://onco.cc/technologies/generic-drug-shortage-response/)
- drugs: [Abiraterone acetate](https://onco.cc/drugs/abiraterone/), [Imatinib](https://onco.cc/drugs/imatinib/)
- bottlenecks: [No incentive to repurpose cheap drugs](https://onco.cc/bottlenecks/b-generic-repurposing/), [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/)

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