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Drug Price Competition and Patent Term Restoration Act
Acronym / colloquial name	Hatch-Waxman amendments
Citations
Codification
Legislative history
Introduced in the as by on Committee consideration by: Passed the on () Passed the on () Signed into law by President on
Major amendments

U.S. drug regulation

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Prescription drugs Over-the-counter drugs Law Federal Food, Drug, and Cosmetic Act Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substances Act Prescription Drug Marketing Act Drug Price Competition and Patent Term Restoration Act Hatch-Waxman exemption Government agencies United States Department of Health and Human Services Food and Drug Administration Drug Enforcement Administration National Institutes of Health Center for Drug Evaluation and Research Process Drug development New drug application Investigational new drug Clinical trial (Phase I, II, III, IV) Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval International coordination International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre World Health Organization Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs Non-governmental organizations Institute of Medicine Research on Adverse Drug events And Reports

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The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act" [Public Law 98-417], is a 1984 United States federal law which established the modern system of generic drugs. The informal name comes from the Act's two sponsors, representative Henry Waxman of California and senator Orrin Hatch of Utah.

Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505(j) 21 U.S.C. 355(j) sets forth the process by which would-be marketers of generic drugs can file Abbreviated New Drug Applications (ANDAs) to seek FDA approval of the generic. Section 505(j)(5)(B)(iv), the so called Paragraph IV, allows 180 day exclusivity to companies that are the "first-to-file" an ANDA against holders of patents for branded counterparts.

Hatch-Waxman Amendments grant generic manufacturers standing to mount a validity challenge without incurring the cost of entry or risking enormous damages flowing from any possible infringement. Hatch-Waxman essentially redistributes the relative risk assessments and explains the flow of settlement funds and their magnitude. Hatch-Waxman gives generics considerable leverage in patent litigation: the exposure to liability amounts to litigation costs, but pales in comparison to the immense volume of generic sales and profits. ^[1]

See also

• Bill text on THOMAS

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• Research exemption
• ANDA
• Term of patent in the United States

References

1. ^

   Schering-Plough v. FTC (11th Cir. 2005)