Drug Price Competition and Patent Term Restoration Act of 1984

E165704

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, is a U.S. law that streamlined the approval of generic drugs while providing patent term extensions to brand-name drug manufacturers to balance innovation and competition.

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Predicate Object
instanceOf United States federal statute
pharmaceutical law
abbreviation ANDA
administeredBy Food and Drug Administration
surface form: U.S. Food and Drug Administration

United States Patent and Trademark Office
affects pharmaceutical patent litigation
timing of generic drug market entry
aimsTo balance pharmaceutical innovation and generic competition
allows generic applicants to rely on safety and efficacy data of reference drugs
amends Federal Food, Drug, and Cosmetic Act
Patent Act of 1952
componentOf United States drug approval framework
country United States of America
surface form: United States
creates mechanism for extending patent life of certain drugs
patent term restoration for time lost during FDA regulatory review
criticizedFor encouraging certain patent evergreening strategies
effect facilitated growth of U.S. generic drug industry
increased availability of lower-cost generic medicines
enactedInYear 1984
establishes Abbreviated New Drug Application process
Paragraph I certification
Paragraph II certification
Paragraph III certification
Paragraph IV certification
hasAlias Drug Price Competition and Patent Term Restoration Act of 1984 self-linksurface differs
surface form: Hatch-Waxman Act
influenced subsequent U.S. generic drug legislation
introduces Orange Book patent listing requirements
jurisdiction federal law of the United States
legalCitation Public Law 98-417
objective maintain incentives for new drug research and development
reduce drug prices through generic competition
policyArea health care
intellectual property
pharmaceutical regulation
primaryGoal provide patent term restoration for certain brand-name drugs
streamline approval of generic drugs
provides 180-day market exclusivity for first generic filer with Paragraph IV certification
regulates approval process for generic drugs
patent term extensions for pharmaceuticals
relatedTo Biologics Price Competition and Innovation Act
requires brand-name drug manufacturers to list patents in the FDA Orange Book
generic drugs to demonstrate bioequivalence to reference listed drugs
sector pharmaceutical industry
signedIntoLawBy Ronald Reagan
sponsors Henry Waxman
Orrin Hatch

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Federal Food, Drug, and Cosmetic Act amendedBy Drug Price Competition and Patent Term Restoration Act of 1984
Drug Price Competition and Patent Term Restoration Act of 1984 hasAlias Drug Price Competition and Patent Term Restoration Act of 1984 self-linksurface differs
this entity surface form: Hatch-Waxman Act