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.

All labels observed (4)

How this entity was disambiguated

Statements (46)

Predicate Object
instanceOf United States federal statute ⓘ
pharmaceutical law ⓘ
abbreviation ANDA ⓘ
administeredBy 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 ⓘ
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 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 ⓘ

How these facts were elicited

Referenced by (8)

Full triples — surface form annotated when it differs from this entity's canonical label.

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 → Hatch-Waxman Act ⓘ
linked to: Drug Price Competition and Patent Term Restoration Act of 1984
Henry Waxman → sponsoredLegislation → Hatch–Waxman Act ⓘ
linked to: Drug Price Competition and Patent Term Restoration Act of 1984
ANDA → legalBasis → Hatch-Waxman Amendments ⓘ
linked to: Drug Price Competition and Patent Term Restoration Act of 1984
Paragraph I certification → definedIn → Hatch-Waxman Act ⓘ
linked to: Drug Price Competition and Patent Term Restoration Act of 1984
Biologics Price Competition and Innovation Act → relatedTo → Hatch–Waxman Act ⓘ
linked to: Drug Price Competition and Patent Term Restoration Act of 1984
Public Law 98-417 → hasShortTitle → Drug Price Competition and Patent Term Restoration Act of 1984 ⓘ
Public Law 98-417 → hasCommonName → Hatch–Waxman Act ⓘ
linked to: Drug Price Competition and Patent Term Restoration Act of 1984