Public Law 98-417
E643467
Public Law 98-417 is a landmark U.S. federal statute that created the modern generic drug approval pathway while balancing pharmaceutical innovation through patent term restoration.
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
Act of Congress
ⓘ
United States federal statute ⓘ pharmaceutical law ⓘ |
| abbreviation | ANDA NERFINISHED ⓘ |
| aimsTo | balance pharmaceutical innovation and generic drug competition ⓘ |
| amends |
Federal Food, Drug, and Cosmetic Act
NERFINISHED
ⓘ
Title 35 of the United States Code NERFINISHED ⓘ |
| appliesTo |
certain veterinary and biological products through related provisions
ⓘ
human prescription drugs ⓘ |
| branchOfGovernment | legislative branch of the United States ⓘ |
| country |
United States of America
ⓘ
surface form:
United States
|
| creates |
mechanism for generic challenges to listed patents
ⓘ
modern generic drug approval pathway ⓘ paragraph I–IV certification framework for ANDAs ⓘ |
| dateSigned | 1984-09-24 ⓘ |
| effect |
facilitated widespread entry of lower-cost generic drugs
ⓘ
strengthened incentives for pharmaceutical research and development through patent term restoration ⓘ |
| enactedBy | 98th United States Congress NERFINISHED ⓘ |
| establishes |
Abbreviated New Drug Application process
ⓘ
Orange Book patent listing framework ⓘ |
| hasCommonName | Hatch–Waxman Act NERFINISHED ⓘ |
| hasLanguage | English ⓘ |
| hasShortTitle | Drug Price Competition and Patent Term Restoration Act of 1984 NERFINISHED ⓘ |
| jurisdiction | federal law of the United States ⓘ |
| legalCitationType | Public Law NERFINISHED ⓘ |
| namedAfter |
Henry Waxman
NERFINISHED
ⓘ
Orrin Hatch NERFINISHED ⓘ |
| policyArea |
health law
ⓘ
intellectual property law ⓘ pharmaceutical regulation ⓘ |
| primaryPurpose |
to create an abbreviated approval pathway for generic drugs
ⓘ
to restore a portion of patent term lost during regulatory review ⓘ |
| providesFor |
180-day exclusivity for first generic applicants making certain patent challenges
ⓘ
market exclusivity periods for certain drug products ⓘ patent term extensions for certain drug patents ⓘ |
| publicLawNumber | P.L. 98-417 NERFINISHED ⓘ |
| regulates | approval standards for bioequivalent generic drugs ⓘ |
| regulatoryAgencyInvolved | U.S. Food and Drug Administration NERFINISHED ⓘ |
| requires | listing of relevant drug patents with the FDA ⓘ |
| signedBy | Ronald Reagan ⓘ |
| sponsors |
Henry Waxman
NERFINISHED
ⓘ
Orrin Hatch NERFINISHED ⓘ |
| statutesAtLargeCitation | 98 Stat. 1585 ⓘ |
| subjectMatter |
drug price competition
ⓘ
generic drugs ⓘ patent term restoration ⓘ pharmaceutical patents ⓘ |
| yearEnacted | 1984 ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.
Drug Price Competition and Patent Term Restoration Act of 1984
→
legalCitation
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Public Law 98-417
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