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.

All labels observed (2)

Label Occurrences
P.L. 98-417 1
Public Law 98-417 canonical 1

How this entity was disambiguated

Statements (48)

Predicate Object
instanceOf Act of Congress ⓘ
United States federal statute ⓘ
pharmaceutical law ⓘ
abbreviation ANDA ⓘ
aimsTo balance pharmaceutical innovation and generic drug competition ⓘ
amends Federal Food, Drug, and Cosmetic Act ⓘ
Title 35 of the United States Code ⓘ
appliesTo certain veterinary and biological products through related provisions ⓘ
human prescription drugs ⓘ
branchOfGovernment legislative branch of the United States ⓘ
country 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 ⓘ
establishes Abbreviated New Drug Application process ⓘ
Orange Book patent listing framework ⓘ
hasCommonName Hatch–Waxman Act ⓘ
hasLanguage English ⓘ
hasShortTitle Drug Price Competition and Patent Term Restoration Act of 1984 ⓘ
jurisdiction federal law of the United States ⓘ
legalCitationType Public Law ⓘ
namedAfter Henry Waxman ⓘ
Orrin Hatch ⓘ
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 ⓘ
linked to: Public Law 98-417
regulates approval standards for bioequivalent generic drugs ⓘ
regulatoryAgencyInvolved U.S. Food and Drug Administration ⓘ
requires listing of relevant drug patents with the FDA ⓘ
signedBy Ronald Reagan ⓘ
sponsors Henry Waxman ⓘ
Orrin Hatch ⓘ
statutesAtLargeCitation 98 Stat. 1585 ⓘ
subjectMatter drug price competition ⓘ
generic drugs ⓘ
patent term restoration ⓘ
pharmaceutical patents ⓘ
yearEnacted 1984 ⓘ

How these facts were elicited

Referenced by (2)

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

Public Law 98-417 → publicLawNumber → P.L. 98-417 ⓘ
linked to: Public Law 98-417