# OnCo record hatch-waxman (term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/terms/hatch-waxman/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "hatch-waxman" ;
  schema:name "Hatch-Waxman Act 1984"@en ;
  schema:alternateName "Hatch-Waxman"@en, "Drug Price Competition and Patent Term Restoration Act"@en, "Paragraph IV"@en, "Paragraph IV certification"@en, "ANDA pathway"@en, "abbreviated new drug application"@en, "ANDA"@en, "180-day exclusivity"@en, "30-month stay"@en, "patent term restoration"@en, "Bolar exemption"@en, "Orange Book"@en ;
  schema:description "The 1984 US law that created the modern generic drug: copies are approved on bioequivalence alone, brands get patent time restored for years lost in review, and the two sides fight it out through patent challenges with a 30-month pause."@en ;
  schema:url <https://onco.cc/terms/hatch-waxman/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Drug_Price_Competition_and_Patent_Term_Restoration_Act> ;
  schema:citation <https://en.wikipedia.org/wiki/Drug_Price_Competition_and_Patent_Term_Restoration_Act>, <https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/hatch-waxman-letters>, <https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity> ;
  onco:tag "law", "us" ;
  onco:related <https://onco.cc/terms/us-regulatory-exclusivity/>, <https://onco.cc/terms/bpcia/>, <https://onco.cc/terms/biosimilar/>, <https://onco.cc/terms/orphan-drug-act/>, <https://onco.cc/terms/bpca-prea/>, <https://onco.cc/terms/inflation-reduction-act/>, <https://onco.cc/terms/spc/>, <https://onco.cc/terms/trips-doha/>, <https://onco.cc/technologies/generic-drug-shortage-response/> ;
  onco:drugs <https://onco.cc/drugs/imatinib/>, <https://onco.cc/drugs/abiraterone/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-drug-pricing/>, <https://onco.cc/bottlenecks/b-generic-repurposing/> .