# OnCo record us-regulatory-exclusivity (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/us-regulatory-exclusivity/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "us-regulatory-exclusivity" ;
  schema:name "US regulatory exclusivity periods"@en ;
  schema:alternateName "data exclusivity"@en, "market exclusivity"@en, "regulatory exclusivity"@en, "NCE exclusivity"@en, "new chemical entity exclusivity"@en, "five-year exclusivity"@en, "three-year exclusivity"@en, "exclusivity period"@en, "exclusivity periods"@en, "loss of exclusivity"@en ;
  schema:description "Separate from patents, US law gives an approved drug fixed periods during which the FDA will not approve a copy: five years for a new chemical, three for new clinical studies, seven for an orphan indication, twelve for a biologic, plus six months for paediatric studies."@en ;
  schema:url <https://onco.cc/terms/us-regulatory-exclusivity/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Test_data_exclusivity> ;
  schema:citation <https://en.wikipedia.org/wiki/Test_data_exclusivity>, <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/hatch-waxman/>, <https://onco.cc/terms/bpcia/>, <https://onco.cc/terms/orphan-drug-act/>, <https://onco.cc/terms/bpca-prea/>, <https://onco.cc/terms/eu-data-exclusivity/>, <https://onco.cc/terms/spc/>, <https://onco.cc/terms/biosimilar/>, <https://onco.cc/terms/inflation-reduction-act/>, <https://onco.cc/terms/trips-doha/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-drug-pricing/>, <https://onco.cc/bottlenecks/b-incentive-misalignment/> .