Hatch-Waxman Act

GPTKB entity

Statements (57)
Predicate Object
gptkbp:instanceOf gptkb:United_States_federal_law
gptkbp:amends gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
multiple times
gptkbp:appliesTo generic pharmaceuticals
brand-name pharmaceuticals
gptkbp:associated_with generic drug manufacturers
brand-name drug manufacturers
the pharmaceutical supply chain
gptkbp:challenges in courts
gptkbp:enactedBy gptkb:United_States_Congress
gptkbp:encourages research and development in pharmaceuticals
gptkbp:facilitates abbreviated new drug applications (ANDAs)
gptkbp:has_a_focus_on healthcare_reform_discussions
gptkbp:has_implications_for patient access to medications
drug innovation
gptkbp:hasConflictWith over patent validity
https://www.w3.org/2000/01/rdf-schema#label Hatch-Waxman Act
gptkbp:impact pharmaceutical industry
pharmaceutical patent strategies
gptkbp:influenced international drug policy discussions
gptkbp:influences drug pricing
gptkbp:involves patent litigation provisions
gptkbp:is_a_key_component_of the_U.S._drug_approval_system
gptkbp:is_a_model_for other countries' drug laws
gptkbp:is_a_subject_of public policy debates
academic research
legislative review
political scrutiny
legal analysis
gptkbp:is_essential_for public health
generic drug approval.
gptkbp:is_involved_in trade agreements
gptkbp:is_linked_to drug safety regulations
gptkbp:is_part_of U.S._healthcare_policy
the_U.S._legal_framework_for_pharmaceuticals
gptkbp:is_referenced_in healthcare_policy_debates
gptkbp:is_studied_in economic studies of drug markets
gptkbp:is_used_in congressional hearings
legal cases regarding drug patents
pharmaceutical law courses
gptkbp:landmark legislation in drug policy
gptkbp:led_to increased availability of generic drugs
gptkbp:mandates patent term extensions
gptkbp:operates_in gptkb:Food_and_Drug_Administration_(FDA)
gptkbp:previousName Drug Price Competition and Patent Term Restoration Act
gptkbp:promotes competition in drug market
gptkbp:provides market exclusivity for brand-name drugs
gptkbp:purpose to encourage the development of generic drugs
gptkbp:reduces time for generic drug approval
gptkbp:related_to intellectual property law
biologics regulation
drug approval processes
pharmaceutical regulation
gptkbp:was_a_factor_in drug patent expirations
generic drug pricing strategies
gptkbp:was_a_response_to high drug prices
gptkbp:yearEstablished 1984