Drug Price Competition and Patent Term Restoration Act

GPTKB entity

Predicate	Object
gptkbp:instanceOf	gptkb:United_States_federal_law
gptkbp:affects	pharmaceutical industry brand-name drug manufacturers generic drug manufacturers
gptkbp:alsoKnownAs	gptkb:Hatch-Waxman_Act
gptkbp:citation	gptkb:98_Stat._1585
gptkbp:codifiedIn	gptkb:21_U.S.C._§_355 gptkb:35_U.S.C._§_156
gptkbp:dateEnacted	1984
gptkbp:enactedBy	gptkb:United_States_Congress
gptkbp:establishes	gptkb:Abbreviated_New_Drug_Application
https://www.w3.org/2000/01/rdf-schema#label	Drug Price Competition and Patent Term Restoration Act
gptkbp:impact	increased availability of generic drugs lowered drug prices
gptkbp:publicLawNumber	gptkb:Pub.L._98–417
gptkbp:purpose	to encourage the manufacture of generic drugs to establish a process for generic drug approval to restore patent life lost during FDA approval process
gptkbp:relatedTo	gptkb:Food_and_Drug_Administration gptkb:United_States_patent_law pharmaceutical patents
gptkbp:section	gptkb:Title_I:_Abbreviated_New_Drug_Applications gptkb:Title_II:_Patent_Term_Restoration
gptkbp:signedBy	gptkb:Ronald_Reagan
gptkbp:sponsor	gptkb:Henry_Waxman gptkb:Orrin_Hatch
gptkbp:bfsParent	gptkb:Title_21_of_the_United_States_Code gptkb:505(j)_pathway gptkb:Hatch-Waxman_Act gptkb:Food,_Drug,_and_Cosmetic_Act
gptkbp:bfsLayer	7