Drug Price Competition and Patent Term Restoration Act of 1984

URI: https://gptkb.org/entity/Drug_Price_Competition_and_Patent_Term_Restoration_Act_of_1984
GPTKB entity
Statements (29)
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:amendedBy gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
gptkb:Patent_Act_of_1952
gptkbp:citation gptkb:98_Stat._1585
gptkbp:country gptkb:United_States
gptkbp:dateEnacted September 24, 1984
gptkbp:enactedBy gptkb:United_States_Congress
gptkbp:establishes gptkb:Abbreviated_New_Drug_Application_(ANDA)
https://www.w3.org/2000/01/rdf-schema#label Drug Price Competition and Patent Term Restoration Act of 1984
gptkbp:providesFor patent term extension
market exclusivity for generic drugs
gptkbp:publicLawNumber Public Law 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 FDA regulation
pharmaceutical patents
generic drug approval
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:35_U.S.C._§_156
gptkbp:bfsLayer 8