|
gptkbp:instanceOf
|
gptkb:United_States_federal_law
|
|
gptkbp:affects
|
gptkb:Food_and_Drug_Administration
pharmaceutical industry
|
|
gptkbp:amendedBy
|
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
gptkb:Patent_Act_of_1952
|
|
gptkbp:codifiedIn
|
gptkb:35_U.S.C._§_156
gptkb:21_U.S.C._§_355(j)
|
|
gptkbp:dateEnacted
|
1984
|
|
gptkbp:enactedBy
|
gptkb:United_States_Congress
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
Hatch-Waxman Amendments
|
|
gptkbp:impact
|
increased availability of generic drugs
lowered drug costs
|
|
gptkbp:nickname
|
gptkb:Hatch-Waxman_Act
|
|
gptkbp:officialName
|
gptkb:Drug_Price_Competition_and_Patent_Term_Restoration_Act
|
|
gptkbp:providesFor
|
gptkb:Abbreviated_New_Drug_Application
patent term extension
market exclusivity for generic drugs
|
|
gptkbp:purpose
|
to balance patent protection for brand-name drugs
to encourage the manufacture of generic drugs
|
|
gptkbp:relatedTo
|
brand-name drug patents
generic drug approval
|
|
gptkbp:section
|
gptkb:Paragraph_IV_certification
180-day exclusivity period
|
|
gptkbp:signedBy
|
gptkb:Ronald_Reagan
September 24, 1984
|
|
gptkbp:sponsor
|
gptkb:Henry_Waxman
gptkb:Orrin_Hatch
|
|
gptkbp:bfsParent
|
gptkb:Hatch-Waxman_Act
|
|
gptkbp:bfsLayer
|
7
|