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- Drug_Price_Competition_and_Patent_Term_Restoration_Act abstract "The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act" [Public Law 98-417], is a 1984 United States federal law which encouraged the manufacture of generic drugs by the pharmaceutical industry and established the modern system for government generic drug regulation. The informal name comes from the Act's two sponsors, representative Henry Waxman of California and senator Orrin Hatch of Utah.Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505(j) 21 U.S.C. 355(j) sets forth the process by which would-be marketers of generic drugs can file Abbreviated New Drug Applications (ANDAs) to seek FDA approval of the generic. Section 505(j)(2)(A)(vii)(IV), the so-called Paragraph IV, allows 180 day exclusivity to companies that are the "first-to-file" an ANDA against holders of patents for branded counterparts.Hatch-Waxman Amendments grant generic manufacturers the ability to mount a validity challenge without incurring the cost of entry or risking enormous damages flowing from any possible infringement. Hatch-Waxman essentially redistributes the relative risk assessments and explains the flow of settlement funds and their magnitude. Hatch-Waxman gives generics considerable leverage in patent litigation: the exposure to liability amounts to litigation costs.".
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- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageExternalLink STATUTE-98-Pg1585.pdf.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageExternalLink glossary.htm.
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- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageExternalLink the-generic-drug-scandal.html.
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- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageID "3663417".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageRevisionID "593993724".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act acronym "Hatch-Waxman amendments".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act actsAmended Federal_Food,_Drug,_and_Cosmetic_Act.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act citePublicLaw "98".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act committees United_States_Senate_Committee_on_the_Judiciary.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act conferencedate "1984-09-06".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act effectiveDate "1984-09-24".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act enactedBy "98".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act hasPhotoCollection Drug_Price_Competition_and_Patent_Term_Restoration_Act.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act introducedby "Charles McC. Mathias, Jr.".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act introduceddate "1983-06-23".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act introducedin "Senate".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act leghisturl z?d098:SN01538:@@@S.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act longtitle "An Act to amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new drug applications, to amend title 35, United States Code, to authorize the extension of the patents for certain regulated products, and for other purposes.".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act passedbody "House".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act passedbody "Senate".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act passeddate "1984-06-29".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act passeddate "1984-09-06".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act passeddate "1984-09-12".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act passeddate "1984-09-19".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act passedvote "signed".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act passedvote "voice vote agreed".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act passedvote "voice vote agreed, with amendments".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act passedvote "voice vote".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act publicLawUrl STATUTE-98-Pg1585.pdf.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act sectionsAmended "Chapter 9 § 301 et seq.".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act shorttitle "Drug Price Competition and Patent Term Restoration Act".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act signeddate "1984-09-24".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act signedpresident Ronald_Reagan.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act titleAmended "21".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act subject Category:1984_in_law.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act subject Category:Biotechnology_law.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act subject Category:United_States_federal_health_legislation.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act subject Category:United_States_federal_patent_legislation.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act comment "The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act" [Public Law 98-417], is a 1984 United States federal law which encouraged the manufacture of generic drugs by the pharmaceutical industry and established the modern system for government generic drug regulation.".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act label "Drug Price Competition and Patent Term Restoration Act".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act sameAs m.09t29s.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act sameAs Q5308858.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act sameAs Q5308858.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wasDerivedFrom Drug_Price_Competition_and_Patent_Term_Restoration_Act?oldid=593993724.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act isPrimaryTopicOf Drug_Price_Competition_and_Patent_Term_Restoration_Act.