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- Drug_Price_Competition_and_Patent_Term_Restoration_Act abstract "The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law which encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States. Representative Henry Waxman of California and Senator Orrin Hatch of Utah sponsored the act.Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505(j) of the Act, codified as 21 U.S.C. § 355(j), outlines the process for pharmaceutical manufacturers to file an Abbreviated New Drug Application (ANDA) for approval of a generic drug by the Food and Drug Administration (FDA). Section 505(j)(2)(A)(vii)(IV), often referred to as Paragraph IV, gives the first company to file an ANDA for a particular drug 180 days of exclusive rights to market the drug as the generic alternative to the branded drug. The 180 days begins on the first day of marketing the drug under the ANDA, if the paragraph IV certification is not challenged by the pioneer manufacturer. If the paragraph IV certification is challenged by the pioneer manufacturer, the 180 days begins on the date a court finds that,as required under paragraph IV, the patent of the pioneer manufacturer was not valid, enforceable, or not infringed. The Act enables a generic pharmaceutical manufacturer to develop copy of a patented innovator drug without duplicating the clinical and non-clinical studies or risking liability for patent infringement damages. The generic manufacturer must only demonstrate bioequivalence to the innovator.".
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- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Abbreviated_New_Drug_Application.
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- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Category:1984_in_law.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Category:Biotechnology_law.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Category:United_States_federal_health_legislation.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Category:United_States_federal_patent_legislation.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Charles_Mathias.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Federal_Food,_Drug,_and_Cosmetic_Act.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Food_and_Drug_Administration.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Generic_drug.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Henry_Waxman.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Maryland.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Orrin_Hatch.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Pharmaceutical_industry.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Republican_Party_(United_States).
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Research_exemption.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Ronald_Reagan.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Thalidomide.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Title_21_of_the_United_States_Code.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink United_States_Code.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink United_States_House_of_Representatives.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink United_States_Senate.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink United_States_Senate_Committee_on_the_Judiciary.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLink Utah.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLinkText "Drug Price Competition and Patent Term Restoration Act of 1984".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLinkText "Drug Price Competition and Patent Term Restoration Act".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLinkText "Drug, Price and Competition Act".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLinkText "Hatch-Waxman Act".
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageWikiLinkText "Hatch-Waxman amendments".
- 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 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 wikiPageUsesTemplate Template:Infobox_U.S._legislation.
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- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageUsesTemplate Template:United_States_patent_law.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act wikiPageUsesTemplate Template:Usstat.
- 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 hypernym United.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act type Redirect.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act comment "The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law which encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States. Representative Henry Waxman of California and Senator Orrin Hatch of Utah sponsored the act.Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act.".
- 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 Q5308858.
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- 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=708178186.
- Drug_Price_Competition_and_Patent_Term_Restoration_Act isPrimaryTopicOf Drug_Price_Competition_and_Patent_Term_Restoration_Act.