S 504 · 113th Congress · Health
FAIR Generics Act
Bill Progress
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Introduced2
Committee3
Senate Vote4
House5
EnactedLatest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.(2013-03-07)
Plain Language Summary
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Fair And Immediate Release of Generic Drugs Act or FAIR Generics Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise the definition of “first applicant” for purposes of the 180-day exclusivity period given to first applicants to file an abbreviated new drug application (generic drug). Makes applicants for a generic drug eligible for the exclusivity period only if they have not entered into a disqualifying agreement (an agreement between a generic drug applicant and the holder of the application for the listed drug [brand name drug] or the patent holder for the brand name drug whereby the generic drug applicant agrees not to seek approval of its generic drug or not to begin the commercial marketing of its generic drug until the expiration of the exclusivity period awarded to another generic applicant). Expands the definition of “first applicant” to include an applicant that meets the following criteria: (1) the applicant is not the first generic applicant; (2) either no action for patent infringement was brought, such action was withdrawn or dismissed by a court without a decision that the patent was valid and infringed, or the court decid…
Summarized by Claude AI · Non-partisan · For informational purposes only
Cosponsors (6)
4 Democrats1 Republican1 Independent