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Expanding Access to Low-Cost Generics Act of 2021

USA117th CongressS-2910| Senate 
| Updated: 10/20/2021
Tina Smith

Tina Smith

Democratic Senator

Minnesota

Cosponsors (1)
Mike Braun (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Expanding Access to Low-Cost Generics Act of 2021 This bill modifies provisions related to market exclusivity for a generic drug. Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug. The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant, and (4) no first applicant's application has been effectively approved on the date that all such conditions are met.
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Timeline

Bill from Previous Congress

S 116-3092
Expanding Access to Low-Cost Generics Act of 2019
Sep 30, 2021
Introduced in Senate
Sep 30, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Oct 20, 2021
Star Print ordered on the bill.
  • Bill from Previous Congress

    S 116-3092
    Expanding Access to Low-Cost Generics Act of 2019


  • September 30, 2021
    Introduced in Senate


  • September 30, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • October 20, 2021
    Star Print ordered on the bill.

Health

Drug safety, medical device, and laboratory regulationPrescription drugs

Expanding Access to Low-Cost Generics Act of 2021

USA117th CongressS-2910| Senate 
| Updated: 10/20/2021
Expanding Access to Low-Cost Generics Act of 2021 This bill modifies provisions related to market exclusivity for a generic drug. Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug. The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant, and (4) no first applicant's application has been effectively approved on the date that all such conditions are met.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

S 116-3092
Expanding Access to Low-Cost Generics Act of 2019
Sep 30, 2021
Introduced in Senate
Sep 30, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Oct 20, 2021
Star Print ordered on the bill.
  • Bill from Previous Congress

    S 116-3092
    Expanding Access to Low-Cost Generics Act of 2019


  • September 30, 2021
    Introduced in Senate


  • September 30, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • October 20, 2021
    Star Print ordered on the bill.
Tina Smith

Tina Smith

Democratic Senator

Minnesota

Cosponsors (1)
Mike Braun (Republican)

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationPrescription drugs