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S 2910 117th Congress Senate Health Drug safety, medical device, and laboratory regulation Prescription drugs

Expanding Access to Low-Cost Generics Act of 2021

Introduced: September 30, 2021 Introduced by: Smith, Tina Democratic · Minnesota See on congress.gov
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 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 20, 2021
Star Print ordered on the bill.
Sep 30, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sep 30, 2021
Introduced in Senate
 Plain-English summary Congressional Research Service

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.

What's happening now October 20, 2021

Star Print ordered on the bill.

 Committees of jurisdiction 1