HR 1051
To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.
Jurisdiction
US Congress
Session
119th Congress (2025-2026)
Last updated at
Jun 14, 2026, 6:33 AM
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Sign in to take action- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Bill overview
This bill changes how the FDA approves generic drugs. Currently, a first generic drug applicant gets 180 days of market exclusivity. This bill allows a subsequent applicant to get approval for a generic drug even if the first applicant hasn’t started selling it, provided certain conditions are met, such as a waiting period and a certification that commercial marketing will begin within 75 days. If the first applicant fails to market the drug within 75 days, their approval becomes tentative, and the subsequent applicant may not receive approval unless they can demonstrate unforeseen issues were resolved.
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