REMEDY Act
Sponsored By: Senator Durbin, Richard J. [D-IL]
Introduced
Summary
Would limit 'evergreening' by forcing abbreviated new drug application applicants to pick a single 'covered patent' eligible for the 30‑month stay and by tightening which patents can trigger that stay. It would also align how infringement suits operate before and after enactment and tie timing rules to when an application is deemed substantially complete.
Show full summary
- Generic drug applicants: ANDA filers who submit patent information would have to designate one covered patent for any 30‑month stay. That selection could not be changed or amended.
- Brand drug patent owners: Owners or licensees could seek the 30‑month stay only for the designated covered patent, narrowing which patents can be used to extend exclusivity.
- Patent litigation and FDA timing: The bill would make infringement actions focus on the specific patent or covered patent and clarify timing references to the application submission or substantial completeness date.
Personalized for You
How does this bill affect your finances?
Personalize government policy and PRIA will tell you what this bill means for your household, plus every other piece of legislation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Limit patents that delay generics
If enacted, this bill would limit which patents can trigger the FDA's 30‑month delay for approving generic drug applications. For drugs approved on or after the date of enactment, an ANDA filer would have to pick one "covered patent" that alone could give rise to the 30‑month stay. That selection could not be changed. Drugs approved before enactment would keep the current rule. If passed, this could speed some generic entries and help lower drug costs over time.
Sponsors & CoSponsors
Sponsor
Durbin, Richard J. [D-IL]
IL • D
Cosponsors
Sen. Cassidy, Bill [R-LA]
LA • R
Sponsored 7/31/2025
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov