S. 2620 · Where this bill is now
In committee
Introduced in the Senate, Jul 31, 2025
What this bill does
In plain words · AI-written from the official summaryLimits drug patent delays to one
When a pharmaceutical company applies to the FDA for approval of a new drug, the company would have to pick just one patent to protect with a 30-month delay on generic drug approval. Currently, a brand-name drug can have multiple patents eligible for this delay. The bill would mean that if patent litigation happens, only the one selected patent could trigger the FDA's pause on approving a generic version.
How it affects you
This mainly affects people who take generic medications. If you rely on affordable generic drugs, this change could potentially speed up when generic versions become available by limiting how long brand-name patent disputes can block FDA approval. The change also touches pharmaceutical companies and patent holders, who would have fewer patents triggering approval delays.
Read the official summary (Introduced in Senate, Jul 31, 2025)
Reforming Evergreening and Manipulation that Extends Drug Years Act or the REMEDY Act
This bill limits the scope of a 30-month stay on approval of a generic drug by the Food and Drug Administration (FDA) while patent litigation involving the reference (brand-name) drug is ongoing.
Generally, entities seeking approval of a new drug must provide the FDA with information on patents claiming the drug or a method of use. Entities seeking approval of a generic drug must certify for each such patent on the reference drug that (1) the patent has expired or will expire before the generic is marketed, or (2) the patent is invalid or inapplicable to the generic drug. If a generic drug applicant certifies that a patent is invalid or inapplicable and a patent infringement suit is timely brought, the FDA is prohibited from approving the generic for 30 months (unless the patent litigation is resolved sooner). Under current law, this 30-month stay applies to patent litigation on any number of patents on a reference drug, provided the patent information was filed with the FDA before the generic application.
Under the bill, when an entity applies to the FDA for approval of a new drug, the entity must select only one patent to be eligible for the 30-month stay. This selection may not be changed or amended. After the bill’s enactment, only patent litigation related to the reference drug’s selected patent may trigger the 30-month stay on approval of a generic.
Written by AI (Claude) using only the official summary by the Congressional Research Service, the Library of Congress’s nonpartisan research staff. It can miss nuance, so check the official summary and the bill text for details.
1st SessionS. 2620
A BILL
REMEDY Act
Sponsor: Sen. Richard J. Durbin (D-IL) · Introduced Jul 31, 2025 · Health · 1 version of the text
Sources: Congress.gov actions and votes · bill text from GovInfo · latest official action Jul 31, 2025: “Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S5000)”