REMEDY Act

Richard J. Durbin

Democrat · IL · Senator

Source: Congress.gov · FEC

1 cosponsor on record at Congress.gov. The named list is syncing into Govwatch and will appear here shortly — view on Congress.gov in the meantime.

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S5000)

2025-07-31

Source: Congress.gov

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.

Plain-English rewrite of the Congressional Research Service summary published on Congress.gov. Cached and reviewed.

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