3.0.0 2620 2026-07-01T16:00:43Z 2026-07-01T16:00:43Z Senate S S 2025-07-31 119 https://www.congress.gov/bill/119th-congress/senate-bill/2620 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred To 2025-07-31T20:08:09Z 2025-07-31 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S5000) IntroReferral 2025-07-31 Introduced in Senate IntroReferral 10000 9 Library of Congress D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. N C001075 Sen. Cassidy, Bill [R-LA] Bill Cassidy R LA 2025-07-31 True Health Health 2025-09-18T19:45:41Z 00 2025-07-31 Introduced in Senate 2026-07-01T15:58:33Z 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.

]]> REMEDY Act Display Title 45 REMEDY Act 2025-08-12T03:23:24Z Short Title(s) as Introduced 101 REMEDY Act 2025-08-12T03:23:22Z Introduced in Senate IS Short Title(s) as Introduced 101 Reforming Evergreening and Manipulation that Extends Drug Years Act 2025-08-12T03:23:22Z Introduced in Senate IS Official Title as Introduced 6 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications. 2025-08-12T03:18:24Z Introduced in Senate IS Introduced in Senate 2025-07-31T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-119s2620is/xml/BILLS-119s2620is.xml 2025-07-31 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S5000) text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.