S. 2620 – REMEDY Act | Legislate.dev

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Updated November 23, 2025 at 11:01 PM UTC

The REMEDY Act amends the Federal Food, Drug, and Cosmetic Act to change how patent litigation works for drugs approved through abbreviated new drug applications (ANDA). It requires the holder of an approved application to select a single "covered patent" that will determine eligibility for a thirty‑month exclusivity period and related infringement actions. The changes affect brand‑name drug manufacturers, generic drug applicants, and patent owners.

Key Provisions

Creates a "covered patent" concept: for drugs approved after the law takes effect, the applicant must pick one patent from a specified list that will be used for the thirty‑month exclusivity period; the choice cannot be changed.
Modifies the language governing when infringement lawsuits can be filed, limiting actions to the covered patent (or any patent for drugs approved before the law) and tying the filing deadline to the date the ANDA was submitted.
Clarifies that the thirty‑month exclusivity period applies to any patent that meets the statutory requirements.
Updates additional sections to similarly require infringement actions to target the covered patent for post‑enactment drugs and to specify timing relative to the ANDA submission.
Adds language to reference the thirty‑month period for any patent that satisfies the required conditions in related infringement provisions.

Legislative Activity

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1 earlier action

SenateIntro Referral Latest Action

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

Health, Education, Labor, and Pensions Committee

July 31, 2025

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SenateIntro Referral

Introduced in Senate

July 31, 2025

SenateIntro Referral

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

Health, Education, Labor, and Pensions Committee

July 31, 2025

Floor Debate

4 members

What members said about S. 2620 on the floor

2 Republicans2 Democrats

Sen. Alex PadillaD-CA · Jul 31, 2025

Mr. President, I rise today to introduce the bipartisan Forest Legacy Management Flexibility Act, which would give States the option to designate accredited nonprofit land trusts to hold conservation…

Mr. President, I rise today to introduce the bipartisan Forest Legacy Management Flexibility Act, which would give States the option to designate accredited nonprofit land trusts to hold conservation easements purchased with Federal funding from the U.S. Forest Service's Forest Legacy Program.

As my colleagues may know, the Forest Legacy Program is a conservation program administered by the U.S. Forest Service, in partnership with State agencies, that encourages the protection of privately owned forestlands through conservation easements or land purchases.

Protection of private forests through FLP maintains a multitude of public benefits, including opportunities to hunt, fish, and camp; clean and abundant drinking water; habitats for fish and wildlife; and timber, fuel wood, and other forest products. Since its creation in 1990, FLP has conserved over 3 million acres of forestland and expanded across the country to 53 States and territories.

Current law requires that Federal or State governments hold conservation easements purchased under the Forest Legacy Program. This bill would amend this existing law to ensure that States have the option to designate accredited nonprofit land trusts to hold conservation easements purchased with Federal funding from the U.S. Forest Service's Forest Legacy Program.

I would like to thank Senator Sheehy for working with me on this crucial piece of legislation. I also want to extend my appreciation to Representatives Garamendi and Calvert for leading the House version of this bill.

Mr. President, I rise to speak in support of the Transportation Emergency Relief Extension Act, which I introduced today.

When disasters strike, entire communities are left to pick up the pieces. Families lose their homes, businesses are destroyed, and essential infrastructure is severely damaged. In the wake of natural disasters like the California wildfires in January or the severe flooding that devastated Texas just a month ago, many States turn to the Federal Highway Administration's Emergency Relief Program to rebuild highways, roads, and bridges.

This program is essential, but as it currently stands, its regulations include rigid deadlines that do not reflect realities on the ground. Under current law, the Department of Transportation can claw this money back if the state has not initiated the funded projects by the end of the second fiscal year following the disaster.

While this requirement was designed to encourage prompt action, in practice it often punishes States for circumstances beyond their control, even when they strive to initiate their projects in a timely manner.

These include ongoing supply chain disruptions that have driven up the cost of materials and caused long lead times for equipment and lengthy regulatory steps such as environmental reviews and other permitting challenges. The delays caused by these hurdles are not due to the lack of effort by States; they are simply the reality of rebuilding critical, large-scale infrastructure.

While States can request 1-year extensions of these funds, those extensions are not guaranteed. Additionally, the lengthy DOT review process adds another layer of uncertainty that complicates States' efforts to plan and execute long-term recovery projects.

The bipartisan, bicameral Transportation Emergency Relief Extension Act would give States additional time to use the emergency relief funds they have been allocated, ensuring they do not lose out on critical funding because of factors they cannot control.

This extension is not about delaying progress: it is about giving States the flexibility they need to complete these projects responsibly, efficiently, and without the looming threat of losing Federal support just as they get underway.

When a community is struck by disaster, recovery is long and challenging. This commonsense legislation will help the Federal Government strengthen our role as a partner in that recovery. I want to thank Senator Cornyn for coleading this bill with me, and I hope our colleagues will join us to ensure that all our communities have the support they need to rebuild strong, resilient infrastructure when they need it most.

Sen. John ThuneR-SD · Jul 31, 2025

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Sen. Richard J. DurbinD-IL · Jul 31, 2025

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Sen. John BarrassoR-WY · Jul 31, 2025

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Sen. Richard J. DurbinD-IL · Jul 31, 2025

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Bill Text

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Introduced in SenateIssued July 31, 2025

II

119th CONGRESS

1st Session

S. 2620

IN THE SENATE OF THE UNITED STATES

July 31, 2025

Mr. Durbin (for himself and Mr. Cassidy) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications.

1.

Short title

This Act may be cited as the Reforming Evergreening and Manipulation that Extends Drug Years Act or the REMEDY Act.

2.

Amendments to ANDA approval provisions

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended—

(1)

in subsection (c)(2) by adding at the end the following: With respect to a drug approved on or after the date of enactment of the Reforming Evergreening and Manipulation that Extends Drug Years Act, when a holder of an approved application first files information under this paragraph with respect to one or more patents described in subsection (b)(1)(A)(viii), the holder shall select one such patent with respect to which the owner or licensee may be eligible for the thirty-month period under paragraph (3)(C) or subsection (j)(5)(B)(iii), as applicable; for purposes of paragraphs (3)(C) and (3)(E)(ii) and subsections (j)(5)(B)(iii) and (j)(5)(F)(ii), such patent shall be referred to as the covered patent. The selection of such covered patent may not be changed or amended.;

(2)

in subsection (c)(3)(C)—

(A)

in the matter preceding clause (i)—

(i)

by striking an action is brought for infringement and all that follows through the period at the end of the first sentence and inserting with respect to a drug approved under this subsection before the date of enactment of the Reforming Evergreening and Manipulation that Extends Drug Years Act, an action is brought for infringement of any patent that is the subject of the certification and for which information was submitted to the Secretary under paragraph (2) before the date on which the application (excluding an amendment or supplement to the application) was submitted, or, with respect to a drug approved under this subsection on or after the date of enactment of the Reforming Evergreening and Manipulation that Extends Drug Years Act, an action is brought for infringement of the covered patent (as described in paragraph (2)) that is the subject of the certification and for which information was submitted to the Secretary under paragraph (2) before the date on which the application (excluding an amendment or supplement to the application) was submitted.; and

(ii)

by striking an action is brought before and inserting an action with respect to a patent or a covered patent, as applicable, is brought before; and

(B)

in clause (i), by striking decides that the patent and inserting decides that the patent or the covered patent, as applicable;

(3)

in the second sentence of subsection (c)(3)(E)(ii), by inserting with respect to any patent for which the requirements are met for the thirty-month period described in subparagraph (C) after action for patent infringement;

(4)

in subsection (j)(5)(B)(iii)—

(A)

in the matter preceding subclause (I)—

(i)

by striking an action is brought for infringement and all that follows through the period at the end of the first sentence and inserting with respect to a drug approved under subsection (c) before the date of enactment of the Reforming Evergreening and Manipulation that Extends Drug Years Act, an action is brought for infringement of any patent that is the subject of the certification and for which information was submitted to the Secretary under subsection (c)(2) before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted, or, with respect to a drug approved under subsection (c) on or after the date of enactment of the Reforming Evergreening and Manipulation that Extends Drug Years Act, an action is brought for infringement of the covered patent (as described in subsection (c)(2)) that is the subject of the certification and for which information was submitted to the Secretary under subsection (c)(2) before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted.; and

(ii)

by striking an action is brought before and inserting an action with respect to a patent or a covered patent, as applicable, is brought before; and

(B)

in subclause (I), by striking decides that the patent and inserting decides that the patent or covered patent, as applicable,; and

(5)

in the second sentence of subsection (j)(5)(F)(ii), by inserting with respect to any patent for which the requirements are met for the thirty-month period described in subparagraph (B)(iii), after action for patent infringement.