Key Provisions of the Remedy Act and Their Impact on Hatch‑Waxman Litigation

In the United States, both patent law and U.S. Food and Drug Administration (FDA) regulations govern the commercial availability of drug products and any potential periods of market exclusivity. Proposed legislation, however, would limit the extent of the 30-month regulatory stay period preventing generic drugs from entering the market currently afforded to patent owners by the Hatch-Waxman Act.

Presently, the Hatch-Waxman Act allows a company who owns any patents listed in the Orange Book[1] for any approved drug product or method of use to benefit from an automatic 30-month stay of FDA approval of generic competitors while patent litigation is ongoing. The REMEDY Act (“Reforming Evergreening and Manipulation that Extends Drug Years Act”) (S. 2620), however, proposes to limit the 30-month stay to a single Orange Book-listed patent, rather than any or all of the multiple patents that may be associated with an FDA-approved drug product.[2]

Senator Richard Durbin of Illinois and Senator Bill Cassidy of Louisiana, sponsors of the REMEDY Act, aim to reduce prescription drug costs for consumers by “promot[ing] competition by removing barriers to the Food and Drug Administration (FDA) approval for lower-cost generic drugs.”[3] The same sponsors previously introduced the bill in the Senate in July 2024 during the 118th Congressional Session, but the bill failed to make it out of committee for a full vote.[4] Senators Durbin and Cassidy reintroduced the REMEDY Act in the Senate on July 31, 2025, where it is again in committee.[5]

The most notable provisions of the bill introduce major amendments to the Hatch-Waxman Act:

• New Drug Application holders may select only one “covered patent” that would trigger the 30-month stay, as opposed to any number of Orange Book-listed patents associated with a particular approved drug; and
• The “covered patent” must be designated in advance, and “may not be changed or amended.”[6]

The REMEDY Act has the potential to change how patent-owning pharmaceutical companies assert their patent portfolio against Abbreviated New Drug Application-filers, as well as which patents Abbreviated New Drug Application-filers might challenge. It also has the potential to increase injunction practice because Orange Book patents that are not designated for a 30-month stay will no longer independently delay FDA approval.

[1] The Orange Book is more formally known as the Approved Drug Products with Therapeutic Equivalence Evaluations. The Orange Book “identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) . . . and related patent and exclusivity information.” FDA, Approved Drug Products with Therapeutic Equivalence Evaluations, available at https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book (last visited Mar. 27, 2026).

[2] Sec. 2. Amendments to ANDA Approval Provisions, Reforming Evergreening and Manipulation that Extends Drug Years Act (REMEDY Act), S. 2620 – 119th Congress (2025-2026): REMEDY Act, S. 2620, 119th Cong. § 2 (2025), https://www.congress.gov/bill/119th-congress/senate-bill/2620/text (last visited Mar. 31, 2026).

[3] Press Release, U.S. Sen. Dick Durbin, “Durbin, Cassidy REMEDY Act To Lower Prescription Costs By Promoting Generic Competition” (July 31, 2025), available at https://www.durbin.senate.gov/newsroom/press-releases/durbin-cassidy-remedy-act-to-lower-prescription-costs-by-promoting-generic-competition (last visited Mar. 27, 2026).

[4] Reforming Evergreening and Manipulation that Extends Drug Years Act (REMEDY Act), S. 4878 – 118th Congress (2023-2024): REMEDY Act, S. 4878, 118th Cong. (2024), https://www.congress.gov/bill/118th-congress/senate-bill/4878/text (last visited Mar. 31, 2026).

[5] Reforming Evergreening and Manipulation that Extends Drug Years Act (REMEDY Act), S. 2620 – 119th Congress (2025-2026): REMEDY Act, S. 2620, 119th Cong. (2025), https://www.congress.gov/bill/119th-congress/senate-bill/2620/all-actions (last visited Mar. 31, 2026).

[6] Sec. 2. Amendments to ANDA Approval Provisions, Reforming Evergreening and Manipulation that Extends Drug Years Act (REMEDY Act), S. 2620 – 119th Congress (2025-2026): REMEDY Act, S. 2620, 119th Cong. § 2 (2025), https://www.congress.gov/bill/119th-congress/senate-bill/2620/text.