REMEDY Act would limit Hatch-Waxman 30-month stays to one Orange Book-listed patent

The REMEDY Act would limit the 30-month regulatory stay under the Hatch-Waxman Act to a single Orange Book-listed patent for an approved drug product, rather than any or all of the multiple patents that may be associated with an FDA-approved drug product. The bill was reintroduced in the Senate on July 31, 2025 and is again in committee.

Presently, the Hatch-Waxman Act allows a company who owns any patents listed in the Orange Book 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, or Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 2620), proposes to limit the 30-month stay to a single Orange Book-listed patent.

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.
• The “covered patent” must be designated in advance, and “may not be changed or amended.”

The sponsors said the bill aims to reduce prescription drug costs for consumers by promoting competition by removing barriers to FDA approval for lower-cost generic drugs. 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.

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.