Generic drug makers that want to sell a lower-cost version of a brand-name medication often have to wait out a 30-month delay while patent disputes are resolved, and brand-name companies have sometimes filed many overlapping patents to trigger that delay more than once for the same drug, a practice known as patent evergreening. For any drug approved after this law takes effect, the brand-name patent holder would have to pick a single patent eligible for that 30-month stay, rather than being able to draw out the process through multiple separate patents. Patents already listed before the law's enactment would keep the current rules. Consumers and pharmacies waiting for cheaper generic alternatives could see faster generic competition reach the market, since drug companies would no longer be able to chain multiple 30-month blocking periods together.
Corporate Benefits
- 30-month regulatory stay — Limited to one selected patent per drug for brand-name manufacturers
Average Household Impact
- Generic drug competition — Faster market entry likely as brand-name evergreening tactics are narrowed
Congressional Summary
Reforming Evergreening and Manipulation that Extends Drug Years Act or the REMEDY ActThis 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.
Details
- Congress
- 119th
- Chamber
- Senate
- Status
- summarized
- Action
- Introduced in Senate
- Action Date
- 2025-07-31
- Date Added
- 2026-07-02
- Source
- Congress.gov →
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