The Reforming Evergreening and Manipulation that Extends Drug Years Act, or REMEDY Act, aims to amend the Federal Food, Drug, and Cosmetic Act to streamline the approval process for abbreviated new drug applications (ANDAs). This legislation specifically targets practices that can delay the market entry of generic drugs, often referred to as evergreening . A key provision of the bill mandates that for any drug approved on or after the Act's enactment, the patent holder must select only one patent as the "covered patent" when first submitting patent information to the Food and Drug Administration. This selection is irreversible and cannot be amended. Consequently, for these newer drugs, only an infringement action related to this single covered patent will trigger the statutory 30-month stay on generic drug approval. By limiting the 30-month stay to a single, pre-identified patent, the bill seeks to prevent brand-name drug manufacturers from repeatedly delaying generic competition by asserting multiple patents sequentially. This change is intended to accelerate the availability of more affordable generic medications by reducing strategic patent litigation tactics.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S5000: 1)
Health
REMEDY Act
USA119th CongressS-2620| Senate
| Updated: 7/31/2025
The Reforming Evergreening and Manipulation that Extends Drug Years Act, or REMEDY Act, aims to amend the Federal Food, Drug, and Cosmetic Act to streamline the approval process for abbreviated new drug applications (ANDAs). This legislation specifically targets practices that can delay the market entry of generic drugs, often referred to as evergreening . A key provision of the bill mandates that for any drug approved on or after the Act's enactment, the patent holder must select only one patent as the "covered patent" when first submitting patent information to the Food and Drug Administration. This selection is irreversible and cannot be amended. Consequently, for these newer drugs, only an infringement action related to this single covered patent will trigger the statutory 30-month stay on generic drug approval. By limiting the 30-month stay to a single, pre-identified patent, the bill seeks to prevent brand-name drug manufacturers from repeatedly delaying generic competition by asserting multiple patents sequentially. This change is intended to accelerate the availability of more affordable generic medications by reducing strategic patent litigation tactics.