REMEDY Act

This bill changes how the FDA handles generic drug approvals by updating parts of the law that deal with patents during the abbreviated new drug application (ANDA) process. It adds clearer language so that legal actions and decisions in the approval process apply to “a patent or a covered patent,” not just a single type of patent. These edits appear in multiple spots in Section 505 of the Food, Drug, and Cosmetic Act, which governs how generics get approved .

The title signals a goal of reducing “evergreening” and other tactics that can stretch out brand-name drug exclusivity, which can slow down generic competition. By tightening how patents are referenced across the ANDA steps, the bill aims to make the process more consistent and fair for reviewing generics .

• Key points
  • Who is affected: Patients, generic drug makers, brand-name drug companies, and the FDA .
  • What changes: Clarifies that actions and decisions in the ANDA process cover “a patent or a covered patent” across several legal provisions tied to generic approval and patent disputes .
  • When: The text provided does not list an effective date .