Advancing Botanical Drug Development Act of 2026

This bill would change federal drug law to give botanical drugs, which are drugs made from plants and approved by the Food and Drug Administration, a 12-year period of market exclusivity. During those 12 years, the FDA could not make effective a generic or similar drug application that references or relies on the approved botanical drug. This would apply only to botanical drugs approved through applications submitted after the bill becomes law. The Secretary would define which drugs count as botanical drugs through regulation.

Full text and official record on Congress.gov

Sponsors

• Lauren Boebert Republican sponsor
• 1 cosponsors