Orange Book Transparency Act of 2020
United States116th CongressHR-1503House of Representatives
Updated: Jan 5, 2021
Summary
Orange Book Transparency Act of 2020 This bill modifies requirements for the Food and Drug Administration (FDA) to list and publish drug patent and exclusivity information. Specifically, the FDA must include on its list certain patent information and must specify each drug exclusivity period that has not concluded. The holder of an approved drug application must notify the FDA when a listed patent is invalidated by a court or by the Patent Trial and Appeal Board. The FDA must remove invalidated patents from its list, subject to the 180-day drug exclusivity period.
Bill texts
Timeline
Motion to reconsider laid on the table Agreed to without objection.
House of Representatives
Presented to President.
House of Representatives
Signed by President.
Became Public Law No: 116-290.