FDA Issues New Guidance for Submitting Patent Information for Listing in the "Orange Book"

The US Food and Drug Administration (FDA) has issued draft guidance on Forms 3542/3542a, which outlines procedures for submitting patent information for listing in the Orange Book, a database of approved drugs with their corresponding patents. The guidance aims to clarify and update existing procedures, providing pharmaceutical companies with a clearer understanding of the requirements for listing their patents. Comments on the draft guidance are due by August 14, 2026, allowing stakeholders to provide feedback and suggestions before the final guidance is issued. The Orange Book plays a crucial role in the Hatch-Waxman Act, which governs the approval of generic versions of patented drugs. By ensuring accurate and up-to-date patent information, the FDA can facilitate the timely approval of generic drugs, promoting competition and potentially reducing costs for consumers.