FDA Orange Book Excerpt Publication

The FDA has published an excerpt of the Orange Book, a reference that lists approved drug products and their patent and exclusivity information. This update, dated March 24, 2026, serves as a notification to stakeholders regarding available information on these critical aspects of drug approval and market exclusivity.

While this publication is informational and does not impose new compliance obligations, regulated entities, particularly drug manufacturers and pharmaceutical companies, should ensure they are referencing the most current version of the Orange Book for accurate information regarding drug approvals, patents, and exclusivity periods. This information is crucial for strategic planning, market entry, and potential litigation related to intellectual property.