Which source should the regulatory professional consult to determine when a product's patent and exclusivity will expire?

The Orange Book is the correct source for determining when a product's patent and exclusivity will expire. The Orange Book, officially known as the "Approved Drug Products with Therapeutic Equivalence Evaluations," is published by the U.S. Food and Drug Administration (FDA) and provides information on drug patents and exclusivity periods. It lists approved drug products along with their associated patent information and exclusivity dates, making it an essential reference for regulatory professionals seeking to understand the status of drug patents and any exclusivity granted under the Hatch-Waxman Act.

In contrast, the Federal Register primarily contains proposed regulations and notices from federal agencies and may not provide specific details about individual drug patents or their expirations. The Patent and Trademark Office deals with the application and registration of patents but does not catalog the expiration dates of patents as they relate to drug products. The Copyright Office focuses on copyright laws and protections, which are not relevant for drug patents or exclusivity information. Therefore, the Orange Book is uniquely positioned as the definitive source for this specific regulatory inquiry.