What source should a regulatory professional consult to find out when a product's patent and exclusivity expires?

The correct choice is the Orange Book, which is a critical resource for regulatory professionals seeking information about drug patents and exclusivity. Formally known as the "Approved Drug Products with Therapeutic Equivalence Evaluations," the Orange Book is published by the U.S. Food and Drug Administration (FDA) and lists all FDA-approved prescription and over-the-counter drugs, including important details such as patent information and periods of marketing exclusivity.

This resource is particularly valuable because it not only provides the expiration dates of patents associated with specific drug products but also indicates whether the drugs are subject to exclusivity protections. Understanding the status of patents and exclusivity is essential for regulatory professionals, especially when evaluating the potential for generic competition or planning for drug development.

In contrast, while the Federal Register is a publication that can provide various updates and information on regulations, it does not focus specifically on patent and exclusivity information. The United States Patent and Trademark Office is primarily concerned with the issuance and registration of patents but does not compile a comprehensive list that connects FDA-approved drugs with their patent and exclusivity statuses. Finally, the Copyright Office deals with copyright issues and is not relevant to patent or exclusivity matters related to pharmaceutical products.