Drug Approval and Patent Listing Process -

Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and the FDA must approve the NDA.2,3 After NDA approval, branded drug manufacturers typically timely submit for listing4 in the Orange Book5 applicable U.S. patents having claims covering the approved drug, its formulation(s), and methods of use, all as approved by the FDA.

When Orange Book listing method of treatment U.S. patents, the branded drug manufacturer must fill in a use code in FDA Form 3542,6 and submit the form to the FDA. Without attempting to determine the scope or accuracy of the use code in relation to the patent’s claims, the FDA then publishes relevant information in the Orange Book, including the patent number, expiration date, and use code(s).