Orange Book Patent Listing Dispute List
Section 314.53(f)(1) outlines a process through which a person can dispute the accuracy or relevance of patent information published in the Orange Book, as well as the process for the relevant new drug application (NDA) holder to respond to such disputes. For all patent listing disputes, FDA promptly posts information on (1) whether a patent listing dispute has been submitted to FDA and (2) whether the NDA holder has timely responded to the patent listing dispute. The Patent Listing Dispute List contains relevant drug product information and the disputed patent. The list is cumulative in nature and is organized by drug product established name and patent number(s).