ꟷ Can only cover the approved use as described in the labeling. The new regulations will result in other new Orange Book firsts as FDA is required to make several changes to the Orange Book, including identifying patents.This session will discuss how to submit and make changes to patent information that'll include a in-depth discussion about patent expiration date extensions. An applicant described in paragraph (a) of this section must submit to its NDA the required information, on the required FDA declaration form. • The New Drug Application (NDA) holder must submit patent information to its NDA using the appropriate form (see 21 CFR 314.53(d)). Earlier this year, two new laws were enacted that impact patent listings in the Orange Book (drugs) and Purple Book (biologics). Training mode is an interactive simulation where you can safely practice filing DOCX and PDF documents. This way, you have all of the fees listed in the history of one credit card. LB: That's a very good question. If we patent it, it will be on behalf of the company.