Following the submission of a Form FDA 3542 that the Agency determines is acceptable, the patent information will be reflected in the Orange Book. Q14. On May 27, 2020, FDA issued draft guidance on questions and answers related to the Orange Book.FDA intends the guidance to assist drug product applicants. Drugs may be issued multiple patents. The Orange Book is the FDA's official register of drugs that the agency has deemed to be safe and effective, as well as any patents covering those drugs. Patent Center is available to all users for electronic filing and management of patent applications. It should not be used to prepare a patent application without legal counsel. The FTC filed an amicus brief in the Teva v. What patents can't be listed in the Orange Book? While you can file a patent application as an unregistered user, you will not benefit from the tools available to registered users.