ORANGE BOOK

Orange Book.Patents. A list of patents on drugs or drug products for which generic-drug applications may be submitted to the Food and Drug Administration. • The expiration dates of the patents are also listed. An applicant may submit a generic-drug application at any time, but the applicant must either accept deferral of FDA approval until the patent expires or contest the patent’s validity. The Orange Book’s official title is Approved Drug Products with Therapeutic Equivalence Evaluations.

[Blacks Law 8th]