Typically, these are patents claiming the formulation. ꟷ "a composition comprising the compound of claim 1 and a pharmaceutically effective.When filing an ANDA, an ANDA applicant submits a certification as to each patent listed in the Orange Book. Patents listed in the Orange Book must claim the reference listed drug or a method of using it. 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. The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit comments on the listing of patent information. A natural orange juice concentrate prepared from natural orange compounds is disclosed. Separate FDA publication known as the "Purple Book. ") (2) "claims a method of using such drug for which approval. Include comparative data.