Formally known as the Approved Drug Products with Therapeutic Equivalence Evaluations. A publication maintained by the Food and Drug Administration (FDA) listing approved drug products and information, including:

Under the Food, Drug, and Cosmetic Act, applicants seeking approval for a new drug using a new drug application (NDA) must submit to the FDA the patent number and expiration date of patents that claim the drug or a method of using that drug. Applicants may submit information for inclusion in the Orange Book for:

The FDA publishes this patent information in the Orange Book after it approves the NDA.

Any applicant seeking approval for a generic version of an approved drug must file an abbreviated new drug application (ANDA), including a certification concerning any patent listed in the Orange Book for the reference drug.

For more information on the FDA's drug approval process and patent litigation arising from an ANDA filing, see Practice Note, Hatch-Waxman Act: Overview.