FDA Draft Guidance on the Orange Book - Questions and Answers

On May 27, 2020, FDA issued draft guidance on questions and answers related to the Orange Book.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 and other interested parties in utilizing the Orange Book.

The questions for which FDA provides answers relate to (1) the content and format of the Orange Book, (2) petitioned ANDAs, (3) moving drug products between the active and discontinued sections of the Orange Book, and (4) patent listings.

For example, FDA explains that newly approved NDA drug products will generally appear in the active section of the Orange Book in the month following their approval and generally remain thereafter. However, if the NDA holder notifies FDA that the drug product will not be available for sale within 180 days of approval, then the NDA drug product will, in the month following such approval, appear in the discontinued section of the Orange Book. In addition, FDA explains that a person other than an NDA holder can dispute the accuracy or relevance of patent information published in the Orange Book by submitting a narrative statement of dispute to FDA in a written or electronic communication describing the specific grounds for disagreement. FDA will then forward the statement to the applicable NDA holder without review or redaction.

Readers are encouraged to read the draft guidance, also available on FDA’s website.