USA – FDA looks to overhaul Orange Book, seeks input on patent listings

Nearly 40 years after its creation, the US Food and Drug Administration (FDA) is looking to modernize its Orange Book, which lists patent, exclusivity and therapeutic equivalence information for approved drugs, as part of its effort to increase drug competition.

Specifically, FDA is seeking input on how the Orange Book is used and by whom, and on the types of patents that should  be submitted for listing in the book, such as those covering the device constituent of a drug-device combination product or a patent for a risk evaluation and mitigation strategy (REMS) for an approved drug.
The agency also released a draft guidance featuring 19 questions and answers covering general questions related to the Orange Book; petitioned abbreviated new drug applications (ANDAs); the movement of products between the active and discontinued section of the Orange Book; and patent listings.
“Although the Orange Book already provides extensive information about approved drug products, we want to ensure that it provides as much value as possible to those that rely on it, including consumers, health care professionals and drug developers,” said Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research (CDER)…