What are the FDA “Orange Book” publications?
The FDA Orange Book is the agency’s official list of drugs approved under the Federal Food, Drug, and Cosmetic Act. It includes, for each approved drug, key information such as the active ingredient, dosage form/route, drug product information, and—when applicable—patent and exclusivity details that affect market competition.
Why do people use the Orange Book (patent and exclusivity lookups)?
Searchers typically use it to understand the regulatory “protected periods” for a drug. Patent and exclusivity information in the Orange Book is often what determines whether an applicant can submit certain abbreviated applications and when generic or biosimilar competition may be possible under FDA rules.
How do FDA Orange Book entries relate to generics and “ANDA” approvals?
Orange Book patent and exclusivity data are used during generic drug development to identify which listed patents/exclusivities are tied to the reference listed drug. That information is central to FDA pathways like ANDAs, because the applicant must address the relevant listed information.
Where can I find the Orange Book online?
Drug listings and Orange Book information are provided through FDA’s Orange Book website (the “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations”).
Do you need a specific drug’s Orange Book record?
If you share the drug name (brand or generic), I can help you pinpoint what Orange Book entry to look for and what kinds of patent/exclusivity fields to check on that page.