Orange Book
The FDA-maintained list of approved drug products with patent and exclusivity information.
Definition
The Orange Book ("Approved Drug Products with Therapeutic Equivalence Evaluations") is the FDA publication listing all approved drug products, along with associated patents, market exclusivities, and therapeutic equivalence codes used by pharmacies for generic substitution.
See also
- Paragraph IV — A generic manufacturer's certification that a brand drug's patents are invalid or not infringed.
- ANDA — The FDA pathway for approving a generic copy of a previously-approved small-molecule drug.