The FDA Orange Book lists approved generic drugs and tells pharmacists which ones can safely replace brand-name medications. It's the backbone of drug substitution in the U.S., using therapeutic equivalence codes to guide safe swaps.
Learn how to find and interpret patent expiration dates in the FDA Orange Book - the official source for tracking when generic drugs can enter the market. Includes step-by-step search tips and key limitations.
Authorized generics let brand drugmakers sell their own cheaper versions after patent expiration. They're identical to the brand, avoid FDA approval delays, and lower prices - but can confuse patients and delay competition.
