Updated Orange Book, Patent/Exclusivity FAQs
Orange Book
identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and related patent and exclusivity information. LEARN
Patent Submission Date
date on which FDA receives patent information from NDA holder (21 C.F.R. 314.53(d)(ii)(5) LEARN
Orange Book Update
search results and drug listings now show patent submission dates where available; may help generic drug manufacturers determine earliest date for marketing LEARN
Patent vs. Exclusivity
Patent– granted by US Patent and Trademark Office anytime during drug development; encompass a wide range of claims.
Exclusivity– granted per FD&C Act. delays and prohibitions on approval of competitor drugs; for NDA and ANDA holders; promote balance between new drug innovation and generic drug competition LEARN
Image credit: FDA