November 2017 – Drug and Device Digest

Updated Orange Book, Patent/Exclusivity FAQs

Orange Book 2.0  New Look, New Features

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

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