Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Patents Exclusivity topic
No spam. Unsubscribe anytime.
Truong explains Orange Book patent and exclusivity listings, and how to submit patent data
Summary
Truong said NDA holders must submit patent information using Form FDA 3542 and described which patent fields appear in the Orange Book (patent number, expiry dates, substance/product flags, use codes and delist request flags).
Truong described how patent and exclusivity information enter the Orange Book and what fields are recorded. "NDA holder submits the patent information through form FDA 35 42, and then DOPRA reviews it for technical completeness as a ministerial role," the presenter said, indicating that patent submissions are processed and recorded with fields such as patent number, expiry dates, drug substance and drug product flags, and use codes (MOU). The speaker noted the Orange Book also records submission dates and delisting-request flags where applicable.
On exclusivity, Truong said the Orange Book is the official reference for marketing-exclusivity periods associated with listed drugs and pointed attendees to a March 2026 Q&A document on clinical-investigation (three-year) exclusivity. The presenter advised using the current FDA form available on the agency website for patent submissions and to check downloadable patent text files when verifying listing details.
