What does the FDA Orange Book say about VEOZAH (fezolinetant) patents and expiration?
VEOZAH (fezolinetant) is listed in the FDA’s Orange Book (the FDA’s database of approved drug products and patent/exclusivity information). The Orange Book is where you can verify which specific patents are tied to VEOZAH and the dates those patents are scheduled to expire, along with any relevant exclusivity periods. [1]
To identify the exact expiration date(s) for fezolinetant from the Orange Book, you typically need to look up:
- The approved “drug product” entry for VEOZAH (fezolinetant) and confirm the patent(s) listed for that product, then
- Check the listed “patent expiration” fields for each relevant patent, and
- Note whether any “exclusivity” entries (separate from patents) also apply, since exclusivity can delay generic entry even after patent expiry. [1]
Why can patent expiration and “Orange Book exclusivity” differ for generics?
Even if the patent expiration date passes, generic manufacturers may still be blocked by FDA-granted exclusivity listed in the Orange Book (which can be separate from patents). The FDA’s Orange Book distinguishes patent listings from exclusivity information, so the practical “earliest approval” timing for a generic can depend on both. [1]
How do you find the specific Orange Book expiration date for fezolinetant quickly?
The fastest way is to search the Orange Book for:
- Proprietary name: “VEOZAH”
- Active ingredient: “fezolinetant”
Then open the corresponding drug product entry and read the “Patent Expiration” column for each listed patent and any exclusivity entries shown for that product. [1]
Where can you verify the current dates yourself (and what can change)?
Orange Book records reflect FDA-maintained patent and exclusivity status, but details can change over time as companies submit updates or as FDA records are corrected. For that reason, the most reliable source for “current” expiration timing is the Orange Book entry itself. [1]
---
Sources
- FDA Orange Book (search by drug name, e.g., VEOZAH/fezolinetant): https://www.accessdata.fda.gov/scripts/cder/daf/