Drug facts
BrandBrukinsa (Zanubrutinib)
No generic zanubrutinib is approved; the latest Brukinsa patent or exclusivity in the Orange Book runs to 01/19/2043.
Brukinsa was first approved by the FDA on 06/10/2025 under NDA 218785; the application holder is Beone Medicines USA Inc.
Holder Beone Medicines USA IncApplication NDA 218785Approved 06/10/2025
01Patents and exclusivity
When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.
5,924days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved06/10/2025
Exclusivity ends03/07/2031
Last patent01/19/2043
2026202920322035203820412044
- Latest patent
- 01/19/2043Brukinsa Orange Book
- Exclusivity
- 03/07/2031Brukinsa Orange Book
02Competition
- Generics
- No generic approved Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Brukinsa profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Beone Medicines USA Inc Orange Book
- Application
- NDA 218785 Orange Book
- First approved
- 06/10/2025 Orange Book
- Dosage forms
- tablet
- Routes
- oral
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.