FDA Orange Book · active-ingredient family
Zanubrutinib
Zanubrutinib is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:BRUKINSA · NDA 218785
2
Brand (NDA)
0
Generics (ANDA)
13
Listed patents
14
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BRUKINSARLD | BEONE MEDICINES USA | NDA 218785 | — | Jun 10, 2025 | |
| BRUKINSARLD | BEONE MEDICINES USA | NDA 213217 | — | Nov 14, 2019 |
Marketing exclusivity (14)
- I-817New indication exclusivity (3 years)
Jan 19, 2026
5 mo ago
- I-936New indication exclusivity (3 years)
Mar 07, 2027
in 9 mo
- ODE-274Orphan-drug exclusivity (7 years)
Jan 19, 2030
in 3 yr 8 mo
- ODE-276Orphan-drug exclusivity (7 years)
Nov 14, 2026
in 5 mo
- ODE-370Orphan-drug exclusivity (7 years)
Sep 14, 2028
in 2 yr 3 mo
- ODE-371Orphan-drug exclusivity (7 years)
Aug 31, 2028
in 2 yr 3 mo
- ODE-467Orphan-drug exclusivity (7 years)
Mar 07, 2031
in 4 yr 9 mo
- I-817New indication exclusivity (3 years)
Jan 19, 2026
5 mo ago
- I-936New indication exclusivity (3 years)
Mar 07, 2027
in 9 mo
- ODE*FDA marketing exclusivity
Mar 07, 2031
in 4 yr 9 mo
- ODE*FDA marketing exclusivity
Sep 14, 2028
in 2 yr 3 mo
- ODE*FDA marketing exclusivity
Jan 19, 2030
in 3 yr 8 mo
- ODE*FDA marketing exclusivity
Aug 31, 2028
in 2 yr 3 mo
- ODE*FDA marketing exclusivity
Nov 14, 2026
in 5 mo
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9447106 | Apr 22, 2034 | in 7 yr 11 mo | SubstanceProductU-2145 |
| 10570139 | Apr 22, 2034 | in 7 yr 11 mo | U-1745 |
| 11142528 | Apr 22, 2034 | in 7 yr 11 mo | ProductU-2666 |
| 11884674 | Aug 15, 2037 | in 11 yr 4 mo | U-1745 |
| 11591340 | Aug 15, 2037 | in 11 yr 4 mo | U-1745 |
| 11970500 | Aug 15, 2037 | in 11 yr 4 mo | U-1745 |
| 11851437 | Aug 15, 2037 | in 11 yr 4 mo | SubstanceProduct |
| 10927117 | Aug 15, 2037 | in 11 yr 4 mo | SubstanceProduct |
| 11701357 | Jun 24, 2039 | in 13 yr 2 mo | U-3860 |
| 12233069 | Jun 10, 2040 | in 14 yr 2 mo | Product |
| 11911386 | Jan 19, 2043 | in 16 yr 10 mo | U-3715 |
| 11786531 | Jan 19, 2043 | in 16 yr 10 mo | U-3875 |
| 11896596 | Jan 19, 2043 | in 16 yr 10 mo | U-3715 |
Zanubrutinib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
