zanubrutinib · Beone Medicines Usa · NDA 213217, 218785
Brukinsa
Earliest generic entry, as listed
19 Jan 2043
Blocked by patent: US 11786531, US 11896596, US 11911386. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 13 unexpired
69 Orange Book listing rows for 13 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11786531 | use U-3715, U-3716, U-3717, U-3718, U-3719, U-3720, U-3875 | 19 Jan 2043 |
| US 11786531 listing row | use U-3715 · sets the listed date | 19 Jan 2043 |
| US 11786531 listing row | use U-3716 · sets the listed date | 19 Jan 2043 |
| US 11786531 listing row | use U-3717 · sets the listed date | 19 Jan 2043 |
| US 11786531 listing row | use U-3718 · sets the listed date | 19 Jan 2043 |
| US 11786531 listing row | use U-3719 · sets the listed date | 19 Jan 2043 |
| US 11786531 listing row | use U-3720 · sets the listed date | 19 Jan 2043 |
| US 11786531 listing row | use U-3875 · sets the listed date | 19 Jan 2043 |
| US 11896596 | use U-3715, U-3716, U-3717, U-3718, U-3719, U-3720, U-3875 | 19 Jan 2043 |
| US 11896596 listing row | use U-3715 · sets the listed date | 19 Jan 2043 |
| US 11896596 listing row | use U-3716 · sets the listed date | 19 Jan 2043 |
| US 11896596 listing row | use U-3717 · sets the listed date | 19 Jan 2043 |
| US 11896596 listing row | use U-3718 · sets the listed date | 19 Jan 2043 |
| US 11896596 listing row | use U-3719 · sets the listed date | 19 Jan 2043 |
| US 11896596 listing row | use U-3720 · sets the listed date | 19 Jan 2043 |
| US 11896596 listing row | use U-3875 · sets the listed date | 19 Jan 2043 |
| US 11911386 | use U-3715, U-3716, U-3717, U-3718, U-3719, U-3720, U-3875 | 19 Jan 2043 |
| US 11911386 listing row | use U-3715 · sets the listed date | 19 Jan 2043 |
| US 11911386 listing row | use U-3716 · sets the listed date | 19 Jan 2043 |
| US 11911386 listing row | use U-3717 · sets the listed date | 19 Jan 2043 |
| US 11911386 listing row | use U-3718 · sets the listed date | 19 Jan 2043 |
| US 11911386 listing row | use U-3719 · sets the listed date | 19 Jan 2043 |
| US 11911386 listing row | use U-3720 · sets the listed date | 19 Jan 2043 |
| US 11911386 listing row | use U-3875 · sets the listed date | 19 Jan 2043 |
| US 12233069 | drug product | 10 Jun 2040 |
| US 11701357 | use U-3860 | 24 Jun 2039 |
| US 10927117 | drug substance, drug product | 15 Aug 2037 |
| US 11591340 | use U-1745, U-2145, U-2537, U-2666, U-3063, U-3486, U-3727, U-3728, U-3729 | 15 Aug 2037 |
| US 11591340 listing row | use U-1745 | 15 Aug 2037 |
| US 11591340 listing row | use U-2145 | 15 Aug 2037 |
| US 11591340 listing row | use U-2537 | 15 Aug 2037 |
| US 11591340 listing row | use U-2666 | 15 Aug 2037 |
| US 11591340 listing row | use U-3063 | 15 Aug 2037 |
| US 11591340 listing row | use U-3486 | 15 Aug 2037 |
| US 11591340 listing row | use U-3727 | 15 Aug 2037 |
| US 11591340 listing row | use U-3728 | 15 Aug 2037 |
| US 11591340 listing row | use U-3729 | 15 Aug 2037 |
| US 11851437 | drug substance, drug product | 15 Aug 2037 |
| US 11884674 | use U-1745, U-2145, U-2537, U-2666, U-3063, U-3486, U-3860 | 15 Aug 2037 |
| US 11884674 listing row | use U-1745 | 15 Aug 2037 |
| US 11884674 listing row | use U-2145 | 15 Aug 2037 |
| US 11884674 listing row | use U-2537 | 15 Aug 2037 |
| US 11884674 listing row | use U-2666 | 15 Aug 2037 |
| US 11884674 listing row | use U-3063 | 15 Aug 2037 |
| US 11884674 listing row | use U-3486 | 15 Aug 2037 |
| US 11884674 listing row | use U-3860 | 15 Aug 2037 |
| US 11970500 | use U-1745, U-2145, U-2537, U-2666, U-3063, U-3486, U-3860 | 15 Aug 2037 |
| US 11970500 listing row | use U-1745 | 15 Aug 2037 |
| US 11970500 listing row | use U-2145 | 15 Aug 2037 |
| US 11970500 listing row | use U-2537 | 15 Aug 2037 |
| US 11970500 listing row | use U-2666 | 15 Aug 2037 |
| US 11970500 listing row | use U-3063 | 15 Aug 2037 |
| US 11970500 listing row | use U-3486 | 15 Aug 2037 |
| US 11970500 listing row | use U-3860 | 15 Aug 2037 |
| US 10570139 | use U-1745, U-2145, U-2537, U-2666, U-3063, U-3486, U-3860 | 22 Apr 2034 |
| US 10570139 listing row | use U-1745 | 22 Apr 2034 |
| US 10570139 listing row | use U-2145 | 22 Apr 2034 |
| US 10570139 listing row | use U-2537 | 22 Apr 2034 |
| US 10570139 listing row | use U-2666 | 22 Apr 2034 |
| US 10570139 listing row | use U-3063 | 22 Apr 2034 |
| US 10570139 listing row | use U-3486 | 22 Apr 2034 |
| US 10570139 listing row | use U-3860 | 22 Apr 2034 |
| US 11142528 | drug product, use U-1745, U-2145, U-2537, U-2666, U-3063, U-3486, U-3860 | 22 Apr 2034 |
| US 11142528 listing row | drug product, use U-1745 | 22 Apr 2034 |
| US 11142528 listing row | drug product, use U-2145 | 22 Apr 2034 |
| US 11142528 listing row | drug product, use U-2537 | 22 Apr 2034 |
| US 11142528 listing row | drug product, use U-2666 | 22 Apr 2034 |
| US 11142528 listing row | drug product, use U-3063 | 22 Apr 2034 |
| US 11142528 listing row | drug product, use U-3486 | 22 Apr 2034 |
| US 11142528 listing row | drug product, use U-3860 | 22 Apr 2034 |
| US 9447106 | drug substance, drug product, use U-1745, U-2145, U-2537, U-2666, U-3063, U-3486, U-3860 | 22 Apr 2034 |
| US 9447106 listing row | drug substance, drug product, use U-1745 | 22 Apr 2034 |
| US 9447106 listing row | drug substance, drug product, use U-2145 | 22 Apr 2034 |
| US 9447106 listing row | drug substance, drug product, use U-2537 | 22 Apr 2034 |
| US 9447106 listing row | drug substance, drug product, use U-2666 | 22 Apr 2034 |
| US 9447106 listing row | drug substance, drug product, use U-3063 | 22 Apr 2034 |
| US 9447106 listing row | drug substance, drug product, use U-3486 | 22 Apr 2034 |
| US 9447106 listing row | drug substance, drug product, use U-3860 | 22 Apr 2034 |
Exclusivities · 7 unexpired
| ODE* | 7 Mar 2031 | |
| ODE-467 | orphan drug (7 years) | 7 Mar 2031 |
| ODE-274 | orphan drug (7 years) | 19 Jan 2030 |
| ODE* | 19 Jan 2030 | |
| ODE-370 | orphan drug (7 years) | 14 Sep 2028 |
| ODE* | 14 Sep 2028 | |
| ODE* | 31 Aug 2028 | |
| ODE-371 | orphan drug (7 years) | 31 Aug 2028 |
| I-936 | new indication (3 years) | 7 Mar 2027 |
| ODE* | 14 Nov 2026 | |
| ODE-276 | orphan drug (7 years) | 14 Nov 2026 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Exclusivity expires within 90 days ODE* · 218785-001Exclusivity expires 14 Nov 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days ODE-276 · 213217-001Exclusivity expires 14 Nov 2026Detected 24 Oct 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213217 · 001 · RLD · discontinued | capsule, oral | 80MG | 19 Jan 2043 |
| 218785 · 001 · RLD | tablet, oral | 160MG | 19 Jan 2043 |
Expired or delisted (1)
- I-817 · 19 Jan 2026