FDA Orange Book
Is there a generic for Brukinsa?
Brukinsa contains zanubrutinib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Brukinsa (zanubrutinib). The Orange Book shows its last listed patent expires January 19, 2043 and its last listed exclusivity ends March 7, 2031.
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Brukinsa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 80MG | Discontinued | None | 0 | None |
| tablet, oral | 160MG | Marketed (Rx) | None | 0 | None |
NDA 213217, 218785, held by BEONE MEDICINES USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Brukinsa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9447106 | April 22, 2034 | Drug substance, Drug product | U-2145 | 213217 |
| 9447106 | April 22, 2034 | Drug substance, Drug product | U-1745 | 213217 |
| 10570139 | April 22, 2034 | Method of use | U-1745 | 213217 |
| 9447106 | April 22, 2034 | Drug substance, Drug product | U-3063 | 213217 |
| 9447106 | April 22, 2034 | Drug substance, Drug product | U-2537 | 213217 |
| 9447106 | April 22, 2034 | Drug substance, Drug product | U-2666 | 213217 |
| 10570139 | April 22, 2034 | Method of use | U-2666 | 213217 |
| 10570139 | April 22, 2034 | Method of use | U-2537 | 213217 |
| 11142528 | April 22, 2034 | Drug product | U-2666 | 213217 |
| 11142528 | April 22, 2034 | Drug product | U-2537 | 213217 |
| 11142528 | April 22, 2034 | Drug product | U-1745 | 213217 |
| 11142528 | April 22, 2034 | Drug product | U-2145 | 213217 |
| 11142528 | April 22, 2034 | Drug product | U-3063 | 213217 |
| 9447106 | April 22, 2034 | Drug substance, Drug product | U-3860 | 213217 |
| 10570139 | April 22, 2034 | Method of use | U-3860 | 213217 |
| 11142528 | April 22, 2034 | Drug product | U-3860 | 213217 |
| 10570139 | April 22, 2034 | Method of use | U-3063 | 213217 |
| 10570139 | April 22, 2034 | Method of use | U-3486 | 213217 |
| 9447106 | April 22, 2034 | Drug substance, Drug product | U-3486 | 213217 |
| 11142528 | April 22, 2034 | Drug product | U-3486 | 213217 |
| 10570139 | April 22, 2034 | Method of use | U-2145 | 213217 |
| 11884674 | August 15, 2037 | Method of use | U-1745 | 213217 |
| 11884674 | August 15, 2037 | Method of use | U-2145 | 213217 |
| 11884674 | August 15, 2037 | Method of use | U-2537 | 213217 |
| 11884674 | August 15, 2037 | Method of use | U-2666 | 213217 |
| 11884674 | August 15, 2037 | Method of use | U-3063 | 213217 |
| 11884674 | August 15, 2037 | Method of use | U-3486 | 213217 |
| 11591340 | August 15, 2037 | Method of use | U-1745 | 213217 |
| 11591340 | August 15, 2037 | Method of use | U-2145 | 213217 |
| 11591340 | August 15, 2037 | Method of use | U-2537 | 213217 |
| 11591340 | August 15, 2037 | Method of use | U-2666 | 213217 |
| 11591340 | August 15, 2037 | Method of use | U-3063 | 213217 |
| 11591340 | August 15, 2037 | Method of use | U-3486 | 213217 |
| 11970500 | August 15, 2037 | Method of use | U-1745 | 213217 |
| 11970500 | August 15, 2037 | Method of use | U-3860 | 213217 |
| 11970500 | August 15, 2037 | Method of use | U-3486 | 213217 |
| 11970500 | August 15, 2037 | Method of use | U-3063 | 213217 |
| 11970500 | August 15, 2037 | Method of use | U-2666 | 213217 |
| 11970500 | August 15, 2037 | Method of use | U-2537 | 213217 |
| 11970500 | August 15, 2037 | Method of use | U-2145 | 213217 |
| 11884674 | August 15, 2037 | Method of use | U-3860 | 213217 |
| 11591340 | August 15, 2037 | Method of use | U-3727 | 213217 |
| 11591340 | August 15, 2037 | Method of use | U-3729 | 213217 |
| 11591340 | August 15, 2037 | Method of use | U-3728 | 213217 |
| 11851437 | August 15, 2037 | Drug substance, Drug product | None | 213217 |
| 10927117 | August 15, 2037 | Drug substance, Drug product | None | 213217 |
| 11701357 | June 24, 2039 | Method of use | U-3860 | 213217 |
| 12233069 | June 10, 2040 | Drug product | None | 218785 |
| 11911386 | January 19, 2043 | Method of use | U-3715 | 213217 |
| 11911386 | January 19, 2043 | Method of use | U-3720 | 213217 |
| 11911386 | January 19, 2043 | Method of use | U-3719 | 213217 |
| 11911386 | January 19, 2043 | Method of use | U-3718 | 213217 |
| 11911386 | January 19, 2043 | Method of use | U-3717 | 213217 |
| 11911386 | January 19, 2043 | Method of use | U-3716 | 213217 |
| 11911386 | January 19, 2043 | Method of use | U-3875 | 213217 |
| 11786531 | January 19, 2043 | Method of use | U-3875 | 213217 |
| 11786531 | January 19, 2043 | Method of use | U-3715 | 213217 |
| 11786531 | January 19, 2043 | Method of use | U-3716 | 213217 |
| 11786531 | January 19, 2043 | Method of use | U-3717 | 213217 |
| 11786531 | January 19, 2043 | Method of use | U-3718 | 213217 |
Showing 60 of 69 listed patents.
Brukinsa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-817 | New indication | January 19, 2026 | 213217 |
| ODE-276 | Orphan drug exclusivity | November 14, 2026 | 213217 |
| ODE* | See the Orange Book exclusivity code list | November 14, 2026 | 218785 |
| I-936 | New indication | March 7, 2027 | 213217 |
| ODE-371 | Orphan drug exclusivity | August 31, 2028 | 213217 |
| ODE* | See the Orange Book exclusivity code list | August 31, 2028 | 218785 |
| ODE-370 | Orphan drug exclusivity | September 14, 2028 | 213217 |
| ODE* | See the Orange Book exclusivity code list | September 14, 2028 | 218785 |
| ODE-274 | Orphan drug exclusivity | January 19, 2030 | 213217 |
| ODE* | See the Orange Book exclusivity code list | January 19, 2030 | 218785 |
| ODE-467 | Orphan drug exclusivity | March 7, 2031 | 213217 |
| ODE* | See the Orange Book exclusivity code list | March 7, 2031 | 218785 |
Brukinsa NDC codes
Questions
Is there a generic for Brukinsa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Brukinsa (zanubrutinib). The Orange Book shows its last listed patent expires January 19, 2043 and its last listed exclusivity ends March 7, 2031.
What is the generic name for Brukinsa?
The active ingredient in Brukinsa is zanubrutinib, per the FDA Orange Book.
When does the Brukinsa patent expire?
The last patent listed for Brukinsa in the Orange Book expires January 19, 2043. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.