Prescription medicine

Zanubrutinib Brand names: Brukinsa

Zanubrutinib (Brukinsa) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the zanubrutinib FDA label on DailyMed (effective July 21, 2026, BeOne Medicines USA, Inc.); the NDA 213217 record on Drugs@FDA; every zanubrutinib label on DailyMed.

Highlights of the record

FDA label of July 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have received at least one prior therapy.

Forms and strengths

80 mg
160 mg

Capsule; film-coated tablet.

On the market

Earliest approval on file: November 14, 2019 Brukinsa, Beone Medicines Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: January 19, 2043 Brukinsa tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is zanubrutinib used for?

From the label: indications and usage
BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have received at least one prior therapy. ( 1.1 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Waldenström's macroglobulinemia (WM). ( 1.2 ) Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. ( 1.3 ) This indication is approved under accelerated approval based on overall response rate. […]

Conditions named in the indications of zanubrutinib's FDA labels, with every medicine labeled for each:

Leukemia, lymphoma and myeloma

From other zanubrutinib labels
Leukemia, lymphoma and myeloma: Mantle Cell Lymphoma BRUKINSA is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

FDA pharmacologic class: Kinase Inhibitor.

Source: FDA drug label (BRUKINSA), BeOne Medicines USA, Inc., effective July 21, 2026 (SPL set 3e08fe23-d70e-424c-bc51-1222e320f902), via openFDA; the full label on DailyMed

Is there a generic for zanubrutinib (Brukinsa)?

No generic zanubrutinib is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 13 patents for Brukinsa tablets: the compound patent runs to August 15, 2037, and the last listed entry to January 19, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2019 earliest approval on file
2043 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What else is labeled for the same conditions as zanubrutinib?

37 other medicines are given the same way (oral) and in the same FDA class as zanubrutinib or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (oral)	Pharmacy cost	Shortage
Dasatinib	Leukemia, lymphoma and myeloma	14 labelers	$26.46 per tablet 100 mg tablet	No current entry
Imatinib	Leukemia, lymphoma and myeloma	20 labelers	$0.624 per tablet 100 mg tablet	No current entry
Nilotinib	Leukemia, lymphoma and myeloma	6 labelers	n/a	No current entry
Bosutinib	Leukemia, lymphoma and myeloma	3 labelers	n/a	No current entry
Ibrutinib	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry
Ponatinib	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry
Acalabrutinib	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry
Pirtobrutinib	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry

Every medicine labeled for the same conditions as zanubrutinib

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to zanubrutinib: 37 medicines for the same use
Other kinase inhibitors: the pharmacologic class, with prices and generics
Check an interaction: what two or more labels say about each other