Brukinsa
An oral targeted therapy used to treat mantle cell lymphoma and other blood cancers.
Where Zanubrutinib is approved
All regulators →Of the three regulators tracked here, the first to approve Zanubrutinib was the US, on 14 Nov 2019. It is approved in 3 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for treatment of marginal zone lymphoma (20 May 2021, withdrawn)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Zanubrutinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Zanubrutinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 13 listed patents; the last listed expires 19 Jan 2043 (US 11896596).
- Latest patent on the drug substance itself: 15 Aug 2037 (US 10927117).
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 7 Mar 2031.
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 19 Jan 2030.
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 14 Sep 2028.
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 31 Aug 2028.
- Exclusivity I-936: New indication: treatment of adult patients with relapsed or refractory follicular lymphoma (fl), in combination with obinutuzumab, after t…, until 7 Mar 2027.
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 14 Nov 2026.
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Zanubrutinib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Zanubrutinib works
All drug targets →- Tyrosine-protein kinase BTK inhibitor InhibitorTarget: BTK Bruton tyrosine kinase✓ In ChEMBL and the Guide to Pharmacology
- B-cell non-Hodgkin lymphomaPhase 3
- Diffuse large B-cell lymphomaPhase 3
- Follicular lymphomaPhase 3
- Hemophagocytic syndromePhase 3
- High grade B-cell lymphomaPhase 3
- Marginal zone lymphomaPhase 3
- Non-Hodgkin lymphomaPhase 3
- Splenic marginal zone lymphomaPhase 3
- Kidney disorderPhase 2/3
- COVID-19Phase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3936761, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 9861, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Zanubrutinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Zanubrutinib. 5 are current, and 4 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Zanubrutinib for treating relapsed or refractory mantle cell lymphoma NICE TA1081 | Optimised | 10 Jul 2025 | Current |
| Zanubrutinib for treating marginal zone lymphoma after anti-CD20-based treatment NICE TA1001 | Recommended | 4 Sep 2024 | Current |
| Zanubrutinib with obinutuzumab for treating relapsed or refractory B-cell follicular lymphoma after 2 or more treatments (terminated appraisal) NICE TA978 | Terminated (no company submission) | 29 May 2024 | Current |
| Zanubrutinib for treating chronic lymphocytic leukaemia NICE TA931 | Optimised | 22 Nov 2023 | Current |
| Zanubrutinib for treating Waldenstrom’s macroglobulinaemia NICE TA833 | Optimised | 19 Oct 2022 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Zanubrutinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: BrukinsaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Zanubrutinib
- ChEMBL
- CHEMBL3936761
- DrugBank
- DB15035
- PubChem CID
- 135565884
- CAS number
- 1691249-45-2
- FDA UNII
- AG9MHG098Z
- Wikidata
- Q75192022
- Wikipedia
- Zanubrutinib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Brukinsa is used for
Zanubrutinib (Brukinsa) is an oral targeted therapy used to treat mantle cell lymphoma and other blood cancers. It belongs to the BTK inhibitor class.
Related clinical trials recruiting now
Compare Brukinsa with
Explore more
How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 11 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.