Imbruvica
An oral targeted therapy for chronic lymphocytic leukaemia and lymphomas.
Where Ibrutinib is approved
All regulators →Of the three regulators tracked here, the first to approve Ibrutinib was the US, on 12 Feb 2014. It is approved in 3 of the 3 regulators tracked here.
- 5 EU orphan designations, most recently for treatment of graft-versus-host disease (18 Nov 2016, withdrawn)
- 1 EU safety letter (DHPC), latest: post-authorisation measure for Imbruvica, 3 Nov 2022
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.
Ibrutinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Ibrutinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 41 listed patents; the last listed expires 14 Jun 2039 (US 12201690).
- Latest patent on the drug substance itself: 30 Apr 2034 (US 9296753, with paediatric extension).
- Exclusivity PED: Pediatric exclusivity, until 24 Feb 2030.
- Exclusivity ODE-405: Orphan drug exclusivity: treatment of pediatric patients age 1 year and older with chronic graft-versus-host disease (cgvhd) after failure …, until 24 Aug 2029.
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 Ibrutinib
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 Ibrutinib 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
- Burkitt lymphomaPhase 3
- Waldenstrom macroglobulinemiaPhase 3
- Chronic graft versus host diseasePhase 3
- Diffuse large B-cell lymphomaPhase 3
- Follicular lymphomaPhase 3
- Indolent B-cell non-Hodgkin lymphomaPhase 3
- Malignant pancreatic neoplasmPhase 3
- Marginal zone lymphomaPhase 3
- Non-Hodgkin lymphomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1873475, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 6912, 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 Ibrutinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 9 technology appraisals of Ibrutinib. 8 are current, and 2 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.
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 Ibrutinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 5 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: ImbruvicaEMA 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 Ibrutinib
- ATC code
- L01XE27
- ChEMBL
- CHEMBL1873475
- DrugBank
- DB09053
- PubChem CID
- 24821094
- CAS number
- 936563-96-1
- FDA UNII
- 1X70OSD4VX
- Wikidata
- Q5984881
- Wikipedia
- Ibrutinib
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 Imbruvica is used for
IMBRUVICA is a kinase inhibitor indicated for the treatment of: Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) ( 1.1 ). Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion ( 1.2 ). Adult patients with Waldenström’s macroglobulinemia (WM) ( 1.3 ). Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy ( 1.4 ). 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). 1. 2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphom…
How it works
12.1 Mechanism of Action Ibrutinib is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK). Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. BTK’s role in signaling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion. Nonclinical studies show that ibrutinib inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro .
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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 8 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.