Jakafi
An oral medication used to treat bone marrow disorders like myelofibrosis and polycythemia vera.
Where Ruxolitinib is approved
All regulators →Of the three regulators tracked here, the first to approve Ruxolitinib was the US, on 16 Nov 2011. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of polycythaemia vera (19 Feb 2014, withdrawn)
- 1 EU safety letter (DHPC), latest: quality defect for Opzelura, 24 Apr 2025
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.
Ruxolitinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Ruxolitinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 34 listed patents; the last listed expires 5 May 2041 (US 11602536).
- Exclusivity PED: Pediatric exclusivity, until 22 Mar 2029.
- Exclusivity ODE-373: Orphan drug exclusivity: treatment of chronic graft-versus-host disease (cgvhd) after failure of one or two lines of systemic therapy in ad…, until 22 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 22 Sep 2028.
- Exclusivity NPP: New patient population, until 18 Sep 2028.
- Exclusivity PED: Pediatric exclusivity, until 24 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 Ruxolitinib
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 Ruxolitinib works
All drug targets →- Tyrosine-protein kinase JAK1 inhibitor InhibitorTarget: JAK1 Janus kinase 1✓ In ChEMBL and the Guide to Pharmacology
- Tyrosine-protein kinase JAK2 inhibitor InhibitorTarget: JAK2 Janus kinase 2✓ In ChEMBL and the Guide to Pharmacology
- Tyrosine-protein kinase JAK3 inhibitor InhibitorTarget: JAK3 Janus kinase 3✓ In ChEMBL and the Guide to Pharmacology
- Tyrosine-protein kinase TYK2 inhibitor InhibitorTarget: TYK2 tyrosine kinase 2✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- Acute graft versus host diseasePhase 3
- Acute respiratory distress syndromePhase 3
- Exocrine pancreatic carcinomaPhase 3
- Hand eczemaPhase 3
- Hemophagocytic syndromePhase 3
- Hidradenitis suppurativaPhase 3
- Macrophage activation syndromePhase 3
- Malignant pancreatic neoplasmPhase 3
- Pancreatic adenocarcinomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1789941, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 5688, 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 Ruxolitinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 10 technology appraisals of Ruxolitinib. 8 are current, and 4 of these recommend it for at least some patients. 2 older appraisals were 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 Ruxolitinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 4 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- 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 Ruxolitinib
- ATC code
- L01XE18
- ChEMBL
- CHEMBL1789941
- DrugBank
- DB08877
- PubChem CID
- 25126798
- CAS number
- 941678-49-5
- FDA UNII
- 82S8X8XX8H
- Wikidata
- Q7383611
- Wikipedia
- Ruxolitinib
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 Jakafi is used for
JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. ( 1.1 ) polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. ( 1.2 ) steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. ( 1.3 ) chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. ( 1.4 ) 1.1 Myelofibrosis JAKAFI/JAKAFI XR is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF in adults. 1.2 Polycythemia Vera JAKAFI/JAKAFI XR is indicated for treatment of polycy…
How it works
12.1 Mechanism of Action Ruxolitinib, a kinase inhibitor, inhibits Janus Associated Kinases (JAKs), JAK1 and JAK2, which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation, and subsequent localization of STATs to the nucleus leading to modulation of gene expression. MF and PV are myeloproliferative neoplasms (MPNs) known to be associated with dysregulated JAK1 and JAK2 signaling. In a mouse model of JAK2V617F-positive MPN, oral administration of ruxolitinib prevented splenomegaly, preferent…
Related clinical trials recruiting now
Compare Jakafi 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 12 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.