Xeljanz
An oral JAK inhibitor for rheumatoid arthritis and ulcerative colitis.
Where Tofacitinib is approved
All regulators →Of the three regulators tracked here, the first to approve Tofacitinib was the US, on 6 Nov 2012. It is approved in 3 of the 3 regulators tracked here.
- 3 EU safety letters (DHPC), latest: referral - article 20 procedure for Cibinqo / Jyseleca / Olumiant / Rinvoq / Xeljanz, 21 Feb 2023
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.
Tofacitinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Tofacitinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 3 listed patents; the last listed expires 14 Sep 2034 (US 11253523, including a 6-month paediatric extension).
- Exclusivity PED: Pediatric exclusivity, until 21 Aug 2028.
- Exclusivity M-14: Other exclusivity: additional clinical trial information added to pediatric use subsection, until 21 Feb 2028.
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 Tofacitinib
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 Tofacitinib works
All drug targets →- Janus Kinase (JAK) inhibitor InhibitorTarget: Janus Kinase (JAK)✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- Takayasu arteritisPhase 3
- Acute respiratory distress syndromePhase 3
- Alopecia areataPhase 3
- Alopecia totalisPhase 3
- Alopecia universalis congenitaPhase 3
- Ankylosing spondylitisPhase 3
- Enthesitis-related juvenile idiopathic arthritisPhase 3
- GlioblastomaPhase 3
- Granulomatosis with polyangiitisPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL221959, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 5677, 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 Tofacitinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Tofacitinib. 5 are current, and 5 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Tofacitinib for treating active ankylosing spondylitis NICE TA920 | Optimised | 18 Oct 2023 | Current |
| Tofacitinib for treating juvenile idiopathic arthritis NICE TA735 | Optimised | 20 Oct 2021 | Current |
| Tofacitinib for moderately to severely active ulcerative colitis NICE TA547 | Recommended | 28 Nov 2018 | Current |
| Tofacitinib for treating active psoriatic arthritis after inadequate response to DMARDs NICE TA543 | Recommended | 3 Oct 2018 | Current |
| Tofacitinib for moderate to severe rheumatoid arthritis NICE TA480 | Optimised | 11 Oct 2017 | 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 Tofacitinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 8 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: XeljanzEMA 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 Tofacitinib
- ATC code
- L04AA29
- ChEMBL
- CHEMBL221959
- DrugBank
- DB08895
- PubChem CID
- 9926791
- CAS number
- 477600-75-2
- FDA UNII
- 87LA6FU830
- Wikidata
- Q3530324
- Wikipedia
- Tofacitinib
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 Xeljanz is used for
XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) are Janus kinase (JAK) inhibitors. XELJANZ tablets and XELJANZ XR are indicated for the treatment of adult patients with: • Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. • Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers. • Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. • Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. XELJANZ (tablets and oral solution) are indicated for the treatment of pediatric patients 2 years of age and older with: • Active PsA, who have had an inadequate response or intolerance to …
How it works
12.1 Mechanism of Action Tofacitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate Signal Transducers and Activators of Transcription (STATs) which modulate intracellular activity including gene expression. Tofacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs. JAK enzymes transmit cytokine signaling through pairing of JAKs (e.g., JAK1/JAK3, JAK1/JAK2, JAK1/TyK2, …
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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 9 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.