Rinvoq
An oral daily medication used to treat rheumatoid arthritis, eczema, ulcerative colitis, and Crohn's disease.
Where Upadacitinib is approved
All regulators →Of the three regulators tracked here, the first to approve Upadacitinib was the US, on 16 Aug 2019. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of systemic sclerosis (20 Apr 2026, positive)
- 1 EU safety letter (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.
Upadacitinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Upadacitinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 45 listed patents; the last listed expires 9 Mar 2038 (US 11607411).
- Exclusivity ODE-538: Orphan drug exclusivity: treatment of adults with giant cell arteritis, until 28 Apr 2032.
- Exclusivity ODE-481: Orphan drug exclusivity: treatment of pediatric patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis w…, until 26 Apr 2031.
- Exclusivity I-966: New indication: treatment of adults with giant cell arteritis, until 28 Apr 2028.
- Exclusivity I-946: New indication: treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pjia) who have had …, until 26 Apr 2027.
- Exclusivity NPP: New patient population, until 26 Apr 2027.
- Exclusivity NP: New product, until 26 Apr 2027.
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 Upadacitinib
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 Upadacitinib works
All drug targets →- Tyrosine-protein kinase TYK2 inhibitor InhibitorTarget: TYK2 tyrosine 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 JAK2 inhibitor InhibitorTarget: JAK2 Janus kinase 2✓ In ChEMBL and the Guide to Pharmacology
- Tyrosine-protein kinase JAK1 inhibitor InhibitorTarget: JAK1 Janus kinase 1✓ In ChEMBL and the Guide to Pharmacology
- Cognitive impairmentPhase 3
- DyspneaPhase 3
- FatiguePhase 3
- Respiratory distressPhase 3
- Sleep disturbancePhase 3
- Takayasu arteritisPhase 3
- Alopecia areataPhase 3
- Hidradenitis suppurativaPhase 3
- Systemic lupus erythematosusPhase 3
- Systemic-onset juvenile idiopathic arthritisPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3622821, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 9246, 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 Upadacitinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 8 technology appraisals of Upadacitinib. 8 are current, and 8 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Upadacitinib for previously treated moderately to severely active Crohn’s disease NICE TA905 | Optimised | 21 Jun 2023 | Current |
| Upadacitinib for treating active non-radiographic axial spondyloarthritis NICE TA861 | Optimised | 1 Feb 2023 | Current |
| Upadacitinib for treating moderately to severely active ulcerative colitis NICE TA856 | Recommended | 4 Jan 2023 | Current |
| Upadacitinib for treating active ankylosing spondylitis NICE TA829 | Optimised | 30 Sep 2022 | Current |
| Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis NICE TA814 | Optimised | 3 Aug 2022 | Current |
| Upadacitinib for treating active psoriatic arthritis after inadequate response to DMARDs NICE TA768 | Optimised | 2 Feb 2022 | Current |
| Upadacitinib for treating moderate rheumatoid arthritis NICE TA744 | Optimised | 10 Nov 2021 | Current |
| Upadacitinib for treating severe rheumatoid arthritis NICE TA665 | Optimised | 9 Dec 2020 | 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 Upadacitinib
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: RinvoqEMA 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 Upadacitinib
- ChEMBL
- CHEMBL3622821
- DrugBank
- DB15091
- PubChem CID
- 58557659
- CAS number
- 1310726-60-3
- FDA UNII
- 4RA0KN46E0
- Wikidata
- Q27074125
- Wikipedia
- Upadacitinib
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 Rinvoq is used for
RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor. RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. ( 1.1 ) Limitations of Use RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.1 ) RINVOQ/RINVOQ LQ is indicated for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. ( 1.2 ) Limitation s of Use RINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.2 ) RINVOQ is indicated for the trea…
How it works
12.1 Mechanism of Action Upadacitinib 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. Upadacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs. JAK enzymes transmit cytokine signaling through their pairing (e.g., JAK1/JAK2, JAK1/JAK3, JAK1/TYK2, …
Related clinical trials recruiting now
Compare Rinvoq 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.