Xarelto
An oral anticoagulant for clot prevention and treatment.
Where Rivaroxaban is approved
All regulators →Of the three regulators tracked here, the first to approve Rivaroxaban was Canada, on 15 Sep 2008. It is approved in 3 of the 3 regulators tracked here.
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.
Rivaroxaban patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Rivaroxaban, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 1 listed patent; the last listed expires 17 Aug 2034 (US 9539218, including a 6-month paediatric extension).
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 Rivaroxaban
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 Rivaroxaban works
All drug targets →- Coagulation factor X inhibitor InhibitorTarget: F10 coagulation factor X✓ In ChEMBL and the Guide to Pharmacology
- Behcet diseasePhase 3
- Portal vein thrombosisPhase 3
- ST Elevation Myocardial InfarctionPhase 3
- ThrombocytopeniaPhase 3
- ThromboembolismPhase 3
- Aortic stenosisPhase 3
- Autoimmune polyendocrinopathyPhase 3
- Cardiovascular disorderPhase 3
- HemorrhagePhase 3
- Mitral valve stenosisPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL198362, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 6388, 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 Rivaroxaban
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Rivaroxaban. 5 are current, and 5 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Rivaroxaban for preventing adverse outcomes after acute management of acute coronary syndrome NICE TA335 | Recommended | 25 Mar 2015 | Current |
| Rivaroxaban for treating pulmonary embolism and preventing recurrent venous thromboembolism NICE TA287 | Recommended | 26 Jun 2013 | Current |
| Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism NICE TA261 | Recommended | 25 Jul 2012 | Current |
| Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation NICE TA256 | Recommended | 23 May 2012 Updated 2 Jul 2021 | Current |
| Rivaroxaban for preventing venous thromboembolism after hip or knee replacement surgery NICE TA170 | Recommended | 22 Apr 2009 | 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 Rivaroxaban
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 65 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Xarelto, Rivaroxaban Accord (generic), Rivaroxaban Viatris (previously Rivaroxaban Mylan) (generic), Svariya (previously Rivaroxaban Koanaa) (generic)EMA 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 Rivaroxaban
- ATC code
- B01AF01
- ChEMBL
- CHEMBL198362
- DrugBank
- DB06228
- PubChem CID
- 9875401
- CAS number
- 366789-02-8
- FDA UNII
- 9NDF7JZ4M3
- Wikidata
- Q420262
- Wikipedia
- Rivaroxaban
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 Xarelto is used for
XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1 ) for treatment of deep vein thrombosis (DVT) ( 1.2 ) for treatment of pulmonary embolism (PE) ( 1.3 ) for reduction in the risk of recurrence of DVT or PE ( 1.4 ) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5 ) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6 ) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) ( 1.7 ) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD ( 1.8 ) for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth…
How it works
12.1 Mechanism of Action XARELTO is a selective inhibitor of FXa. It does not require a cofactor (such as Anti-thrombin III) for activity. Rivaroxaban inhibits free FXa and prothrombinase activity. Rivaroxaban has no direct effect on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin. By inhibiting FXa, rivaroxaban decreases thrombin generation.
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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 10 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.