Xarelto(rivaroxaban)
Rivaroxaban, Xarelto (rivaroxaban) is a small molecule pharmaceutical. Rivaroxaban was first approved as Xarelto on 2008-09-30. It is used to treat pulmonary embolism and venous thrombosis in the USA. It has been approved in Europe to treat acute coronary syndrome, atrial fibrillation, coronary artery disease, peripheral arterial disease, and pulmonary embolism amongst others. The pharmaceutical is active against coagulation factor X.
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Commercial
Trade Name
FDA
EMA
Rivaroxaban, Xarelto (discontinued: Rivaroxaban)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Rivaroxaban
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XARELTO | Johnson & Johnson | N-022406 RX | 2011-07-01 | 4 products, RLD |
| XARELTO | Johnson & Johnson | N-215859 RX | 2021-12-20 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| rivaroxaban | ANDA | 2026-04-29 |
| rivaroxaban granule | ANDA | 2026-04-13 |
| xarelto | New Drug Application | 2026-02-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| venous thrombosis | — | D020246 | I82.40 |
| pulmonary embolism | EFO_0003827 | D011655 | I26 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
RIVAROXABAN, XARELTO, JANSSEN PHARMS | |||
| 2025-06-20 | PED | ||
| 2025-02-23 | PED | ||
| 2024-12-20 | NP | ||
| 2024-08-23 | I-867 | ||
| 2023-09-10 | PED | ||
| 2023-04-11 | PED | ||
| 2023-03-10 | M-284 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Rivaroxaban, Xarelto, Janssen Pharms | |||
| 10828310 | 2039-01-31 | U-3207, U-3208 | |
| 9539218 | 2034-02-17 | U-1953, U-1954, U-1955, U-1957, U-2143, U-2641, U-3285, U-3288, U-3289 | |
| 9415053 | 2024-11-13 | DP | U-1167, U-1200, U-1301, U-1302, U-2142, U-2435, U-2640, U-3205, U-3206, U-3284, U-3286, U-3287 |
| 7157456 | 2024-08-28 | DS, DP | U-1301, U-1302 |
HCPCS
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Clinical
Clinical Trials
673 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | 4 | 7 | 19 | 41 | 134 | 204 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | 5 | 13 | 33 | 13 | 51 | 112 |
| Thrombosis | D013927 | — | — | 8 | 9 | 18 | 11 | 47 | 90 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | 6 | 18 | 15 | 40 | 77 |
| Venous thrombosis | D020246 | — | I82.40 | 5 | 7 | 19 | 13 | 34 | 76 |
| Thromboembolism | D013923 | — | — | 4 | 6 | 19 | 8 | 37 | 73 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 3 | 3 | 14 | 10 | 23 | 52 |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | — | 2 | 7 | 9 | 27 | 44 |
| Embolism | D004617 | — | — | 3 | 1 | 2 | 6 | 25 | 37 |
| Ischemic stroke | D000083242 | — | — | — | 4 | 7 | 6 | 20 | 35 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 18 | 4 | 1 | — | 2 | 24 |
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | — | — | 5 | — | 5 | 10 |
| Hemostatic disorders | D020141 | — | — | 3 | 1 | 1 | — | 5 | 9 |
| Heart valve diseases | D006349 | EFO_0009551 | I08 | — | 2 | 2 | — | 3 | 6 |
| Transient ischemic attack | D002546 | EFO_0003764 | G45.9 | — | 1 | 2 | — | 2 | 5 |
| Patent foramen ovale | D054092 | — | Q21.12 | — | 1 | 2 | — | 2 | 5 |
| Postoperative complications | D011183 | — | — | — | — | 1 | — | 3 | 4 |
| Cerebral hemorrhage | D002543 | — | — | — | 1 | 1 | — | 2 | 4 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | 1 | — | 2 | 4 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | 2 | — | 2 | 4 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vascular diseases | D014652 | EFO_0004264 | I77 | 1 | 1 | — | — | 2 | 4 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | 2 | 3 |
| Bariatric surgery | D050110 | — | — | 1 | 1 | — | — | 1 | 3 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 1 | 1 | — | — | — | 2 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | 1 | — | — | — | 2 |
| Brain ischemia | D002545 | EFO_0003883 | I67.82 | — | 1 | — | — | 1 | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 1 | — | — | — | 1 |
| Esophageal neoplasms | D004938 | — | C15 | — | 1 | — | — | — | 1 |
| Duodenal neoplasms | D004379 | — | — | — | 1 | — | — | — | 1 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 4 | — | — | — | — | 4 |
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | 1 | 3 |
| Coagulation protein disorders | D020147 | — | — | 3 | — | — | — | — | 3 |
| Anthrax | D000881 | — | A22 | 2 | — | — | — | — | 2 |
| Poisoning | D011041 | EFO_0008546 | T65.91 | 2 | — | — | — | — | 2 |
| Morbid obesity | D009767 | EFO_0001074 | — | 1 | — | — | — | 1 | 2 |
| Biological availability | D001682 | — | — | 2 | — | — | — | — | 2 |
| Inflammation | D007249 | MP_0001845 | — | 1 | — | — | — | 1 | 2 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | 1 | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | — | 1 |
Show 13 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 5 | 5 |
| Postoperative hemorrhage | D019106 | — | — | — | — | — | — | 3 | 3 |
| Postphlebitic syndrome | D011186 | — | I87.0 | — | — | — | — | 3 | 3 |
| Gastrointestinal hemorrhage | D006471 | — | K92.2 | — | — | — | — | 3 | 3 |
| Thrombophilia | D019851 | — | D68.59 | — | — | — | — | 2 | 2 |
| Oral surgical procedures | D019647 | — | — | — | — | — | — | 2 | 2 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | — | — | — | 2 | 2 |
| Length of stay | D007902 | — | — | — | — | — | — | 2 | 2 |
| Therapeutic chemoembolization | D016461 | — | — | — | — | — | — | 2 | 2 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 2 | 2 |
Show 64 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Rivaroxaban |
| INN | rivaroxaban |
| Description | Rivaroxaban is a monocarboxylic acid amide obtained by formal condensation of the carboxy group of 5-chlorothiophene-2-carboxylic acid with the amino group of 4-{4-[(5S)-5-(aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one. It is an anticoagulant used for prophylaxis of venous thromboembolism in patients with knee or hip replacement surgery. It has a role as an anticoagulant and an EC 3.4.21.6 (coagulation factor Xa) inhibitor. It is a member of thiophenes, an organochlorine compound, an oxazolidinone, a member of morpholines, a lactam, an aromatic amide and a monocarboxylic acid amide. Rivaroxaban is an orally bioavailable oxazolidinone derivative and direct inhibitor of the coagulation factor Xa with anticoagulant activity. Upon oral administration, rivaroxaban selectively binds to both free factor Xa and factor Xa bound in the prothrombinase complex. This interferes with the conversion of prothrombin (factor II) to thrombin and eventually prevents the formation of cross-linked fibrin clots. Rivaroxaban does not affect existing thrombin levels. |
| Classification | Small molecule |
| Drug class | antithrombotics, blood coagulation factor XA inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1 |
Identifiers
| PDB | — |
| CAS-ID | 366789-02-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL198362 |
| ChEBI ID | 68579 |
| PubChem CID | 9875401 |
| DrugBank | DB06228 |
| UNII ID | 9NDF7JZ4M3 (ChemIDplus, GSRS) |
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Xarelto – Johnson & Johnson
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Rivaroxaban
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Safety
Black-box Warning
Black-box warning for: Rivaroxaban, Rivaroxaban granule, Xarelto
Adverse Events
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148,412 adverse events reported
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