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
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 | 2025-05-20 |
| xarelto | New Drug Application | 2025-04-07 |
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
646 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 | 2 | 5 | 7 | 3 | 47 | 63 |
| Thromboembolism | D013923 | — | — | 3 | 7 | 15 | 1 | 20 | 45 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | 1 | 6 | 14 | 1 | 20 | 42 |
| Thrombosis | D013927 | — | — | 7 | 6 | 10 | 2 | 15 | 39 |
| Embolism | D004617 | — | — | 2 | — | 6 | 4 | 15 | 27 |
| Venous thrombosis | D020246 | — | I82.40 | 4 | 5 | 6 | 1 | 10 | 26 |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | — | — | 4 | 4 | 9 | 17 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | 3 | 1 | 7 | 12 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | 2 | 2 | 3 | 7 |
| Coronary artery disease | D003324 | — | I25.1 | — | 1 | 1 | 2 | 2 | 6 |
Show 19 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | 2 | 1 | — | 5 | 8 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | 1 | — | 2 | 4 |
| Infarction | D007238 | EFO_0009463 | — | — | — | 2 | — | 1 | 3 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 2 | — | 1 | 3 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 1 | — | 1 | 2 |
| Rheumatic diseases | D012216 | — | M79.0 | — | — | 2 | — | — | 2 |
| Percutaneous coronary intervention | D062645 | — | — | — | — | 1 | — | 1 | 2 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 2 | — | — | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | 1 | — | — | 2 |
| Hematoma | D006406 | EFO_0010680 | — | — | — | 1 | — | — | 1 |
Show 23 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemic stroke | D000083242 | — | — | — | 1 | — | — | 3 | 4 |
| Ischemia | D007511 | EFO_0000556 | — | — | 1 | — | — | 2 | 3 |
| Transient ischemic attack | D002546 | EFO_0003764 | G45.9 | — | 1 | — | — | 1 | 2 |
| Bariatric surgery | D050110 | — | — | 1 | 1 | — | — | — | 2 |
| Cerebral infarction | D002544 | — | I63 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 6 | — | — | — | 1 | 7 |
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Biological availability | D001682 | — | — | 2 | — | — | — | — | 2 |
| Morbid obesity | D009767 | EFO_0001074 | — | 1 | — | — | — | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | — | 1 |
| Disease | D004194 | EFO_0000408 | R69 | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Replacement arthroplasty knee | D019645 | — | — | — | — | — | — | 2 | 2 |
| Replacement arthroplasty hip | D019644 | — | — | — | — | — | — | 2 | 2 |
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | — | — | — | — | 1 | 1 |
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Brain ischemia | D002545 | EFO_0003883 | I67.82 | — | — | — | — | 1 | 1 |
| Congenital heart defects | D006330 | — | Q24.9 | — | — | — | — | 1 | 1 |
| Fontan procedure | D018729 | — | — | — | — | — | — | 1 | 1 |
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, Xarelto
Adverse Events
Top Adverse Reactions
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146,405 adverse events reported
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