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AboutPricing
Drug ReportsRivaroxaban
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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
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2Y
5Y
Max
Events
FDA approval date
EMA approval date
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Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
nervous system diseasesD009422
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
operative surgical proceduresD013514
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
XARELTOJohnson & JohnsonN-022406 RX2011-07-01
4 products, RLD
XARELTOJohnson & JohnsonN-215859 RX2021-12-20
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
rivaroxabanANDA2025-08-19
rivaroxaban granuleANDA2025-09-22
xareltoNew Drug Application2025-08-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
venous thrombosis—D020246I82.40
pulmonary embolismEFO_0003827D011655I26
Agency Specific
FDA
EMA
Expiration
Code
RIVAROXABAN, XARELTO, JANSSEN PHARMS
2025-06-20PED
2025-02-23PED
2024-12-20NP
2024-08-23I-867
2023-09-10PED
2023-04-11PED
2023-03-10M-284
Patent Expiration
Patent
Expires
Flag
FDA Information
Rivaroxaban, Xarelto, Janssen Pharms
108283102039-01-31U-3207, U-3208
95392182034-02-17U-1953, U-1954, U-1955, U-1957, U-2143, U-2641, U-3285, U-3288, U-3289
94150532024-11-13DPU-1167, U-1200, U-1301, U-1302, U-2142, U-2435, U-2640, U-3205, U-3206, U-3284, U-3286, U-3287
71574562024-08-28DS, DPU-1301, U-1302
ATC Codes
B: Blood and blood forming organ drugs
— B01: Antithrombotic agents
— B01A: Antithrombotic agents
— B01AF: Direct factor xa inhibitors
— B01AF01: Rivaroxaban
HCPCS
No data
Clinical
Clinical Trials
652 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 fibrillationD001281EFO_0000275I48.0——523542
Venous thrombosisD020246—I82.4022311321
Pulmonary embolismD011655EFO_0003827I26—1321117
Coronary artery diseaseD003324—I25.1—112—4
Peripheral arterial diseaseD058729EFO_0004265———22—4
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Venous thromboembolismD054556EFO_0004286I74—37—1727
StrokeD020521EFO_0000712I63.9——7—1320
ThromboembolismD013923——2111—619
ThrombosisD013927——414—817
EmbolismD004617——111—1013
Acute coronary syndromeD054058EFO_0005672——21—47
NeoplasmsD009369—C80——1—34
Transient ischemic attackD002546EFO_0003764G45.9——2—13
Heart failureD006333EFO_0003144I50——2—13
SyndromeD013577———11——2
Show 18 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiovascular diseasesD002318EFO_0000319I98—2——13
Embolism and thrombosisD016769———1——23
Vascular diseasesD014652EFO_0004264I77—1——12
Bariatric surgeryD050110———1———1
Respiratory tract diseasesD012140———1———1
Acquired immunodeficiency syndromeD000163EFO_0000765B20—1———1
Lung diseasesD008171EFO_0003818J98.4—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5————5
Renal insufficiencyD051437—N191———12
PharmacokineticsD010599——2————2
Biological availabilityD001682——2————2
Chronic kidney failureD007676EFO_0003884N18.61————1
Hemophilia bD002836—D671————1
Therapeutic equivalencyD013810——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Intracranial hemorrhagesD020300EFO_0000551I62————22
Gastrointestinal hemorrhageD006471—K92.2————22
Personal satisfactionD010549——————22
HemorrhageD006470MP_0001914R58————11
Uterine hemorrhageD014592——————11
AnemiaD000740EFO_0004272D64.9————11
IschemiaD007511EFO_0000556—————11
Brain ischemiaD002545EFO_0003883I67.82————11
Replacement arthroplasty kneeD019645——————11
Replacement arthroplasty hipD019644——————11
Show 3 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRivaroxaban
INNrivaroxaban
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 classantithrombotics, blood coagulation factor XA inhibitors
Image (chem structure or protein)Loading
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-ID366789-02-8
RxCUI—
ChEMBL IDCHEMBL198362
ChEBI ID68579
PubChem CID9875401
DrugBankDB06228
UNII ID9NDF7JZ4M3 (ChemIDplus, GSRS)
Target
Agency Approved
F10
F10
Organism
Homo sapiens
Gene name
F10
Gene synonyms
NCBI Gene ID
2159
Protein name
coagulation factor X
Protein synonyms
factor X, factor Xa, prothrombinase, Stuart factor, Stuart-Prower factor
Uniprot ID
Q14340
Mouse ortholog
F10 (14058)
coagulation factor X (Q99L32)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Xarelto – Johnson & Johnson
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Tabular view
Estimated US medical usage
Rivaroxaban
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 25,029 documents
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Safety
Black-box Warning
Black-box warning for: Rivaroxaban, Rivaroxaban granule, Xarelto
Adverse Events
Top Adverse Reactions
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147,117 adverse events reported
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