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Drug ReportsRituximab
Rituxan, Mabthera(rituximab)
MabThera, Riabni, Rituxan, Ruxience, Truxima (rituximab) is an antibody pharmaceutical. Rituximab was first approved as Rituxan on 1997-11-26. It is used to treat b-cell lymphoma, granulomatosis with polyangiitis, lymphoid leukemia, mantle-cell lymphoma, and microscopic polyangiitis amongst others in the USA. It has been approved in Europe to treat b-cell chronic lymphocytic leukemia, microscopic polyangiitis, non-hodgkin lymphoma, pemphigus, and rheumatoid arthritis amongst others. The pharmaceutical is active against B-lymphocyte antigen CD20.
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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
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
neoplasmsD009369
musculoskeletal diseasesD009140
respiratory tract diseasesD012140
nervous system diseasesD009422
cardiovascular diseasesD002318
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Riabni, Rituxan, Ruxience, Truxima
Combinations
Rituxan hycela
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Rituximab
Tradename
Proper name
Company
Number
Date
Products
RituxanrituximabGenentechN-103705 RX1997-11-26
2 products
Show 1 discontinued
Hyaluronidase human
+
Rituximab
Tradename
Proper name
Company
Number
Date
Products
Rituxan Hycelarituximab and hyaluronidase humanGenentechN-761064 RX2017-06-22
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
rituxan hycelaBiologic Licensing Application2021-06-30
Agency Specific
FDA
EMA
Expiration
Code
rituximab, Rituxan, Genentech, Inc.
2026-09-27Orphan excl.
rituximab / hyaluronidase human, Rituxan Hycela, Genentech, Inc.
2024-06-22Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01X: Other antineoplastic agents in atc
L01XC: Monoclonal antibodies, antineoplastic
L01XC02: Rituximab
HCPCS
Code
Description
J9311
Injection, rituximab 10 mg and hyaluronidase
J9312
Injection, rituximab, 10 mg
Q5115
Injection, rituximab-abbs, biosimilar, (truxima), 10 mg
Q5119
Injection, rituximab-pvvr, biosimilar, (ruxience), 10 mg
Q5123
Injection, rituximab-arrx, biosimilar, (riabni), 10 mg
Clinical
Clinical Trials
2477 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Large b-cell lymphoma diffuseD016403C83.310021164422347
Non-hodgkin lymphomaD008228C85.911119152922334
B-cell chronic lymphocytic leukemiaD015451C91.18513338423249
Follicular lymphomaD008224C826610746112199
Mantle-cell lymphomaD020522C83.1541071914158
Rheumatoid arthritisD001172EFO_0000685M06.91319322133113
B-cell lymphomaD016393384761380
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0245265177
Waldenstrom macroglobulinemiaD008258HP_0005508C88.0275451172
Burkitt lymphomaD002051C83.7203612149
Show 35 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C801516123
Multiple myelomaD009101C90.01411120
Hairy cell leukemiaD007943C91.4711115
Lymphomatoid granulomatosisD008230C83.881215
Hematologic neoplasmsD01933786114
Intraocular lymphomaD0640908913
Plasma cell neoplasmsD0542194610
Biphenotypic leukemia acuteD015456C95.0469
Prolymphocytic leukemiaD015463448
Aids-related lymphomaD016483EFO_1001365167
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Indications Without Phase
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRituximab
INNrituximab
Description
Rituximab, sold under the brand name Rituxan among others, is a medication used to treat certain autoimmune diseases and types of cancer. It is used for non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, idiopathic thrombocytopenic purpura, pemphigus vulgaris, myasthenia gravis and Epstein–Barr virus-positive mucocutaneous ulcers. It is given by slow injection into a vein.
Classification
Antibody
Drug classmonoclonal antibodies: chimeric, tumors as target
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
>1L6X:A|IMMUNOGLOBULIN GAMMA-1 HEAVY CHAIN CONSTANT REGION GPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNG KEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPP VLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSL >1L6X:B|Minimized B-domain of Protein A Z34C FNMQCQRRFYEALHDPNLNEEQRNAKIKSIRDDC
Identifiers
PDB1L6X, 2OSL, 4KAQ, 6VJA, 6Y90
CAS-ID
RxCUI
ChEMBL IDCHEMBL1201576
ChEBI ID
PubChem CID
DrugBankDB00073
UNII ID4F4X42SYQ6 (ChemIDplus, GSRS)
Target
Agency Approved
MS4A1
MS4A1
Organism
Homo sapiens
Gene name
MS4A1
Gene synonyms
CD20
NCBI Gene ID
Protein name
B-lymphocyte antigen CD20
Protein synonyms
B-lymphocyte cell-surface antigen B1, B-lymphocyte surface antigen B1, Bp35, CD20, CD20 antigen, CD20 receptor, Leukocyte surface antigen Leu-16, Membrane-spanning 4-domains subfamily A member 1, membrane-spanning 4-domains, subfamily A, member 1
Uniprot ID
Mouse ortholog
Ms4a1 (12482)
B-lymphocyte antigen CD20 (P19437)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
£
Rituxan Biogen
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Rituxan Roche
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Ruxience Pfizer
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Tabular view
Estimated US medical usage
Rituximab
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 75,350 documents
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Safety
Black-box Warning
Black-box warning for: Rituxan hycela
Adverse Events
Top Adverse Reactions
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138,528 adverse events reported
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