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Bendamustine
Belrapzo, Bendeka, Treanda, Vivimusta (bendamustine) is a small molecule pharmaceutical. Bendamustine was first approved as Treanda on 2008-03-20. It is used to treat lymphoid leukemia and non-hodgkin lymphoma in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Belrapzo, Bendeka, Treanda, Vivimusta (generic drugs available since 2022-12-07)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bendamustine hydrochloride
Tradename
Company
Number
Date
Products
BENDAMUSTINE HYDROCHLORIDEApotexN-215033 RX2022-12-07
1 products, RLD, RS
BENDAMUSTINE HYDROCHLORIDEBaxterN-216078 RX2022-12-15
1 products, RLD, RS
TREANDACephalonN-022249 RX2008-03-20
2 products, RLD, RS
BELRAPZOEagle PharmaceuticalsN-205580 RX2018-05-15
1 products, RLD, RS
BENDEKAEagle PharmaceuticalsN-208194 RX2015-12-07
1 products, RLD, RS
BENDAMUSTINE HYDROCHLORIDEHospiraN-211530 PEND2022-12-15
3 products, RLD
VIVIMUSTASlayback PharmaN-212209 RX2022-12-07
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
belrapzoNew Drug Application2021-02-18
bendamustine hydrochlorideANDA2023-06-20
bendekaNew Drug Application2021-01-15
treandaNew Drug Application2020-05-27
vivimustaNew Drug Application2022-12-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
lymphoid leukemia—D007945C91
non-hodgkin lymphoma—D008228C85.9
Agency Specific
FDA
EMA
Expiration
Code
BENDAMUSTINE HYDROCHLORIDE, BENDAMUSTINE HYDROCHLORIDE, ACCORD HLTHCARE
2023-06-05PC
Patent Expiration
Patent
Expires
Flag
FDA Information
Bendamustine Hydrochloride, Bendeka, Eagle Pharms
90000212033-03-15U-1542
90349082033-03-15U-1542
91445682033-03-15U-1542
95728872033-03-15U-1971, U-1972
95793842033-03-15U-1971, U-1972
95973972033-03-15U-1971, U-1972
95973982033-03-15U-1971
95973992033-03-15U-1971, U-1972
100523852033-03-15U-1971, U-1972
Bendamustine Hydrochloride, Belrapzo, Eagle Pharms
86097072031-08-11DPU-1542, U-1971, U-1972
92658312031-01-28DP
95727962031-01-28DPU-1971, U-1972
95727972031-01-28U-1971, U-1972
100105332031-01-28DP
111034832031-01-28DPU-1971, U-1972
87912702026-01-12DPU-1542, U-1790, U-1971, U-1972
Bendamustine Hydrochloride, Treanda, Cephalon
84361902030-10-26DP
83440062029-09-23DPU-1402
84455242029-03-26DS, DPU-1402
86692792029-03-26DPU-1402
88838362029-03-26DPU-1402
95339552029-03-26DPU-1949, U-1952
86098632026-01-12DP
88957562026-01-12DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01A: Alkylating agents
— L01AA: Nitrogen mustard analogues
— L01AA09: Bendamustine
HCPCS
Code
Description
J9033
Injection, bendamustine hcl (treanda), 1 mg
J9034
Injection, bendamustine hcl (bendeka), 1 mg
J9036
Injection, bendamustine hydrochloride, (belrapzo/bendamustine), 1 mg
Clinical
Clinical Trials
314 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell chronic lymphocytic leukemiaD015451C91.12735221380
Follicular lymphomaD008224C82142091—36
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228C85.9252416—157
Mantle-cell lymphomaD020522C83.118247—141
Multiple myelomaD009101C90.020261——33
Hodgkin diseaseD006689C8116211—129
Large b-cell lymphoma diffuseD016403C83.310205——27
LymphomaD008223C85.913132——25
NeoplasmsD009369C80731——10
LeukemiaD007938C95351——7
Lymphoid leukemiaD007945C91—21——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell lymphoma marginal zoneD018442C88.466———10
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.067———9
Waldenstrom macroglobulinemiaD008258C88.054———8
Myeloid leukemia acuteD015470C92.056———7
B-cell lymphomaD01639362———7
T-cell lymphoma peripheralD016411C84.923———5
Burkitt lymphomaD002051C83.743———5
Myelodysplastic syndromesD009190D4635———5
Breast neoplasmsD001943EFO_0003869C5033———4
T-cell lymphomaD01639913———4
Show 31 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Immune system diseasesD007154D89.92————2
Immunoproliferative disordersD007160C88.92————2
Lymphoproliferative disordersD008232Orphanet_2442D47.91———12
NeuroblastomaD009447EFO_00006211————1
Primary cutaneous anaplastic large cell lymphomaD054446C86.61————1
Mycosis fungoidesD009182C84.01————1
T-cell lymphoma cutaneousD016410C84.A1————1
Lymphomatoid papulosisD017731C86.61————1
Plasma cell leukemiaD007952C90.11————1
Large granular lymphocytic leukemiaD0540661————1
Show 3 more
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBENDAMUSTINE
INNbendamustine
Description
Bendamustine is a member of benzimidazoles.
Classification
Small molecule
Drug classantineoplastics (chloroethylamine derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cn1c(CCCC(=O)O)nc2cc(N(CCCl)CCCl)ccc21
Identifiers
PDB—
CAS-ID16506-27-7
RxCUI134547
ChEMBL IDCHEMBL487253
ChEBI ID—
PubChem CID65628
DrugBankDB06769
UNII ID9266D9P3PQ (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Bendeka - Eagle Pharmaceuticals
$
€
£
₣
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Treanda - Cephalon
$
€
£
₣
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Belrapzo - Eagle Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,084 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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1,122 adverse events reported
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