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Drug ReportsBendamustine
Bendamustine
Belrapzo, Bendamustine, 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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Drug
Target
Variants
Financial
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Events Timeline
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1M
3M
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EMA approval date
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Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Belrapzo, Bendamustine, Bendeka, Treanda, Vivimusta (discontinued: Bendamustine, Treanda)
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
VIVIMUSTAAzurityN-212209 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
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
belrapzoNew Drug Application2024-09-23
bendamustineANDA2023-06-05
bendamustine hydrochlorideANDA2024-09-19
bendekaNew Drug Application2024-01-19
treandaNew Drug Application2022-10-27
vivimustaNew Drug Application2024-02-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-hodgkin lymphoma—D008228C85.9
lymphoid leukemia—D007945C91
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Bendamustine Hydrochloride, Vivimusta, Slayback Pharma Llc
118447842042-07-29DP
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
118447832031-01-28U-1542, U-1971, U-1972
118722142031-01-28DP
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
417 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.99013958210260
B-cell chronic lymphocytic leukemiaD015451—C91.1374225110105
LeukemiaD007938—C9539432119100
Lymphoid leukemiaD007945—C9133372111092
Follicular lymphomaD008224—C822129202266
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228—C85.9434123—394
Mantle-cell lymphomaD020522——233512—365
B-cell lymphomaD016393——32355—261
Large b-cell lymphoma diffuseD016403—C83.319317—146
Multiple myelomaD009101—C90.024301—344
Plasma cell neoplasmsD054219——21281—239
Hodgkin diseaseD006689—C8119254—238
B-cell lymphoma marginal zoneD018442—C88.41196——23
T-cell lymphomaD016399——772——15
T-cell lymphoma peripheralD016411——672——14
Show 4 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD012008——127———15
Precursor cell lymphoblastic leukemia-lymphomaD054198——88———13
Waldenstrom macroglobulinemiaD008258HP_0005508C88.057———11
Myeloid leukemia acuteD015470—C92.057———9
Myelodysplastic syndromesD009190—D4636———7
Myeloid leukemiaD007951—C9255———7
Large-cell lymphoma anaplasticD017728—C84.653———6
MycosesD009181—B35-B4942———5
Sezary syndromeD012751—C84.142———5
Mycosis fungoidesD009182—C84.042———5
Show 55 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lymphoproliferative disordersD008232Orphanet_2442D47.92———24
Immune system diseasesD007154—D89.92————2
Immunoproliferative disordersD007160—C88.92————2
AdenocarcinomaD000230——2————2
NeuroblastomaD009447EFO_0000621—1————1
Primary cutaneous anaplastic large cell lymphomaD054446—C86.61————1
Lymphomatoid papulosisD017731—C86.61————1
Plasma cell leukemiaD007952—C90.11————1
Large granular lymphocytic leukemiaD054066——1————1
Prolymphocytic leukemiaD015463——1————1
Show 17 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)Loading
Structure (InChI/SMILES or Protein Sequence)
Cn1c(CCCC(=O)O)nc2cc(N(CCCl)CCCl)ccc21
Identifiers
PDB—
CAS-ID16506-27-7
RxCUI—
ChEMBL IDCHEMBL487253
ChEBI ID—
PubChem CID65628
DrugBankDB06769
UNII ID9266D9P3PQ (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Bendeka – Eagle Pharmaceuticals
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Treanda – Cephalon
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Belrapzo – Eagle Pharmaceuticals
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,491 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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19,558 adverse events reported
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