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
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 HYDROCHLORIDE | Apotex | N-215033 RX | 2022-12-07 | 1 products, RLD, RS |
BENDAMUSTINE HYDROCHLORIDE | Baxter | N-216078 RX | 2022-12-15 | 1 products, RLD, RS |
TREANDA | Cephalon | N-022249 RX | 2008-03-20 | 2 products, RLD, RS |
BELRAPZO | Eagle Pharmaceuticals | N-205580 RX | 2018-05-15 | 1 products, RLD, RS |
BENDEKA | Eagle Pharmaceuticals | N-208194 RX | 2015-12-07 | 1 products, RLD, RS |
BENDAMUSTINE HYDROCHLORIDE | Hospira | N-211530 PEND | 2022-12-15 | 3 products, RLD |
VIVIMUSTA | Slayback Pharma | N-212209 RX | 2022-12-07 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
belrapzo | New Drug Application | 2021-02-18 |
bendamustine hydrochloride | ANDA | 2023-06-20 |
bendeka | New Drug Application | 2021-01-15 |
treanda | New Drug Application | 2020-05-27 |
vivimusta | New Drug Application | 2022-12-07 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
BENDAMUSTINE HYDROCHLORIDE, BENDAMUSTINE HYDROCHLORIDE, ACCORD HLTHCARE | |||
2023-06-05 | PC |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Bendamustine Hydrochloride, Bendeka, Eagle Pharms | |||
9000021 | 2033-03-15 | U-1542 | |
9034908 | 2033-03-15 | U-1542 | |
9144568 | 2033-03-15 | U-1542 | |
9572887 | 2033-03-15 | U-1971, U-1972 | |
9579384 | 2033-03-15 | U-1971, U-1972 | |
9597397 | 2033-03-15 | U-1971, U-1972 | |
9597398 | 2033-03-15 | U-1971 | |
9597399 | 2033-03-15 | U-1971, U-1972 | |
10052385 | 2033-03-15 | U-1971, U-1972 | |
Bendamustine Hydrochloride, Belrapzo, Eagle Pharms | |||
8609707 | 2031-08-11 | DP | U-1542, U-1971, U-1972 |
9265831 | 2031-01-28 | DP | |
9572796 | 2031-01-28 | DP | U-1971, U-1972 |
9572797 | 2031-01-28 | U-1971, U-1972 | |
10010533 | 2031-01-28 | DP | |
11103483 | 2031-01-28 | DP | U-1971, U-1972 |
8791270 | 2026-01-12 | DP | U-1542, U-1790, U-1971, U-1972 |
Bendamustine Hydrochloride, Treanda, Cephalon | |||
8436190 | 2030-10-26 | DP | |
8344006 | 2029-09-23 | DP | U-1402 |
8445524 | 2029-03-26 | DS, DP | U-1402 |
8669279 | 2029-03-26 | DP | U-1402 |
8883836 | 2029-03-26 | DP | U-1402 |
9533955 | 2029-03-26 | DP | U-1949, U-1952 |
8609863 | 2026-01-12 | DP | |
8895756 | 2026-01-12 | DP |
Clinical
Clinical Trials
314 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Non-hodgkin lymphoma | D008228 | C85.9 | 25 | 24 | 16 | — | 1 | 57 | |
Mantle-cell lymphoma | D020522 | C83.1 | 18 | 24 | 7 | — | 1 | 41 | |
Multiple myeloma | D009101 | C90.0 | 20 | 26 | 1 | — | — | 33 | |
Hodgkin disease | D006689 | C81 | 16 | 21 | 1 | — | 1 | 29 | |
Large b-cell lymphoma diffuse | D016403 | C83.3 | 10 | 20 | 5 | — | — | 27 | |
Lymphoma | D008223 | C85.9 | 13 | 13 | 2 | — | — | 25 | |
Neoplasms | D009369 | C80 | 7 | 3 | 1 | — | — | 10 | |
Leukemia | D007938 | C95 | 3 | 5 | 1 | — | — | 7 | |
Lymphoid leukemia | D007945 | C91 | — | 2 | 1 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
B-cell lymphoma marginal zone | D018442 | C88.4 | 6 | 6 | — | — | — | 10 | |
Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 6 | 7 | — | — | — | 9 | |
Waldenstrom macroglobulinemia | D008258 | C88.0 | 5 | 4 | — | — | — | 8 | |
Myeloid leukemia acute | D015470 | C92.0 | 5 | 6 | — | — | — | 7 | |
B-cell lymphoma | D016393 | 6 | 2 | — | — | — | 7 | ||
T-cell lymphoma peripheral | D016411 | C84.9 | 2 | 3 | — | — | — | 5 | |
Burkitt lymphoma | D002051 | C83.7 | 4 | 3 | — | — | — | 5 | |
Myelodysplastic syndromes | D009190 | D46 | 3 | 5 | — | — | — | 5 | |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 3 | — | — | — | 4 |
T-cell lymphoma | D016399 | 1 | 3 | — | — | — | 4 |
Show 31 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Immune system diseases | D007154 | D89.9 | 2 | — | — | — | — | 2 | |
Immunoproliferative disorders | D007160 | C88.9 | 2 | — | — | — | — | 2 | |
Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | 1 | — | — | — | 1 | 2 |
Neuroblastoma | D009447 | EFO_0000621 | 1 | — | — | — | — | 1 | |
Primary cutaneous anaplastic large cell lymphoma | D054446 | C86.6 | 1 | — | — | — | — | 1 | |
Mycosis fungoides | D009182 | C84.0 | 1 | — | — | — | — | 1 | |
T-cell lymphoma cutaneous | D016410 | C84.A | 1 | — | — | — | — | 1 | |
Lymphomatoid papulosis | D017731 | C86.6 | 1 | — | — | — | — | 1 | |
Plasma cell leukemia | D007952 | C90.1 | 1 | — | — | — | — | 1 | |
Large granular lymphocytic leukemia | D054066 | 1 | — | — | — | — | 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 name | BENDAMUSTINE |
INN | bendamustine |
Description | Bendamustine is a member of benzimidazoles. |
Classification | Small molecule |
Drug class | antineoplastics (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-ID | 16506-27-7 |
RxCUI | 134547 |
ChEMBL ID | CHEMBL487253 |
ChEBI ID | — |
PubChem CID | 65628 |
DrugBank | DB06769 |
UNII ID | 9266D9P3PQ (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
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1,122 adverse events reported
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