Scroll

bendamustine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antineoplastic, alkylating agents, (beta-chloroethyl)amine derivatives	302	16506-27-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: bendamustine bendamustine hydrochloride treanda bendamustine HCl	A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA. Molecular weight: 358.26 Formula: C16H21Cl2N3O2 CLOGP: 3.24 LIPINSKI: 0 HAC: 5 HDO: 1 TPSA: 58.36 ALOGS: -3.76 ROTB: 9 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

bendamustine
bendamustine hydrochloride
treanda
bendamustine HCl

A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA.

Molecular weight: 358.26
Formula: C16H21Cl2N3O2
CLOGP: 3.24
LIPINSKI: 0
HAC: 5
HDO: 1
TPSA: 58.36
ALOGS: -3.76
ROTB: 9

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

Show entries

Search:

Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	6.26 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
CL (Clearance)	4.49 mL/min/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	1 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	0.41 hours	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.22 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.05 %	Lombardo F, Berellini G, Obach RS

Showing 1 to 7 of 7 entries

Previous1Next

Approvals:

Date	Agency	Company	Orphan
March 20, 2008	FDA	CEPHALON
Sept. 27, 2010	PMDA	SymBio Pharmaceuticals Limited

FDA Adverse Event Reporting System (Female)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Disease progression	816.58	21.27	498	19591	122260	63346673
Progressive multifocal leukoencephalopathy	486.57	21.27	175	19914	12796	63456137
Neutropenia	471.39	21.27	411	19678	174594	63294339
Pancytopenia	407.48	21.27	296	19793	96637	63372296
Febrile neutropenia	382.18	21.27	309	19780	118140	63350793
Lymphoma	345.73	21.27	134	19955	12053	63456880
Neutrophil count decreased	338.90	21.27	215	19874	56191	63412742
Cytomegalovirus infection	325.01	21.27	150	19939	20802	63448131
Blood lactate dehydrogenase increased	310.94	21.27	150	19939	22966	63445967
Diffuse large B-cell lymphoma recurrent	282.16	21.27	77	20012	2243	63466690

Showing 1 to 10 of 159 entries

Previous1 2 3 4 5…16Next

FDA Adverse Event Reporting System (Male)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Disease progression	878.93	17.43	735	29598	107342	34819256
Febrile neutropenia	418.04	17.43	552	29781	136297	34790301
Progressive multifocal leukoencephalopathy	360.79	17.43	174	30159	9590	34917008
Off label use	327.15	17.43	946	29387	418578	34508020
Cytomegalovirus infection	316.97	17.43	226	30107	25909	34900689
Pyrexia	300.77	17.43	793	29540	332220	34594378
Neutrophil count decreased	273.88	17.43	276	30057	50828	34875770
Lymphocyte count decreased	259.13	17.43	189	30144	22433	34904165
Neutropenia	239.42	17.43	461	29872	156317	34770281
Myelosuppression	229.85	17.43	165	30168	19100	34907498

Showing 1 to 10 of 218 entries

Previous1 2 3 4 5…22Next

FDA Adverse Event Reporting System (Geriatric)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Disease progression	1119.80	16.45	861	41265	183501	79518761
Progressive multifocal leukoencephalopathy	723.53	16.45	305	41821	20295	79681967
Febrile neutropenia	673.59	16.45	714	41412	230285	79471977
Cytomegalovirus infection	555.39	16.45	321	41805	42323	79659939
Neutropenia	500.22	16.45	684	41442	287026	79415236
Off label use	491.81	16.45	1307	40819	905908	78796354
Myelosuppression	486.95	16.45	289	41837	40007	79662255
Pyrexia	473.47	16.45	1078	41048	677631	79024631
Neutrophil count decreased	446.46	16.45	381	41745	93578	79608684
Cytopenia	389.71	16.45	198	41928	20185	79682077

Showing 1 to 10 of 338 entries

Previous1 2 3 4 5…34Next

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Show entries

Search:

Source	Code	Description
ATC	L01AA09	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS ALKYLATING AGENTS Nitrogen mustard analogues
FDA EPC	N0000175558	Alkylating Drug
FDA MoA	N0000000236	Alkylating Activity
MeSH PA	D000477	Alkylating Agents
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D018906	Antineoplastic Agents, Alkylating
MeSH PA	D009676	Noxae

Showing 1 to 7 of 7 entries

Previous1Next

Drug Use | Suggest Off label Use Form| |View source of the data|

Show entries

Search:

Disease	Relation	SNOMED_ID
Chronic lymphoid leukemia, disease	indication	92814006
Follicular non-Hodgkin's lymphoma	indication	308121000
Treatment prior to tumor-specific T-cell infusion therapy	indication
Indolent B-Cell Lymphoma	indication
Diffuse large B-cell lymphoma refractory	indication
Mantle cell lymphoma	off-label use	443487006
Fluid volume disorder	contraindication	1860003
Hyperkalemia	contraindication	14140009
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004

Showing 1 to 10 of 21 entries

Previous1 2 3Next

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.61	acidic
pKa2	6.18	Basic
pKa3	2.83	Basic

Orange Book patent data (new drug applications)

Show entries

Search:

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	8791270	Jan. 12, 2026	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	8791270	Jan. 12, 2026	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	8791270	Jan. 12, 2026	FOR USE IN TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	11103483	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	11103483	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	9572796	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	9572796	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	9572797	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	9572797	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	11103483	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Showing 1 to 10 of 48 entries

Previous1 2 3 4 5Next

Orange Book exclusivity data (new drug applications)

Show entries

Search:

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG/VIAL	BENDAMUSTINE HYDROCHLORIDE	ACCORD HLTHCARE	A205574	Dec. 7, 2022	RX	POWDER	IV (INFUSION)	June 5, 2023	PATENT CHALLENGE
25MG/VIAL	BENDAMUSTINE HYDROCHLORIDE	ACCORD HLTHCARE	A205574	Dec. 7, 2022	RX	POWDER	IV (INFUSION)	June 5, 2023	PATENT CHALLENGE

Showing 1 to 2 of 2 entries

Previous1Next

Bioactivity Summary:

Show entries

Search:

Target	Class	Pharos	UniProt	Type	Activity value (-log[M])	Bioact source
Histone deacetylase 5	Enzyme	Q9UQL6	HDAC5_HUMAN	IC50	8	CHEMBL
Histone deacetylase 2	Enzyme	Q92769	HDAC2_HUMAN	IC50	8.05	CHEMBL
Histone deacetylase 1	Enzyme	Q13547	HDAC1_HUMAN	IC50	7.77	CHEMBL
Histone deacetylase 3	Enzyme	O15379	HDAC3_HUMAN	IC50	7.60	CHEMBL
Histone deacetylase 6	Enzyme	Q9UBN7	HDAC6_HUMAN	IC50	8.22	CHEMBL
Histone deacetylase 8	Enzyme	Q9BY41	HDAC8_HUMAN	IC50	6.97	CHEMBL
Histone deacetylase 4	Enzyme	P56524	HDAC4_HUMAN	IC50	8	CHEMBL
Histone deacetylase 10	Enzyme	Q969S8	HDA10_HUMAN	IC50	7.14	CHEMBL

Showing 1 to 8 of 8 entries

Previous1Next

External reference:

Show entries

Search:

ID	Source
006925	NDDF
006926	NDDF
1114693	RXNORM
132929	MMSL
241056	MMSL
25220	MMSL
275320	MMSL
3543-75-7	SECONDARY_CAS_RN
4027339	VUID
4027339	VANDF

Showing 1 to 10 of 26 entries

Previous1 2 3Next

Pharmaceutical products:

Show entries

Search:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
BELRAPZO	HUMAN PRESCRIPTION DRUG LABEL	1	42367-521	INJECTION	100 mg	INTRAVENOUS	NDA	29 sections
BELRAPZO	HUMAN PRESCRIPTION DRUG LABEL	1	42367-521	INJECTION	100 mg	INTRAVENOUS	NDA	29 sections
Bendamustine	HUMAN PRESCRIPTION DRUG LABEL	1	71288-102	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 mg	INTRAVENOUS	ANDA	28 sections
Bendamustine	HUMAN PRESCRIPTION DRUG LABEL	1	71288-103	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	28 sections
BENDAMUSTINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	10019-079	INJECTION	100 mg	INTRAVENOUS	NDA	26 sections
bendamustine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	16729-250	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 mg	INTRAVENOUS	ANDA	26 sections
bendamustine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	16729-251	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	26 sections
BENDAMUSTINE HYDROCHLORIDE	Human Prescription Drug Label	1	55150-391	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 mg	INTRAVENOUS	ANDA	27 sections
BENDAMUSTINE HYDROCHLORIDE	Human Prescription Drug Label	1	55150-392	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	27 sections
Bendamustine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	60505-6095	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 mg	INTRAVENOUS	ANDA	24 sections

Showing 1 to 10 of 25 entries

Previous1 2 3Next