Bendamustine - PharmaKB

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.

Download report

Favorite

Events Timeline

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

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

Mock data
Subscribe for the real data

Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
hemic and lymphatic diseases	D006425
immune system diseases	D007154

Trade Name

FDA

EMA

Belrapzo, Bendeka, Treanda, Vivimusta (generic drugs available since 2022-12-07)

Drug Products

FDA

EMA

New Drug Application (NDA)

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	2024-01-19
bendamustine	ANDA	2023-06-05
bendamustine hydrochloride	New Drug Application	2024-02-28
bendeka	New Drug Application	2024-01-19
treanda	New Drug Application	2022-10-27
vivimusta	New Drug Application	2022-12-07

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
lymphoid leukemia	—	D007945	C91
non-hodgkin lymphoma	—	D008228	C85.9

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Bendamustine Hydrochloride, Vivimusta, Slayback Pharma Llc
11844784	2042-07-29	DP
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
11844783	2031-01-28		U-1542, U-1971, U-1972
11872214	2031-01-28	DP
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

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

399 clinical trials

View more details

Mock data
Subscribe for the real data

Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	31	40	24	1	10	97
Follicular lymphoma	D008224	—	C82	17	23	11	2	2	48

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-hodgkin lymphoma	D008228	—	C85.9	27	26	18	—	3	65
Mantle-cell lymphoma	D020522	—	C83.1	21	28	8	—	1	50
Multiple myeloma	D009101	—	C90.0	22	29	1	—	2	40
Large b-cell lymphoma diffuse	D016403	—	C83.3	13	24	5	—	1	35
Lymphoma	D008223	—	C85.9	16	16	3	—	1	31
Hodgkin disease	D006689	—	C81	16	21	1	—	1	30
Neoplasms	D009369	—	C80	10	5	1	—	—	13
Leukemia	D007938	—	C95	3	5	1	—	—	7
Lymphoid leukemia	D007945	—	C91	—	2	1	—	1	4

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
Waldenstrom macroglobulinemia	D008258	HP_0005508	C88.0	5	5	—	—	—	9
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	6	6	—	—	—	9
Myeloid leukemia acute	D015470	—	C92.0	5	5	—	—	—	7
B-cell lymphoma	D016393	—	—	6	2	—	—	—	7
T-cell lymphoma peripheral	D016411	—	—	3	3	—	—	—	6
Large-cell lymphoma anaplastic	D017728	—	C84.6	4	3	—	—	—	5
Burkitt lymphoma	D002051	—	C83.7	4	2	—	—	—	5
Myelodysplastic syndromes	D009190	—	D46	3	4	—	—	—	5
Breast neoplasms	D001943	EFO_0003869	C50	3	3	—	—	—	4

Show 34 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 5 more

Indications Without Phase

No data

Epidemiology

Epidemiological information for investigational and approved indications

View more details

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