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BENDAMUSTINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for bendamustine hydrochloride and what is the scope of bendamustine hydrochloride freedom to operate?

Bendamustine hydrochloride is the generic ingredient in three branded drugs marketed by Cephalon and Eagle Pharms, and is included in three NDAs. There are twenty-four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bendamustine hydrochloride has one hundred and two patent family members in thirty-one countries.

There are twenty-three drug master file entries for bendamustine hydrochloride. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for BENDAMUSTINE HYDROCHLORIDE

International Patents:	102
US Patents:	24
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	23
Suppliers / Packagers:	3
Bulk Api Vendors:	98
Clinical Trials:	277
Patent Applications:	859
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BENDAMUSTINE HYDROCHLORIDE
DailyMed Link:	BENDAMUSTINE HYDROCHLORIDE at DailyMed

Pharmacology for BENDAMUSTINE HYDROCHLORIDE

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for BENDAMUSTINE HYDROCHLORIDE

Antineoplastic Agents, Alkylating

Synonyms for BENDAMUSTINE HYDROCHLORIDE

16506-27-7 (Parent)

1H-Benzimidazole-2-butanoic acid, 5-(bis(2-chloroethyl)amino)-1-methyl-, monohydrochloride

1H-Benzimidazole-2-butanoic acid, 5-(bis(2-chloroethyl)amino)-1-methyl-, monohydrochloride (9CI)

1H-Benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1-methyl monohydrochloride

1H-Benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1-methyl-, hydrochloride (1:1)

1H-Benzimidazole-2-butanoic acid,5-[bis(2-chloroethyl)amino]-1-methyl-, hydrochloride

1H-Benzimidazole-2-butanoicacid, 5-[bis(2-chloroethyl)amino]-1-methyl-, hydrochloride (1:?)

2-Benzimidazolebutyric acid, 5-(bis(2-chloroethyl)amino)-1-methyl-, monohydrochloride

2-Benzimidazolebutyric acid, 5-(bis(2-chloroethyl)amino)-1-methyl-, monohydrochloride (8CI)

2-Benzimidazolebutyric acid, monohydrochloride

2-Benzimidazolinebutryric acid, 1-methyl-5-bis(2-chloroethyl)amino-, hydrochloride

2-Benzimidazolinebutryric acid, hydrochloride

3543-75-7

4-(5-(Bis(2-chloroethyl)amino)-1-methyl-1H-benzo-[d]imidazol-2-yl)butanoic acid hydrochloride

4-(5-(Bis(2-chloroethyl)amino)-1-methyl-1H-benzo[d]imidazol-2-yl)butanoic acid hydrochloride

4-[5-[bis(2-chloroethyl)amino]-1-methyl-benzimidazol-2-yl]butanoic acid hydrochloride

4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid hydrochloride

4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid;hydrochloride

4-{5-[bis(2-chlorethyl)amino]-1-methyl-1h-benzimidazol-2-yl}butans

4CA-0266

5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazole-2-butanoic acid hydrochloride

5-[Bis(2-chloroethyl)amino]-1-methylbenzimidazole-2-butyric Acid Hydrochloride

543B757

97832-05-8

981Y8SX18M

AB0017997

AB1008551

ABP000613

AC-1619

AC1L2SBO

AC1Q3BIE

ACN-040196

AK-94013

AKOS015951203

AM20090666

AN-34706

AN-664

ANW-58063

API0002176

AS-15856

B4033

BC684636

BCP02107

BCP9000390

BCPP000348

Benda

Bendamustin hydrochloride

Bendamustine (hydrochloride)

Bendamustine HCl

Bendamustine HCL (SDX-105, Cytostasane)

Bendamustine hydrochloride (JAN/USAN)

Bendamustine hydrochloride [USAN:JAN]

Bendamustine Hydrochloride Injection

Bendamustine Hydrochloride/

Bendeka

Bendit

C16H22Cl3N3O2

CCG-221927

CCRIS 1864

CHEMBL1201734

CS-1771

CTK3I6647

Cytostasan

Cytostosan

D07085

DTXSID40188912

FT-0080832

FT-0650624

FT-0696296

gamma(1-Methyl-5-bis(beta-chloraethyl)aminobenzimidazoyl-2)buttersaeurehydrochlorid

gamma(1-Methyl-5-bis(beta-chloraethyl)aminobenzimidazoyl-2)buttersaeurehydrochlorid [German]

GP6515

HY-B0077

IMET 3393

Inno-P08001

Innomustine

KB-289694

KS-00000FOM

Levact

LP00623

LS-33224

MFCD16879055

MLS006010156

MolPort-006-823-040

NCGC00261308-01

NSC 138783

NSC-138783

NSC138783

Ribomustin

Ribomustin (TN)

Ribomustine

s1212

SB17462

SC-24142

SCHEMBL18843

SDX 105

SDX-105

SMR004234484

ST24042980

SW219266-1

SyB L-0501

Symbenda

TC-010264

Tox21_500623

Treakisym

Treanda

Treanda (TN)

UNII-981Y8SX18M

WLN: T56 BN DNJ B1 C3VQ GN2G2G &GH

ZHSKUOZOLHMKEA-UHFFFAOYSA-N

ZIMET 33/93

Generic filers with tentative approvals for BENDAMUSTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		100MG	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for BENDAMUSTINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes			Y
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	205580-001	May 15, 2018		RX	Yes	Yes			Y
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	205580-001	May 15, 2018		RX	Yes	Yes			Y
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-002	May 1, 2009		RX	Yes	Yes					Y

International Patents for BENDAMUSTINE HYDROCHLORIDE

Country	Patent Number	Estimated Expiration
Japan	6250628
Mexico	2010010398
San Marino	T201700043
Israel	184394
China	104271135
World Intellectual Property Organization (WIPO)	2013142358
European Patent Office	2827862