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TREANDA Drug Profile

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When do Treanda patents expire, and what generic alternatives are available?

Treanda is a drug marketed by Cephalon and is included in one NDA. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-five patent family members in twenty-one countries.

The generic ingredient in TREANDA is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

Summary for TREANDA

International Patents:	65
US Patents:	9
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	98
Clinical Trials:	83
Patent Applications:	545
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TREANDA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TREANDA
Prior Art and Litigation Support	Order Prior Art and Litigation support for TREANDA
DailyMed Link:	TREANDA at DailyMed

Pharmacology for TREANDA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for TREANDA

Antineoplastic Agents, Alkylating

Synonyms for TREANDA

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

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 (TN)

UNII-981Y8SX18M

WLN: T56 BN DNJ B1 C3VQ GN2G2G &GH

ZHSKUOZOLHMKEA-UHFFFAOYSA-N

ZIMET 33/93

US Patents and Regulatory Information for TREANDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-002	May 1, 2009		RX	Yes	Yes			Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-001	Mar 20, 2008		RX	Yes	Yes					Y
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	022249-004	Sep 13, 2013		DISCN	Yes	No					Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-002	May 1, 2009		RX	Yes	Yes					Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-002	May 1, 2009		RX	Yes	Yes					Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-001	Mar 20, 2008		RX	Yes	Yes					Y

Paragraph IV (Patent) Challenges for TREANDA

Drugname	Dosage	Strength	RLD	Date
	Injection	90 mg/mL, 0.5 mL and 2 mL in single-dose vials
	Injection	25 mg/vial and 100 mg/vial

International Patents for TREANDA

Country	Patent Number	Estimated Expiration
Taiwan	200944508
Taiwan	I472515
Hong Kong	1211462
Japan	2011515472
World Intellectual Property Organization (WIPO)	2009120386
Israel	184394