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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-two 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. Four suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

Summary for TREANDA

International Patents:	62
US Patents:	9
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	87
Clinical Trials:	83
Patent Applications:	485
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TREANDA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

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

1H-Benzimidazole-2-butanoic acid, monohydrochloride

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

3B1-009307

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

4-{5-[bis(2-chloroethyl)amino]-1-methyl-1H-1,3-benzodiazol-2-yl}butanoic acid hydrochloride

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

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/

Bendamustinehydrochloride

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

HE066504

HE420430

HY-B0077

IMET 3393

IN2037

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

SC-24142

SCHEMBL18843

SDX 105

SDX-105

SMR004234484

ST24042980

SyB L-0501

Symbenda

TC-010264

Tox21_500623

Treakisym

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	AP	RX	Yes	Yes			Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-001	Mar 20, 2008	AP	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	AP	RX	Yes	Yes					Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-002	May 1, 2009	AP	RX	Yes	Yes					Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-001	Mar 20, 2008	AP	RX	Yes	Yes					Y
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	022249-003	Sep 13, 2013		DISCN	Yes	No					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	Document Number	Estimated Expiration
Japan	2011515472
Canada	2718939
Japan	2012503666
Norway	20073722
China	105693620
Hong Kong	1220966
China	104224703