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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Chinese Patent Office
Chubb
Julphar
Boehringer Ingelheim
Healthtrust
Dow
Fish and Richardson
Merck

Generated: July 21, 2018

DrugPatentWatch Database Preview

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-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
Drug patent expirations by year for TREANDA
Pharmacology for TREANDA
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for TREANDA
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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Cephalon TREANDA bendamustine hydrochloride POWDER;IV (INFUSION) 022249-001 Mar 20, 2008 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Cephalon TREANDA bendamustine hydrochloride SOLUTION;IV (INFUSION) 022249-004 Sep 13, 2013 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Cephalon TREANDA bendamustine hydrochloride POWDER;IV (INFUSION) 022249-002 May 1, 2009 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for TREANDA
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 90 mg/mL, 0.5 mL and 2 mL in single-dose vials ➤ Subscribe ➤ Sign Up
➤ Subscribe Injection 25 mg/vial and 100 mg/vial ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for TREANDA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,461,350 Bendamustine pharmaceutical compositions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Baxter
Chinese Patent Office
Deloitte
Citi
Covington
Medtronic
Boehringer Ingelheim
Chubb

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