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Last Updated: April 4, 2020

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BENDEKA Drug Profile


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Which patents cover Bendeka, and what generic alternatives are available?

Bendeka is a drug marketed by Eagle Pharms and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-three patent family members in thirty-one countries.

The generic ingredient in BENDEKA 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.

US ANDA Litigation and Generic Entry Outlook for Bendeka

There have been thirteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are nine tentative approvals for the generic drug (bendamustine hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for BENDEKA
Drug Prices for BENDEKA

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Recent Clinical Trials for BENDEKA

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SponsorPhase
Wake Forest University Health SciencesPhase 2
Washington University School of MedicinePhase 1/Phase 2
SanofiPhase 1/Phase 2

See all BENDEKA clinical trials

Recent Litigation for BENDEKA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Teva Pharmaceuticals International GmbH v. Lupin, Ltd.2019-07-02
Eagle Pharmaceuticals, Inc. v. Slayback Pharma LLC2018-12-11
Eagle Pharmaceuticals, Inc. v. Slayback Pharma LLC2018-09-20

See all BENDEKA litigation

PTAB Litigation
PetitionerDate
Fresenius Kabi USA, LLC2015-10-28
2015-10-09

See all BENDEKA litigation

Pharmacology for BENDEKA
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Synonyms for BENDEKA
16506-27-7
1H-Benzimidazole-2-butanoic acid, 5-(bis(2-chloroethyl)amino)-1-methyl-
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-
1H-Benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1-methyl-, hydrochloride (1:1)
1H-Benzimidazole-2-butanoicacid, 5-[bis(2-chloroethyl)amino]-1-methyl-
1H-Benzimidazole-2-butanoicacid, 5-[bis(2-chloroethyl)amino]-1-methyl-, hydrochloride (1:?)
2-Benzimidazolebutyric acid, 5-(bis(2-chloroethyl)amino)-1-methyl-
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
4-(5-(Bis(2-chloroethyl)amino)-1-methyl-1H-benzo[d]imidazol-2-yl)butanoic acid hydrochloride
4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid
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-chloroethyl)amino]-1-methyl-1H-1,3-benzodiazol-2-yl}butanoic acid
4-{5-[bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazol-2-yl}butanoic acid
4CA-0265
4CA-0266
5-(Bis(2-chloroethyl)amino)-1-methyl-1H-benzimidazole-2-butanoic acid
5-(Bis(2-chloroethyl)amino)-1-methyl-2-benzimidazolebutyric acid
5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazole-2-butanoic acid hydrochloride
5-[Bis(2-chloroethyl)amino]-1-methylbenzimidazole-2-butyric Acid Hydrochloride
506B277
543B757
9266D9P3PQ
97832-05-8
981Y8SX18M
AB0017997
AB01273966_03
AB01273966-01
AB01273966-02
AB1008551
ABP000613
AC-1619
AC-22488
ACN-040196
AK-94013
AKOS015951203
AKOS022181343
AM20090666
ANW-58063
API0002176
API0005688
AS-15856
AS-73546
B4033
BCP02107
BCP04111
BCP0726000100
BCP9000389
BCP9000390
BCPP000348
BDBM173621
Benda
bendamustin
Bendamustin hydrochloride
Bendamustina
Bendamustina [Spanish]
Bendamustine
Bendamustine (hydrochloride)
Bendamustine (INN)
Bendamustine [INN:BAN]
Bendamustine [INN]
Bendamustine free base
Bendamustine HCl
Bendamustine HCL (SDX-105, Cytostasane)
Bendamustine hydrochloride
Bendamustine hydrochloride (JAN/USAN)
Bendamustine hydrochloride [USAN:JAN]
Bendamustine Hydrochloride Injection
Bendamustine Hydrochloride/
Bendamustine-Hydrochloride
Bendamustinum
Bendamustinum [Latin]
Bendit
BRD-K17068645-003-02-6
C-23733
C16H22Cl3N3O2
CAS-16506-27-7
CC-24269
CCG-221927
CCRIS 1864
CHEBI:135515
CHEMBL1201734
CHEMBL487253
CS-1771
CTK0H6928
CTK3I6647
Cytostasan
Cytostosan
D07085
D07501
DB06769
DD63046000
DSSTox_CID_26888
DSSTox_GSID_46888
DSSTox_RID_81991
DTXSID2046888
DTXSID40188912
FT-0080832
FT-0650624
FT-0696296
FT-0742187
gamma-(1-methyl-5-bis(beta-chloroethyl)aminobenzimidazole)-(2)-butyric acid
gamma(1-Methyl-5-bis(beta-chloraethyl)aminobenzimidazoyl-2)buttersaeurehydrochlorid
gamma(1-Methyl-5-bis(beta-chloraethyl)aminobenzimidazoyl-2)buttersaeurehydrochlorid [German]
GP6515
GTPL7478
HSDB 7763
HY-B0077
IMET 3393
InChI=1/C16H21Cl2N3O2/c1-20-14-6-5-12(21(9-7-17)10-8-18)11-13(14)19-15(20)3-2-4-16(22)23/h5-6,11H,2-4,7-10H2,1H3,(H,22,23
Inno-P08001
Innomustine
J-010179
KS-00000FOM
Levact
LP00623
LS-173588
LS-32675
LS-33224
MFCD16879055
MLS006010156
NCGC00181170-01
NCGC00181170-02
NCGC00181170-03
NCGC00261308-01
NIOSH/DD6304600
NSC 138783
NSC-138783
NSC138783
omega-(1-Methyl-5-bis(beta-chloroethyl)aminobenzimidazole-(2)-butyric acid
Q27272066
Q425745
Ribomustin
Ribomustin (TN)
Ribomustine
s1212
s5939
SB17462
SC-19231
SC-24142
SCHEMBL18843
SCHEMBL26319
SDX 105
SDX-105
SDX-105 (Cytostasane) HCl
SMR004234484
ST24042979
ST24042980
SW219266-1
SyB L-0501
SYBL-0501
Symbenda
TC-010264
Tox21_112771
Tox21_112771_1
Tox21_500623
Treakisym
Treanda
Treanda (TN)
TX-012243
UNII-9266D9P3PQ
UNII-981Y8SX18M
US9096627, CY190602
WLN: T56 BN DNJ B1 C3VQ GN2G2G &GH
YTKUWDBFDASYHO-UHFFFAOYSA-N
ZHSKUOZOLHMKEA-UHFFFAOYSA-N
ZIMET 33/93
Zimet 3393
ZINC4214955
Paragraph IV (Patent) Challenges for BENDEKA
Tradename Dosage Ingredient NDA Submissiondate
BENDEKA SOLUTION;IV (INFUSION) bendamustine hydrochloride 208194 2017-05-04

US Patents and Regulatory Information for BENDEKA

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   Start Trial   Start Trial   Start Trial
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Medtronic
Merck
Johnson and Johnson
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.