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Last Updated: December 9, 2019

DrugPatentWatch Database Preview

Bendamustine hydrochloride - Generic Drug Details

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What are the generic drug sources for bendamustine hydrochloride and what is the scope of patent protection?

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 twelve 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 are nine tentative approvals for this compound.

Recent Clinical Trials for bendamustine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Emory UniversityPhase 2
SanofiPhase 1/Phase 2
Washington University School of MedicinePhase 1/Phase 2

See all bendamustine hydrochloride clinical trials

Recent Litigation for bendamustine hydrochloride

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 bendamustine hydrochloride litigation

PTAB Litigation
PetitionerDate
Fresenius Kabi USA, LLC2015-11-02
Fresenius Kabi USA, LLC2015-10-28
AGILA SPECIALTIES INC.2015-10-09

See all bendamustine hydrochloride litigation

Generic filers with tentative approvals for BENDAMUSTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial100MG/VIALPOWDER;IV (INFUSION)
  Start Trial  Start Trial25MG/VIALPOWDER;IV (INFUSION)
  Start Trial  Start Trial100MG/VIALPOWDER;IV (INFUSION)

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

Pharmacology for bendamustine hydrochloride
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for bendamustine hydrochloride
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
Paragraph IV (Patent) Challenges for BENDAMUSTINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
BELRAPZO SOLUTION;IV (INFUSION) bendamustine hydrochloride 205580 2018-07-17
BENDEKA SOLUTION;IV (INFUSION) bendamustine hydrochloride 208194 2017-05-04
TREANDA SOLUTION;IV (INFUSION) bendamustine hydrochloride 022249 2014-06-19
TREANDA POWDER;IV (INFUSION) bendamustine hydrochloride 022249 2014-06-19
TREANDA SOLUTION;IV (INFUSION) bendamustine hydrochloride 022249 2013-06-04
TREANDA POWDER;IV (INFUSION) bendamustine hydrochloride 022249 2013-06-04

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
Cephalon TREANDA bendamustine hydrochloride SOLUTION;IV (INFUSION) 022249-004 Sep 13, 2013 DISCN Yes No   Start Trial   Start Trial Y   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 Y   Start Trial
Cephalon TREANDA bendamustine hydrochloride SOLUTION;IV (INFUSION) 022249-003 Sep 13, 2013 DISCN Yes No   Start Trial   Start Trial Y   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:

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Moodys

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