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BENDAMUSTINE HYDROCHLORIDE - Generic Drug Details
What are the generic drug sources for bendamustine hydrochloride and what is the scope of freedom to operate?
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.
Summary for BENDAMUSTINE HYDROCHLORIDE
International Patents: | 112 |
US Patents: | 24 |
Tradenames: | 3 |
Applicants: | 2 |
NDAs: | 3 |
Drug Master File Entries: | 23 |
Suppliers / Packagers: | 3 |
Bulk Api Vendors: | 101 |
Clinical Trials: | 283 |
Patent Applications: | 1,045 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BENDAMUSTINE HYDROCHLORIDE |
DailyMed Link: | BENDAMUSTINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for BENDAMUSTINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Emory University | Phase 2 |
Sanofi | Phase 1/Phase 2 |
Washington University School of Medicine | Phase 1/Phase 2 |
Recent Litigation for BENDAMUSTINE HYDROCHLORIDE
Identify potential future generic entrants
District Court Litigation
Case Name | Date |
---|---|
Teva Pharmaceuticals International GmbH v. Lupin, Ltd. | 2019-07-02 |
Eagle Pharmaceuticals, Inc. v. Slayback Pharma LLC | 2018-12-11 |
Eagle Pharmaceuticals, Inc. v. Slayback Pharma LLC | 2018-09-20 |
See all BENDAMUSTINE HYDROCHLORIDE litigation
PTAB Litigation
Petitioner | Date |
---|---|
Fresenius Kabi USA, LLC | 2015-11-02 |
Fresenius Kabi USA, LLC | 2015-10-28 |
AGILA SPECIALTIES INC. | 2015-10-09 |
Generic filers with tentative approvals for BENDAMUSTINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 100MG/VIAL | POWDER;IV (INFUSION) |
Start Trial | Start Trial | 25MG/VIAL | POWDER;IV (INFUSION) |
Start Trial | Start Trial | 100MG/VIAL | POWDER;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 Class | Alkylating Drug |
Mechanism of Action | Alkylating 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 | POWDER;IV (INFUSION) | bendamustine hydrochloride | 022249 | 2014-06-19 |
TREANDA | SOLUTION;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) | 022249-003 | Sep 13, 2013 | DISCN | Yes | No | 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 | |||
Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Cephalon | TREANDA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 022249-003 | 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 | ||||
Cephalon | TREANDA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 022249-004 | Sep 13, 2013 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Eagle Pharms | BELRAPZO | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 205580-001 | May 15, 2018 | RX | Yes | Yes | 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 |
International Patents for BENDAMUSTINE HYDROCHLORIDE
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 5726833 | Start Trial |
China | 101119708 | Start Trial |
World Intellectual Property Organization (WIPO) | 2013142358 | Start Trial |
World Intellectual Property Organization (WIPO) | 2013142359 | Start Trial |
Slovenia | 2827863 | Start Trial |
European Patent Office | 2271315 | Start Trial |
Australia | 2009296734 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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