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Bendamustine hydrochloride - Generic Drug Details
What are the generic 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.
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 | SOLUTION;IV (INFUSION) | bendamustine hydrochloride | 022249 | 2014-06-19 |
| TREANDA | POWDER;IV (INFUSION) | bendamustine hydrochloride | 022249 | 2014-06-19 |
| TREANDA | POWDER;IV (INFUSION) | bendamustine hydrochloride | 022249 | 2013-06-04 |
| TREANDA | SOLUTION;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 | POWDER;IV (INFUSION) | 022249-002 | May 1, 2009 | RX | Yes | Yes | 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 | 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 | BELRAPZO | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 205580-001 | May 15, 2018 | RX | Yes | Yes | 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 | 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 |
|---|---|---|
| Spain | 2609106 | Start Trial |
| Japan | 6381761 | Start Trial |
| Japan | 5726833 | Start Trial |
| Serbia | 58744 | Start Trial |
| Japan | 6224064 | Start Trial |
| Hong Kong | 1211462 | Start Trial |
| China | 102078305 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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 verifification 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.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.