DrugPatentWatch Database Preview
TREANDA Drug Profile
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-six patent family members in twenty-one countries.
The generic ingredient in TREANDA 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.
Summary for TREANDA
| International Patents: | 66 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 101 |
| Clinical Trials: | 86 |
| Patent Applications: | 620 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TREANDA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TREANDA |
| DailyMed Link: | TREANDA at DailyMed |
Recent Clinical Trials for TREANDA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sanofi | Phase 1/Phase 2 |
| Washington University School of Medicine | Phase 1/Phase 2 |
| Emory University | Phase 1/Phase 2 |
Recent Litigation for TREANDA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Teva Pharmaceuticals International GmbH v. Apotex Inc. | 2017-08-18 |
| Cephalon, Inc. v. Slayback Pharma Limited Liability Company | 2017-08-16 |
| Cephalon Inc. v. Dr Reddy's Laboratories Ltd | 2015-02-23 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Fresenius Kabi USA, LLC | 2015-11-02 |
| Fresenius Kabi USA, LLC | 2015-10-28 |
| AGILA SPECIALTIES INC. | 2015-10-09 |
Pharmacology for TREANDA
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
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 (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 |
| 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 (TN) |
| UNII-981Y8SX18M |
| WLN: T56 BN DNJ B1 C3VQ GN2G2G &GH |
| ZHSKUOZOLHMKEA-UHFFFAOYSA-N |
| ZIMET 33/93 |
Paragraph IV (Patent) Challenges for TREANDA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| 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 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 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-001 | Mar 20, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Cephalon | TREANDA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 022249-004 | Sep 13, 2013 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-002 | May 1, 2009 | 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 TREANDA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 343659 | Start Trial |
| Australia | 2006204817 | Start Trial |
| Japan | 5536753 | Start Trial |
| New Zealand | 556435 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
