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TREANDA Drug Profile
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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-seven patent family members in twenty-two 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.
US ANDA Litigation and Generic Entry Outlook for Treanda
Treanda was eligible for patent challenges on March 20, 2012.
There have been eleven 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
Summary for TREANDA
| International Patents: | 67 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 100 |
| Clinical Trials: | 87 |
| Patent Applications: | 655 |
| 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 |
| Bayer | 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 | POWDER;IV (INFUSION) | bendamustine hydrochloride | 022249 | 2014-06-19 |
| TREANDA | SOLUTION;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 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 | |||
| 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) | 022249-003 | 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 |
International Patents for TREANDA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 101918188 | Start Trial |
| Canada | 2718939 | Start Trial |
| Mexico | 2011002936 | Start Trial |
| Spain | 2405611 | Start Trial |
| Japan | 2013056902 | Start Trial |
| Japan | 5726833 | Start Trial |
| Australia | 2018202107 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
