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BANZEL Drug Profile
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When do Banzel patents expire, and when can generic versions of Banzel launch?
Banzel is a drug marketed by Eisai Inc and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.
This drug has eighty-seven patent family members in thirty-four countries.
The generic ingredient in BANZEL is rufinamide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rufinamide profile page.
US ANDA Litigation and Generic Entry Outlook for Banzel
A generic version of BANZEL was approved as rufinamide by GLENMARK PHARMS LTD on January 24th, 2020.
Summary for BANZEL
| International Patents: | 87 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 92 |
| Patent Applications: | 469 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BANZEL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BANZEL |
| DailyMed Link: | BANZEL at DailyMed |
Recent Litigation for BANZEL
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Eisai Co., Ltd. v. Bionpharma Inc. | 2018-04-24 |
| Eisai Co. Ltd. v. Hetero Labs Ltd. | 2013-07-24 |
| Eisai Co. Ltd. v. Roxane Laboratories Inc. | 2013-07-24 |
Synonyms for BANZEL
| 1-(2,6-Difluorobenzyl)-1H-1,2,3-triazol-4-carboxamide |
| 1-(2,6-Difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide |
| 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide |
| 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-Triazole-4-carboxamide |
| 1-[(2,6-difluorophenyl)methyl]-4-triazolecarboxamide |
| 1-[(2,6-difluorophenyl)methyl]triazole-4-carboxamide |
| 1-[[2,6-bis(fluoranyl)phenyl]methyl]-1,2,3-triazole-4-carboxamide |
| 106308-44-5 |
| 1H-1,2,3-Triazole-4-carboxamide, 1-((2,6-difluorophenyl)methyl)- |
| 1H-1,2,3-Triazole-4-carboxamide, 1-[(2,6-difluorophenyl)methyl]- |
| 308R445 |
| A801414 |
| AB0017630 |
| AB00918347_06 |
| AB00918347-05 |
| AB1008455 |
| AC-1429 |
| AC1L2V8C |
| AKOS005145897 |
| AN-598 |
| AS-13861 |
| AS07135 |
| Banzel (TN) |
| BC224496 |
| BCP21828 |
| C10H8F2N4O |
| CAS-106308-44-5 |
| CCG-222100 |
| CGP 33,101 |
| Cgp 33101 |
| CGP-33101 |
| CGP33101 |
| CHEBI:134966 |
| CHEMBL1201754 |
| CS-1455 |
| CTK8E9248 |
| D05775 |
| DB06201 |
| DSSTox_CID_26506 |
| DSSTox_GSID_46506 |
| DSSTox_RID_81675 |
| DTXSID1046506 |
| E 2080 |
| E2080 |
| F0001-2404 |
| FT-0656828 |
| GTPL7470 |
| HMS2232M19 |
| HMS3262O14 |
| HMS3371A06 |
| HMS3651O05 |
| HY-A0042 |
| I06-1425 |
| Inovelon |
| J-001568 |
| J10459 |
| KS-00000YSQ |
| LP00796 |
| MCULE-6872329028 |
| MFCD00865314 |
| MLS001332513 |
| MLS001332514 |
| MolPort-005-942-441 |
| NCGC00165883-01 |
| NCGC00165883-02 |
| NCGC00165883-03 |
| NCGC00165883-04 |
| NCGC00261481-01 |
| POGQSBRIGCQNEG-UHFFFAOYSA-N |
| PubChem14896 |
| Q503 |
| R0143 |
| RT-015464 |
| RUF 331 |
| RUF-331 |
| Rufinamide |
| Rufinamide (Banzel) |
| Rufinamide (JAN/USAN/INN) |
| Rufinamide [USAN:INN:BAN] |
| Rufinamide, >=98% (HPLC), powder |
| Rufinamide, United States Pharmacopeia (USP) Reference Standard |
| s1256 |
| SB18904 |
| SCHEMBL230448 |
| SMR000857122 |
| SR-01000842156 |
| SR-01000842156-4 |
| SW219770-1 |
| SYN-111 |
| SYN111 |
| Tox21 112267 |
| Tox21_112267 |
| Tox21_112267_1 |
| Tox21_500796 |
| UNII-WFW942PR79 |
| W-5135 |
| WFW942PR79 |
| Xilep |
| Z1541638521 |
| ZB000661 |
| ZINC7782 |
Paragraph IV (Patent) Challenges for BANZEL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BANZEL | SUSPENSION;ORAL | rufinamide | 201367 | 2014-06-16 |
| BANZEL | TABLET;ORAL | rufinamide | 021911 | 2012-11-14 |
US Patents and Regulatory Information for BANZEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eisai Inc | BANZEL | rufinamide | SUSPENSION;ORAL | 201367-001 | Mar 3, 2011 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-003 | Nov 14, 2008 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-001 | Nov 14, 2008 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-003 | Nov 14, 2008 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for BANZEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-003 | Nov 14, 2008 | Start Trial | Start Trial |
| Eisai Inc | BANZEL | rufinamide | SUSPENSION;ORAL | 201367-001 | Mar 3, 2011 | Start Trial | Start Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-002 | Nov 14, 2008 | Start Trial | Start Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-001 | Nov 14, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BANZEL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Colombia | 4940448 | Start Trial |
| Peru | 80999 | Start Trial |
| Taiwan | 526195 | Start Trial |
| European Patent Office | 0994863 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BANZEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0994863 | 300284 | Netherlands | Start Trial | 300284, 20180608, EXPIRES: 20220115 |
| 0994863 | 91345 | Luxembourg | Start Trial | CERTIFICATE NAME: RUFINAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (INOVELON); FIRST REGISTRATION DATE: 20070116 |
| 0994863 | 303 | Finland | Start Trial | |
| 0994863 | SPC/GB07/041 | United Kingdom | Start Trial | PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
