BANZEL Drug Patent Profile
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Which patents cover Banzel, and when can generic versions of Banzel launch?
Banzel is a drug marketed by Eisai Inc and is included in two NDAs. There is one patent 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. Ten suppliers are listed for this compound. Additional details are available on the rufinamide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Banzel
A generic version of BANZEL was approved as rufinamide by GLENMARK PHARMS LTD on May 16th, 2016.
Summary for BANZEL
| International Patents: | 87 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 117 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,456 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BANZEL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BANZEL |
| What excipients (inactive ingredients) are in BANZEL? | BANZEL excipients list |
| DailyMed Link: | BANZEL at DailyMed |
Recent Clinical Trials for BANZEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Eisai Inc. | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for BANZEL
Paragraph IV (Patent) Challenges for BANZEL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BANZEL | Oral Suspension | rufinamide | 40 mg/mL | 201367 | 1 | 2014-06-16 |
| BANZEL | Tablets | rufinamide | 200 mg and 400 mg | 021911 | 5 | 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-003 | Nov 14, 2008 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-001 | Nov 14, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-002 | Nov 14, 2008 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-001 | Nov 14, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Eisai Inc | BANZEL | rufinamide | SUSPENSION;ORAL | 201367-001 | Mar 3, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-003 | Nov 14, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-002 | Nov 14, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-003 | Nov 14, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for BANZEL
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Eisai GmbH | Inovelon | rufinamide | EMEA/H/C/000660 Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older. |
Authorised | no | no | no | 2007-01-16 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for BANZEL
See the table below for patents covering BANZEL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Malaysia | 120156 | CRYSTAL MODIFICATION OF 1-(2,6-DIFLUOROBENZYL)-1H-1,2,3-TRIAZOLE-4-CARBOXAMIDE | ⤷ Try a Trial |
| Russian Federation | 2198167 | CRYSTALLINE MODIFICATIONS OF 1-(2,6-DIFLUOROBENZYL)-1H-1,2,3-TRAZOL-4-CARBOXAMIDE AND PHARMACEUTICAL COMPOSITION | ⤷ Try a Trial |
| Turkey | 9801631 | ⤷ Try a Trial | |
| Slovakia | 109398 | CRYSTAL MODIFICATION OF 1-(2,6-DIFLUOROBENZYL)-1H-1,2,3- -TRIAZOLE-4-CARBOXAMIDE AND ITS USE AS ANTIEPILEPTIC | ⤷ Try a Trial |
| European Patent Office | 0994863 | MODIFICATION CRISTALLINE DE 1-(2,6-DIFLUOROBENZYLE)-1H-1,2,3-TRIAZOLE-4-CARBOXAMIDE ET SON UTILISATION EN TANT QU'ANTI-EPILEPTIQUE (CRYSTAL MODIFICATION OF 1-(2,6-DIFLUOROBENZYL)-1H-1,2,3-TRIAZOLE-4-CARBOXAMIDE AND ITS USE AS ANTIEPILEPTIC) | ⤷ Try a Trial |
| Colombia | 4940448 | MODIFICACION A CRISTAL DE UNA SUSTANCIA DE MEDICAMENTO | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BANZEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0994863 | 300284 | Netherlands | ⤷ Try a Trial | 300284, 20180608, EXPIRES: 20220115 |
| 0994863 | 91345 | Luxembourg | ⤷ Try a Trial | CERTIFICATE NAME: RUFINAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (INOVELON); FIRST REGISTRATION DATE: 20070116 |
| 0994863 | C00994863/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: RUFINAMID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58097 06.01.2009 |
| 0994863 | CA 2007 00037 | Denmark | ⤷ Try a Trial | PRODUCT NAME: RUFINAMID, KRYSTALMODIFIKATION A |
| 0994863 | 303 | Finland | ⤷ Try a Trial | |
| 0994863 | SPC026/2007 | Ireland | ⤷ Try a Trial | SPC026/2007: 20071026, EXPIRES: 20220115 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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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