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.
The generic ingredient in BANZEL is rufinamide. There are seven drug master file entries for this compound. Eleven 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
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 122 |
Clinical Trials: | 1 |
Patent Applications: | 1,172 |
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 | ⤷ Try a Trial | |||
Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-003 | Nov 14, 2008 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-001 | Nov 14, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-002 | Nov 14, 2008 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 | TABLET;ORAL | 021911-002 | 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 | 021911-002 | 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 |
---|---|---|---|
Netherlands | 300284 | ⤷ Try a Trial | |
Hong Kong | 1028241 | ⤷ Try a Trial | |
Turkey | 9801630 | ⤷ 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 |
Indonesia | 21014 | ⤷ 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 |
---|---|---|---|---|
0994864 | SPC/GB07/041 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015 |
0994863 | C00994863/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: RUFINAMID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58097 06.01.2009 |
0994863 | 300284 | Netherlands | ⤷ Try a Trial | 300284, 20180608, EXPIRES: 20220115 |
0994863 | SPC026/2007 | Ireland | ⤷ Try a Trial | SPC026/2007: 20071026, EXPIRES: 20220115 |
0994863 | CA 2007 00037 | Denmark | ⤷ Try a Trial | PRODUCT NAME: RUFINAMID, KRYSTALMODIFIKATION A |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |