BANZEL Drug Patent Profile

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. Twelve 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 16^th, 2016.

Summary for BANZEL

US Patents:	0
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-003	Nov 14, 2008	AB	RX	Yes	Yes
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-001	Nov 14, 2008		DISCN	Yes	No
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008	AB	RX	Yes	No

International Patents for BANZEL

See the table below for patents covering BANZEL around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	012945	FORMAS CRISTALINAS B Y C DEL COMPUESTO 1-(2,6-DIFLUORBENCIL)-1H-1,2,3- TRIAZOL-4 CARBOXAMIDA, UN PREPARADO FARMACEUTICO Y USO PARA LA OBTENCIONDEL MISMO Y PARA LA MANUFACTURA DE UN MEDICAMENTO
Argentina	012946	FORMA CRISTALINA A DE 1-(2,6-DIFLUORBENCIL)-1H-1,2,3-TRIAZOL-4-CARBOXAMIDA, PREPARACIONES FARMACEUTICAS QUE LOS CONTIENEN Y SU USO PARA LA PREPARACION DE MEDICAMENTOS
Argentina	061004	FORMAS CRISTALINAS B Y C DEL COMPUESTO 1-(2,6-DIFLUOROBENCIL)-1H-1,2,3-TRIAZOL-4- CARBOXAMIDA, UN PREPARADO FARMACEUTICO Y USO PARA LA OBTENCION DEL MISMO Y PARA LA MANUFACTURA DE UN MEDICAMENTO
Argentina	061005	FORMA CRISTALINA A DE 1-(2,6- DIFLUOROBENCIL)-1H-1,2,3- TRIAZOL-4-CARBOXAMIDA, PREPARACIONES FARMACEUTICAS QUE LAS CONTIENEN Y SU USO PARA LA PREPARACION DE MEDICAMENTOS
Austria	232852
Austria	237599
Australia	725517

Supplementary Protection Certificates for BANZEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0994863	91345	Luxembourg		CERTIFICATE NAME: RUFINAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (INOVELON); FIRST REGISTRATION DATE: 20070116
0994863	SPC/GB07/041	United Kingdom		PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015
0994863	07C0037	France		PRODUCT NAME: MODIFICATION CRISTALLINE A DU RUFINAMIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/378/001 DU 20070116; REGISTRATION NO/DATE AT EEC: EU/1/06/378/001-016 DU 20070116
0994863	C00994863/01	Switzerland		PRODUCT NAME: RUFINAMID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58097 06.01.2009
0994863	303	Finland
0994863	CA 2007 00037	Denmark		PRODUCT NAME: RUFINAMID, KRYSTALMODIFIKATION A
0994863	300284	Netherlands		300284, 20180608, EXPIRES: 20220115