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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 three 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 six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rufinamide profile page.

Summary for BANZEL

International Patents:	87
US Patents:	3
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	77
Patent Applications:	352
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	BANZEL at DailyMed

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

3B1-000291

A801414

AB0017630

AB00918347_06

AB00918347-05

AB1008455

AC-1429

AC1L2V8C

AKOS005145897

AN-598

API0012839

AS-13861

AS07135

Banzel (TN)

Banzel, Rufinamide

BC224496

C10H8F2N4O

CAS-106308-44-5

CCG-222100

Cgp 33101

CGP-33101

CGP33101

CHEBI:134966

CHEMBL1201754

CS-1455

CTK8E9248

D02OBK

D05775

D0MD2L

DB06201

DSSTox_CID_26506

DSSTox_GSID_46506

DSSTox_RID_81675

DTXSID1046506

E 2080

E-2080

E2080

EN300-120881

F0001-2404

FT-0656828

GTPL7470

HE005618

HE293185

HE293186

HMS2232M19

HMS3262O14

HMS3371A06

HMS3651O05

HY-A0042

I06-1425

Inovelon

Inovelon/Banzel

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)

Rufinamide [USAN:INN:BAN]

Rufinamide, >=98% (HPLC), powder

Rufinamide, United States Pharmacopeia (USP) Reference Standard

s1256

SBB070637

SCHEMBL230448

SMR000857122

SR-01000842156

SR-01000842156-4

SYN-111

SYN111

Tox21 112267

Tox21_112267

Tox21_112267_1

Tox21_500796

UNII-WFW942PR79

W-5135

WFW942PR79

Xilep

Z1541638521

ZB000661

ZINC7782

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		RX	Yes	Yes					Y
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008	AB	RX	Yes	No					Y
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-001	Nov 14, 2008		DISCN	Yes	No					Y
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008	AB	RX	Yes	No					Y

Paragraph IV (Patent) Challenges for BANZEL

Drugname	Dosage	Strength	RLD	Submissiondate
	Tablets	100 mg, 200 mg and 400 mg		2012-11-14
	Oral Suspension	40 mg/mL		2014-06-16

Non-Orange Book US Patents for BANZEL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,455,556	Crystal modifications of 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide

International Patents for BANZEL

Country	Document Number	Estimated Expiration
Australia	725528
European Patent Office	0994863
Luxembourg	91345
European Patent Office	0994864

Supplementary Protection Certificates for BANZEL

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB07/041	United Kingdom		PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015
2007 00037	Denmark		PRODUCT NAME: RUFINAMID, KRYSTALMODIFIKATION A
0994863/01	Switzerland		PRODUCT NAME: RUFINAMID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58097 06.01.2009
C/GB07/041	United Kingdom		PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015