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Rufinamide - Generic Drug Details

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What are the generic sources for rufinamide and what is the scope of freedom to operate?

Rufinamide is the generic ingredient in two branded drugs marketed by Eisai Inc, Bionpharma Inc, Hikma, Glenmark Pharms Ltd, and Mylan, and is included in seven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Rufinamide has eighty-seven patent family members in thirty-four countries.

There are seven drug master file entries for rufinamide. One supplier is listed for this compound.

Summary for rufinamide

International Patents:	87
US Patents:	2
Tradenames:	2
Applicants:	5
NDAs:	7
Drug Master File Entries:	7
Suppliers / Packagers:	1
Bulk Api Vendors:	92
Clinical Trials:	10
Patent Applications:	748
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rufinamide
DailyMed Link:	rufinamide at DailyMed

Recent Clinical Trials for rufinamide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Central Manchester University Hospitals NHS Foundation Trust	Phase 4
Matthew's Friends	Phase 4
Bristol Royal Hospital for Children	Phase 4

See all rufinamide clinical trials

Recent Litigation for rufinamide

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

See all rufinamide litigation

Synonyms for rufinamide

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

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 (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 RUFINAMIDE

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 rufinamide

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	TABLET;ORAL	021911-003	Nov 14, 2008	AB	RX	Yes	Yes
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008	AB	RX	Yes	No
Bionpharma Inc	RUFINAMIDE	rufinamide	SUSPENSION;ORAL	211388-001	Apr 23, 2019	AB	RX	No	No
Glenmark Pharms Ltd	RUFINAMIDE	rufinamide	TABLET;ORAL	205075-002	May 16, 2016	AB	RX	No	No
Hikma	RUFINAMIDE	rufinamide	TABLET;ORAL	204988-002	May 16, 2016	AB	RX	No	No
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008	AB	RX	Yes	No					Y
Mylan	RUFINAMIDE	rufinamide	TABLET;ORAL	205095-001	May 16, 2016		DISCN	No	No

Expired US Patents for rufinamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-003	Nov 14, 2008
Eisai Inc	BANZEL	rufinamide	SUSPENSION;ORAL	201367-001	Mar 3, 2011
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-001	Nov 14, 2008
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-001	Nov 14, 2008
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-003	Nov 14, 2008
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008

International Patents for rufinamide

Country	Patent Number	Estimated Expiration
Turkey	9801630
New Zealand	331371
European Patent Office	0994864
Australia	8437298
Norway	329315
Colombia	4940448
Japan	3672574

Supplementary Protection Certificates for rufinamide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0994863	SPC/GB07/041	United Kingdom		PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015
0994863	300284	Netherlands		300284, 20180608, EXPIRES: 20220115
0994863	C00994863/01	Switzerland		PRODUCT NAME: RUFINAMID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58097 06.01.2009
0994863	91345	Luxembourg		CERTIFICATE NAME: RUFINAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (INOVELON); FIRST REGISTRATION DATE: 20070116
0994863	303	Finland
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	SPC026/2007	Ireland		SPC026/2007: 20071026, EXPIRES: 20220115