Rufinamide - Generic Drug Details

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What are the generic sources for rufinamide and what is the scope of patent protection?

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
Cambridge University Hospitals NHS Foundation Trust	Phase 4
Guy's and St Thomas' NHS Foundation Trust	Phase 4
Birmingham Children's Hospital NHS Foundation Trust	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. Lupin Ltd.	2013-07-24
Eisai Co. Ltd. v. Hetero Labs Ltd.	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	RUFINAMIDE	rufinamide	TABLET;ORAL	205095-001	May 16, 2016		DISCN	No	No	Start Trial	Start Trial				Start Trial
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-003	Nov 14, 2008	AB	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-001	Nov 14, 2008		DISCN	Yes	No	Start Trial	Start Trial			Y	Start 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 rufinamide

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

International Patents for rufinamide

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Country	Patent Number	Estimated Expiration
Japan	2000516258	Start Trial
Indonesia	27660	Start Trial
Colombia	4940448	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for rufinamide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0994863	07C0037	France	Start Trial	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	300284	Netherlands	Start Trial	300284, 20180608, EXPIRES: 20220115
0994864	SPC/GB07/041	United Kingdom	Start Trial	PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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