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Last Updated: January 22, 2020

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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 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.

Recent Clinical Trials for rufinamide

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

SponsorPhase
Cambridge University Hospitals NHS Foundation TrustPhase 4
Guy's and St Thomas' NHS Foundation TrustPhase 4
Birmingham Children's Hospital NHS Foundation TrustPhase 4

See all rufinamide clinical trials

Recent Litigation for rufinamide

Identify potential future generic entrants

District Court Litigation
Case NameDate
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

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

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

Supplementary Protection Certificates for rufinamide

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
McKesson
Johnson and Johnson
Moodys
AstraZeneca

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