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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Medtronic
Citi
Federal Trade Commission
Cerilliant
UBS
Healthtrust
Boehringer Ingelheim
Dow

Generated: July 17, 2018

DrugPatentWatch Database Preview

Rufinamide - Generic Drug Details

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

Rufinamide
is the generic ingredient in two branded drugs marketed by Eisai Inc, Glenmark Pharms Ltd, Mylan Pharms Inc, and West-ward Pharms Int, and is included in five NDAs. There are three 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 six drug master file entries for rufinamide. One supplier is listed for this compound.
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
3B1-000291
A801414
AB0017630
AB00918347_06
AB00918347-05
AB1008455
AC-1429
AC1L2V8C
AKOS005145897
AN-598
API0012839
AS-13861
AS07135
Banzel
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 (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 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 SUSPENSION;ORAL 201367-001 Mar 3, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-003 Nov 14, 2008 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-002 Nov 14, 2008 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-001 Nov 14, 2008 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for rufinamide

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 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for rufinamide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
345 Luxembourg ➤ Sign Up CERTIFICATE NAME: RUFINAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (INOVELON); FIRST REGISTRATION DATE: 20070116
0994863/01 Switzerland ➤ Sign Up PRODUCT NAME: RUFINAMID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58097 06.01.2009
C0037 France ➤ Sign Up 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
3 Finland ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Healthtrust
Harvard Business School
Accenture
Federal Trade Commission
UBS
Cerilliant
Johnson and Johnson
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.