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Dow
Julphar
Teva
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Healthtrust
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US Army

Generated: December 16, 2018

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BANZEL Drug Profile

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Which patents cover Banzel, 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 seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rufinamide profile page.

Drug patent expirations by year for BANZEL
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 ➤ 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
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 SUSPENSION;ORAL 201367-001 Mar 3, 2011 RX Yes Yes ➤ 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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Expired US Patents for BANZEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-003 Nov 14, 2008 ➤ Sign Up ➤ Sign Up
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-001 Nov 14, 2008 ➤ Sign Up ➤ Sign Up
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-002 Nov 14, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for BANZEL
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 100 mg, 200 mg and 400 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Oral Suspension 40 mg/mL ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for BANZEL

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

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Julphar
Teva
Medtronic
Healthtrust
Boehringer Ingelheim
Deloitte
Express Scripts
US Army

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