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Last Updated: January 18, 2021

DrugPatentWatch Database Preview

Rufinamide - Generic Drug Details

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What are the generic drug 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 is one patent 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. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for rufinamide

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

SponsorPhase
Guy's and St Thomas' NHS Foundation TrustPhase 4
Birmingham Children's Hospital NHS Foundation TrustPhase 4
The Leeds Teaching Hospitals NHS TrustPhase 4

See all rufinamide clinical trials

Generic filers with tentative approvals for RUFINAMIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial40MG/MLSUSPENSION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Hikma RUFINAMIDE rufinamide SUSPENSION;ORAL 207363-001 Apr 23, 2019 AB RX No No   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
Eisai Inc BANZEL rufinamide SUSPENSION;ORAL 201367-001 Mar 3, 2011 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glenmark Pharms Ltd RUFINAMIDE rufinamide TABLET;ORAL 205075-002 May 16, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma RUFINAMIDE rufinamide TABLET;ORAL 204988-001 May 16, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan RUFINAMIDE rufinamide TABLET;ORAL 205095-001 May 16, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan RUFINAMIDE rufinamide TABLET;ORAL 205095-002 May 16, 2016 DISCN No No   Start Trial   Start Trial   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 021911-002 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 021911-001 Nov 14, 2008   Start Trial   Start Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-003 Nov 14, 2008   Start Trial   Start Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-002 Nov 14, 2008   Start Trial   Start Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-001 Nov 14, 2008   Start Trial   Start Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-003 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 300284 Netherlands   Start Trial 300284, 20180608, EXPIRES: 20220115
0994863 SPC026/2007 Ireland   Start Trial SPC026/2007: 20071026, EXPIRES: 20220115
0994863 CA 2007 00037 Denmark   Start Trial PRODUCT NAME: RUFINAMID, KRYSTALMODIFIKATION A
0994863 SPC/GB07/041 United Kingdom   Start Trial PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015
0994864 SPC/GB07/041 United Kingdom   Start Trial PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015
0994863 C00994863/01 Switzerland   Start Trial PRODUCT NAME: RUFINAMID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58097 06.01.2009
0994863 91345 Luxembourg   Start Trial CERTIFICATE NAME: RUFINAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (INOVELON); FIRST REGISTRATION DATE: 20070116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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