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Last Updated: December 8, 2022

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, Alkem Labs Ltd, Aurobindo Pharma, Bionpharma Inc, Glasshouse Pharms, Hikma, Lupin Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, and Mylan, and is included in thirteen 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. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for rufinamide

See drug prices for rufinamide

Recent Clinical Trials for rufinamide

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

SponsorPhase
Guy's and St Thomas' NHS Foundation TrustPhase 4
The Leeds Teaching Hospitals NHS TrustPhase 4
Cambridge University Hospitals NHS Foundation TrustPhase 4

See all rufinamide clinical trials

Generic filers with tentative approvals for RUFINAMIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing40MG/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 Strength NDA ANDAs Submitted Submissiondate
BANZEL Oral Suspension rufinamide 40 mg/mL 201367 1 2014-06-16
BANZEL Tablets rufinamide 200 mg and 400 mg 021911 5 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkem Labs Ltd RUFINAMIDE rufinamide SUSPENSION;ORAL 213410-001 Feb 23, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma RUFINAMIDE rufinamide TABLET;ORAL 204988-001 May 16, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma RUFINAMIDE rufinamide SUSPENSION;ORAL 216549-001 Oct 26, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin Ltd RUFINAMIDE rufinamide TABLET;ORAL 204964-001 Aug 17, 2022 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 SUSPENSION;ORAL 201367-001 Mar 3, 2011 See Plans and Pricing See Plans and Pricing
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-002 Nov 14, 2008 See Plans and Pricing See Plans and Pricing
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-003 Nov 14, 2008 See Plans and Pricing See Plans and Pricing
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-002 Nov 14, 2008 See Plans and Pricing See Plans and Pricing
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-003 Nov 14, 2008 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for rufinamide

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Eisai GmbH Inovelon rufinamide EMEA/H/C/000660
Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older.
Authorised no no no 2007-01-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for rufinamide

Country Patent Number Title Estimated Expiration
Colombia 4940452 MODIFICACION A CRISTAL DE UNA SUSTANCIA ACTIVA DE MEDICAMEN- TO See Plans and Pricing
Germany 69813560 See Plans and Pricing
Israel 125733 CRYSTAL MODIFICATION OF THE COMPOUND 1-(2,6-DIFLUOROBENZYL)-1H-1,2,3-TRIAZOLE-4-CARBOXAMIDE AND PHARMACEUTICAL COMPOSITIONS FOR TREATING EPILEPSY COMPRISING THE SAME See Plans and Pricing
Austria 237599 See Plans and Pricing
Poland 192114 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for rufinamide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0994863 303 Finland See Plans and Pricing
0994863 91345 Luxembourg See Plans and Pricing CERTIFICATE NAME: RUFINAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (INOVELON); FIRST REGISTRATION DATE: 20070116
0994863 300284 Netherlands See Plans and Pricing 300284, 20180608, EXPIRES: 20220115
0994864 SPC/GB07/041 United Kingdom See Plans and Pricing PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015
0994863 SPC/GB07/041 United Kingdom See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

Express Scripts
Moodys
McKesson
Mallinckrodt
AstraZeneca
Dow

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 verification 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.