Rufinamide - Generic Drug Details

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.

Summary for rufinamide

International Patents:	87
US Patents:	1
Tradenames:	2
Applicants:	10
NDAs:	13
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	12
Patent Applications:	2,068
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for rufinamide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rufinamide
What excipients (inactive ingredients) are in rufinamide?	rufinamide excipients list
DailyMed Link:	rufinamide at DailyMed

See drug prices for rufinamide

Recent Clinical Trials for rufinamide

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

Sponsor	Phase
Guy's and St Thomas' NHS Foundation Trust	Phase 4
The Leeds Teaching Hospitals NHS Trust	Phase 4
Cambridge University Hospitals NHS Foundation Trust	Phase 4

See all rufinamide clinical trials

Generic filers with tentative approvals for RUFINAMIDE

Applicant	Application No.	Strength	Dosage Form
		40MG/ML	SUSPENSION;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
Alkem Labs Ltd	RUFINAMIDE	rufinamide	SUSPENSION;ORAL	213410-001	Feb 23, 2021	AB	RX	No	No
Hikma	RUFINAMIDE	rufinamide	TABLET;ORAL	204988-001	May 16, 2016	AB	RX	No	No
Aurobindo Pharma	RUFINAMIDE	rufinamide	SUSPENSION;ORAL	216549-001	Oct 26, 2022	AB	RX	No	No
Lupin Ltd	RUFINAMIDE	rufinamide	TABLET;ORAL	204964-001	Aug 17, 2022		RX	No	No

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
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-003	Nov 14, 2008
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-003	Nov 14, 2008

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

International Patents for rufinamide

Country	Patent Number	Title	Estimated Expiration
Colombia	4940452	MODIFICACION A CRISTAL DE UNA SUSTANCIA ACTIVA DE MEDICAMEN- TO
Germany	69813560
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
Austria	237599
Poland	192114

Supplementary Protection Certificates for rufinamide

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