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BANZEL

NDA

RUFINAMIDE | N201367 | EISAI INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

10 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303 NCT03778424	—	AVAILABLE	Eisai Inc.	—	—
Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD)NCT00595231	Phase 2	Completed	Biotie Therapies Inc.	239	2008-03 → 2008-10
Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects NCT02332174	Phase 1	Completed	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	40	2014-03 → 2014-06
A Long Term Extension Study of E2080 in Lennox-Gastaut Patients NCT01151540	Phase 3	Completed	Eisai Co., Ltd.	54	2010-11 → 2013-08
Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures NCT00334958	Phase 3	Completed	Eisai Inc.	356	2006-02-13 → 2009-05-20
A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)NCT01146951	Phase 3	Completed	Eisai Limited	66	2010-06 → 2011-08
Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs NCT01405053	Phase 3	Completed	Eisai Inc.	37	2011-06-16 → 2015-11-02
Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures NCT00448539	Phase 3	Terminated	Eisai Inc.	286	2007-03-15 → 2010-05-14
Ketogenic Diet in Infants With Epilepsy (KIWE)NCT02205931	Phase 4	UNKNOWN	University College, London	160	2015-01 → 2019-06
Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome NCT02095899	Phase 2	Withdrawn	University of Zurich	—	2014-03 → 2015-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$3.65

per ml

Lowest NADAC/Unit

$3.65

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62856058446BANZEL 40 MG/ML SUSPENSION	$3.65	ML	Brand	$0.2262	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$1312.24

Highest Price

$1732.48

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62856-0584-46BANZEL OS	$1732.48	FSS	Eisai, Inc.	05/31/2029
62856-0584-46BANZEL OS	$1312.24	Big4	Eisai, Inc.	05/31/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain8 active DMFs1 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

DIPHARMA FRANCIS SRLRUFINAMIDE USP

DMF 256762012

ALIVUS LIFE SCIENCES LTDRUFINAMIDE

DMF 262092012

LUPIN MANUFACTURING SOLUTIONS LTDRUFINAMIDE USP

DMF 263162012

MSN LABORATORIES PRIVATE LTDRUFINAMIDE USP [ROUTE CODE "RU"]

DMF 263852012

APOTEX INCRUFINAMIDE USP

DMF 290342015

MSN LIFE SCIENCES PRIVATE LTDRUFINAMIDE USP

DMF 327132018

HETERO DRUGS LTDRUFINAMIDE

DMF 360772021

MICRO LABS LTDRUFINAMIDE USP

DMF 381822023

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveRUFINAMIDE

DMF 282842014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Oct 11, 2023	SUPPL -11	View Letter (PDF)
Nov 29, 2019	SUPPL -8	View Letter (PDF)
Jun 26, 2015	SUPPL -5	View Letter (PDF)
Feb 17, 2015	SUPPL -3	View Letter (PDF)
Jun 3, 2011	SUPPL -1	View Letter (PDF)
Mar 8, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/ML

RLDAB

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Mar 3, 2011

No patent or exclusivity listings for this strength.