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BANZEL

NDA

RUFINAMIDE | N021911 | EISAI INC

3 strengths0 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

8 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Eisai Co., Ltd. et al v. MSN Pharmaceuticals Inc. 1:2020cv00791	D. Del.	2020-06-10	Terminated 2020-10-15	—
Eisai Co., Ltd. et al v. Lupin Limited et al 1:2019cv01336	D. Del.	2019-07-17	Terminated 2020-03-10	—
Eisai Co., Ltd. et al v. Alkem Laboratories Ltd. et al 1:2019cv01213	D. Del.	2019-06-26	Terminated 2019-12-16	—
Eisai Co., Ltd. et al v. Glenmark Pharmaceuticals Limited et al 1:2019cv01214	D. Del.	2019-06-26	Terminated 2019-08-26	—
Eisai Co., Ltd. et al v. Bionpharma Inc. 1:2018cv00618	D. Del.	2018-04-24	Terminated 2018-10-24	—
Eisai Co. Ltd. et al. v. Lupin Ltd. et al. 1:2013cv01279 3 patentsANDA 205075rufinamide	D. Del.	2013-07-24	Terminated 2016-10-13	—
Eisai Co. Ltd. et al. v. Lupin Ltd., et al. 1:2013cv01281 3 patentsANDA 204964rufinamide	D. Del.	2013-07-24	Terminated 2016-10-13	—
Eisai Co. Ltd. et al v. Hetero Labs Ltd., et al. 1:2013cv01280 3 patentsANDA 204993rufinamide	D. Del.	2013-07-24	Terminated 2015-08-04	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Reguliance, LLC on behalf of Medichem, S.A. FDA-2020-P-0624 · 7 docket documents Reguliance LLC on behalf of Medichem, S.A. submitted an ANDA Suitability Petition requesting that the FDA determine Rufinamide 800 mg film-coated tablets are suitable for submission as an abbreviated new drug application under 21 CFR 505(j), with the Reference Listed Drug being Banzel (Rufinamide) T	Other	2020-02-05	Granted	Medichem, S.A.
Lupin Pharmaceuticals, Inc. - Citizen Petition FDA-2013-P-0573 · 4 docket documents Lupin Pharmaceuticals, Inc. filed this citizen petition on May 9, 2013, requesting that the FDA determine whether Eisai Inc.'s BANZEL (rufinamide) Tablets, 100 mg (NDA 21911) was voluntarily withdrawn from marketing for safety or effectiveness reasons, and if not, to find the product eligible for AN	505(q)	2013-05-23	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

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 | 2 NDCs

Highest NADAC/Unit

$25.26

per ea

Lowest NADAC/Unit

$12.60

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62856058352BANZEL 400 MG TABLET	$25.26	EA	Brand	$1.39	2026-06-17
62856058252BANZEL 200 MG TABLET	$12.60	EA	Brand	$0.8636	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$1183.68

Highest Price

$3120.24

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62856-0582-52BANZEL 200MG TAB	$1560.12	FSS	Eisai, Inc.	05/31/2029
62856-0582-52BANZEL 200MG TAB	$1183.68	Big4	Eisai, Inc.	05/31/2029
62856-0583-52BANZEL 400MG TAB	$3120.24	FSS	Eisai, Inc.	05/31/2029
62856-0583-52BANZEL 400MG TAB	$2368.18	Big4	Eisai, Inc.	05/31/2029

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

Medicare Part D Spending

CMS annual spending data for Banzel (2024)

Total Spending

$17.6M

Total Claims

3,673

Beneficiaries

480

Avg Cost/Unit

$21.67

Spending Trend

$103.7M(2019)→$116.3M(2020)→$79.9M(2021)→$27.8M(2022)→$21.9M(2023)→$17.6M(2024)

YoY Change:-4.3%

5yr CAGR:+0.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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

8 letters from Drugs@FDA

Date	Submission	Document
Nov 29, 2019	SUPPL -17	View Letter (PDF)
Jun 26, 2015	SUPPL -13	View Letter (PDF)
Feb 17, 2015	SUPPL -12	View Letter (PDF)
Jun 3, 2011	SUPPL -8	View Letter (PDF)
Mar 8, 2011	SUPPL -7	View Letter (PDF)
Nov 10, 2010	SUPPL -5	View Letter (PDF)
Nov 24, 2009	SUPPL -4	View Letter (PDF)
Nov 18, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 14, 2008

No patent or exclusivity listings for this strength.

#002 — 200MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 14, 2008

#003 — 400MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 14, 2008