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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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
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. Hetero Labs Ltd., et al. 1:2013cv01280 3 patentsANDA 204993rufinamide	D. Del.	2013-07-24	Terminated 2015-08-04	—
Eisai Co. Ltd. et al. v. Lupin Ltd., et al. 1:2013cv01281 3 patentsANDA 204964rufinamide	D. Del.	2013-07-24	Terminated 2016-10-13	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Banzel (2023)

Total Spending

$21.9M

Total Claims

4,446

Beneficiaries

542

Avg Cost/Unit

$22.65

Spending Trend

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

YoY Change:+3.8%

5yr CAGR:+3.0%

Source: CMS Medicare Part D Spending by Drug (2023). 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