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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

No clinical trials found on ClinicalTrials.gov for this drug

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.