Viewing data from:

RUFINAMIDE

ANDA

RUFINAMIDE | A207363 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: BANZEL(TE code: AB)

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$0.2262

per ml

Lowest NADAC/Unit

$0.2262

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00054052863RUFINAMIDE 40 MG/ML SUSPENSION	$0.2262	ML	Generic	—	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 | 1 NDC (1 FSS)

Lowest Price

$961.52

Highest Price

$961.52

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00054-0528-63RUFINAMIDE 40MG/ML SUSP,ORAL	$961.52	FSS	Golden State Medical Supply, Inc.	06/14/2028

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

1 letter from Drugs@FDA

Date	Submission	Document
May 21, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/ML

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Apr 23, 2019

No patent or exclusivity listings for this strength.