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AMANTADINE HYDROCHLORIDE

ANDA

AMANTADINE HYDROCHLORIDE | A075060 | PHARMOBEDIENT CONSULTING LLC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Osmotica Pharmaceutical US LLC et al v. Adamas Pharmaceuticals, Inc. et al 1:2018cv00278 14 patentsANDA 075060amantadine hydrochloride	D. Del.	2018-02-16	Terminated 2021-01-07	—

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

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$0.0488

per ml

Lowest NADAC/Unit

$0.0488

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00116401016AMANTADINE 50 MG/5 ML SOLUTION	$0.0488	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 | 2 NDCs (2 FSS)

Lowest Price

$25.78

Highest Price

$343.32

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00116-4010-16AMANTADINE HCL 50MG/5ML SYRUP	$25.78	FSS	AvKare, LLC	06/14/2028
00116-4010-41AMANTADINE HCL 50MG/5ML SYRUP	$343.32	FSS	AvKare, LLC	06/14/2028

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

API Supply Chain5 active DMFs1 inactive

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

MOEHS IBERICA SLAMANTADINE HYDROCHLORIDE

DMF 69241987

OLPHA ASAMANTADINE HYDROCHLORIDE

DMF 235282010

ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTDAMANTADINE HYDROCHLORIDE USP

DMF 251512011

ANONIMA MATERIE SINTETICHE AND AFFINI (AMSA) SPAAMANTADINE HYDROCHLORIDE

DMF 294862015

ALEMBIC PHARMACEUTICALS LTDAMANTADINE HYDROCHLORIDE USP

DMF 415172025

NORTHEAST GENERAL PHARMACEUTICAL FACTORYInactiveAMANTADINE HYDROCHLORIDE

DMF 96651992

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 24, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/5ML

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Dec 24, 1998

No patent or exclusivity listings for this strength.