Viewing data from:

AMANTADINE HYDROCHLORIDE

ANDA

AMANTADINE HYDROCHLORIDE | A214897 | ZYDUS WORLDWIDE DMCC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ADAMAS PHARMA, LLC v. ZYDUS WORLDWIDE DMCC et al 3:2020cv10463 15 patentsANDA 214897amantadine hydrochloride	D.N.J.	2020-08-13	Terminated 2021-02-03	—

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

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
Nov 28, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 68.5MG BASE

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Aug 26, 2024

No patent or exclusivity listings for this strength.