Viewing data from:

MEMANTINE HYDROCHLORIDE

ANDA

MEMANTINE HYDROCHLORIDE | A206310 | MACLEODS PHARMACEUTICALS LTD

4 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Allergan Sales LLC et al v. Macleods Pharmaceuticals, Ltd. et al 1:2017cv00672 4 patentsANDA 206310memantine hydrochloride	D. Del.	2017-06-02	Terminated 2018-04-05	—

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

API Supply Chain27 active DMFs6 inactive

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

OLON SPAMEMANTINE HYDROCHLORIDE

DMF 185622005

INDUSTRIALE CHIMICA SRLMEMANTINE HYDROCHLORIDE USP

DMF 194652006

AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPAMEMANTINE HYDROCHLORIDE

DMF 195492006

MATRIX PHARMACORP PRIVATE LTDMEMANTINE HYDROCHLORIDE USP

DMF 203622007

LUPIN LTDMEMANTINE HYDROCHLORIDE USP

DMF 204562007

OLPHA ASMEMANTINE HYDROCHLORIDE

DMF 205432007

DR REDDYS LABORATORIES LTDMEMANTINE HYDROCHLORIDE USP

DMF 208412007

ORBION PHARMACEUTICALS PRIVATE LTDMEMANTINE HYDROCHLORIDE

DMF 208482007

TAPI NL BVMEMANTINE HYDROCHLORIDE

DMF 208682007

SUN PHARMACEUTICAL INDUSTRIES LTDMEMANTINE HYDROCHLORIDE USP

DMF 209402007

APOTEX INCMEMANTINE HYDROCHLORIDE USP

DMF 211992007

MSN PHARMACHEM PRIVATE LTDMEMANTINE HYDROCHLORIDE USP [ROUTE CODE - MH]

DMF 221122008

UNICHEM LABORATORIES LTDMEMANTINE HYDROCHLORIDE USP

DMF 228862009

ALEMBIC PHARMACEUTICALS LTDMEMANTINE HYDROCHLORIDE USP

DMF 231082009

HIKAL LTDMEMANTINE HYDROCHLORIDE USP

DMF 235672010

MACLEODS PHARMACEUTICALS LTDMEMANTINE HYDROCHLORIDE

DMF 243812010

HETERO DRUGS LTDMEMANTINE HYDROCHLORIDE

DMF 247782011

SHARON BIO MEDICINE LTDMEMANTINE HYDROCHLORIDE

DMF 251942011

EMCURE PHARMACEUTICALS LTDMEMANTINE HYDROCHLORIDE USP

DMF 253212011

MEGAFINE PHARMA P LTDMEMANTINE HYDROCHLORIDE USP

DMF 254022011

PROCOS SPAMEMANTINE HYDROCHLORIDE

DMF 262692012

COHANCE LIFESCIENCES LTDMEMANTINE HYDROCHLORIDE USP

DMF 291802015

MACLEODS PHARMACEUTICALS LTDMEMANTINE HYDROCHLORIDE EXTENDED RELEASE PELLETS 28 MG

DMF 298552015

TAPI NL BVMEMANTINE HYDROCHLORIDE 7SM1037

DMF 353242020

ZYDUS LIFESCIENCES LTDMEMANTINE HYDROCHLORIDE USP

DMF 365742021

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDMEMANTINE HYDROCHLORIDE

DMF 384252023

WANYANG HENGSHUI PHARMACEUTICAL CO LTDMEMANTINE HYDROCHLORIDE

DMF 409422025

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveMEMANTINE HYDROCHLORIDE

DMF 184362005

ESTEVE QUIMICA SAInactiveMEMANTINE HYDROCHLORIDE

DMF 190242005

TAI HENG INDUSTRY CO LTDInactiveMEMANTINE HYDROCHLORIDE

DMF 201512007

CADILA HEALTHCARE LTDInactiveMEMANTINE HYDROCHLORIDE

DMF 203882007

RANBAXY LABORATORIES LTDInactiveMEMANTINE HYDROCHLORIDE

DMF 209412007

ANHUI POLY PHARM CO LTDInactiveMEMANTINE HYDROCHLORIDE USP

DMF 377042022

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 3, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 7MG

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Aug 28, 2025

No patent or exclusivity listings for this strength.

#002 — 14MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Aug 28, 2025

#003 — 21MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Aug 28, 2025

#004 — 28MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Aug 28, 2025