Memantine Hydrochloride

Treats moderate to severe dementia of the Alzheimer’s type. Sold as Namenda, Namenda Xr. Every FDA application for this active ingredient: 3 branded and 44 generic.

As of Nov 15, 2026, FDA lists 47 applications for Memantine Hydrochloride (sold as Namenda, Namenda Xr), first approved Oct 16, 2003, with 1 new use approved and 0 published complete response letters.

First approved: Oct 16, 2003
Applications: 47
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $223M
First approved in the EU: May 15, 2002
First approved in Japan: Jan 21, 2011

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Memantine HCl	Part D	$171M	+2%	1,074,357
Memantine HCl ER	Part D	$51.7M	-19%	114,523
Namenda	Part D	$12K	-84%	33
Namenda XR	Part D	$0K	-100%	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

MEMANTINE HCL 10 MG TABLET: $0.063 per unitGeneric · -2% in a year
MEMANTINE HCL 2 MG/ML SOLUTION: $0.811 per MLGeneric · +32% in a year
MEMANTINE HCL 5 MG TABLET: $0.078 per unitGeneric · -2% in a year
MEMANTINE HCL ER 14 MG CAPSULE: $0.344 per unitGeneric · -8% in a year
MEMANTINE HCL ER 21 MG CAPSULE: $0.354 per unitGeneric · +1% in a year
MEMANTINE HCL ER 28 MG CAPSULE: $0.325 per unitGeneric · -38% in a year
MEMANTINE HCL ER 7 MG CAPSULE: $0.307 per unitGeneric · -27% in a year

Approvals in the EU (EMA)

First approved in the EU 17 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Memantine Accord, genericAccord Healthcare S.L.U. · Dec 3, 2013
Memantine ratiopharm, genericRatiopharm GmbH · Jun 12, 2013
Marixino (previously Maruxa), genericKRKA tovarna zdravil d.d. Novo mesto · Apr 28, 2013
Nemdatine, genericActavis Group PTC ehf · Apr 22, 2013
Memantine Mylan, genericMylan Pharmaceuticals Limited · Apr 21, 2013
Memantine LEK, genericPharmathen S.A. · Apr 21, 2013 · withdrawn
Memantine MerzMerz Pharmaceuticals GmbH · Nov 22, 2012
AxuraMerz Pharmaceuticals GmbH · May 17, 2002

Approvals in Japan (PMDA)

First approved in Japan 87 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Memary, new ingredientDrugs with a new active ingredient indicated for inhibition of progression of symptoms of dementia in moderate and severe Alzheimer's dementia. · Daiichi Sankyo Company, Limited · Jan 21, 2011 · Review report

Clinical Trials

36 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Memantine Targeting Neurovascular Dysfunction After Mild and Moderate Traumatic Brain Injury (MEND)Traumatic Brain Injury, Mild Traumatic Brain Injury · Nova Scotia Health Authority	Phase 2	Not yet recruiting	Oct 9, 2026
Synaptic Mechanisms of Continuous Theta Burst Stimulation in DepressionMajor Depression · Mclean Hospital	Early phase 1	Recruiting	May 1, 2026
Escalating Doses of Memantine in Down Syndrome (MEDS-123)Down Syndrome, Intellectual Disability · University Hospitals Cleveland Medical Center	Phase 1	Not yet recruiting	Apr 15, 2026
SMART Trial: Cognitive Sparing Brain Radiotherapy for Multiple Brain MetastasesBrain Metastases From Solid Tumors · National Taiwan University Hospital	Phase 2	Not yet recruiting	Apr 1, 2026
Neuroprotection of Memantine and RosuvastatinPeripheral Nerve Disease · Tanta University	Phase 2 / Phase 3	Not yet recruiting	Mar 31, 2026
Memantine +/- Raloxifene for Cognitive Preservation After Radiation Therapy to the BrainBrain Tumor · The University of Texas Health Science Center at San Antonio	Phase 2	Recruiting	Mar 13, 2026
Efficacy and Safety of DMB-I (INN: Latrepirdine) in Patients With Alzheimer Type DementiaAlzheimer Type Dementia · Bigespas LTD	Phase 3	Recruiting	Nov 26, 2025
Memory Avoidance Whole Brain Radiotherapy vs Hippocampal Avoidance Whole Brain Radiotherapy (Athena 2 Trial)Brain Metastases · Case Comprehensive Cancer Center	Phase 2	Recruiting	Nov 25, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 16, 2003	NamendaNDA 21487 · New molecular entity	Abbvie	14	Discontinued
Apr 18, 2005	NamendaNDA 21627 · New dosage form	Allergan	5	Discontinued
Apr 14, 2010	Memantine HydrochlorideANDA 90048	Dr Reddys Labs Ltd	2	Marketed
May 5, 2010	Memantine HydrochlorideANDA 90058	Sun Pharm	2	Marketed
Jun 21, 2010	Namenda XrNDA 22525 · New dosage form	Abbvie	9	Discontinued
Oct 25, 2011	Memantine HydrochlorideANDA 90052	Teva Pharms	1	Discontinued
Mar 12, 2012	Memantine HydrochlorideANDA 90044	Orbion Pharms	2	Discontinued
Jan 30, 2015	Memantine HydrochlorideANDA 79225	Rising	0	Discontinued
Apr 10, 2015	Memantine HydrochlorideANDA 90041	Amneal Pharms	1	Marketed
Apr 10, 2015	Memantine HydrochlorideANDA 90051	Lupin	1	Marketed
Jul 31, 2015	Memantine HydrochlorideANDA 90043	Upsher Smith Labs	1	Marketed
Sep 4, 2015	Memantine HydrochlorideANDA 90073	Pharmazone	1	Discontinued
Oct 13, 2015	Memantine HydrochlorideANDA 91585	Jubilant Generics	0	Discontinued
Oct 13, 2015	Memantine HydrochlorideANDA 200022	Unichem	1	Marketed
Oct 13, 2015	Memantine HydrochlorideANDA 200155	Torrent	1	Discontinued
Oct 13, 2015	Memantine HydrochlorideANDA 200891	Alembic	1	Marketed
Oct 13, 2015	Memantine HydrochlorideANDA 202790	Macleods Pharms	1	Marketed
Oct 13, 2015	Memantine HydrochlorideANDA 202840	Macleods Pharms Ltd	2	Marketed
Oct 13, 2015	Memantine HydrochlorideANDA 203175	Aurobindo Pharma Ltd	1	Marketed
Oct 13, 2015	Memantine HydrochlorideANDA 204033	Chartwell Molecular	0	Marketed
Nov 17, 2015	Memantine HydrochlorideANDA 206855	Puracap Pharm LLC	1	Marketed
Nov 30, 2015	Memantine HydrochlorideANDA 206528	Ajanta Pharma Ltd	1	Marketed
Dec 7, 2015	Memantine HydrochlorideANDA 205446	Pharmazone	0	Discontinued
Sep 28, 2016	Memantine HydrochlorideANDA 206028	Lupin	2	Marketed
Sep 28, 2016	Memantine HydrochlorideANDA 205905	Sun Pharm	2	Discontinued
Sep 28, 2016	Memantine HydrochlorideANDA 206032	Rising	3	Marketed
Oct 12, 2016	Memantine HydrochlorideANDA 205825	Amneal Pharms	2	Marketed
Nov 10, 2016	Memantine HydrochlorideANDA 207236	Lannett Co Inc	0	Discontinued
Nov 22, 2016	Memantine HydrochlorideANDA 206135	Apotex	1	Discontinued
May 23, 2017	Memantine HydrochlorideANDA 202350	Strides Pharma	1	Discontinued
Jun 9, 2017	Memantine HydrochlorideANDA 205784	Ph Health	1	Discontinued
Jul 10, 2017	Memantine HydrochlorideANDA 90961	Zydus Lifesciences	1	Marketed
Aug 3, 2017	Memantine HydrochlorideANDA 203293	Zydus Pharms	1	Marketed
Feb 9, 2018	Memantine HydrochlorideANDA 209955	Apotex	0	Marketed
May 7, 2018	Memantine HydrochlorideANDA 209527	Somerset Theraps LLC	0	Marketed
Jul 11, 2018	Memantine HydrochlorideANDA 90244	Chartwell	1	Discontinued
Feb 28, 2020	Memantine HydrochlorideANDA 205365	Ani Pharms	0	Discontinued
Feb 28, 2020	Memantine HydrochlorideANDA 208173	Hikma	0	Discontinued
Apr 3, 2020	Memantine HydrochlorideANDA 212947	Pharmobedient	1	Marketed
Aug 31, 2020	Memantine HydrochlorideANDA 210319	Pharmazone	0	Marketed
Dec 11, 2020	Memantine HydrochlorideANDA 210587	Puracap Labs Blu	0	Marketed
Apr 2, 2021	Memantine HydrochlorideANDA 211100	Yichang Humanwell	0	Marketed
Aug 9, 2021	Memantine HydrochlorideANDA 214651	Aurobindo Pharma Ltd	0	Marketed
Sep 26, 2022	Memantine HydrochlorideANDA 204389	Hetero Labs Ltd V	0	Marketed
Oct 11, 2022	Memantine HydrochlorideANDA 213985	H2-Pharma	1	Marketed
Aug 28, 2025	Memantine HydrochlorideANDA 206310	Macleods Pharms	0	Marketed
—	Memantine HydrochlorideANDA 214731	Novast Labs Ltd	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA