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memantine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
adamantane derivatives	1679	19982-08-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: memantine alzantin memantina memantine hydrochloride ebixa namenda maruxa memantine HCl nemdatine	AMANTADINE derivative that has some dopaminergic effects. It has been proposed as an antiparkinson agent. Molecular weight: 179.31 Formula: C12H21N CLOGP: 3.03 LIPINSKI: 0 HAC: 1 HDO: 1 TPSA: 26.02 ALOGS: -3.60 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

memantine
alzantin
memantina
memantine hydrochloride
ebixa
namenda
maruxa
memantine HCl
nemdatine

AMANTADINE derivative that has some dopaminergic effects. It has been proposed as an antiparkinson agent.

Molecular weight: 179.31
Formula: C12H21N
CLOGP: 3.03
LIPINSKI: 0
HAC: 1
HDO: 1
TPSA: 26.02
ALOGS: -3.60
ROTB: 0

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
20	mg	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	99 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
EoM (Fraction excreted unchanged in urine)	48 %	Hosey CM, Chan R, Benet LZ
S (Water solubility)	30 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Hosey CM, Chan R, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.32 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
fu (Fraction unbound in plasma)	0.53 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

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Approvals:

Date	Agency	Company	Orphan
May 15, 2002	EMA	H. Lundbeck A/S
Oct. 16, 2003	FDA	FOREST LABS LLC

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Fall	308.35	14.81	495	20077	391839	63076611
Agitation	230.21	14.81	175	20397	59582	63408868
Confusional state	214.15	14.81	319	20253	236061	63232389
Aggression	167.93	14.81	101	20471	23397	63445053
Hallucination	160.99	14.81	137	20435	54680	63413770
Dementia	145.31	14.81	85	20487	18709	63449741
Abnormal behaviour	145.14	14.81	89	20483	21337	63447113
Body tinea	144.85	14.81	44	20528	1841	63466609
Somnolence	137.64	14.81	224	20348	178461	63289989
Inhibitory drug interaction	123.14	14.81	43	20529	2806	63465644

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hallucination	277.44	15.40	204	14408	51294	34891025
Confusional state	235.72	15.40	295	14317	143865	34798454
Fall	224.83	15.40	344	14268	202541	34739778
Dementia	141.91	15.40	82	14530	13666	34928653
Aggression	124.44	15.40	114	14498	38850	34903469
Abnormal behaviour	116.72	15.40	91	14521	24878	34917441
Somnolence	104.15	15.40	175	14437	110941	34831378
Agitation	91.08	15.40	116	14496	57283	34885036
Gait disturbance	83.61	15.40	137	14475	85003	34857316
Delusion	72.28	15.40	52	14560	12583	34929736

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Fall	437.32	13.81	696	28324	486933	79228435
Confusional state	355.92	13.81	504	28516	317493	79397875
Hallucination	300.18	13.81	249	28771	85496	79629872
Aggression	230.05	13.81	172	28848	50786	79664582
Agitation	226.12	13.81	227	28793	99488	79615880
Dementia	195.19	13.81	118	28902	24541	79690827
Somnolence	184.80	13.81	320	28700	238661	79476707
Abnormal behaviour	171.22	13.81	126	28894	36295	79679073
Bradycardia	138.20	13.81	206	28814	135351	79580017
Body tinea	136.36	13.81	43	28977	1811	79713557

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N06DA52	NERVOUS SYSTEM PSYCHOANALEPTICS ANTI-DEMENTIA DRUGS Anticholinesterases
ATC	N06DA53	NERVOUS SYSTEM PSYCHOANALEPTICS ANTI-DEMENTIA DRUGS Anticholinesterases
ATC	N06DX01	NERVOUS SYSTEM PSYCHOANALEPTICS ANTI-DEMENTIA DRUGS Other anti-dementia drugs
CHEBI has role	CHEBI:35469	antidepressants
CHEBI has role	CHEBI:48407	antiparkinson agent
CHEBI has role	CHEBI:48560	dopaminergic agents
CHEBI has role	CHEBI:60643	N-methyl-D-aspartate receptor antagonists
CHEBI has role	CHEBI:63726	neuroprotective agents
FDA EPC	N0000175745	N-methyl-D-aspartate Receptor Antagonist
FDA MoA	N0000020015	NMDA Receptor Antagonists

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Moderate to Severe Alzheimer's Type Dementia	indication
Acute nephropathy	contraindication	58574008
Impaired renal function disorder	contraindication	197663003
Disease of liver	contraindication	235856003	DOID:409

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.37	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10MG;14MG	NAMZARIC	ABBVIE	N206439	Dec. 23, 2014	RX	CAPSULE, EXTENDED RELEASE	ORAL	8173708	Nov. 22, 2025	MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;14MG	NAMZARIC	ABBVIE	N206439	Dec. 23, 2014	RX	CAPSULE, EXTENDED RELEASE	ORAL	8283379	Nov. 22, 2025	MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;14MG	NAMZARIC	ABBVIE	N206439	Dec. 23, 2014	RX	CAPSULE, EXTENDED RELEASE	ORAL	8338486	Nov. 22, 2025	MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;14MG	NAMZARIC	ABBVIE	N206439	Dec. 23, 2014	RX	CAPSULE, EXTENDED RELEASE	ORAL	8362085	Nov. 22, 2025	MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;14MG	NAMZARIC	ABBVIE	N206439	Dec. 23, 2014	RX	CAPSULE, EXTENDED RELEASE	ORAL	8580858	Nov. 22, 2025	MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;14MG	NAMZARIC	ABBVIE	N206439	Dec. 23, 2014	RX	CAPSULE, EXTENDED RELEASE	ORAL	8039009	March 24, 2029	MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;14MG	NAMZARIC	ABBVIE	N206439	Dec. 23, 2014	RX	CAPSULE, EXTENDED RELEASE	ORAL	8058291	Dec. 5, 2029	MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;21MG	NAMZARIC	ABBVIE	N206439	July 18, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8173708	Nov. 22, 2025	MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;21MG	NAMZARIC	ABBVIE	N206439	July 18, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8283379	Nov. 22, 2025	MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;21MG	NAMZARIC	ABBVIE	N206439	July 18, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8338486	Nov. 22, 2025	MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Glutamate receptor ionotropic, NMDA 3A	Ion channel	Q8TCU5	NMD3A_HUMAN	NEGATIVE ALLOSTERIC MODULATOR			WOMBAT-PK	CHEMBL
Glutamate receptor ionotropic, NMDA 1	Ion channel	Q05586	NMDZ1_HUMAN	NEGATIVE ALLOSTERIC MODULATOR	IC50	5.02	CHEMBL	CHEMBL
Glutamate NMDA receptor; GRIN1/GRIN2B	Ion channel	Q05586 Q13224	NMDZ1_HUMAN NMDE2_HUMAN	NEGATIVE ALLOSTERIC MODULATOR	IC50	5.26	CHEMBL	CHEMBL
Glutamate NMDA receptor; GRIN1/GRIN2A	Ion channel	Q05586 Q12879	NMDZ1_HUMAN NMDE1_HUMAN	NEGATIVE ALLOSTERIC MODULATOR	IC50	9.02	CHEMBL	CHEMBL
Solute carrier family 22 member 1	Transporter	O15245	S22A1_HUMAN		IC50	4.57	CHEMBL
Acetylcholinesterase	Enzyme	P22303	ACES_HUMAN		IC50	8.31	CHEMBL
5-hydroxytryptamine receptor 3A	Ion channel	P46098	5HT3A_HUMAN				WOMBAT-PK
Glutamate receptor ionotropic, NMDA 2C	Ion channel		NMDE3_RAT		Ki	6.15	CHEMBL

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External reference:

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ID	Source
377	PDB_CHEM_ID
006597	NDDF
006598	NDDF
169783	MMSL
17635	MMSL
203022	MMSL
236685	RXNORM
3952	INN_ID
4021409	VUID
4021409	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Memantine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0850	SOLUTION	10 mg	ORAL	ANDA	32 sections
Memantine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0850	SOLUTION	10 mg	ORAL	ANDA	32 sections
Memantine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1221	TABLET	5 mg	ORAL	ANDA	27 sections
Memantine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1221	TABLET	5 mg	ORAL	ANDA	27 sections
Memantine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1222	TABLET	10 mg	ORAL	ANDA	27 sections
Memantine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1222	TABLET	10 mg	ORAL	ANDA	27 sections
Memantine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1943	SOLUTION	2 mg	ORAL	ANDA	28 sections
Memantine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1943	SOLUTION	2 mg	ORAL	ANDA	28 sections
Memantine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1943	SOLUTION	2 mg	ORAL	ANDA	28 sections
memantine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3870	TABLET	5 mg	ORAL	NDA	29 sections

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