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

Stem definitionDrug idCAS RN
adamantane derivatives 1679 19982-08-2

Description:

MoleculeDescription

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:

DoseUnitRoute
20 mg O

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.32 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Hosey CM, Chan R, Benet LZ
EoM (Fraction excreted unchanged in urine) 48 % Hosey CM, Chan R, Benet LZ
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Oct. 16, 2003 FDA FOREST LABS LLC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Fall 485.37 38.73 192 2012 46907 2308974
Confusional state 458.01 38.73 155 2049 24189 2331692
Agitation 346.09 38.73 104 2100 10947 2344934
Somnolence 276.41 38.73 106 2098 23379 2332502
Loss of consciousness 250.71 38.73 93 2111 18674 2337207
Abnormal behaviour 216.40 38.73 60 2144 4700 2351181
Aggression 206.90 38.73 58 2146 4728 2351153
Seizure 206.40 38.73 87 2117 24379 2331502
Dizziness 191.80 38.73 109 2095 58556 2297325
Condition aggravated 177.88 38.73 85 2119 31894 2323987
Hallucination 160.46 38.73 54 2150 8094 2347787
Asthenia 149.83 38.73 86 2118 46840 2309041
Bradycardia 149.73 38.73 54 2150 9927 2345954
Myoclonus 148.98 38.73 39 2165 2444 2353437
Hallucination, visual 146.59 38.73 40 2164 2939 2352942
Dementia Alzheimer's type 144.48 38.73 31 2173 815 2355066
Urinary tract infection 140.67 38.73 71 2133 29871 2326010
General physical health deterioration 131.45 38.73 54 2150 14085 2341796
Gait disturbance 119.25 38.73 58 2146 22487 2333394
Decreased appetite 116.88 38.73 62 2142 28829 2327052
Vomiting 114.29 38.73 85 2119 71517 2284364
Drug interaction 110.71 38.73 60 2144 29103 2326778
Psychomotor hyperactivity 109.56 38.73 29 2175 1893 2353988
Hyponatraemia 104.11 38.73 45 2159 13280 2342601
Pulmonary embolism 93.97 38.73 46 2158 18037 2337844
Syncope 93.93 38.73 45 2159 16830 2339051
Delirium 92.47 38.73 32 2172 5191 2350690
Malaise 90.78 38.73 67 2137 55518 2300363
Disorientation 89.94 38.73 33 2171 6339 2349542
Encephalopathy 88.76 38.73 30 2174 4531 2351350
Speech disorder 85.80 38.73 32 2172 6432 2349449
Tremor 85.30 38.73 45 2159 20616 2335265
Dementia 82.52 38.73 25 2179 2656 2353225
Cognitive disorder 80.14 38.73 29 2175 5352 2350529
Cerebral atrophy 79.81 38.73 19 2185 802 2355079
Product administration interrupted 79.66 38.73 12 2192 33 2355848
Dyskinesia 79.60 38.73 28 2176 4761 2351120
Dehydration 76.59 38.73 43 2161 22252 2333629
Lethargy 76.48 38.73 32 2172 8698 2347183
Medication error 76.45 38.73 29 2175 6102 2349779
Mental status changes 75.41 38.73 28 2176 5554 2350327
Altered state of consciousness 73.56 38.73 25 2179 3835 2352046
Restlessness 73.25 38.73 26 2178 4537 2351344
Epilepsy 72.83 38.73 26 2178 4613 2351268
Pancreatitis acute 69.70 38.73 24 2180 3829 2352052
Accidental overdose 68.98 38.73 24 2180 3948 2351933
Hepatitis 68.43 38.73 27 2177 6310 2349571
Weight decreased 67.00 38.73 43 2161 28328 2327553
Balance disorder 66.64 38.73 30 2174 9717 2346164
Generalised tonic-clonic seizure 65.49 38.73 25 2179 5347 2350534
Disturbance in attention 64.12 38.73 25 2179 5660 2350221
Hypotension 64.11 38.73 44 2160 32392 2323489
Aphasia 63.93 38.73 24 2180 4904 2350977
Cardiac failure 60.47 38.73 30 2174 12064 2343817
Blood glucose increased 60.01 38.73 30 2174 12260 2343621
Coma 59.14 38.73 27 2177 9029 2346852
Nausea 58.81 38.73 72 2132 112117 2243764
Gait inability 56.08 38.73 23 2181 5932 2349949
Urinary retention 55.47 38.73 20 2184 3647 2352234
Blood creatinine increased 55.24 38.73 27 2177 10506 2345375
Atrial fibrillation 53.97 38.73 29 2175 13739 2342142
Anxiety 53.71 38.73 38 2166 29321 2326560
Fatigue 53.62 38.73 60 2144 84813 2271068
Electrocardiogram PR prolongation 53.08 38.73 10 2194 132 2355749
Hypersomnia 51.72 38.73 17 2187 2349 2353532
International normalised ratio increased 48.28 38.73 22 2182 7314 2348567
Acute kidney injury 48.22 38.73 35 2169 28087 2327794
Extrapyramidal disorder 47.85 38.73 16 2188 2331 2353550
Pneumonia 45.89 38.73 43 2161 49253 2306628
Urinary incontinence 45.55 38.73 18 2186 4215 2351666
Suicidal ideation 45.25 38.73 24 2180 11063 2344818
Blood urea increased 44.72 38.73 17 2187 3588 2352293
Electrocardiogram QT prolonged 43.89 38.73 21 2183 7793 2348088
Depression 43.70 38.73 33 2171 28099 2327782
Product use issue 43.16 38.73 24 2180 12145 2343736
Oedema peripheral 41.69 38.73 30 2174 23733 2332148
Crying 41.45 38.73 17 2187 4379 2351502
Metastases to central nervous system 41.25 38.73 14 2190 2134 2353747
Death 40.48 38.73 51 2153 81417 2274464
Renal failure 40.16 38.73 26 2178 17323 2338558
Blood albumin decreased 39.64 38.73 13 2191 1782 2354099
Dysphagia 39.35 38.73 23 2181 12782 2343099
Toxicity to various agents 39.27 38.73 33 2171 32721 2323160
Deep vein thrombosis 39.14 38.73 23 2181 12909 2342972
Diet refusal 39.10 38.73 8 2196 165 2355716

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Confusional state 306.54 34.28 115 1410 21163 1724093
Aggression 255.24 34.28 79 1446 8036 1737220
Agitation 247.27 34.28 83 1442 10943 1734313
Fall 238.58 34.28 103 1422 27111 1718145
Somnolence 154.71 34.28 66 1459 16673 1728583
Gait disturbance 137.27 34.28 56 1469 12614 1732642
Condition aggravated 136.81 34.28 65 1460 21085 1724171
Hallucination 134.54 34.28 49 1476 8121 1737135
Asthenia 130.47 34.28 74 1451 34596 1710660
Delirium 123.01 34.28 43 1482 6319 1738937
Seizure 114.56 34.28 57 1468 20384 1724872
Abnormal behaviour 104.17 34.28 38 1487 6304 1738952
Depressed level of consciousness 95.41 34.28 36 1489 6556 1738700
Dizziness 91.88 34.28 59 1466 34302 1710954
Dehydration 86.44 34.28 45 1480 17613 1727643
Dementia Alzheimer's type 77.55 34.28 18 1507 593 1744663
Cognitive disorder 71.23 34.28 26 1499 4304 1740952
Inappropriate antidiuretic hormone secretion 67.42 34.28 20 1505 1728 1743528
Decreased appetite 66.14 34.28 42 1483 23829 1721427
Syncope 66.10 34.28 35 1490 14134 1731122
Epilepsy 58.58 34.28 22 1503 3937 1741319
Drug interaction 57.76 34.28 41 1484 27917 1717339
Blood glucose increased 57.56 34.28 29 1496 10555 1734701
Disorientation 55.04 34.28 23 1502 5446 1739810
Bradyarrhythmia 52.44 34.28 12 1513 370 1744886
Speech disorder 52.14 34.28 21 1504 4527 1740729
Restlessness 49.69 34.28 20 1505 4301 1740955
Loss of consciousness 48.31 34.28 29 1496 14846 1730410
Off label use 48.10 34.28 42 1483 38529 1706727
Hallucination, visual 47.99 34.28 17 1508 2575 1742681
Generalised tonic-clonic seizure 47.47 34.28 19 1506 4027 1741229
Sedation 46.97 34.28 18 1507 3399 1741857
Cerebral atrophy 44.42 34.28 12 1513 737 1744519
Urinary tract infection 44.26 34.28 24 1501 10129 1735127
General physical health deterioration 43.69 34.28 26 1499 13092 1732164
Dementia 43.62 34.28 15 1510 2081 1743175
Accidental overdose 43.52 34.28 18 1507 4146 1741110
Urinary incontinence 43.37 34.28 16 1509 2720 1742536
Mental status changes 43.13 34.28 20 1505 6055 1739201
Lethargy 42.92 34.28 21 1504 7163 1738093
Dyspnoea 42.73 34.28 45 1480 52014 1693242
Myoclonus 42.28 34.28 15 1510 2280 1742976
Ataxia 41.92 34.28 15 1510 2338 1742918
Conduction disorder 41.47 34.28 10 1515 388 1744868
Memory impairment 41.37 34.28 20 1505 6643 1738613
Balance disorder 40.84 34.28 19 1506 5793 1739463
Hypophagia 39.56 34.28 16 1509 3481 1741775
Tremor 38.52 34.28 24 1501 13107 1732149
Hypotension 38.35 34.28 33 1492 29621 1715635
Bradycardia 38.01 34.28 22 1503 10512 1734744
Pneumonia 38.00 34.28 40 1485 46142 1699114
Muscle rigidity 37.57 34.28 13 1512 1835 1743421
Product use issue 36.61 34.28 20 1505 8551 1736705
International normalised ratio increased 34.44 34.28 19 1506 8280 1736976

Pharmacologic Action:

SourceCodeDescription
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
FDA MoA N0000020015 NMDA Receptor Antagonists
FDA EPC N0000175745 N-methyl-D-aspartate Receptor Antagonist
CHEBI has role CHEBI:48560 dopaminergic agent
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:35469 antidepressant
MeSH PA D018726 Anti-Dyskinesia Agents
MeSH PA D000978 Antiparkinson Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D018691 Excitatory Amino Acid Antagonists
MeSH PA D018377 Neurotransmitter Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
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

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.37 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
14MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8173708 Nov. 22, 2025 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
14MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8283379 Nov. 22, 2025 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
14MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8362085 Nov. 22, 2025 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
21MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8173708 Nov. 22, 2025 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
21MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8283379 Nov. 22, 2025 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
21MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8362085 Nov. 22, 2025 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
28MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8173708 Nov. 22, 2025 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
28MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8283379 Nov. 22, 2025 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
28MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8362085 Nov. 22, 2025 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
7MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8173708 Nov. 22, 2025 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
7MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8283379 Nov. 22, 2025 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
7MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8362085 Nov. 22, 2025 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
14MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
14MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
14MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
14MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
14MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
21MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
21MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
21MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
21MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8362085 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
21MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8580858 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
28MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
28MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
28MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
28MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
28MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
7MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
7MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
7MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
7MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8362085 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
7MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8580858 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
14MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8039009 March 24, 2029 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
21MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8039009 March 24, 2029 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
28MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8039009 March 24, 2029 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
7MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL 8039009 March 24, 2029 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
14MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
21MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8039009 March 24, 2029 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
28MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
7MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8039009 March 24, 2029 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
14MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
21MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8058291 Dec. 5, 2029 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
28MG NAMZARIC ALLERGAN 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 ALZHEIMER'S TYPE
7MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8058291 Dec. 5, 2029 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glutamate NMDA receptor; GRIN1/GRIN2B Ion channel NEGATIVE ALLOSTERIC MODULATOR IC50 5.26 CHEMBL CHEMBL
Glutamate receptor ionotropic, NMDA 3A Ion channel NEGATIVE ALLOSTERIC MODULATOR WOMBAT-PK CHEMBL
Glutamate NMDA receptor; GRIN1/GRIN2A Ion channel NEGATIVE ALLOSTERIC MODULATOR IC50 9.02 CHEMBL CHEMBL
Glutamate receptor ionotropic, NMDA 1 Ion channel NEGATIVE ALLOSTERIC MODULATOR IC50 5.02 CHEMBL CHEMBL
Solute carrier family 22 member 1 Transporter IC50 4.57 CHEMBL
5-hydroxytryptamine receptor 3A Ion channel WOMBAT-PK
Glutamate receptor ionotropic, NMDA 2C Ion channel Ki 6.15 CHEMBL

External reference:

IDSource
4021409 VUID
N0000148824 NUI
C0025242 UMLSCUI
D04905 KEGG_DRUG
406457005 SNOMEDCT_US
6719 RXNORM
406458000 SNOMEDCT_US
4021409 VANDF
d04899 MMSL
006597 NDDF
4054 PUBCHEM_CID
CHEBI:64312 CHEBI
CHEMBL807 ChEMBL_ID
DB01043 DRUGBANK_ID
CHEMBL1699 ChEMBL_ID
JY0WD0UA60 UNII
41100-52-1 SECONDARY_CAS_RN
377 PDB_CHEM_ID
3952 INN_ID
D008559 MESH_DESCRIPTOR_UI
4253 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Memantine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0121-0850 SOLUTION 10 mg ORAL ANDA 19 sections
Memantine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-5435 CAPSULE, EXTENDED RELEASE 7 mg ORAL ANDA 17 sections
Memantine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-5436 CAPSULE, EXTENDED RELEASE 14 mg ORAL ANDA 17 sections
Memantine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-5437 CAPSULE, EXTENDED RELEASE 21 mg ORAL ANDA 17 sections
Memantine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-5438 CAPSULE, EXTENDED RELEASE 28 mg ORAL ANDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1207 CAPSULE 7 mg ORAL NDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1214 CAPSULE 14 mg ORAL NDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1221 CAPSULE 21 mg ORAL NDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1228 CAPSULE 28 mg ORAL NDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 8 0456-1229 KIT 14 mg ORAL NDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 8 0456-1229 KIT 21 mg ORAL NDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 8 0456-1229 KIT 7 mg ORAL NDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 8 0456-1229 KIT 28 mg ORAL NDA 17 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 2 0456-3200 KIT 5 mg ORAL NDA 17 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 2 0456-3200 KIT 10 mg ORAL NDA 17 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 1 0456-3202 SOLUTION 2 mg ORAL NDA 17 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 1 0456-3205 TABLET 5 mg ORAL NDA 17 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 1 0456-3210 TABLET 10 mg ORAL NDA 17 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 4 0456-3400 KIT 28 mg ORAL NDA 17 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 4 0456-3400 KIT 7 mg ORAL NDA 17 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 4 0456-3400 KIT 21 mg ORAL NDA 17 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 4 0456-3400 KIT 14 mg ORAL NDA 17 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 1 0456-3407 CAPSULE, EXTENDED RELEASE 7 mg ORAL NDA 17 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 1 0456-3414 CAPSULE, EXTENDED RELEASE 14 mg ORAL NDA 17 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 1 0456-3421 CAPSULE, EXTENDED RELEASE 21 mg ORAL NDA 17 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 1 0456-3428 CAPSULE, EXTENDED RELEASE 28 mg ORAL NDA 17 sections
Memantine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1221 TABLET 5 mg ORAL ANDA 17 sections
Memantine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1222 TABLET 10 mg ORAL ANDA 17 sections
Memantine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1943 SOLUTION 2 mg ORAL ANDA 19 sections
memantine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-3870 TABLET 5 mg ORAL NDA 17 sections