memantine Indications/Contra | FAERs | Orange Book | 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

Drug dosage:

DoseUnitRoute
20 mg O

Approvals:

DateAgencyCompanyOrphan
Oct. 16, 2003 FDA FOREST LABS LLC

FDA Adverse Event Reporting System

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 843.71 36.35 292 3500 37706 3344361
Fall 719.03 36.35 292 3500 58591 3323476
Agitation 560.13 36.35 183 3609 19523 3362544
Somnolence 457.97 36.35 179 3613 32025 3350042
Aggression 389.63 36.35 122 3670 11263 3370804
Seizure 340.64 36.35 155 3637 40245 3341822
Abnormal behaviour 324.39 36.35 103 3689 9925 3372142
Dizziness 302.10 36.35 176 3616 76336 3305731
Loss of consciousness 291.81 36.35 125 3667 28022 3354045
Hallucination 284.00 36.35 100 3692 13240 3368827
Gait disturbance 266.19 36.35 117 3675 27875 3354192
Asthenia 256.05 36.35 150 3642 65515 3316552
Condition aggravated 243.19 36.35 122 3670 39111 3342956
Delirium 231.14 36.35 79 3713 9549 3372518
Urinary tract infection 201.55 36.35 100 3692 31228 3350839
Decreased appetite 199.77 36.35 109 3683 41381 3340686
Drug interaction 187.48 36.35 109 3683 46703 3335364
Myoclonus 172.64 36.35 51 3741 3832 3378235
Dementia Alzheimer's type 171.74 36.35 40 3752 1177 3380890
General physical health deterioration 169.73 36.35 78 3714 20511 3361556
Dementia 168.01 36.35 50 3742 3854 3378213
Hallucination, visual 161.26 36.35 50 3742 4426 3377641
Dehydration 160.69 36.35 88 3704 33561 3348506
Syncope 153.47 36.35 78 3714 25555 3356512
Disorientation 153.02 36.35 59 3733 10020 3372047
Bradycardia 139.98 36.35 64 3728 16605 3365462
Epilepsy 135.94 36.35 49 3743 6896 3375171
Speech disorder 129.89 36.35 51 3741 9081 3372986
Blood glucose increased 128.48 36.35 63 3729 19092 3362975
Tremor 124.39 36.35 70 3722 28074 3353993
Hyponatraemia 121.98 36.35 60 3732 18299 3363768
Depressed level of consciousness 121.98 36.35 52 3740 11413 3370654
Cognitive disorder 119.14 36.35 46 3746 7828 3374239
Lethargy 118.22 36.35 54 3738 13961 3368106
Cerebral atrophy 111.50 36.35 29 3763 1355 3380712
Mental status changes 111.17 36.35 47 3745 10100 3371967
Hypotension 108.29 36.35 79 3713 49435 3332632
Inappropriate antidiuretic hormone secretion 106.56 36.35 34 3758 3298 3378769
Malaise 105.56 36.35 87 3705 65090 3316977
Sedation 104.39 36.35 39 3753 6062 3376005
Vomiting 104.10 36.35 99 3693 89432 3292635
Altered state of consciousness 102.89 36.35 38 3754 5720 3376347
Electrocardiogram QT prolonged 101.87 36.35 45 3747 10750 3371317
Pancreatitis acute 97.25 36.35 38 3754 6670 3375397
Restlessness 96.88 36.35 39 3753 7399 3374668
Encephalopathy 96.76 36.35 39 3753 7423 3374644
Pulmonary embolism 95.90 36.35 59 3733 27829 3354238
Urinary incontinence 94.06 36.35 36 3756 5976 3376091
Generalised tonic-clonic seizure 93.94 36.35 39 3753 8003 3374064
Pneumonia 91.97 36.35 83 3709 70060 3312007
Medication error 91.54 36.35 43 3749 11828 3370239
Weight decreased 89.91 36.35 65 3727 40046 3342021
Gait inability 89.61 36.35 37 3755 7488 3374579
Disturbance in attention 86.77 36.35 37 3755 8111 3373956
Product use issue 85.01 36.35 45 3747 15956 3366111
Accidental overdose 84.76 36.35 35 3757 7083 3374984
International normalised ratio increased 83.06 36.35 43 3749 14572 3367495
Balance disorder 77.66 36.35 39 3753 12400 3369667
Fatigue 77.26 36.35 92 3700 107148 3274919
Nausea 77.11 36.35 101 3691 129544 3252523
Constipation 76.09 36.35 53 3739 30759 3351308
Aphasia 75.85 36.35 32 3760 6829 3375238
Coma 74.40 36.35 38 3754 12514 3369553
Dyskinesia 74.00 36.35 32 3760 7253 3374814
Off label use 72.89 36.35 65 3727 53912 3328155
Blood urea increased 72.86 36.35 32 3760 7528 3374539
Urinary retention 72.81 36.35 32 3760 7540 3374527
Suicidal ideation 72.64 36.35 42 3750 17663 3364404
Hypertension 72.05 36.35 56 3736 38410 3343657
Sinus bradycardia 70.44 36.35 25 3767 3354 3378713
Blood alkaline phosphatase increased 68.56 36.35 34 3758 10519 3371548
Aspartate aminotransferase increased 68.31 36.35 43 3749 21070 3360997
Extrapyramidal disorder 67.94 36.35 25 3767 3718 3378349
Blood creatinine increased 67.02 36.35 43 3749 21775 3360292
Crying 66.66 36.35 27 3765 5196 3376871
Blood pressure increased 66.28 36.35 43 3749 22187 3359880
Renal failure 66.16 36.35 50 3742 32890 3349177
Blood sodium increased 64.35 36.35 17 3775 843 3381224
Apathy 64.06 36.35 21 3771 2216 3379851
Hypersomnia 63.95 36.35 23 3769 3206 3378861
Dysphagia 63.51 36.35 40 3752 19611 3362456
Bundle branch block left 63.04 36.35 19 3773 1523 3380544
Memory impairment 62.77 36.35 36 3756 14902 3367165
Electrocardiogram PR prolongation 62.45 36.35 13 3779 223 3381844
Haemoglobin decreased 60.86 36.35 46 3746 30248 3351819
Cardiac failure 60.20 36.35 39 3753 20066 3362001
Failure to thrive 59.58 36.35 19 3773 1836 3380231
Delusion 58.21 36.35 22 3770 3523 3378544
Oedema peripheral 57.84 36.35 47 3745 34314 3347753
Muscle rigidity 57.79 36.35 21 3771 3013 3379054
Orthostatic hypotension 57.36 36.35 24 3768 5012 3377055
Haematocrit decreased 57.04 36.35 27 3765 7540 3374527
Alanine aminotransferase increased 56.78 36.35 40 3752 23600 3358467
Hepatitis 56.62 36.35 29 3763 9596 3372471
Paranoia 56.39 36.35 22 3770 3837 3378230
Loss of personal independence in daily activities 56.31 36.35 24 3768 5246 3376821
Death 54.99 36.35 94 3698 152230 3229837
Pancreatitis 53.69 36.35 32 3760 14213 3367854
Psychotic disorder 53.36 36.35 27 3765 8707 3373360
Cerebrovascular accident 52.61 36.35 45 3747 35243 3346824
Blood pressure decreased 51.93 36.35 31 3761 13805 3368262
Depression 51.86 36.35 47 3745 39723 3342344
Dyspnoea 51.69 36.35 74 3718 102860 3279207
Incoherent 50.31 36.35 16 3776 1532 3380535
Anxiety 50.04 36.35 46 3746 39583 3342484
Mental impairment 49.79 36.35 20 3772 3765 3378302
Psychomotor hyperactivity 49.40 36.35 19 3773 3188 3378879
Eating disorder 48.36 36.35 18 3774 2761 3379306
Blood albumin decreased 46.92 36.35 18 3774 3000 3379067
Unresponsive to stimuli 46.72 36.35 24 3768 7984 3374083
Acute kidney injury 46.57 36.35 49 3743 49634 3332433
Subdural haematoma 46.21 36.35 20 3772 4535 3377532
Blood pressure systolic increased 45.90 36.35 18 3774 3181 3378886
Blood creatine phosphokinase increased 45.85 36.35 28 3764 12985 3369082
Muscular weakness 45.57 36.35 33 3759 20308 3361759
Hypernatraemia 45.52 36.35 15 3777 1607 3380460
Atrial fibrillation 45.08 36.35 35 3757 23906 3358161
Hypotonia 44.19 36.35 17 3775 2854 3379213
Diet refusal 44.01 36.35 10 3782 262 3381805
Electroencephalogram abnormal 43.81 36.35 14 3778 1361 3380706
White blood cell count increased 43.79 36.35 27 3765 12733 3369334
Hypophagia 43.76 36.35 21 3771 6040 3376027
Rhabdomyolysis 43.39 36.35 29 3763 15700 3366367
Pleural effusion 43.28 36.35 31 3761 18748 3363319
Headache 43.05 36.35 64 3728 91916 3290151
Cardiac failure congestive 42.34 36.35 37 3755 29785 3352282
Blood sodium decreased 42.02 36.35 19 3773 4777 3377290
Mobility decreased 41.84 36.35 24 3768 9924 3372143
Musculoskeletal stiffness 41.58 36.35 27 3765 13923 3368144
Faecaloma 40.77 36.35 13 3779 1255 3380812
Pneumonia aspiration 40.65 36.35 21 3771 7067 3375000
Dysarthria 39.87 36.35 23 3769 9611 3372456
Respiratory rate increased 39.58 36.35 15 3777 2418 3379649
Cerebral ischaemia 38.07 36.35 14 3778 2075 3379992
Anaemia 37.96 36.35 46 3746 54287 3327780
Renal impairment 37.23 36.35 28 3764 18233 3363834
Rash 37.08 36.35 52 3740 70769 3311298
Cardiac arrest 36.99 36.35 33 3759 27286 3354781
Hip fracture 36.79 36.35 18 3774 5397 3376670
Insomnia 36.49 36.35 37 3755 35861 3346206

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
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 D018683 Excitatory Amino Acid Agents
MeSH PA D018691 Excitatory Amino Acid Antagonists
MeSH PA D018377 Neurotransmitter Agents
FDA MoA N0000020015 NMDA Receptor Antagonists
FDA EPC N0000175745 N-methyl-D-aspartate Receptor Antagonist

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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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 FOREST LABS LLC 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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
14MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL Jan. 3, 2018 PEDIATRIC EXCLUSIVITY
21MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL Jan. 3, 2018 PEDIATRIC EXCLUSIVITY
28MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL Jan. 3, 2018 PEDIATRIC EXCLUSIVITY
7MG NAMENDA XR FOREST LABS LLC N022525 June 21, 2010 RX CAPSULE, EXTENDED RELEASE ORAL Jan. 3, 2018 PEDIATRIC EXCLUSIVITY

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
CHEBI:64312 CHEBI
4253 IUPHAR_LIGAND_ID
4021409 VUID
N0000148824 NUI
C0025242 UMLSCUI
D04905 KEGG_DRUG
DB01043 DRUGBANK_ID
CHEMBL807 ChEMBL_ID
6719 RXNORM
406457005 SNOMEDCT_US
406458000 SNOMEDCT_US
4021409 VANDF
d04899 MMSL
N0000010349 NDFRT
N0000148824 NDFRT
006597 NDDF
CHEMBL1699 ChEMBL_ID
D008559 MESH_DESCRIPTOR_UI
JY0WD0UA60 UNII
41100-52-1 SECONDARY_CAS_RN
3952 INN_ID
4054 PUBCHEM_CID
377 PDB_CHEM_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Memantine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-1103 TABLET 5 mg ORAL ANDA 17 sections
Memantine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-1104 TABLET 10 mg ORAL ANDA 17 sections
Memantine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-5435 CAPSULE, EXTENDED RELEASE 7 mg ORAL ANDA 18 sections
Memantine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-5436 CAPSULE, EXTENDED RELEASE 14 mg ORAL ANDA 18 sections
Memantine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-5437 CAPSULE, EXTENDED RELEASE 21 mg ORAL ANDA 18 sections
Memantine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-5438 CAPSULE, EXTENDED RELEASE 28 mg ORAL ANDA 18 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1207 CAPSULE 7 mg ORAL NDA 18 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1214 CAPSULE 14 mg ORAL NDA 18 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1221 CAPSULE 21 mg ORAL NDA 18 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1228 CAPSULE 28 mg ORAL NDA 18 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 8 0456-1229 KIT 21 mg ORAL NDA 18 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 8 0456-1229 KIT 7 mg ORAL NDA 18 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 8 0456-1229 KIT 28 mg ORAL NDA 18 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 8 0456-1229 KIT 14 mg ORAL NDA 18 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 2 0456-3200 KIT 5 mg ORAL NDA 18 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 2 0456-3200 KIT 10 mg ORAL NDA 18 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 1 0456-3202 SOLUTION 2 mg ORAL NDA 18 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 1 0456-3205 TABLET 5 mg ORAL NDA 18 sections
Namenda HUMAN PRESCRIPTION DRUG LABEL 1 0456-3210 TABLET 10 mg ORAL NDA 18 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 7 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 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