amantadine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
adamantane derivatives 144 768-94-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • amantadine
  • adamantamine
  • adamantanamine
  • adamantylamine
  • amantadine hydrochloride
  • amantidine
  • adamantamine fumarate
  • amantadine HCl
  • amantadine sulfate
An antiviral that is used in the prophylactic or symptomatic treatment of influenza A. It is also used as an antiparkinsonian agent, to treat extrapyramidal reactions, and for postherpetic neuralgia. The mechanisms of its effects in movement disorders are not well understood but probably reflect an increase in synthesis and release of dopamine, with perhaps some inhibition of dopamine uptake.
  • Molecular weight: 151.25
  • Formula: C10H17N
  • CLOGP: 2
  • LIPINSKI: 0
  • HAC: 1
  • HDO: 1
  • TPSA: 26.02
  • ALOGS: -3.25
  • ROTB: 0

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.20 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 85 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 37.78 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 90 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 6.60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 4.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.33 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 16 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Feb. 14, 1968 FDA ENDO PHARMS

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
Dyskinesia 368.62 13.96 182 16791 27679 50560472
Hallucination 346.87 13.96 208 16765 46449 50541702
Multiple sclerosis relapse 279.63 13.96 176 16797 42788 50545363
Hallucination, visual 221.20 13.96 109 16864 16473 50571678
Fall 203.78 13.96 385 16588 334547 50253604
Multiple sclerosis 156.35 13.96 93 16880 20400 50567751
Stoma site discharge 146.56 13.96 41 16932 1234 50586917
Freezing phenomenon 146.29 13.96 39 16934 976 50587175
On and off phenomenon 133.55 13.96 39 16934 1373 50586778
Tremor 128.89 13.96 175 16798 114728 50473423
Gait disturbance 125.61 13.96 199 16774 149806 50438345
Bradykinesia 122.20 13.96 47 16926 3896 50584255
Dystonia 112.03 13.96 62 16911 11864 50576287
Therapeutic response shortened 111.88 13.96 53 16920 7336 50580815
Psychotic disorder 102.37 13.96 73 16900 21739 50566412
Balance disorder 101.99 13.96 122 16851 70468 50517683
Neuroleptic malignant syndrome 91.42 13.96 53 16920 11077 50577074
Corneal oedema 91.33 13.96 29 16944 1358 50586793
Stoma site erythema 90.43 13.96 26 16947 865 50587286
Urinary tract infection 85.70 13.96 214 16759 223806 50364345
Hyperkinesia 81.92 13.96 27 16946 1425 50586726
Muscle rigidity 81.24 13.96 47 16926 9782 50578369
Stoma site pain 70.77 13.96 21 16952 782 50587369
Seizure 66.93 13.96 132 16841 117742 50470409
Parkinsonism hyperpyrexia syndrome 66.22 13.96 14 16959 122 50588029
Delusion 65.42 13.96 42 16931 10527 50577624
Livedo reticularis 60.62 13.96 24 16949 2148 50586003
Diarrhoea 58.49 13.96 67 16906 588409 49999742
Dysphagia 58.19 13.96 98 16875 77420 50510731
Hallucinations, mixed 54.76 13.96 27 16946 4076 50584075
Acute psychosis 53.25 13.96 22 16951 2198 50585953
Impulse-control disorder 52.48 13.96 16 16957 654 50587497
Speech disorder 52.22 13.96 62 16911 35486 50552665
Joint swelling 51.35 13.96 10 16963 245276 50342875
Hypokinesia 50.77 13.96 38 16935 12179 50575972
Akinesia 50.52 13.96 19 16954 1480 50586671
Myoclonus 49.26 13.96 40 16933 14430 50573721
Rash 47.67 13.96 46 16927 437425 50150726
Rheumatoid arthritis 47.49 13.96 6 16967 202544 50385607
Stoma site inflammation 46.37 13.96 13 16960 394 50587757
Delirium 45.52 13.96 60 16913 38132 50550019
Infusion related reaction 42.33 13.96 4 16969 169553 50418598
Stoma site hypergranulation 41.15 13.96 11 16962 278 50587873
Orthostatic hypotension 40.97 13.96 50 16923 29431 50558720
Stoma site reaction 39.44 13.96 10 16963 204 50587947
Abnormal dreams 38.59 13.96 29 16944 9348 50578803
Dysstasia 36.46 13.96 37 16936 17782 50570369
Gait inability 36.37 13.96 53 16920 36974 50551177
Dopamine dysregulation syndrome 36.30 13.96 9 16964 167 50587984
Drug hypersensitivity 34.15 13.96 21 16952 250989 50337162
Therapeutic product effect variable 33.80 13.96 13 16960 1077 50587074
Stoma site infection 32.85 13.96 11 16962 610 50587541
Paratonia 32.77 13.96 6 16967 22 50588129
Prescribed underdose 32.42 13.96 33 16940 15916 50572235
Muscle spasticity 32.13 13.96 34 16939 17150 50571001
Agitation 30.51 13.96 60 16913 53324 50534827
Nightmare 30.38 13.96 32 16941 16054 50572097
Corneal decompensation 29.93 13.96 6 16967 39 50588112
Cognitive disorder 29.46 13.96 53 16920 44070 50544081
Abdominal discomfort 29.32 13.96 21 16952 231620 50356531
Parkinson's disease 29.20 13.96 12 16961 1183 50586968
Parkinsonism 29.15 13.96 24 16949 8823 50579328
Psychotic symptom 29.03 13.96 12 16961 1200 50586951
Memory impairment 28.35 13.96 74 16899 79286 50508865
Disorientation 28.13 13.96 46 16927 35438 50552713
Relapsing-remitting multiple sclerosis 27.25 13.96 9 16964 478 50587673
Arthralgia 26.84 13.96 68 16905 438634 50149517
Stoma site odour 26.05 13.96 5 16968 25 50588126
Treatment failure 26.01 13.96 7 16966 137630 50450521
Confusional state 25.81 13.96 127 16846 185801 50402350
Posture abnormal 25.67 13.96 13 16960 2076 50586075
Progressive multifocal leukoencephalopathy 25.67 13.96 25 16948 11432 50576719
Muscular weakness 25.57 13.96 80 16893 94933 50493218
Cerebral atrophy 25.34 13.96 17 16956 4584 50583567
Neutropenia 25.31 13.96 9 16964 147956 50440195
Abnormal behaviour 25.16 13.96 32 16941 19626 50568525
Drug intolerance 25.03 13.96 22 16951 219082 50369069
Sleep talking 24.93 13.96 10 16963 926 50587225
Device dislocation 24.37 13.96 33 16940 21513 50566638
Depression 23.68 13.96 114 16859 165309 50422842
Glossodynia 23.56 13.96 5 16968 115564 50472587
Arthropathy 23.20 13.96 12 16961 157894 50430257
Alopecia 23.06 13.96 29 16944 245018 50343133
Gastrointestinal complication associated with device 23.00 13.96 4 16969 10 50588141
Motor dysfunction 22.80 13.96 20 16953 8011 50580140
Wound 22.78 13.96 4 16969 105790 50482361
Lower respiratory tract infection 21.86 13.96 3 16970 95198 50492953
Nausea 21.85 13.96 143 16830 705255 49882896
Systemic lupus erythematosus 21.70 13.96 10 16963 140612 50447539
Pneumonia aspiration 21.67 13.96 38 16935 30966 50557185
Urinary incontinence 21.59 13.96 36 16937 28172 50559979
Tongue biting 21.55 13.96 10 16963 1320 50586831
Device kink 21.49 13.96 11 16962 1796 50586355
Extrapyramidal disorder 21.49 13.96 23 16950 11747 50576404
Stoma site haemorrhage 21.47 13.96 9 16964 932 50587219
Movement disorder 21.47 13.96 28 16945 17604 50570547
Stomatitis 21.46 13.96 4 16969 101340 50486811
Vitamin B6 deficiency 21.17 13.96 5 16968 75 50588076
Dementia 20.41 13.96 26 16947 15971 50572180
Febrile neutropenia 20.37 13.96 4 16969 97663 50490488
Off label use 20.36 13.96 86 16887 474340 50113811
Compulsive shopping 20.27 13.96 8 16965 710 50587441
Choking 19.90 13.96 19 16954 8479 50579672
Secondary progressive multiple sclerosis 18.91 13.96 9 16964 1257 50586894
Camptocormia 18.61 13.96 6 16967 295 50587856
Chorea 18.42 13.96 9 16964 1331 50586820
Central nervous system lesion 18.14 13.96 19 16954 9470 50578681
Lymphopenia 17.77 13.96 24 16949 15597 50572554
Progressive supranuclear palsy 17.76 13.96 4 16969 48 50588103
Asthenia 17.73 13.96 174 16799 318868 50269283
Dry mouth 17.67 13.96 50 16923 56128 50532023
Swelling 17.64 13.96 25 16948 200847 50387304
Muscle spasms 17.58 13.96 86 16887 125467 50462684
Compulsive hoarding 17.12 13.96 4 16969 57 50588094
Stoma site irritation 17.12 13.96 5 16968 176 50587975
Lymphocyte count decreased 16.79 13.96 31 16942 26276 50561875
Resting tremor 16.76 13.96 7 16966 719 50587432
Fibroma 16.67 13.96 7 16966 728 50587423
Progressive multiple sclerosis 16.49 13.96 7 16966 748 50587403
Hypernatraemia 16.47 13.96 15 16958 6306 50581845
Dyspnoea 16.42 13.96 112 16861 547496 50040655
Hypersexuality 16.20 13.96 6 16967 448 50587703
Pain 16.10 13.96 121 16852 578782 50009369
Abdominal wall wound 16.10 13.96 4 16969 75 50588076
Nystagmus 16.09 13.96 14 16959 5547 50582604
Autonomic nervous system imbalance 16.06 13.96 10 16963 2375 50585776
Nasopharyngitis 15.98 13.96 25 16948 192902 50395249
Stoma site candida 15.80 13.96 3 16970 14 50588137
Corneal endotheliitis 15.80 13.96 3 16970 14 50588137
Hyperthermia 15.78 13.96 16 16957 7680 50580471
Hypoaesthesia 15.60 13.96 84 16889 127173 50460978
Somnolence 15.55 13.96 97 16876 154888 50433263
Generalised tonic-clonic seizure 15.55 13.96 30 16943 26280 50561871
Stoma site extravasation 15.41 13.96 5 16968 251 50587900
Sinusitis 15.20 13.96 21 16952 170537 50417614
Device occlusion 15.13 13.96 14 16959 6009 50582142
Urosepsis 14.98 13.96 22 16951 15443 50572708
Hyporesponsive to stimuli 14.93 13.96 7 16966 945 50587206
Maternal exposure during pregnancy 14.92 13.96 19 16954 159759 50428392
Peroneal nerve palsy 14.91 13.96 12 16961 4271 50583880
Fractured coccyx 14.86 13.96 7 16966 956 50587195
Dementia with Lewy bodies 14.83 13.96 5 16968 283 50587868
Hallucination, auditory 14.58 13.96 18 16955 10710 50577441
Lupus vulgaris 14.35 13.96 6 16967 618 50587533
Prolapse 14.20 13.96 3 16970 26 50588125
Immune reconstitution inflammatory syndrome 14.20 13.96 13 16960 5503 50582648
Influenza like illness 14.20 13.96 47 16926 57412 50530739
Corneal disorder 14.03 13.96 8 16965 1618 50586533
Deep brain stimulation 14.01 13.96 3 16970 28 50588123

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
Hallucination 442.35 15.55 263 12673 44449 29517142
Dyskinesia 346.63 15.55 171 12765 19890 29541701
On and off phenomenon 285.28 15.55 80 12856 1848 29559743
Hallucination, visual 244.49 15.55 123 12813 14892 29546699
Dopamine dysregulation syndrome 174.09 15.55 38 12898 291 29561300
Fall 156.18 15.55 278 12658 176900 29384691
Freezing phenomenon 153.63 15.55 45 12891 1218 29560373
Delusion 105.42 15.55 64 12872 11152 29550439
Hypersexuality 100.26 15.55 33 12903 1323 29560268
Muscle rigidity 94.40 15.55 56 12880 9355 29552236
Tremor 92.66 15.55 136 12800 73402 29488189
Gambling disorder 91.56 15.55 32 12904 1543 29560048
Bradykinesia 89.43 15.55 39 12897 3408 29558183
Gait disturbance 88.61 15.55 133 12803 73216 29488375
Impulse-control disorder 87.31 15.55 29 12907 1196 29560395
Stoma site discharge 78.74 15.55 25 12911 892 29560699
Balance disorder 77.32 15.55 87 12849 36083 29525508
Neuroleptic malignant syndrome 73.40 15.55 59 12877 16089 29545502
Stoma site erythema 70.16 15.55 21 12915 613 29560978
Confusional state 65.58 15.55 161 12775 127716 29433875
Serotonin syndrome 65.16 15.55 57 12879 17455 29544136
Agitation 64.73 15.55 95 12841 51209 29510382
Multiple sclerosis relapse 61.19 15.55 46 12890 11373 29550218
Illusion 59.70 15.55 19 12917 683 29560908
Hyperkinesia 58.06 15.55 23 12913 1576 29560015
Parkinsonism hyperpyrexia syndrome 56.95 15.55 12 12924 76 29561515
Stoma site pain 56.61 15.55 17 12919 502 29561089
Multiple sclerosis 55.56 15.55 33 12903 5521 29556070
Dystonia 51.63 15.55 39 12897 9710 29551881
Therapeutic product effect variable 51.18 15.55 22 12914 1855 29559736
Aggression 45.07 15.55 66 12870 35475 29526116
Abnormal behaviour 44.97 15.55 53 12883 23074 29538517
Parkinsonism 42.77 15.55 31 12905 7247 29554344
Speech disorder 42.62 15.55 52 12884 23464 29538127
Hypersomnia 42.01 15.55 36 12900 10718 29550873
Diarrhoea 40.35 15.55 52 12884 332646 29228945
Stoma site infection 39.77 15.55 14 12922 689 29560902
Abnormal dreams 39.59 15.55 29 12907 6891 29554700
Psychotic disorder 38.50 15.55 46 12890 20308 29541283
Paranoia 38.45 15.55 33 12903 9844 29551747
Febrile neutropenia 37.79 15.55 3 12933 112237 29449354
Anticholinergic syndrome 36.49 15.55 14 12922 880 29560711
Reduced facial expression 35.94 15.55 13 12923 693 29560898
Device dislocation 35.40 15.55 23 12913 4504 29557087
Fibroma 35.00 15.55 10 12926 247 29561344
Cognitive disorder 34.78 15.55 47 12889 23452 29538139
Akinesia 34.40 15.55 17 12919 1973 29559618
Memory impairment 34.19 15.55 59 12877 36411 29525180
Parkinson's disease 34.00 15.55 15 12921 1346 29560245
Neutropenia 33.91 15.55 8 12928 131703 29429888
Dysphagia 33.37 15.55 74 12862 54852 29506739
Gambling 32.93 15.55 9 12927 188 29561403
Dementia 31.90 15.55 32 12904 11626 29549965
Therapeutic response shortened 31.84 15.55 22 12914 4769 29556822
Mobility decreased 31.42 15.55 47 12889 25733 29535858
Pneumonia aspiration 31.31 15.55 57 12879 36680 29524911
Compulsive shopping 30.79 15.55 10 12926 384 29561207
Myoclonus 30.10 15.55 33 12903 13276 29548315
Stoma site inflammation 29.86 15.55 10 12926 423 29561168
Hallucination, tactile 29.80 15.55 9 12927 271 29561320
Rapid eye movements sleep abnormal 29.01 15.55 8 12928 173 29561418
Choking 28.39 15.55 20 12916 4471 29557120
Nightmare 27.03 15.55 29 12907 11388 29550203
Embedded device 26.78 15.55 8 12928 232 29561359
Nocturia 26.73 15.55 25 12911 8337 29553254
Deep brain stimulation 26.28 15.55 5 12931 17 29561574
Posture abnormal 26.05 15.55 14 12922 1933 29559658
Somnolence 25.82 15.55 95 12841 93860 29467731
Persecutory delusion 24.81 15.55 14 12922 2127 29559464
Disturbance in attention 24.60 15.55 38 12898 21386 29540205
Insomnia 24.60 15.55 90 12846 88671 29472920
Sensory disturbance 24.56 15.55 20 12916 5549 29556042
Delirium 23.83 15.55 53 12883 39344 29522247
Corneal oedema 23.52 15.55 11 12925 1131 29560460
Autonomic nervous system imbalance 23.45 15.55 14 12922 2362 29559229
Device kink 23.43 15.55 8 12928 359 29561232
Somatic delusion 23.40 15.55 6 12930 97 29561494
Hallucinations, mixed 23.15 15.55 14 12922 2419 29559172
Anaemia 22.69 15.55 33 12903 200918 29360673
Soft tissue mass 22.57 15.55 9 12927 627 29560964
Middle insomnia 22.07 15.55 19 12917 5689 29555902
Dysstasia 22.02 15.55 25 12911 10449 29551142
Sleep talking 21.98 15.55 8 12928 434 29561157
Progressive supranuclear palsy 21.89 15.55 5 12931 48 29561543
Motor dysfunction 21.44 15.55 19 12917 5911 29555680
Urinary tract infection 21.43 15.55 75 12861 72279 29489312
Mydriasis 21.02 15.55 19 12917 6066 29555525
Stoma site reaction 20.74 15.55 6 12930 155 29561436
Anxiety 20.72 15.55 83 12853 85282 29476309
Platelet count decreased 20.62 15.55 10 12926 104662 29456929
Device connection issue 20.38 15.55 7 12929 320 29561271
Stoma site extravasation 20.17 15.55 5 12931 70 29561521
Nasal discomfort 19.91 15.55 10 12926 1202 29560389
Thrombocytopenia 19.68 15.55 18 12918 134805 29426786
Facial paresis 19.63 15.55 13 12923 2628 29558963
Underdose 19.50 15.55 25 12911 11844 29549747
Sexually inappropriate behaviour 18.97 15.55 7 12929 395 29561196
Musculoskeletal stiffness 18.95 15.55 47 12889 37411 29524180
Rash 18.77 15.55 34 12902 189785 29371806
Tic 18.60 15.55 11 12925 1824 29559767
Depression 18.48 15.55 80 12856 85067 29476524
Micturition disorder 18.24 15.55 11 12925 1890 29559701
Band neutrophil percentage increased 18.22 15.55 5 12931 106 29561485
Postural reflex impairment 18.13 15.55 3 12933 3 29561588
Malignant neoplasm progression 18.01 15.55 5 12931 73854 29487737
Stoma site induration 17.37 15.55 4 12932 40 29561551
Hyperkalaemia 17.30 15.55 3 12933 61389 29500202
Pelvic fracture 16.63 15.55 11 12925 2220 29559371
Feeling abnormal 16.60 15.55 57 12879 54388 29507203
Gastrointestinal haemorrhage 16.59 15.55 7 12929 79526 29482065
Saliva altered 16.39 15.55 5 12931 156 29561435
General physical health deterioration 16.10 15.55 88 12848 102769 29458822
Resting tremor 16.06 15.55 7 12929 610 29560981
Intentional underdose 16.00 15.55 7 12929 616 29560975
Disorientation 15.96 15.55 38 12898 29477 29532114
Acute kidney injury 15.93 15.55 61 12875 265206 29296385
Hyperthermia 15.71 15.55 20 12916 9410 29552181
Injection site necrosis 15.70 15.55 6 12930 373 29561218
Stereotypy 15.62 15.55 7 12929 652 29560939

FDA Adverse Event Reporting System (Geriatric)

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
Dyskinesia 589.20 13.18 292 24468 39096 64434876
Hallucination 572.41 13.18 353 24407 72435 64401537
Hallucination, visual 400.25 13.18 201 24559 27633 64446339
On and off phenomenon 337.37 13.18 94 24666 2425 64471547
Fall 294.69 13.18 552 24208 416274 64057698
Multiple sclerosis relapse 245.50 13.18 168 24592 40967 64433005
Freezing phenomenon 208.43 13.18 58 24702 1488 64472484
Dopamine dysregulation syndrome 186.33 13.18 42 24718 437 64473535
Tremor 165.92 13.18 242 24518 147988 64325984
Gait disturbance 154.78 13.18 254 24506 171901 64302071
Neuroleptic malignant syndrome 146.50 13.18 101 24659 24895 64449077
Stoma site discharge 142.44 13.18 44 24716 1638 64472334
Bradykinesia 142.43 13.18 63 24697 6497 64467475
Multiple sclerosis 141.33 13.18 89 24671 18852 64455120
Dystonia 139.15 13.18 88 24672 18777 64455195
Impulse-control disorder 136.41 13.18 42 24718 1546 64472426
Psychotic disorder 129.76 13.18 107 24653 34471 64439501
Balance disorder 128.97 13.18 160 24600 83766 64390206
Muscle rigidity 125.12 13.18 80 24680 17393 64456579
Therapeutic response shortened 124.61 13.18 66 24694 10104 64463868
Parkinsonism hyperpyrexia syndrome 121.92 13.18 26 24734 204 64473768
Delusion 120.44 13.18 79 24681 17935 64456037
Hyperkinesia 116.96 13.18 42 24718 2504 64471468
Corneal oedema 112.73 13.18 40 24720 2303 64471669
Hypersexuality 97.61 13.18 32 24728 1447 64472525
Stoma site erythema 94.82 13.18 30 24730 1209 64472763
Gambling disorder 93.65 13.18 33 24727 1861 64472111
Stoma site pain 93.25 13.18 29 24731 1104 64472868
Agitation 85.59 13.18 135 24625 88232 64385740
Urinary tract infection 78.88 13.18 231 24529 231365 64242607
Myoclonus 72.59 13.18 67 24693 25051 64448921
Diarrhoea 69.08 13.18 107 24653 722597 63751375
Serotonin syndrome 68.66 13.18 80 24680 39202 64434770
Dysphagia 68.25 13.18 136 24624 106676 64367296
Therapeutic product effect variable 67.62 13.18 25 24735 1619 64472353
Confusional state 66.68 13.18 236 24524 260908 64213064
Hallucinations, mixed 62.28 13.18 35 24725 6017 64467955
Abnormal dreams 61.02 13.18 42 24718 10314 64463658
Delirium 60.57 13.18 101 24659 69093 64404879
Speech disorder 59.84 13.18 83 24677 48358 64425614
Parkinsonism 59.24 13.18 47 24713 14326 64459646
Seizure 59.22 13.18 169 24591 166723 64307249
Stoma site infection 59.09 13.18 21 24739 1214 64472758
Akinesia 58.67 13.18 27 24733 3052 64470920
Abnormal behaviour 57.97 13.18 68 24692 33554 64440418
Illusion 57.75 13.18 22 24738 1548 64472424
Acute psychosis 53.59 13.18 27 24733 3725 64470247
Febrile neutropenia 51.21 13.18 6 24754 187651 64286321
Rheumatoid arthritis 51.01 13.18 3 24757 164291 64309681
Neutropenia 49.90 13.18 15 24745 239609 64234363
Hypokinesia 49.37 13.18 45 24715 16551 64457421
Compulsive shopping 48.02 13.18 16 24744 761 64473211
Aggression 46.64 13.18 72 24688 46160 64427812
Pneumonia aspiration 45.95 13.18 82 24678 59189 64414783
Joint swelling 45.73 13.18 13 24747 215369 64258603
Livedo reticularis 45.30 13.18 24 24736 3673 64470299
Cognitive disorder 43.72 13.18 77 24683 55010 64418962
Rash 43.59 13.18 68 24692 458481 64015491
Parkinson's disease 43.41 13.18 18 24742 1583 64472389
Dementia 42.63 13.18 46 24714 20720 64453252
Drug hypersensitivity 42.58 13.18 19 24741 237796 64236176
Prescribed underdose 42.52 13.18 43 24717 17972 64456000
Infusion related reaction 40.80 13.18 7 24753 164460 64309512
Dysstasia 40.09 13.18 47 24713 23168 64450804
Progressive supranuclear palsy 39.22 13.18 9 24751 102 64473870
Autonomic nervous system imbalance 37.45 13.18 22 24738 4110 64469862
Gait inability 37.27 13.18 62 24698 42306 64431666
Nightmare 37.08 13.18 43 24717 20950 64453022
Stoma site odour 36.84 13.18 8 24752 69 64473903
Device dislocation 36.78 13.18 43 24717 21135 64452837
Sleep talking 36.54 13.18 14 24746 1001 64472971
Rapid eye movements sleep abnormal 36.29 13.18 10 24750 247 64473725
Stoma site inflammation 36.19 13.18 12 24748 562 64473410
Pancytopenia 35.77 13.18 6 24754 143303 64330669
Disorientation 35.53 13.18 71 24689 55757 64418215
Hypersomnia 34.18 13.18 40 24720 19677 64454295
Memory impairment 33.55 13.18 90 24670 85592 64388380
Hyperthermia 32.89 13.18 35 24725 15515 64458457
Orthostatic hypotension 32.86 13.18 62 24698 46676 64427296
Deep brain stimulation 32.81 13.18 7 24753 55 64473917
Motor dysfunction 32.20 13.18 30 24730 11343 64462629
Choking 32.18 13.18 29 24731 10509 64463463
Resting tremor 32.05 13.18 14 24746 1400 64472572
Stoma site hypergranulation 32.02 13.18 10 24750 386 64473586
Paratonia 31.96 13.18 6 24754 22 64473950
Paranoia 31.44 13.18 35 24725 16317 64457655
Stoma site extravasation 30.37 13.18 9 24751 290 64473682
Insomnia 30.23 13.18 153 24607 197683 64276289
Nausea 30.07 13.18 178 24582 785622 63688350
Arthralgia 29.74 13.18 80 24680 442180 64031792
Reduced facial expression 29.58 13.18 15 24745 2098 64471874
Postural reflex impairment 28.84 13.18 5 24755 10 64473962
Stomatitis 28.69 13.18 4 24756 109601 64364371
Cerebral atrophy 28.27 13.18 23 24737 7262 64466710
Delusion of grandeur 27.94 13.18 10 24750 590 64473382
Middle insomnia 27.26 13.18 29 24731 12848 64461124
Nocturia 26.99 13.18 27 24733 11138 64462834
Dyspnoea 26.84 13.18 164 24596 718510 63755462
Sensory disturbance 26.66 13.18 29 24731 13179 64460793
Psychotic symptom 26.54 13.18 14 24746 2124 64471848
Gambling 26.34 13.18 8 24752 281 64473691
Anticholinergic syndrome 26.29 13.18 15 24745 2654 64471318
Platelet count decreased 26.15 13.18 16 24744 167695 64306277
Anxiety 25.73 13.18 149 24611 202500 64271472
Stoma site reaction 25.68 13.18 8 24752 306 64473666
Malignant neoplasm progression 25.50 13.18 6 24754 112865 64361107
Posture abnormal 25.38 13.18 16 24744 3390 64470582
Lupus vulgaris 25.11 13.18 6 24754 82 64473890
Persecutory delusion 24.82 13.18 17 24743 4141 64469831
Stereotypy 24.65 13.18 10 24750 832 64473140
Secondary progressive multiple sclerosis 24.00 13.18 11 24749 1232 64472740
Stoma site induration 23.25 13.18 5 24755 41 64473931
Somnolence 22.84 13.18 145 24615 203500 64270472
Muscle spasticity 22.76 13.18 30 24730 16639 64457333
Camptocormia 22.34 13.18 8 24752 473 64473499
Mobility decreased 22.20 13.18 78 24682 85762 64388210
Relapsing-remitting multiple sclerosis 22.00 13.18 10 24750 1098 64472874
Extrapyramidal disorder 21.92 13.18 32 24728 19520 64454452
Urinary incontinence 21.83 13.18 45 24715 36106 64437866
Drug intolerance 21.79 13.18 24 24736 187968 64286004
Underdose 21.65 13.18 37 24723 25792 64448180
Depression 21.49 13.18 132 24628 183159 64290813
Hallucination, auditory 20.87 13.18 29 24731 16910 64457062
Soft tissue mass 20.60 13.18 9 24751 900 64473072
Movement disorder 20.43 13.18 33 24727 21967 64452005
Swelling 20.22 13.18 19 24741 160199 64313773
Withdrawal syndrome 20.15 13.18 34 24726 23458 64450514
Cough 20.03 13.18 55 24705 302093 64171879
Treatment failure 19.86 13.18 10 24750 116806 64357166
Mental status changes 19.80 13.18 60 24700 61102 64412870
Decubitus ulcer 19.71 13.18 25 24735 13354 64460618
Stoma site oedema 19.69 13.18 4 24756 24 64473948
Arthropathy 19.62 13.18 11 24749 120956 64353016
Somatic delusion 19.53 13.18 8 24752 682 64473290
Hip fracture 19.11 13.18 36 24724 27063 64446909
Depressed mood 19.08 13.18 46 24714 40966 64433006
Disturbance in attention 19.04 13.18 46 24714 41028 64432944
Anaemia 18.90 13.18 78 24682 378602 64095370
Sexually inappropriate behaviour 18.82 13.18 7 24753 461 64473511
Device occlusion 18.68 13.18 21 24739 9892 64464080
Neuropathy peripheral 18.62 13.18 11 24749 117514 64356458
Hallucination, tactile 18.60 13.18 7 24753 476 64473496
Blood creatine phosphokinase increased 18.54 13.18 57 24703 58501 64415471
Neuroprosthesis implantation 18.52 13.18 3 24757 3 64473969
Pruritus 18.45 13.18 60 24700 312340 64161632
Device kink 17.99 13.18 10 24750 1683 64472289
Off label use 17.99 13.18 156 24604 632650 63841322
Corneal decompensation 17.80 13.18 4 24756 41 64473931
Headache 17.61 13.18 125 24635 529342 63944630
Hypotension 17.48 13.18 81 24679 380893 64093079
Encephalopathy 17.47 13.18 56 24704 58763 64415209
Musculoskeletal stiffness 17.22 13.18 93 24667 123113 64350859
Device issue 17.12 13.18 31 24729 22617 64451355
Rapid eye movement sleep behaviour disorder 17.08 13.18 6 24754 335 64473637
Cardiac failure congestive 17.06 13.18 15 24745 130565 64343407
Thrombocytopenia 16.96 13.18 38 24722 223763 64250209
Vomiting 16.95 13.18 133 24627 550984 63922988
Urticaria 16.86 13.18 19 24741 147298 64326674
Drug withdrawal syndrome 16.65 13.18 37 24723 31254 64442718
Dry mouth 16.58 13.18 56 24704 60362 64413610
Constipation 16.47 13.18 147 24613 229190 64244782
Progressive multifocal leukoencephalopathy 16.46 13.18 27 24733 18205 64455767
Abdominal discomfort 16.37 13.18 28 24732 182294 64291678
Pain 16.37 13.18 135 24625 553376 63920596
Corneal disorder 16.31 13.18 10 24750 2017 64471955
Intentional underdose 16.17 13.18 10 24750 2048 64471924
Nasopharyngitis 15.94 13.18 32 24728 196041 64277931
Compulsive hoarding 15.87 13.18 4 24756 69 64473903
Saliva altered 15.85 13.18 6 24754 415 64473557
Asthenia 15.74 13.18 241 24519 427803 64046169
Generalised tonic-clonic seizure 15.73 13.18 42 24718 39815 64434157
Volvulus 15.48 13.18 10 24750 2211 64471761
Head injury 15.46 13.18 37 24723 32805 64441167
Alopecia 15.29 13.18 25 24735 165665 64308307
Progressive multiple sclerosis 15.23 13.18 7 24753 789 64473183
Hypernatraemia 15.21 13.18 21 24739 12168 64461804
Therapeutic response unexpected 15.11 13.18 25 24735 16976 64456996
Muscular weakness 15.10 13.18 92 24668 127246 64346726
Incoherent 15.01 13.18 16 24744 7102 64466870
Tongue biting 14.98 13.18 9 24751 1751 64472221
Psychiatric symptom 14.85 13.18 15 24745 6258 64467714
International normalised ratio increased 14.67 13.18 6 24754 79161 64394811
Device connection issue 14.56 13.18 7 24753 872 64473100
Injection site necrosis 14.55 13.18 8 24752 1317 64472655
Mania 14.54 13.18 24 24736 16262 64457710
Micturition disorder 14.50 13.18 11 24749 3137 64470835
Sinusitis 14.44 13.18 21 24739 145907 64328065
Oromandibular dystonia 14.31 13.18 7 24753 906 64473066
Vitamin B6 deficiency 14.12 13.18 5 24755 286 64473686
Periphlebitis 14.01 13.18 3 24757 24 64473948
Psoriasis 14.01 13.18 5 24755 71698 64402274
Chorea 13.92 13.18 9 24751 1991 64471981
Urinary retention 13.85 13.18 46 24714 49155 64424817
Impulsive behaviour 13.83 13.18 10 24750 2653 64471319
Hypersensitivity 13.58 13.18 35 24725 196417 64277555
Glossodynia 13.54 13.18 4 24756 64692 64409280
Urinary hesitation 13.45 13.18 11 24749 3499 64470473
Screaming 13.39 13.18 11 24749 3518 64470454
Tardive dyskinesia 13.28 13.18 17 24743 9161 64464811

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N04BB01 NERVOUS SYSTEM
ANTI-PARKINSON DRUGS
DOPAMINERGIC AGENTS
Adamantane derivatives
FDA MoA N0000175542 M2 Protein Inhibitors
FDA EPC N0000175543 Influenza A M2 Protein Inhibitor
CHEBI has role CHEBI:36044 antiviral drugs
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:22587 antiviral agents
CHEBI has role CHEBI:51065 Dopamine receptor agonist
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D018726 Anti-Dyskinesia Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000978 Antiparkinson Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents

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

DiseaseRelationSNOMED_IDDOID
Postencephalitic parkinsonism indication 19972008 DOID:14332
Parkinsonism indication 32798002
Parkinson's disease indication 49049000 DOID:14330
Extrapyramidal disease indication 76349003
Influenza due to Influenza A virus indication 442438000
Arteriosclerotic Parkinsonism indication
Influenza A Prevention indication
Jakob-Creutzfeldt disease off-label use 792004 DOID:11949
Cognitive impairment following traumatic brain injury off-label use 127295002
Arousal post traumatic brain injury off-label use 127295002
Cognitive Impairment following Traumatic Brain Injury off-label use
Fatigue due to Multiple Sclerosis off-label use
Suicidal thoughts contraindication 6471006
Orthostatic hypotension contraindication 28651003
Eczema contraindication 43116000
Chronic heart failure contraindication 48447003
Substance abuse contraindication 66214007
Psychotic disorder contraindication 69322001
Epilepsy contraindication 84757009 DOID:1826
Kidney disease contraindication 90708001 DOID:557
Edema contraindication 267038008
Malignant melanoma contraindication 372244006
Angle-closure glaucoma contraindication 392291006 DOID:13550
Psychiatric Disturbance contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.4 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8895615 Nov. 23, 2025 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8895616 Nov. 23, 2025 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8895617 Nov. 23, 2025 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8895615 Nov. 23, 2025 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8895616 Nov. 23, 2025 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8895617 Nov. 23, 2025 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895615 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895615 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895616 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895616 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895617 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895617 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 9072697 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 9072697 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8895615 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8895615 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8895616 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8895616 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8895617 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8895617 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 9072697 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 9072697 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895615 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895615 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895616 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895616 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895617 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895617 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 9072697 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 9072697 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8895615 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8895615 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8895616 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8895616 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8895617 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8895617 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 9072697 Nov. 23, 2025 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 9072697 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8574626 Nov. 28, 2025 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8574626 Nov. 28, 2025 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8574626 Nov. 28, 2025 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8574626 Nov. 28, 2025 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING IMMEDIATE RELEASE LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING IMMEDIATE RELEASE LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF PARKINSONS DISEASE
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11197835 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8741343 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9867791 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9867792 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9867793 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9877933 Dec. 2, 2030 TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11197835 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8741343 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9867791 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9867792 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9867793 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9877933 Dec. 2, 2030 TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 10646456 June 17, 2034 TREATMENT OF DYSKINESIA, DECREASING OFF TIME, AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 10646456 June 17, 2034 TREATMENT OF DYSKINESIA, DECREASING OFF TIME, AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 10154971 Dec. 4, 2034 TREATMENT OF DYSKINESIA AND DECREASING OFF TIME IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 10154971 Dec. 4, 2034 TREATMENT OF DYSKINESIA AND DECREASING OFF TIME IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10213393 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10213394 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10500170 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10500171 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10500172 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 129MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10512617 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 10213393 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 10213394 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 10500170 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 10500171 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 10500172 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 161MG BASE OSMOLEX ER ADAMAS PHARMA N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 10512617 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10213393 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10213394 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10500170 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10500171 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10500172 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 193MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10512617 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10213393 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10213394 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10500170 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10500171 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10500172 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 258MG BASE OSMOLEX ER ADAMAS PHARMA N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10512617 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11077073 Aug. 23, 2038 DECREASING OFF TIME IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11077073 Aug. 23, 2038 TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11077073 Aug. 23, 2038 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11077073 Aug. 23, 2038 DECREASING OFF TIME IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11077073 Aug. 23, 2038 TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11077073 Aug. 23, 2038 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 137MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL Aug. 24, 2024 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI ADAMAS PHARMA N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL Aug. 24, 2024 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glutamate [NMDA] receptor Ion channel BLOCKER Ki 4.98 CHEMBL CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 7.69 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 4.42 CHEMBL
Matrix protein 2 Ion channel INHIBITOR IC50 4.80 CHEMBL CHEMBL
Matrix protein 2 Unclassified IC50 4.80 CHEMBL
Matrix protein 2 Unclassified Kd 6.50 CHEMBL
Matrix protein 2 Unclassified EC50 6.18 CHEMBL
Matrix protein 2 Unclassified Kd 6.50 CHEMBL

External reference:

IDSource
4019601 VUID
N0000147697 NUI
D00777 KEGG_DRUG
665-66-7 SECONDARY_CAS_RN
282415 RXNORM
C0002403 UMLSCUI
CHEBI:2618 CHEBI
308 PDB_CHEM_ID
CHEMBL660 ChEMBL_ID
DB00915 DRUGBANK_ID
CHEMBL1569 ChEMBL_ID
D000547 MESH_DESCRIPTOR_UI
2130 PUBCHEM_CID
1816 INN_ID
4128 IUPHAR_LIGAND_ID
31377-23-8 SECONDARY_CAS_RN
BF4C9Z1J53 UNII
2543 MMSL
33122 MMSL
34880 MMSL
4161 MMSL
d00086 MMSL
001640 NDDF
004663 NDDF
006089 NDDF
4018546 VANDF
4019601 VANDF
CHEMBL465617 ChEMBL_ID
372763006 SNOMEDCT_US
51361008 SNOMEDCT_US
64507008 SNOMEDCT_US
703084004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
AMANTADINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0121-0646 SOLUTION 50 mg ORAL ANDA 24 sections
AMANTADINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0121-0646 SOLUTION 50 mg ORAL ANDA 24 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1704 CAPSULE 100 mg ORAL ANDA 22 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1868 CAPSULE 100 mg ORAL ANDA 21 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-4920 TABLET 100 mg ORAL ANDA 19 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8263 CAPSULE 100 mg ORAL ANDA 13 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0832-0111 TABLET 100 mg ORAL ANDA 24 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0832-1015 CAPSULE, GELATIN COATED 100 mg ORAL ANDA 23 sections
amantadine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6630 CAPSULE 100 mg ORAL ANDA 20 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7042 CAPSULE 100 mg ORAL ANDA 13 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10135-692 TABLET 100 mg ORAL ANDA 22 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10135-693 CAPSULE, GELATIN COATED 100 mg ORAL ANDA 22 sections
Amantadine HCl Human Prescription Drug Label 1 10888-5006 CAPSULE, LIQUID FILLED 100 mg ORAL ANDA 19 sections
AMANTADINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-008 CAPSULE 100 mg ORAL ANDA 24 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 17856-0093 SOLUTION 50 mg ORAL ANDA 25 sections
AMANTADINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 17856-0646 SOLUTION 50 mg ORAL ANDA 24 sections
AMANTADINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 17856-0646 SOLUTION 50 mg ORAL ANDA 24 sections
Amantadine HCl HUMAN PRESCRIPTION DRUG LABEL 1 21695-564 CAPSULE 100 mg ORAL ANDA 20 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-362 CAPSULE 100 mg ORAL ANDA 13 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-362 CAPSULE 100 mg ORAL ANDA 13 sections
AMANTADINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 24689-105 CAPSULE 100 mg ORAL ANDA 12 sections
AMANTADINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 24689-112 TABLET 100 mg ORAL ANDA 12 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 33261-773 CAPSULE 100 mg ORAL ANDA 24 sections
Amantadine HCl HUMAN PRESCRIPTION DRUG LABEL 1 42291-125 CAPSULE, LIQUID FILLED 100 mg ORAL ANDA 19 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42543-493 CAPSULE 100 mg ORAL ANDA 17 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42543-497 TABLET 100 mg ORAL ANDA 12 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43353-947 CAPSULE 100 mg ORAL ANDA 24 sections
amantadine Human Prescription Drug Label 1 46708-246 CAPSULE 100 mg ORAL ANDA 19 sections
Amantadine Human Prescription Drug Label 1 46708-586 TABLET 100 mg ORAL ANDA 11 sections
Amantadine HCl HUMAN PRESCRIPTION DRUG LABEL 1 50268-069 CAPSULE, LIQUID FILLED 100 mg ORAL ANDA 19 sections