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 447.99 14.03 208 18312 31794 63438708
Hallucination 397.76 14.03 229 18291 54588 63415914
Multiple sclerosis relapse 292.78 14.03 180 18340 48298 63422204
Hallucination, visual 228.87 14.03 112 18408 19186 63451316
Fall 218.49 14.03 401 18119 391933 63078569
On and off phenomenon 177.45 14.03 50 18470 1785 63468717
Stoma site discharge 174.98 14.03 48 18472 1550 63468952
Freezing phenomenon 171.34 14.03 45 18475 1227 63469275
Multiple sclerosis 166.44 14.03 98 18422 24274 63446228
Tremor 155.35 14.03 192 18328 132047 63338455
Gait disturbance 137.07 14.03 214 18306 182964 63287538
Dystonia 136.83 14.03 71 18449 13748 63456754
Bradykinesia 133.50 14.03 52 18468 5136 63465366
Neuroleptic malignant syndrome 116.66 14.03 61 18459 11995 63458507
Psychotic disorder 112.29 14.03 78 18442 25634 63444868
Stoma site erythema 111.66 14.03 32 18488 1215 63469287
Muscle rigidity 110.74 14.03 58 18462 11442 63459060
Balance disorder 107.89 14.03 128 18392 84294 63386208
Therapeutic response shortened 103.33 14.03 56 18464 11832 63458670
Corneal oedema 93.22 14.03 29 18491 1464 63469038
Urinary tract infection 89.18 14.03 221 18299 264463 63206039
Hyperkinesia 85.39 14.03 28 18492 1676 63468826
Seizure 76.45 14.03 138 18382 132496 63338006
Akinesia 75.11 14.03 25 18495 1568 63468934
Parkinsonism hyperpyrexia syndrome 72.31 14.03 15 18505 138 63470364
Stoma site pain 68.91 14.03 21 18499 989 63469513
Delusion 65.85 14.03 42 18478 11975 63458527
Dysphagia 65.43 14.03 103 18417 88482 63382020
Acute psychosis 63.87 14.03 25 18495 2500 63468002
Hallucinations, mixed 63.19 14.03 30 18490 4799 63465703
Speech disorder 62.74 14.03 68 18452 40561 63429941
Diarrhoea 61.65 14.03 71 18449 715295 62755207
Livedo reticularis 61.24 14.03 24 18496 2408 63468094
Joint swelling 58.87 14.03 12 18508 327654 63142848
Impulse-control disorder 56.35 14.03 17 18503 773 63469729
Infusion related reaction 56.20 14.03 4 18516 245517 63224985
Hypokinesia 55.56 14.03 40 18480 13896 63456606
Delirium 53.87 14.03 70 18450 50471 63420031
Abnormal dreams 53.30 14.03 35 18485 10481 63460021
Rheumatoid arthritis 53.09 14.03 6 18514 253813 63216689
Rash 52.34 14.03 52 18468 560819 62909683
Myoclonus 50.93 14.03 40 18480 15828 63454674
Stoma site inflammation 45.70 14.03 13 18507 480 63470022
Orthostatic hypotension 41.55 14.03 52 18468 36108 63434394
Stoma site hypergranulation 41.49 14.03 11 18509 311 63470191
Abdominal discomfort 39.89 14.03 22 18498 320863 63149639
Stoma site reaction 39.09 14.03 10 18510 245 63470257
Agitation 38.04 14.03 65 18455 59692 63410810
Therapeutic product effect variable 37.74 14.03 14 18506 1209 63469293
Dopamine dysregulation syndrome 37.35 14.03 9 18511 171 63470331
Stoma site extravasation 36.68 14.03 10 18510 315 63470187
Treatment failure 36.32 14.03 7 18513 199036 63271466
Drug hypersensitivity 36.21 14.03 23 18497 310664 63159838
Drug intolerance 35.77 14.03 23 18497 308638 63161864
Arthropathy 35.68 14.03 12 18508 234780 63235722
Glossodynia 35.51 14.03 5 18515 178871 63291631
Dysstasia 35.45 14.03 37 18483 21129 63449373
Stoma site infection 35.34 14.03 12 18508 800 63469702
Corneal decompensation 35.32 14.03 7 18513 50 63470452
Relapsing-remitting multiple sclerosis 34.91 14.03 11 18509 579 63469923
Paratonia 33.61 14.03 6 18514 22 63470480
Systemic lupus erythematosus 32.94 14.03 10 18510 208908 63261594
Arthralgia 32.55 14.03 74 18446 569636 62900866
Rapid eye movement sleep behaviour disorder 32.05 14.03 9 18511 317 63470185
Cognitive disorder 32.01 14.03 58 18462 55757 63414745
Dementia 31.74 14.03 33 18487 18761 63451741
Wound 31.40 14.03 5 18515 163258 63307244
Nightmare 31.16 14.03 33 18487 19161 63451341
Psychotic symptom 31.03 14.03 13 18507 1548 63468954
Cerebral atrophy 31.01 14.03 19 18501 5047 63465455
Parkinsonism 30.69 14.03 25 18495 10414 63460088
Disorientation 30.68 14.03 47 18473 39405 63431097
Alopecia 30.62 14.03 32 18488 337504 63132998
Parkinson's disease 30.59 14.03 12 18508 1207 63469295
Gait inability 30.33 14.03 55 18465 52904 63417598
Muscle spasticity 29.39 14.03 34 18486 21760 63448742
Posture abnormal 29.03 14.03 14 18506 2318 63468184
Memory impairment 28.83 14.03 81 18439 104177 63366325
Abnormal behaviour 28.18 14.03 33 18487 21393 63449109
Parkinsonian gait 27.92 14.03 9 18511 510 63469992
Progressive multifocal leukoencephalopathy 27.91 14.03 26 18494 12945 63457557
Depression 26.84 14.03 121 18399 196371 63274131
Neutropenia 26.48 14.03 9 18511 174996 63295506
Device dislocation 26.44 14.03 35 18485 25670 63444832
Swelling 26.23 14.03 25 18495 275353 63195149
Sleep talking 25.68 14.03 10 18510 986 63469516
Lower respiratory tract infection 25.56 14.03 4 18516 132303 63338199
Stoma site odour 25.31 14.03 5 18515 35 63470467
Pneumonia aspiration 25.25 14.03 40 18480 34500 63436002
Stoma site haemorrhage 24.98 14.03 10 18510 1061 63469441
Muscular weakness 24.52 14.03 85 18435 122268 63348234
Confusional state 24.10 14.03 134 18386 236246 63234256
Lymphopenia 23.72 14.03 28 18492 18299 63452203
Urinary incontinence 23.30 14.03 37 18483 31977 63438525
Gastrointestinal complication associated with device 23.28 14.03 4 18516 11 63470491
Stomatitis 23.05 14.03 6 18514 138719 63331783
Device occlusion 22.37 14.03 18 18502 7369 63463133
Somnolence 22.16 14.03 107 18413 178578 63291924
Motor dysfunction 22.06 14.03 21 18499 10740 63459762
Nasopharyngitis 22.05 14.03 25 18495 254232 63216270
Extrapyramidal disorder 21.85 14.03 23 18497 13261 63457241
Choking 21.64 14.03 20 18500 9859 63460643
Device kink 21.61 14.03 11 18509 2043 63468459
Tongue biting 21.61 14.03 10 18510 1510 63468992
Movement disorder 21.52 14.03 29 18491 21632 63448870
Discomfort 21.47 14.03 11 18509 167363 63303139
Prescribed underdose 21.18 14.03 34 18486 29655 63440847
Stridor 21.07 14.03 13 18507 3497 63467005
Chorea 20.97 14.03 10 18510 1614 63468888
Mutism 20.94 14.03 10 18510 1620 63468882
Compulsive shopping 20.92 14.03 8 18512 751 63469751
Pain 20.73 14.03 129 18391 740499 62730003
Central nervous system lesion 20.38 14.03 20 18500 10615 63459887
Resting tremor 20.29 14.03 8 18512 815 63469687
Vitamin B6 deficiency 20.14 14.03 5 18515 108 63470394
Sinusitis 19.96 14.03 22 18498 226631 63243871
Nausea 19.92 14.03 157 18363 854314 62616188
Febrile neutropenia 19.91 14.03 5 18515 118444 63352058
Hypernatraemia 19.84 14.03 17 18503 7592 63462910
Aggression 19.70 14.03 29 18491 23469 63447033
Encephalopathy 19.49 14.03 38 18482 38582 63431920
Device issue 19.43 14.03 29 18491 23752 63446750
Lymphocyte count decreased 19.36 14.03 33 18487 30224 63440278
Camptocormia 19.28 14.03 6 18514 303 63470199
Secondary progressive multiple sclerosis 19.08 14.03 9 18511 1418 63469084
Blister 19.08 14.03 7 18513 129807 63340695
Off label use 18.59 14.03 118 18402 674344 62796158
Tardive dyskinesia 18.21 14.03 17 18503 8485 63462017
Hyporesponsive to stimuli 18.02 14.03 8 18512 1096 63469406
Generalised tonic-clonic seizure 17.72 14.03 31 18489 28985 63441517
Compulsive hoarding 17.68 14.03 4 18516 57 63470445
Maternal exposure during pregnancy 17.63 14.03 23 18497 220039 63250463
Hepatic enzyme increased 17.42 14.03 20 18500 202308 63268194
Hip fracture 17.37 14.03 31 18489 29443 63441059
Progressive supranuclear palsy 17.37 14.03 4 18516 62 63470440
Nocturia 16.90 14.03 16 18504 8125 63462377
Fibroma 16.74 14.03 7 18513 830 63469672
Immune reconstitution inflammatory syndrome 16.70 14.03 14 18506 6070 63464432
Stoma site irritation 16.62 14.03 5 18515 225 63470277
Dyspnoea 16.57 14.03 119 18401 661194 62809308
Nystagmus 16.43 14.03 14 18506 6206 63464296
Loss of consciousness 16.30 14.03 73 18447 118048 63352454
Stoma site candida 16.22 14.03 3 18517 14 63470488
Muscle spasms 16.22 14.03 89 18431 156061 63314441
Hypersexuality 16.20 14.03 6 18514 516 63469986
Asthenia 16.18 14.03 177 18343 383427 63087075
Abdominal wall wound 16.04 14.03 4 18516 88 63470414
Autonomic nervous system imbalance 15.81 14.03 10 18510 2808 63467694
Urosepsis 15.73 14.03 23 18497 18501 63452001
Mental impairment 15.69 14.03 20 18500 14131 63456371
Hyperthermia 15.32 14.03 16 18504 9140 63461362
Corneal endotheliitis 15.32 14.03 3 18517 20 63470482
Fractured coccyx 15.15 14.03 7 18513 1052 63469450
Peroneal nerve palsy 15.11 14.03 12 18508 4823 63465679
Exposure during pregnancy 14.94 14.03 14 18506 155533 63314969
Device leakage 14.84 14.03 14 18506 7082 63463420
Product use issue 14.81 14.03 26 18494 220494 63250008
Dementia with Lewy bodies 14.73 14.03 5 18515 333 63470169
Malnutrition 14.47 14.03 20 18500 15278 63455224
Progressive multiple sclerosis 14.44 14.03 7 18513 1171 63469331
Withdrawal syndrome 14.40 14.03 23 18497 19974 63450528
Psychiatric symptom 14.29 14.03 12 18508 5211 63465291
Corneal disorder 14.26 14.03 8 18512 1806 63468696
Serotonin syndrome 14.20 14.03 28 18492 28654 63441848

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 517.38 15.75 300 14166 51198 34891267
Dyskinesia 415.51 15.75 197 14269 22216 34920249
On and off phenomenon 335.84 15.75 95 14371 2402 34940063
Hallucination, visual 256.91 15.75 132 14334 17659 34924806
Dopamine dysregulation syndrome 179.87 15.75 41 14425 415 34942050
Fall 178.04 15.75 308 14158 202577 34739888
Freezing phenomenon 177.76 15.75 52 14414 1484 34940981
Bradykinesia 113.23 15.75 47 14419 3846 34938619
Delusion 111.81 15.75 68 14398 12567 34929898
Muscle rigidity 109.83 15.75 63 14403 10455 34932010
Stoma site discharge 101.50 15.75 32 14434 1181 34941284
Gait disturbance 100.09 15.75 148 14318 84992 34857473
Hypersexuality 98.93 15.75 33 14433 1460 34941005
Tremor 96.27 15.75 143 14323 82444 34860021
Gambling disorder 95.50 15.75 33 14433 1627 34940838
Impulse-control disorder 87.17 15.75 29 14437 1272 34941193
Stoma site erythema 86.16 15.75 26 14440 827 34941638
Balance disorder 81.33 15.75 92 14374 40562 34901903
Neuroleptic malignant syndrome 77.14 15.75 62 14404 17872 34924593
Agitation 75.04 15.75 105 14361 57294 34885171
Confusional state 73.45 15.75 175 14291 143985 34798480
Multiple sclerosis 69.89 15.75 40 14426 6605 34935860
Multiple sclerosis relapse 68.70 15.75 51 14415 13082 34929383
Device dislocation 66.75 15.75 38 14428 6211 34936254
Illusion 65.81 15.75 21 14445 806 34941659
Hyperkinesia 64.04 15.75 25 14441 1743 34940722
Serotonin syndrome 63.46 15.75 58 14408 19875 34922590
Stoma site pain 61.22 15.75 19 14447 665 34941800
Dystonia 60.99 15.75 44 14422 10801 34931664
Parkinsonism hyperpyrexia syndrome 57.48 15.75 12 14454 77 34942388
Aggression 53.48 15.75 73 14393 38891 34903574
Corneal oedema 52.12 15.75 20 14446 1331 34941134
Hypersomnia 51.45 15.75 42 14424 12365 34930100
Speech disorder 51.12 15.75 58 14408 25628 34916837
Therapeutic product effect variable 46.68 15.75 22 14444 2434 34940031
Psychotic disorder 46.61 15.75 54 14412 24398 34918067
Embedded device 46.33 15.75 13 14453 318 34942147
Stoma site infection 46.19 15.75 16 14450 794 34941671
Parkinsonism 45.71 15.75 33 14433 8105 34934360
Abnormal behaviour 45.70 15.75 54 14412 24915 34917550
Abnormal dreams 45.49 15.75 32 14434 7546 34934919
Diarrhoea 45.42 15.75 57 14409 389855 34552610
Stoma site inflammation 45.19 15.75 14 14452 487 34941978
Febrile neutropenia 44.92 15.75 3 14463 136846 34805619
Memory impairment 40.67 15.75 68 14398 43250 34899215
Mobility decreased 40.66 15.75 56 14410 30072 34912393
Somnolence 40.32 15.75 119 14347 110997 34831468
Akinesia 36.76 15.75 18 14448 2166 34940299
Cognitive disorder 36.73 15.75 52 14414 28641 34913824
Dysphagia 36.40 15.75 80 14386 62301 34880164
Neutropenia 36.28 15.75 10 14456 156768 34785697
Compulsive shopping 35.22 15.75 11 14455 393 34942072
Reduced facial expression 34.54 15.75 14 14452 1077 34941388
Paranoia 34.33 15.75 33 14433 12035 34930430
Dementia 34.31 15.75 35 14431 13713 34928752
Parkinson's disease 34.15 15.75 15 14451 1409 34941056
Gambling 33.02 15.75 9 14457 197 34942268
Anticholinergic syndrome 32.50 15.75 14 14452 1255 34941210
Delirium 32.25 15.75 62 14404 43929 34898536
Fibroma 31.48 15.75 10 14456 378 34942087
Device connection issue 30.96 15.75 10 14456 399 34942066
Pneumonia aspiration 30.65 15.75 59 14407 41844 34900621
Posture abnormal 30.52 15.75 16 14450 2223 34940242
Choking 29.69 15.75 21 14445 4994 34937471
Rapid eye movements sleep abnormal 29.15 15.75 8 14458 180 34942285
Hallucination, tactile 28.94 15.75 9 14457 317 34942148
Myoclonus 28.87 15.75 33 14433 14692 34927773
Middle insomnia 28.14 15.75 23 14443 6779 34935686
Sensory disturbance 27.93 15.75 22 14444 6155 34936310
Motor dysfunction 27.64 15.75 23 14443 6951 34935514
Nocturia 27.32 15.75 27 14439 10183 34932282
Stoma site reaction 27.08 15.75 8 14458 236 34942229
Deep brain stimulation 26.33 15.75 5 14461 18 34942447
Anaemia 26.17 15.75 35 14431 233300 34709165
Male sexual dysfunction 25.67 15.75 8 14458 284 34942181
Intentional medical device removal by patient 25.12 15.75 8 14458 305 34942160
Saccadic eye movement 24.92 15.75 7 14459 172 34942293
Nightmare 24.48 15.75 30 14436 14361 34928104
Therapeutic response shortened 24.45 15.75 22 14444 7382 34935083
Insomnia 24.20 15.75 96 14370 103811 34838654
Stoma site extravasation 23.73 15.75 6 14460 97 34942368
Thrombocytopenia 23.72 15.75 18 14448 156229 34786236
Somatic delusion 23.67 15.75 6 14460 98 34942367
Platelet count decreased 23.59 15.75 10 14456 119707 34822758
Autonomic nervous system imbalance 23.25 15.75 14 14452 2537 34939928
Urinary tract infection 23.17 15.75 82 14384 83999 34858466
Persecutory delusion 23.10 15.75 14 14452 2566 34939899
Musculoskeletal stiffness 22.97 15.75 56 14410 46624 34895841
Bedridden 22.78 15.75 16 14450 3762 34938703
Device kink 22.63 15.75 8 14458 422 34942043
Hallucinations, mixed 22.57 15.75 14 14452 2675 34939790
Rash 22.44 15.75 36 14430 222716 34719749
Progressive supranuclear palsy 22.17 15.75 5 14461 48 34942417
Disturbance in attention 22.07 15.75 39 14427 25906 34916559
Dysstasia 21.69 15.75 26 14440 12169 34930296
Anxiety 21.67 15.75 90 14376 99338 34843127
Malignant neoplasm progression 21.54 15.75 5 14461 88041 34854424
Feeling abnormal 21.28 15.75 66 14400 63169 34879296
Parkinsonian gait 21.05 15.75 8 14458 518 34941947
Device issue 21.03 15.75 23 14443 9754 34932711
Sleep talking 20.82 15.75 8 14458 534 34941931
Acute kidney injury 20.28 15.75 62 14404 304926 34637539
Movement disorder 19.98 15.75 25 14441 12223 34930242
Mydriasis 19.11 15.75 19 14447 7218 34935247
Soft tissue mass 18.97 15.75 9 14457 1010 34941455
Hyperkalaemia 18.96 15.75 3 14463 69386 34873079
Disorientation 18.71 15.75 42 14424 33146 34909319
Sepsis 18.64 15.75 25 14441 166536 34775929
Facial paresis 18.59 15.75 13 14453 3036 34939429
Band neutrophil percentage increased 18.50 15.75 5 14461 106 34942359
Depression 18.19 15.75 84 14382 97014 34845451
Tic 18.00 15.75 11 14455 2047 34940418
Stoma site odour 17.87 15.75 4 14462 37 34942428
Sexually inappropriate behaviour 17.70 15.75 7 14459 505 34941960
Underdose 17.67 15.75 25 14441 13755 34928710
Nasal discomfort 17.65 15.75 10 14456 1618 34940847
Cerebral hypoperfusion 17.54 15.75 7 14459 517 34941948
Prescribed underdose 17.47 15.75 20 14446 8913 34933552
Tension 17.44 15.75 11 14455 2164 34940301
Micturition disorder 17.11 15.75 11 14455 2237 34940228
Postural reflex impairment 17.08 15.75 3 14463 6 34942459
Stoma site induration 16.85 15.75 4 14462 49 34942416
Corneal opacity 16.78 15.75 7 14459 579 34941886
Depressed mood 16.38 15.75 29 14437 19288 34923177
Neuropathy peripheral 16.33 15.75 7 14459 83256 34859209
Intentional underdose 15.90 15.75 7 14459 661 34941804
Pelvic fracture 15.78 15.75 11 14455 2556 34939909
Resting tremor 15.76 15.75 7 14459 675 34941790

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 716.07 13.40 335 26917 44438 79672698
Hallucination 674.73 13.40 399 26853 85346 79631790
On and off phenomenon 415.65 13.40 114 27138 3126 79714010
Hallucination, visual 414.81 13.40 209 27043 32520 79684616
Fall 318.24 13.40 584 26668 487045 79230091
Freezing phenomenon 257.85 13.40 70 27182 1844 79715292
Multiple sclerosis relapse 256.28 13.40 173 27079 46360 79670776
Dopamine dysregulation syndrome 198.99 13.40 44 27208 473 79716663
Stoma site discharge 190.29 13.40 57 27195 2152 79714984
Tremor 188.38 13.40 260 26992 169823 79547313
Neuroleptic malignant syndrome 174.91 13.40 112 27140 27447 79689689
Bradykinesia 172.52 13.40 74 27178 7969 79709167
Gait disturbance 168.03 13.40 274 26978 207232 79509904
Dystonia 163.81 13.40 98 27154 21301 79695835
Muscle rigidity 159.89 13.40 94 27158 19788 79697348
Multiple sclerosis 155.05 13.40 96 27156 22186 79694950
Psychotic disorder 150.90 13.40 120 27132 41282 79675854
Corneal oedema 148.05 13.40 49 27203 2571 79714565
Impulse-control disorder 140.89 13.40 43 27209 1731 79715405
Balance disorder 135.59 13.40 168 27084 98689 79618447
Parkinsonism hyperpyrexia syndrome 128.72 13.40 27 27225 221 79716915
Hyperkinesia 126.54 13.40 44 27208 2685 79714451
Delusion 124.65 13.40 81 27171 20342 79696794
Stoma site erythema 120.32 13.40 38 27214 1715 79715421
Therapeutic response shortened 112.02 13.40 69 27183 15794 79701342
Agitation 105.14 13.40 149 27103 99566 79617570
Gambling disorder 99.11 13.40 34 27218 1992 79715144
Stoma site pain 97.57 13.40 31 27221 1427 79715709
Hypersexuality 97.25 13.40 32 27220 1648 79715488
Akinesia 82.84 13.40 34 27218 3278 79713858
Urinary tract infection 80.60 13.40 241 27011 274271 79442865
Dysphagia 77.50 13.40 145 27107 121991 79595145
Serotonin syndrome 77.47 13.40 86 27166 44941 79672195
Delirium 76.99 13.40 118 27134 84509 79632627
Abnormal dreams 76.43 13.40 48 27204 11364 79705772
Diarrhoea 75.93 13.40 115 27137 880374 78836762
Speech disorder 73.75 13.40 92 27160 54353 79662783
Myoclonus 73.73 13.40 67 27185 27593 79689543
Hallucinations, mixed 70.02 13.40 38 27214 6861 79710275
Therapeutic product effect variable 69.19 13.40 26 27226 1983 79715153
Confusional state 69.01 13.40 252 27000 317745 79399391
Stoma site infection 68.52 13.40 24 27228 1496 79715640
Seizure 67.37 13.40 178 27074 188656 79528480
Acute psychosis 62.78 13.40 30 27222 4150 79712986
Parkinsonism 62.40 13.40 49 27203 16535 79700601
Abnormal behaviour 61.68 13.40 69 27183 36352 79680784
Illusion 61.66 13.40 23 27229 1718 79715418
Aggression 61.00 13.40 81 27171 50877 79666259
Rheumatoid arthritis 58.83 13.40 3 27249 208467 79508669
Dementia 56.64 13.40 55 27197 24604 79692532
Febrile neutropenia 55.08 13.40 7 27245 230992 79486144
Infusion related reaction 54.84 13.40 7 27245 230230 79486906
Joint swelling 53.67 13.40 16 27236 288630 79428506
Hypokinesia 52.43 13.40 47 27205 19013 79698123
Device dislocation 52.42 13.40 54 27198 25916 79691220
Stoma site extravasation 52.22 13.40 14 27238 351 79716785
Neutropenia 51.61 13.40 17 27235 287693 79429443
Rash 51.23 13.40 74 27178 578284 79138852
Pneumonia aspiration 50.81 13.40 86 27166 66881 79650255
Compulsive shopping 49.08 13.40 16 27236 800 79716336
Stoma site inflammation 47.40 13.40 15 27237 681 79716455
Livedo reticularis 45.57 13.40 24 27228 4079 79713057
Cognitive disorder 45.56 13.40 84 27168 69842 79647294
Parkinson's disease 44.69 13.40 18 27234 1653 79715483
Hypersomnia 43.02 13.40 46 27206 23040 79694096
Drug hypersensitivity 42.07 13.40 25 27227 298891 79418245
Stoma site odour 42.04 13.40 9 27243 82 79717054
Somnolence 40.97 13.40 176 27076 238805 79478331
Rapid eye movement sleep behaviour disorder 40.03 13.40 12 27240 454 79716682
Dysstasia 39.36 13.40 48 27204 27698 79689438
Disorientation 39.13 13.40 74 27178 62702 79654434
Progressive supranuclear palsy 38.99 13.40 9 27243 119 79717017
Autonomic nervous system imbalance 37.50 13.40 22 27230 4608 79712528
Arthralgia 37.42 13.40 88 27164 571715 79145421
Pancytopenia 37.22 13.40 6 27246 165739 79551397
Sleep talking 37.07 13.40 14 27238 1082 79716054
Rapid eye movements sleep abnormal 36.63 13.40 10 27242 269 79716867
Stoma site hypergranulation 36.25 13.40 11 27241 434 79716702
Resting tremor 35.96 13.40 15 27237 1506 79715630
Choking 35.60 13.40 31 27221 12070 79705066
Nightmare 35.49 13.40 44 27208 25817 79691319
Memory impairment 33.57 13.40 99 27153 111635 79605501
Orthostatic hypotension 33.52 13.40 65 27187 56099 79661037
Drug intolerance 33.24 13.40 25 27227 264094 79453042
Nausea 33.15 13.40 192 27060 957004 78760132
Cerebral atrophy 32.86 13.40 25 27227 8050 79709086
Deep brain stimulation 32.68 13.40 7 27245 64 79717072
Paratonia 32.66 13.40 6 27246 22 79717114
Prescribed underdose 32.41 13.40 45 27207 29469 79687667
Hyperthermia 31.96 13.40 35 27217 18002 79699134
Parkinsonian gait 31.67 13.40 12 27240 936 79716200
Stomatitis 31.45 13.40 6 27246 146751 79570385
Gait inability 31.35 13.40 65 27187 58852 79658284
Drug withdrawal syndrome 30.98 13.40 48 27204 34670 79682466
Arthropathy 30.81 13.40 11 27241 177100 79540036
Psychotic symptom 30.59 13.40 16 27236 2681 79714455
Motor dysfunction 30.39 13.40 31 27221 14702 79702434
Posture abnormal 30.34 13.40 18 27234 3848 79713288
Reduced facial expression 30.22 13.40 16 27236 2749 79714387
Paranoia 29.83 13.40 35 27217 19397 79697739
Dyspnoea 29.07 13.40 173 27079 856852 78860284
Male sexual dysfunction 28.89 13.40 8 27244 227 79716909
Stoma site reaction 28.65 13.40 9 27243 399 79716737
Nocturia 28.61 13.40 29 27223 13652 79703484
Postural reflex impairment 28.51 13.40 5 27247 13 79717123
Anxiety 28.31 13.40 163 27089 248349 79468787
Middle insomnia 28.16 13.40 31 27221 16038 79701098
Insomnia 28.05 13.40 161 27091 245009 79472127
Sensory disturbance 28.02 13.40 30 27222 15047 79702089
Swelling 27.93 13.40 20 27232 216691 79500445
Platelet count decreased 27.77 13.40 16 27236 194648 79522488
Treatment failure 27.34 13.40 12 27240 170474 79546662
Gambling 26.96 13.40 8 27244 292 79716844
Mutism 26.70 13.40 14 27238 2358 79714778
Withdrawal syndrome 26.62 13.40 39 27213 26815 79690321
Saccadic eye movement 26.44 13.40 7 27245 167 79716969
Malignant neoplasm progression 26.25 13.40 7 27245 135983 79581153
Relapsing-remitting multiple sclerosis 26.21 13.40 12 27240 1507 79715629
Abdominal discomfort 25.33 13.40 29 27223 250698 79466438
Depressed mood 25.22 13.40 53 27199 48427 79668709
Movement disorder 24.76 13.40 38 27214 27221 79689915
Stereotypy 24.65 13.40 10 27242 935 79716201
Device occlusion 24.54 13.40 25 27227 11841 79705295
Persecutory delusion 24.05 13.40 17 27235 4892 79712244
Secondary progressive multiple sclerosis 23.99 13.40 11 27241 1386 79715750
Anticholinergic syndrome 23.70 13.40 15 27237 3596 79713540
Device connection issue 23.65 13.40 10 27242 1038 79716098
Device issue 23.52 13.40 37 27215 27071 79690065
Death 23.46 13.40 296 26956 566218 79150918
Encephalopathy 23.45 13.40 63 27189 67334 79649802
Camptocormia 23.13 13.40 8 27244 480 79716656
Alopecia 23.10 13.40 27 27225 231328 79485808
Stoma site induration 23.03 13.40 5 27247 49 79717087
Depression 22.63 13.40 139 27113 216651 79500485
Glossodynia 22.62 13.40 4 27248 103333 79613803
Extrapyramidal disorder 22.57 13.40 33 27219 22646 79694490
Mobility decreased 22.48 13.40 92 27160 122083 79595053
Stoma site oedema 22.11 13.40 5 27247 60 79717076
Corneal decompensation 22.03 13.40 5 27247 61 79717075
Nasopharyngitis 21.92 13.40 33 27219 253848 79463288
Pain 21.80 13.40 146 27106 703656 79013480
Urinary incontinence 21.60 13.40 45 27207 40864 79676272
Urticaria 21.46 13.40 19 27233 185182 79531954
Hip fracture 21.36 13.40 38 27214 30723 79686413
Pruritus 21.08 13.40 67 27185 394581 79322555
Mental status changes 20.75 13.40 60 27192 66899 79650237
Delusion of grandeur 20.66 13.40 10 27242 1422 79715714
Headache 20.56 13.40 135 27117 653637 79063499
Somatic delusion 20.12 13.40 8 27244 710 79716426
Discomfort 19.89 13.40 9 27243 125608 79591528
Embedded device 19.84 13.40 13 27239 3306 79713830
Vomiting 19.69 13.40 140 27112 665688 79051448
Neuropathy peripheral 19.61 13.40 12 27240 141293 79575843
Muscle spasticity 19.59 13.40 30 27222 21445 79695691
Generalised tonic-clonic seizure 19.44 13.40 45 27207 43865 79673271
Underdose 19.33 13.40 38 27214 33113 79684023
Hallucination, auditory 19.01 13.40 29 27223 20664 79696472
Anaemia 18.91 13.40 83 27169 444932 79272204
Decubitus ulcer 18.86 13.40 25 27227 15662 79701474
Corneal disorder 18.85 13.40 11 27241 2280 79714856
Thrombocytopenia 18.81 13.40 39 27213 265220 79451916
Systemic lupus erythematosus 18.69 13.40 9 27243 121140 79595996
Soft tissue mass 18.60 13.40 9 27243 1279 79715857
Sexually inappropriate behaviour 18.57 13.40 7 27245 538 79716598
Blood creatine phosphokinase increased 18.37 13.40 57 27195 66033 79651103
Intentional product use issue 18.37 13.40 15 27237 152097 79565039
Disturbance in attention 18.19 13.40 48 27204 50753 79666383
Device kink 18.02 13.40 10 27242 1885 79715251
Tardive dyskinesia 17.84 13.40 20 27232 10551 79706585
Hallucination, tactile 17.82 13.40 7 27245 602 79716534
Progressive multifocal leukoencephalopathy 17.71 13.40 28 27224 20572 79696564
Neuroprosthesis implantation 17.65 13.40 3 27249 6 79717130
Hypernatraemia 17.33 13.40 23 27229 14428 79702708
Head injury 17.32 13.40 39 27213 37330 79679806
Intentional medical device removal by patient 17.02 13.40 6 27246 381 79716755
Blister 16.78 13.40 10 27242 119466 79597670
Psychiatric symptom 16.73 13.40 16 27236 7019 79710117
Mental impairment 16.53 13.40 26 27226 19010 79698126
Compulsive hoarding 16.33 13.40 4 27248 69 79717067
Constipation 16.33 13.40 158 27094 282892 79434244
Sinusitis 16.30 13.40 26 27226 195475 79521661
Musculoskeletal stiffness 16.28 13.40 109 27143 174899 79542237
Stridor 16.10 13.40 14 27238 5439 79711697
Intentional underdose 16.01 13.40 10 27242 2344 79714792
Stoma site candida 15.93 13.40 3 27249 13 79717123
Hypersensitivity 15.83 13.40 42 27210 262197 79454939
Chorea 15.77 13.40 10 27242 2407 79714729
Bedridden 15.69 13.40 20 27232 12059 79705077
Dementia with Lewy bodies 15.60 13.40 7 27245 839 79716297
Incoherent 15.53 13.40 16 27236 7676 79709460
Saliva altered 15.52 13.40 6 27246 494 79716642
Muscular weakness 15.49 13.40 101 27151 160628 79556508
Ataxia 14.96 13.40 29 27223 25010 79692126
Dysarthria 14.96 13.40 54 27198 67568 79649568
Cardiac failure congestive 14.89 13.40 16 27236 142386 79574750
Urinary hesitation 14.76 13.40 12 27240 4254 79712882
Wheezing 14.72 13.40 11 27241 116653 79600483
Incontinence 14.66 13.40 21 27231 14143 79702993
Cough 14.62 13.40 70 27182 366719 79350417
Injection site necrosis 14.61 13.40 8 27244 1470 79715666
Mania 14.58 13.40 24 27228 18236 79698900
Leukocytosis 14.50 13.40 40 27212 43415 79673721
Volvulus 14.44 13.40 10 27242 2786 79714350
Tongue biting 14.40 13.40 9 27243 2112 79715024
Periphlebitis 14.36 13.40 3 27249 24 79717112
Asthenia 14.33 13.40 250 27002 511439 79205697
Therapeutic response unexpected 14.31 13.40 25 27227 19921 79697215
Aspiration 14.12 13.40 25 27227 20133 79697003
Impulsive behaviour 14.11 13.40 10 27242 2890 79714246
Oromandibular dystonia 14.11 13.40 7 27245 1051 79716085
Lower respiratory tract infection 14.09 13.40 14 27238 129206 79587930
Abdominal pain 14.03 13.40 77 27175 389492 79327644
Vitamin B6 deficiency 13.84 13.40 5 27247 341 79716795
Feeding disorder 13.84 13.40 22 27230 16232 79700904
Hypotension 13.77 13.40 91 27161 440226 79276910
Chest pain 13.65 13.40 50 27202 282254 79434882
Screaming 13.47 13.40 11 27241 3922 79713214
Torticollis 13.43 13.40 9 27243 2378 79714758

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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895615 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895616 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895617 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 9072697 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS 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 OPERATIONS N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8895615 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8895616 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8895617 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 9072697 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895615 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895616 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8895617 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 9072697 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8796337 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8895615 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8895616 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8895617 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 9072697 Nov. 23, 2025 TREATMENT OF PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER ADAMAS OPERATIONS 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 OPERATIONS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF PARKINSONS DISEASE
EQ 137MG BASE GOCOVRI ADAMAS OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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 OPERATIONS 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
372763006 SNOMEDCT_US
51361008 SNOMEDCT_US
64507008 SNOMEDCT_US
703084004 SNOMEDCT_US
CHEMBL465617 ChEMBL_ID
4018546 VANDF
4019601 VANDF
001640 NDDF
004663 NDDF
006089 NDDF

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 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 0832-0111 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 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 10135-692 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 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 16571-834 CAPSULE 100 mg ORAL ANDA 11 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 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