amantadine 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 ┬ÁM/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 266.17 41.20 55 546 4734 2352750
Hallucination 221.08 41.20 52 549 8096 2349388
Hallucination, visual 211.37 41.20 42 559 2937 2354547
Fall 152.67 41.20 58 543 47041 2310443
Corneal oedema 143.06 41.20 22 579 330 2357154
Parkinson's disease 132.70 41.20 25 576 1301 2356183
Confusional state 131.82 41.20 44 557 24300 2333184
Toxicity to various agents 126.52 41.20 46 555 32708 2324776
Tremor 122.40 41.20 40 561 20621 2336863
Completed suicide 105.68 41.20 36 565 20998 2336486
Neuroleptic malignant syndrome 104.03 41.20 22 579 2058 2355426
Psychotic disorder 101.29 41.20 25 576 4654 2352830
Gait disturbance 95.54 41.20 34 567 22511 2334973
Hallucinations, mixed 83.54 41.20 15 586 592 2356892
Dry mouth 82.74 41.20 24 577 8229 2349255
Myoclonus 78.28 41.20 18 583 2465 2355019
Therapeutic response shortened 77.85 41.20 14 587 557 2356927
Encephalopathy 72.19 41.20 19 582 4542 2352942
Muscle rigidity 67.02 41.20 15 586 1816 2355668
Delusion 65.23 41.20 15 586 2050 2355434
Delirium 64.99 41.20 18 583 5205 2352279
Dystonia 64.32 41.20 15 586 2179 2355305
Urinary tract infection 62.24 41.20 27 574 29915 2327569
Agitation 59.54 41.20 20 581 11031 2346453
Freezing phenomenon 58.61 41.20 9 592 132 2357352
Balance disorder 57.94 41.20 19 582 9728 2347756
Drug ineffective 54.03 41.20 37 564 101587 2255897
Parkinson's disease psychosis 51.41 41.20 6 595 6 2357478
Dizziness 50.35 41.20 29 572 58636 2298848
Dysphagia 49.11 41.20 18 583 12787 2344697
Impulse-control disorder 48.56 41.20 8 593 187 2357297
Drug interaction 46.86 41.20 22 579 29141 2328343
Loss of consciousness 45.80 41.20 19 582 18748 2338736
Orthostatic hypotension 45.53 41.20 12 589 2867 2354617
Asthenia 45.08 41.20 25 576 46901 2310583
Seizure 44.10 41.20 20 581 24446 2333038
Insomnia 43.10 41.20 20 581 25767 2331717
Parkinsonism 42.56 41.20 10 591 1495 2355989
Psychotic symptom 41.20 41.20 7 594 198 2357286

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
Dyskinesia 293.34 50.76 61 467 3758 1742495
Hallucination, visual 261.41 50.76 52 476 2540 1743713
On and off phenomenon 193.19 50.76 29 499 246 1746007
Hallucination 192.15 50.76 50 478 8120 1738133
Fall 136.56 50.76 51 477 27163 1719090
Parkinson's disease 116.66 50.76 25 503 1717 1744536
Serotonin syndrome 104.95 50.76 25 503 2763 1743490
Insomnia 101.71 50.76 36 492 16240 1730013
Confusional state 95.88 50.76 37 491 21241 1725012
Tremor 89.41 50.76 31 497 13100 1733153
Parkinsonism hyperpyrexia syndrome 87.95 50.76 11 517 16 1746237
Completed suicide 82.84 50.76 31 497 16281 1729972
Dopamine dysregulation syndrome 78.71 50.76 12 516 112 1746141
Parkinson's disease psychosis 77.43 50.76 9 519 3 1746250
Impulse-control disorder 73.41 50.76 13 515 322 1745931
Illusion 65.61 50.76 11 517 195 1746058
Soft tissue mass 64.96 50.76 9 519 39 1746214
Depression 64.37 50.76 26 502 16643 1729610
Delusion 63.48 50.76 16 512 2215 1744038
Agitation 63.38 50.76 23 505 11003 1735250
Hypersexuality 59.29 50.76 11 517 355 1745898
Freezing phenomenon 58.25 50.76 10 518 205 1746048
Autonomic nervous system imbalance 57.60 50.76 11 517 416 1745837
Hyperthermia 57.51 50.76 14 514 1677 1744576
Nasal discomfort 55.58 50.76 10 518 271 1745982
Pelvic fracture 54.89 50.76 10 518 291 1745962
Psychotic disorder 54.72 50.76 17 511 5039 1741214
Neuroleptic malignant syndrome 53.42 50.76 15 513 3133 1743120
Myoclonus 53.27 50.76 14 514 2281 1743972
Balance disorder 52.39 50.76 17 511 5795 1740458
Gambling disorder 51.81 50.76 10 518 400 1745853

Pharmacologic Action:

SourceCodeDescription
ATC N04BB01 NERVOUS SYSTEM
ANTI-PARKINSON DRUGS
DOPAMINERGIC AGENTS
Adamantane derivatives
CHEBI has role CHEBI:36044 antiviral drug
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:48560 dopaminergic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35481 non-narcotic analgesic
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
FDA EPC N0000175543 Influenza A M2 Protein Inhibitor
FDA MoA N0000175542 M2 Protein Inhibitors

Drug Use (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
Fatigue due to Multiple Sclerosis off-label use
Cognitive Impairment following Traumatic Brain Injury 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

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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 129MG BASE OSMOLEX ER OSMOTICA PHARM N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8574626 Nov. 28, 2025 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT
EQ 193MG BASE OSMOLEX ER OSMOTICA PHARM N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8574626 Nov. 28, 2025 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT
EQ 258MG BASE OSMOLEX ER OSMOTICA PHARM N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 8574626 Nov. 28, 2025 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S DISEASE RECEIVING IMMEDIATE RELEASE 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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S 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 PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 129MG BASE OSMOLEX ER OSMOTICA PHARM N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10213393 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT
EQ 129MG BASE OSMOLEX ER OSMOTICA PHARM 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 OSMOTICA PHARM N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10500170 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT
EQ 129MG BASE OSMOLEX ER OSMOTICA PHARM 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 OSMOTICA PHARM 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 OSMOTICA PHARM N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10512617 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 193MG BASE OSMOLEX ER OSMOTICA PHARM N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10213393 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT
EQ 193MG BASE OSMOLEX ER OSMOTICA PHARM 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 OSMOTICA PHARM N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10500170 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT
EQ 193MG BASE OSMOLEX ER OSMOTICA PHARM 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 OSMOTICA PHARM 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 OSMOTICA PHARM 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 OSMOTICA PHARM N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10213393 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT
EQ 258MG BASE OSMOLEX ER OSMOTICA PHARM N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10213394 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 258MG BASE OSMOLEX ER OSMOTICA PHARM N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10500170 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT
EQ 258MG BASE OSMOLEX ER OSMOTICA PHARM N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10500171 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 258MG BASE OSMOLEX ER OSMOTICA PHARM N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10500172 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 258MG BASE OSMOLEX ER OSMOTICA PHARM N209410 Feb. 16, 2018 RX TABLET, EXTENDED RELEASE ORAL 10512617 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS

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, 2020 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S 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, 2020 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S 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 Aug. 24, 2024 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S 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 PARKINSON'S 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

External reference:

IDSource
D000547 MESH_DESCRIPTOR_UI
4019601 VUID
N0000147697 NUI
C0002403 UMLSCUI
D00777 KEGG_DRUG
51361008 SNOMEDCT_US
620 RXNORM
372763006 SNOMEDCT_US
4161 MMSL
d00086 MMSL
4019601 VANDF
004663 NDDF
9921T5P019 UNII
31377-23-8 SECONDARY_CAS_RN
1816 INN_ID
2130 PUBCHEM_CID
CHEBI:2618 CHEBI
CHEMBL660 ChEMBL_ID
DB00915 DRUGBANK_ID
CHEMBL1569 ChEMBL_ID
CHEMBL465617 ChEMBL_ID
308 PDB_CHEM_ID
4128 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
AMANTADINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0121-0646 SOLUTION 50 mg ORAL ANDA 13 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1704 CAPSULE 100 mg ORAL ANDA 12 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1868 CAPSULE 100 mg ORAL ANDA 12 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-4920 TABLET 100 mg ORAL ANDA 12 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-4930 CAPSULE 100 mg ORAL ANDA 13 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-0326 CAPSULE 100 mg ORAL ANDA 13 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8263 CAPSULE 100 mg ORAL ANDA 11 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0832-0111 TABLET 100 mg ORAL ANDA 13 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0832-1015 CAPSULE, GELATIN COATED 100 mg ORAL ANDA 14 sections
amantadine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6630 CAPSULE 100 mg ORAL ANDA 12 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10135-692 TABLET 100 mg ORAL ANDA 12 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10135-693 CAPSULE, GELATIN COATED 100 mg ORAL ANDA 12 sections
Amantadine HCl HUMAN PRESCRIPTION DRUG LABEL 1 10888-5006 CAPSULE, LIQUID FILLED 100 mg ORAL ANDA 12 sections
AMANTADINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-008 CAPSULE 100 mg ORAL ANDA 13 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 17856-0093 SOLUTION 50 mg ORAL ANDA 13 sections
Amantadine HCl HUMAN PRESCRIPTION DRUG LABEL 1 21695-564 CAPSULE 100 mg ORAL ANDA 11 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-362 CAPSULE 100 mg ORAL ANDA 11 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 33261-773 CAPSULE 100 mg ORAL ANDA 13 sections
Amantadine HCl HUMAN PRESCRIPTION DRUG LABEL 1 42291-125 CAPSULE, LIQUID FILLED 100 mg ORAL ANDA 12 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42543-493 CAPSULE 100 mg ORAL ANDA 12 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 13 sections
amantadine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 46672-606 SYRUP 50 mg ORAL ANDA 13 sections
amantadine HUMAN PRESCRIPTION DRUG LABEL 1 46708-246 CAPSULE 100 mg ORAL ANDA 12 sections
Amantadine HCl HUMAN PRESCRIPTION DRUG LABEL 1 50268-069 CAPSULE, LIQUID FILLED 100 mg ORAL ANDA 12 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50383-807 SOLUTION 50 mg ORAL ANDA 12 sections
AMANTADINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 50436-0646 SOLUTION 50 mg ORAL ANDA 13 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 53002-3750 CAPSULE 100 mg ORAL ANDA 12 sections
Amantadine HCl HUMAN PRESCRIPTION DRUG LABEL 1 53808-0933 CAPSULE, LIQUID FILLED 100 mg ORAL ANDA 12 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 54868-0800 CAPSULE 100 mg ORAL ANDA 13 sections