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

Stem definitionDrug idCAS RN
dopamine receptor agonists, dopamine derivatives, used as antiparkinsonism/prolactin inhibitors 1567 59-92-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • levodopa
  • ledopa
  • 3-Hydroxy-L-tyrosine
  • DOPA
  • dihydroxyphenylalanine
The naturally occurring form of DIHYDROXYPHENYLALANINE and the immediate precursor of DOPAMINE. Unlike dopamine itself, it can be taken orally and crosses the blood-brain barrier. It is rapidly taken up by dopaminergic neurons and converted to DOPAMINE. It is used for the treatment of PARKINSONIAN DISORDERS and is usually given with agents that inhibit its conversion to dopamine outside of the central nervous system.
  • Molecular weight: 197.19
  • Formula: C9H11NO4
  • CLOGP: -2.82
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 4
  • TPSA: 103.78
  • ALOGS: -1.78
  • ROTB: 3

Drug dosage:

DoseUnitRoute
3.50 g O
0.60 g O
0.45 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1.65 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 674.47 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 41 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.70 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 23 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.76 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.30 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Sept. 19, 2019 EMA Acorda Therapeutics Ireland Limited
June 4, 1970 FDA

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 456.36 38.53 94 918 4695 2352378
Parkinson's disease 401.25 38.53 69 943 1257 2355816
Tremor 204.66 38.53 67 945 20594 2336479
Impulse-control disorder 175.07 38.53 26 986 169 2356904
Hallucination, visual 161.68 38.53 37 975 2942 2354131
Hallucination 151.49 38.53 43 969 8105 2348968
Neuroleptic malignant syndrome 146.57 38.53 32 980 2048 2355025
Dopamine dysregulation syndrome 146.30 38.53 19 993 35 2357038
On and off phenomenon 140.76 38.53 21 991 141 2356932
Drug ineffective 138.52 38.53 81 931 101543 2255530
Confusional state 129.98 38.53 50 962 24294 2332779
Ileus 128.69 38.53 29 983 2143 2354930
Fall 128.60 38.53 60 952 47039 2310034
Therapeutic response shortened 127.33 38.53 23 989 548 2356525
Compulsive shopping 124.63 38.53 19 993 150 2356923
Anxiety 124.31 38.53 51 961 29308 2327765
Freezing phenomenon 105.08 38.53 16 996 125 2356948
Prescribed overdose 100.69 38.53 23 989 1801 2355272
Gait disturbance 94.68 38.53 39 973 22506 2334567
Dysphagia 92.82 38.53 33 979 12772 2344301
Wrong technique in product usage process 92.65 38.53 37 975 19711 2337362
Nausea 84.71 38.53 62 950 112127 2244946
Somnolence 83.15 38.53 36 976 23449 2333624
Dementia 81.97 38.53 21 991 2660 2354413
Pleurothotonus 81.18 38.53 14 998 252 2356821
Delirium 76.69 38.53 23 989 5200 2351873
Muscle rigidity 74.30 38.53 18 994 1813 2355260
Orthostatic hypotension 70.92 38.53 19 993 2860 2354213
Psychotic disorder 70.39 38.53 21 991 4658 2352415
Stereotypy 69.07 38.53 11 1001 118 2356955
Vascular encephalopathy 66.24 38.53 10 1002 73 2357000
Camptocormia 65.23 38.53 9 1003 31 2357042
Subileus 64.50 38.53 13 999 558 2356515
Vomiting 64.01 38.53 44 968 71558 2285515
Speech disorder 63.71 38.53 21 991 6443 2350630
Psychomotor hyperactivity 63.38 38.53 16 996 1906 2355167
Dropped head syndrome 57.04 38.53 8 1004 32 2357041
Therapeutic product effect decreased 56.74 38.53 22 990 10767 2346306
Depressed level of consciousness 56.53 38.53 20 992 7584 2349489
Hypokinesia 54.86 38.53 14 998 1740 2355333
Asthenia 54.44 38.53 34 978 46892 2310181
Delusion 52.59 38.53 14 998 2051 2355022
Bradykinesia 51.99 38.53 11 1001 600 2356473
Parkinsonism 51.96 38.53 13 999 1492 2355581
Jealous delusion 50.32 38.53 7 1005 26 2357047
Drug interaction 49.30 38.53 27 985 29136 2327937
Abnormal behaviour 49.04 38.53 16 996 4744 2352329
Abdominal distension 46.93 38.53 19 993 10392 2346681
Gastrointestinal sounds abnormal 46.92 38.53 10 1002 565 2356508
Akinesia 46.29 38.53 9 1003 320 2356753
Agitation 45.84 38.53 19 993 11032 2346041
Gait inability 45.52 38.53 16 996 5939 2351134
Movement disorder 43.83 38.53 13 999 2815 2354258
Therapeutic product effect incomplete 43.31 38.53 18 994 10513 2346560
Parkinsonism hyperpyrexia syndrome 42.58 38.53 6 1006 25 2357048
Coma 42.44 38.53 17 995 9039 2348034
Decreased appetite 41.36 38.53 24 988 28867 2328206
Abdominal tenderness 40.95 38.53 10 1002 1037 2356036
Fatigue 40.41 38.53 36 976 84837 2272236
Feeling abnormal 40.28 38.53 22 990 23559 2333514
Hypersexuality 39.87 38.53 7 1005 140 2356933
Heat stroke 39.50 38.53 7 1005 148 2356925
Weight decreased 39.11 38.53 23 989 28348 2328725
Therapeutic product cross-reactivity 39.09 38.53 8 1004 370 2356703

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 588.80 47.71 128 1223 3691 1741739
Parkinson's disease 512.57 47.71 100 1251 1642 1743788
Dopamine dysregulation syndrome 401.50 47.71 56 1295 68 1745362
On and off phenomenon 364.32 47.71 57 1294 218 1745212
Hallucination 295.29 47.71 86 1265 8084 1737346
Hypersexuality 284.68 47.71 48 1303 318 1745112
Prescribed overdose 280.72 47.71 61 1290 1709 1743721
Impulse-control disorder 267.91 47.71 45 1306 290 1745140
Gambling disorder 231.95 47.71 41 1310 369 1745061
Tremor 223.66 47.71 78 1273 13053 1732377
Hallucination, visual 211.12 47.71 52 1299 2540 1742890
Freezing phenomenon 207.82 47.71 34 1317 181 1745249
Fall 194.14 47.71 86 1265 27128 1718302
Muscle rigidity 191.25 47.71 45 1306 1803 1743627
Confusional state 163.61 47.71 71 1280 21207 1724223
Neuroleptic malignant syndrome 144.10 47.71 40 1311 3108 1742322
Gait disturbance 140.42 47.71 55 1296 12615 1732815
Dysphagia 133.63 47.71 50 1301 10118 1735312
Drug ineffective 127.76 47.71 87 1264 63714 1681716
Delirium 112.48 47.71 39 1312 6323 1739107
Akinesia 110.82 47.71 21 1330 284 1745146
Agitation 101.72 47.71 42 1309 10984 1734446
Therapeutic product effect variable 100.32 47.71 17 1334 115 1745315
Psychotic disorder 97.13 47.71 33 1318 5023 1740407
Jealous delusion 94.71 47.71 15 1336 62 1745368
Bradykinesia 94.07 47.71 20 1331 496 1744934
Stereotypy 80.76 47.71 14 1337 110 1745320
Wrong technique in product usage process 80.06 47.71 35 1316 10500 1734930
Aggression 78.46 47.71 32 1319 8083 1737347
Condition aggravated 78.41 47.71 43 1308 21107 1724323
Hyperkinesia 77.24 47.71 15 1336 232 1745198
Compulsive shopping 76.56 47.71 13 1338 89 1745341
Depression 76.22 47.71 39 1312 16630 1728800
Orthostatic hypotension 76.21 47.71 25 1326 3406 1742024
Somnolence 76.07 47.71 39 1312 16700 1728730
Therapeutic response shortened 71.94 47.71 15 1336 337 1745093
Abnormal behaviour 71.68 47.71 28 1323 6314 1739116
Dystonia 67.03 47.71 20 1331 1994 1743436
Hyperthermia 65.99 47.71 19 1332 1672 1743758
Paraphilia 65.61 47.71 10 1341 30 1745400
Delusion 65.01 47.71 20 1331 2211 1743219
Therapeutic product effect decreased 64.85 47.71 26 1325 6271 1739159
Dizziness 63.84 47.71 45 1306 34316 1711114
Feeling abnormal 62.48 47.71 30 1321 11136 1734294
Therapeutic product effect incomplete 61.35 47.71 24 1327 5424 1740006
Balance disorder 59.85 47.71 24 1327 5788 1739642
Drug abuse 53.86 47.71 29 1322 13660 1731770
Oesophageal achalasia 53.46 47.71 9 1342 58 1745372
Autonomic nervous system imbalance 52.57 47.71 12 1339 415 1745015
Depressed mood 51.30 47.71 18 1333 2998 1742432
Anxiety 50.45 47.71 29 1322 15498 1729932
Dementia 49.45 47.71 16 1335 2080 1743350
Obsessive-compulsive disorder 49.43 47.71 13 1338 815 1744615
Soft tissue mass 49.24 47.71 8 1343 40 1745390
Compulsive sexual behaviour 48.45 47.71 8 1343 45 1745385

Pharmacologic Action:

SourceCodeDescription
ATC N04BA01 NERVOUS SYSTEM
ANTI-PARKINSON DRUGS
DOPAMINERGIC AGENTS
Dopa and dopa derivatives
ATC N04BA02 NERVOUS SYSTEM
ANTI-PARKINSON DRUGS
DOPAMINERGIC AGENTS
Dopa and dopa derivatives
ATC N04BA03 NERVOUS SYSTEM
ANTI-PARKINSON DRUGS
DOPAMINERGIC AGENTS
Dopa and dopa derivatives
FDA EPC N0000193220 Aromatic Amino Acid
FDA CS M0370111 Amino Acids, Aromatic
CHEBI has role CHEBI:66956 antidyskinesia agent
CHEBI has role CHEBI:48560 dopaminergic agent
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:50266 prodrug
MeSH PA D018726 Anti-Dyskinesia Agents
MeSH PA D000978 Antiparkinson Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D018377 Neurotransmitter Agents
FDA EPC N0000175754 Aromatic Amino Acid Decarboxylation Inhibitor
FDA MoA N0000175755 DOPA Decarboxylase 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
Restless legs off-label use 32914008 DOID:0050425
Suicidal thoughts contraindication 6471006
Hallucinations contraindication 7011001
Dyskinesia contraindication 9748009
Peptic ulcer contraindication 13200003 DOID:750
Disorder of lung contraindication 19829001 DOID:850
Myocardial infarction contraindication 22298006 DOID:5844
Orthostatic hypotension contraindication 28651003
Obstruction of bile duct contraindication 30144000
Depressive disorder contraindication 35489007
Conduction disorder of the heart contraindication 44808001
Duodenal ulcer disease contraindication 51868009 DOID:1724
Diarrhea contraindication 62315008
Psychotic disorder contraindication 69322001
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Open-angle glaucoma contraindication 84494001 DOID:1067
Kidney disease contraindication 90708001 DOID:557
Acute disease of cardiovascular system contraindication 128487001
Seizure disorder contraindication 128613002
Drug-induced psychosis contraindication 191483003 DOID:1742
Disease of liver contraindication 235856003 DOID:409
Retention of urine contraindication 267064002
Psychoneurotic personality disorder contraindication 268634009
Malignant melanoma contraindication 372244006
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Gastric ulcer contraindication 397825006 DOID:10808

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.31 acidic
pKa2 9.07 acidic
pKa3 13.05 acidic
pKa4 10.01 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
42MG INBRIJA ACORDA N209184 Dec. 21, 2018 RX POWDER INHALATION 6921528 June 19, 2020 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES THROUGH A SINGLE BREATH ACTIVATED STEP
42MG INBRIJA ACORDA N209184 Dec. 21, 2018 RX POWDER INHALATION 8628754 June 19, 2020 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES THROUGH A SINGLE BREATH ACTIVATED STEP
100MG STALEVO 100 ORION PHARMA N021485 June 11, 2003 RX TABLET ORAL 6500867 June 29, 2020 TREATMENT OF PARKINSON'S DISEASE
125MG STALEVO 125 ORION PHARMA N021485 Aug. 29, 2008 RX TABLET ORAL 6500867 June 29, 2020 TREATMENT OF PARKINSON'S DISEASE
150MG STALEVO 150 ORION PHARMA N021485 June 11, 2003 RX TABLET ORAL 6500867 June 29, 2020 TREATMENT OF PARKINSON'S DISEASE
200MG STALEVO 200 ORION PHARMA N021485 Aug. 2, 2007 RX TABLET ORAL 6500867 June 29, 2020 TREATMENT OF PARKINSON'S DISEASE
50MG STALEVO 50 ORION PHARMA N021485 June 11, 2003 RX TABLET ORAL 6500867 June 29, 2020 TREATMENT OF PARKINSON'S DISEASE
75MG STALEVO 75 ORION PHARMA N021485 Aug. 29, 2008 RX TABLET ORAL 6500867 June 29, 2020 TREATMENT OF PARKINSON'S DISEASE
42MG INBRIJA ACORDA N209184 Dec. 21, 2018 RX POWDER INHALATION 6514482 Sept. 19, 2020 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES
42MG INBRIJA ACORDA N209184 Dec. 21, 2018 RX POWDER INHALATION 6613308 Sept. 19, 2020 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES
42MG INBRIJA ACORDA N209184 Dec. 21, 2018 RX POWDER INHALATION 6979437 Sept. 19, 2020 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES
42MG INBRIJA ACORDA N209184 Dec. 21, 2018 RX POWDER INHALATION 7146978 April 16, 2021 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE WITH A POWDER INHALER
42MG INBRIJA ACORDA N209184 Dec. 21, 2018 RX POWDER INHALATION 6858199 Nov. 4, 2021 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES THROUGH A SINGLE BREATH ACTIVATED STEP
42MG INBRIJA ACORDA N209184 Dec. 21, 2018 RX POWDER INHALATION 7556798 Nov. 4, 2021 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES THROUGH A SINGLE BREATH ACTIVATED STEP
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 7094427 May 29, 2022 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 7094427 May 29, 2022 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 7094427 May 29, 2022 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 7094427 May 29, 2022 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
42MG INBRIJA ACORDA N209184 Dec. 21, 2018 RX POWDER INHALATION 8404276 March 19, 2023 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES
42MG INBRIJA ACORDA N209184 Dec. 21, 2018 RX POWDER INHALATION 8586093 March 19, 2023 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9089607 Dec. 26, 2028 METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9089607 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9463246 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9533046 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9901640 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9089607 Dec. 26, 2028 METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9089607 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9463246 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9533046 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9901640 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9089607 Dec. 26, 2028 METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9089607 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9463246 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9533046 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9901640 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9089607 Dec. 26, 2028 METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9089607 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9463246 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9533046 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9901640 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
42MG INBRIJA ACORDA N209184 Dec. 21, 2018 RX POWDER INHALATION RE43711 Feb. 3, 2029 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
42MG INBRIJA ACORDA N209184 Dec. 21, 2018 RX POWDER INHALATION Dec. 21, 2021 NEW PRODUCT
20MG/ML DUOPA ABBVIE INC N203952 Jan. 9, 2015 RX SUSPENSION ENTERAL Jan. 9, 2022 TREATMENT OF MOTOR FLUCTUATIONS IN PATIENTS WITH ADVANCED PARKINSON'S DISEASE

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
D(2) dopamine receptor GPCR AGONIST WOMBAT-PK SCIENTIFIC LITERATURE
D(1A) dopamine receptor GPCR AGONIST WOMBAT-PK SCIENTIFIC LITERATURE
Epidermal growth factor receptor Kinase IC50 5.54 DRUG MATRIX
Tyrosine-protein kinase Lck Kinase IC50 5.43 DRUG MATRIX
Tyrosine-protein kinase Fyn Kinase IC50 5.67 DRUG MATRIX
Arachidonate 15-lipoxygenase Enzyme IC50 5.65 DRUG MATRIX

External reference:

IDSource
D004295 MESH_DESCRIPTOR_UI
4017790 VUID
N0000146151 NUI
C0023570 UMLSCUI
D00059 KEGG_DRUG
46627O600J UNII
2651 INN_ID
15383004 SNOMEDCT_US
387086006 SNOMEDCT_US
1804 MMSL
6375 RXNORM
4971 MMSL
d00277 MMSL
4017790 VANDF
001639 NDDF
6047 PUBCHEM_CID
CHEBI:15765 CHEBI
CHEMBL1009 ChEMBL_ID
DB01235 DRUGBANK_ID
D007980 MESH_DESCRIPTOR_UI
3639 IUPHAR_LIGAND_ID
DB00988 DRUGBANK_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3915 TABLET 100 mg ORAL NDA 12 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3916 TABLET 100 mg ORAL NDA 12 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3917 TABLET 250 mg ORAL NDA 12 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3918 TABLET, EXTENDED RELEASE 100 mg ORAL NDA 12 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3919 TABLET, EXTENDED RELEASE 200 mg ORAL NDA 12 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-6722 TABLET 100 mg ORAL NDA 12 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-6723 TABLET 250 mg ORAL NDA 12 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-6724 TABLET 100 mg ORAL NDA 12 sections
Duopa HUMAN PRESCRIPTION DRUG LABEL 2 0074-3012 SUSPENSION 20 mg ENTERAL NDA 20 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0407 TABLET, FILM COATED 50 mg ORAL NDA 17 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0408 TABLET, FILM COATED 100 mg ORAL NDA 17 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0409 TABLET, FILM COATED 150 mg ORAL NDA 17 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0527 TABLET, FILM COATED 200 mg ORAL NDA 17 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0544 TABLET, FILM COATED 75 mg ORAL NDA 17 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0545 TABLET, FILM COATED 125 mg ORAL NDA 17 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2538 TABLET 100 mg ORAL ANDA 12 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2539 TABLET 100 mg ORAL ANDA 12 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2540 TABLET 250 mg ORAL ANDA 12 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0078 TABLET 100 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0085 TABLET 100 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0088 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0094 TABLET, EXTENDED RELEASE 200 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-1133 TABLET 250 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-5051 TABLET, ORALLY DISINTEGRATING 100 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-5052 TABLET, ORALLY DISINTEGRATING 100 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-5053 TABLET, ORALLY DISINTEGRATING 250 mg ORAL ANDA 11 sections
Carbidopa, Levodopa and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0378-8300 TABLET, FILM COATED 50 mg ORAL NDA authorized generic 16 sections
Carbidopa, Levodopa and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0378-8301 TABLET, FILM COATED 75 mg ORAL NDA authorized generic 16 sections
Carbidopa, Levodopa and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0378-8302 TABLET, FILM COATED 100 mg ORAL NDA authorized generic 16 sections
Carbidopa, Levodopa and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0378-8303 TABLET, FILM COATED 125 mg ORAL NDA authorized generic 16 sections