levodopa Indications/Contra | FAERs | Orange Book | 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

Approvals:

DateAgencyCompanyOrphan
June 4, 1970 FDA

FDA Adverse Event Reporting System

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Dyskinesia 1061.67 38.29 226 2260 7059 3376314
Parkinson's disease 637.27 38.29 122 2364 2149 3381224
Dopamine dysregulation syndrome 527.36 38.29 72 2414 90 3383283
On and off phenomenon 486.19 38.29 70 2416 160 3383213
Hallucination 458.49 38.29 130 2356 13210 3370163
Fall 362.02 38.29 159 2327 58724 3324649
Drug ineffective 360.03 38.29 196 2290 115894 3267479
Tremor 347.86 38.29 126 2360 28018 3355355
Hypersexuality 345.43 38.29 57 2429 396 3382977
Gambling disorder 343.52 38.29 58 2428 471 3382902
Confusional state 307.60 38.29 125 2361 37873 3345500
Hallucination, visual 293.89 38.29 73 2413 4403 3378970
Muscle rigidity 252.89 38.29 60 2426 2974 3380399
Impulse-control disorder 250.39 38.29 43 2443 389 3382984
Drug effect decreased 218.84 38.29 72 2414 11897 3371476
Neuroleptic malignant syndrome 210.96 38.29 56 2430 4385 3378988
Compulsive shopping 209.94 38.29 33 2453 160 3383213
Freezing phenomenon 193.24 38.29 31 2455 175 3383198
Gait disturbance 191.92 38.29 82 2404 27910 3355463
Delirium 176.21 38.29 58 2428 9570 3373803
Agitation 162.81 38.29 66 2420 19640 3363733
Orthostatic hypotension 154.08 38.29 45 2441 4991 3378382
Parkinsonism 146.96 38.29 37 2449 2341 3381032
Bradykinesia 146.43 38.29 31 2455 904 3382469
Abnormal behaviour 146.40 38.29 51 2435 9977 3373396
Dysphagia 145.93 38.29 61 2425 19590 3363783
Dizziness 145.68 38.29 95 2391 76417 3306956
Somnolence 140.66 38.29 69 2417 32135 3351238
Drug interaction 140.63 38.29 78 2408 46734 3336639
Jealous delusion 132.20 38.29 20 2466 71 3383302
Nausea 121.08 38.29 105 2381 129540 3253833
Stereotypy 119.31 38.29 21 2465 221 3383152
Prescribed overdose 115.31 38.29 31 2455 2535 3380838
Aggression 114.46 38.29 44 2442 11341 3372032
Wrong technique in product usage process 114.31 38.29 49 2437 16702 3366671
Delusion 114.25 38.29 33 2453 3512 3379861
Stoma site infection 110.17 38.29 17 2469 71 3383302
Condition aggravated 108.54 38.29 62 2424 39171 3344202
Balance disorder 107.20 38.29 43 2443 12396 3370977
Product quality issue 106.91 38.29 54 2432 26681 3356692
Movement disorder 99.99 38.29 30 2456 3641 3379732
Anxiety 99.98 38.29 59 2427 39570 3343803
Stoma site discharge 99.89 38.29 16 2470 89 3383284
Psychotic disorder 99.51 38.29 37 2449 8697 3374676
Dystonia 90.69 38.29 28 2458 3739 3379634
Adverse event 89.45 38.29 37 2449 11520 3371853
Loss of consciousness 84.57 38.29 47 2439 28100 3355273
Insomnia 84.14 38.29 51 2435 35847 3347526
Overdose 81.50 38.29 49 2437 33929 3349444
Speech disorder 80.13 38.29 32 2454 9100 3374273
Feeling abnormal 80.07 38.29 45 2441 27480 3355893
Disorientation 73.71 38.29 31 2455 10048 3373325
Depression 69.57 38.29 47 2439 39723 3343650
Akinesia 68.72 38.29 15 2471 505 3382868
Syncope 64.10 38.29 38 2448 25595 3357778
Obsessive-compulsive disorder 63.76 38.29 17 2469 1343 3382030
Compulsive sexual behaviour 63.48 38.29 10 2476 49 3383324
Stoma site erythema 62.21 38.29 10 2476 57 3383316
Serotonin syndrome 61.82 38.29 23 2463 5400 3377973
Dysarthria 61.76 38.29 27 2459 9607 3373766
Hypotension 60.32 38.29 47 2439 49467 3333906
Cognitive disorder 60.18 38.29 25 2461 7849 3375524
Eating disorder 59.94 38.29 19 2467 2760 3380613
Malaise 56.86 38.29 51 2435 65126 3318247
Asthenia 56.54 38.29 51 2435 65614 3317759
Parkinsonism hyperpyrexia syndrome 53.89 38.29 8 2478 24 3383349
Purpura senile 53.89 38.29 8 2478 24 3383349
Drug abuse 53.33 38.29 30 2456 18300 3365073
Impulsive behaviour 52.36 38.29 13 2473 773 3382600
Pre-existing condition improved 52.35 38.29 12 2474 506 3382867
Product physical issue 51.10 38.29 14 2472 1225 3382148
Drug withdrawal syndrome 50.52 38.29 25 2461 11760 3371613
Constipation 50.48 38.29 35 2451 30777 3352596
Motor dysfunction 49.90 38.29 15 2471 1826 3381547
Tarsal tunnel syndrome 49.86 38.29 8 2478 45 3383328
Device dislocation 48.77 38.29 21 2465 7195 3376178
Restlessness 48.16 38.29 21 2465 7417 3375956
Memory impairment 47.70 38.29 26 2460 14912 3368461
Persecutory delusion 47.44 38.29 12 2474 770 3382603
Hypokinesia 47.14 38.29 15 2471 2204 3381169
Vomiting 46.67 38.29 53 2433 89478 3293895
Drooling 46.65 38.29 13 2473 1211 3382162
Soft tissue mass 45.71 38.29 8 2478 81 3383292
Dehydration 45.46 38.29 34 2452 33615 3349758
Oromandibular dystonia 45.44 38.29 9 2477 186 3383187
Gait inability 44.70 38.29 20 2466 7505 3375868
Medication error 44.50 38.29 23 2463 11848 3371525
Weight decreased 44.36 38.29 36 2450 40075 3343298
Drug dependence 44.22 38.29 17 2469 4359 3379014
Drug effect incomplete 43.89 38.29 20 2466 7830 3375543
Hyperhidrosis 43.86 38.29 29 2457 23581 3359792
Depressed mood 43.81 38.29 19 2467 6622 3376751
Marital problem 42.94 38.29 8 2478 118 3383255
Psychomotor hyperactivity 41.73 38.29 15 2471 3192 3380181
Sudden onset of sleep 39.87 38.29 9 2477 354 3383019
Illusion 39.82 38.29 9 2477 356 3383017
Pleurothotonus 39.65 38.29 9 2477 363 3383010
Food interaction 38.89 38.29 9 2477 396 3382977

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
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
FDA EPC N0000175754 Aromatic Amino Acid Decarboxylation Inhibitor
FDA MoA N0000175755 DOPA Decarboxylase Inhibitors
FDA EPC N0000193220 Aromatic Amino Acid
FDA Chemical/Ingredient N0000011248 Amino Acids, Aromatic
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

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Postencephalitic parkinsonism indication 19972008 DOID:14332
Parkinsonism indication 32798002 DOID:13548
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 DOID:13580
Depressive disorder contraindication 35489007 DOID:2848
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:2527
Acute disease of cardiovascular system contraindication 128487001
Seizure disorder contraindication 128613002 DOID:1826
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 DOID:1909
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
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
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
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

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL Jan. 7, 2018 NEW DOSAGE FORM
195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL Jan. 7, 2018 NEW DOSAGE FORM
245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL Jan. 7, 2018 NEW DOSAGE FORM
95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL Jan. 7, 2018 NEW DOSAGE FORM
20MG/ML DUOPA ABBVIE INC N203952 Jan. 9, 2015 RX SUSPENSION ENTERAL Jan. 9, 2018 NEW PRODUCT
20MG/ML DUOPA ABBVIE INC N203952 Jan. 9, 2015 RX SUSPENSION ENTERAL Jan. 9, 2022 TREATMENT OF MOTOR FLUCUATIONS 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
CHEBI:15765 CHEBI
3639 IUPHAR_LIGAND_ID
4017790 VUID
N0000146151 NUI
C0023570 UMLSCUI
D00059 KEGG_DRUG
46627O600J UNII
2651 INN_ID
CHEMBL1009 ChEMBL_ID
6047 PUBCHEM_CID
1804 MMSL
6375 RXNORM
15383004 SNOMEDCT_US
387086006 SNOMEDCT_US
4971 MMSL
d00277 MMSL
65955006 SNOMEDCT_US
4017790 VANDF
N0000006700 NDFRT
N0000146151 NDFRT
001639 NDDF
D004295 MESH_DESCRIPTOR_UI
DB01235 DRUGBANK_ID
D007980 MESH_DESCRIPTOR_UI
DB00988 DRUGBANK_ID
DAH PDB_CHEM_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
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 0093-0292 TABLET 100 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0093-0293 TABLET 100 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0093-0294 TABLET 250 mg ORAL ANDA 11 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