levodopa 🐶 Veterinary Use | 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
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

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 µM/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 385.17 15.66 168 11697 27693 50565566
Hallucination 218.36 15.66 136 11729 46521 50546738
Hallucination, visual 172.15 15.66 82 11783 16500 50576759
On and off phenomenon 166.67 15.66 43 11822 1369 50591890
Parkinson's disease 163.77 15.66 41 11824 1154 50592105
Muscle rigidity 157.89 15.66 66 11799 9763 50583496
Impulse-control disorder 154.43 15.66 35 11830 635 50592624
Freezing phenomenon 120.23 15.66 31 11834 984 50592275
Bradykinesia 115.47 15.66 41 11824 3902 50589357
Neuroleptic malignant syndrome 115.37 15.66 55 11810 11075 50582184
Delirium 113.24 15.66 84 11781 38108 50555151
Tremor 108.39 15.66 134 11731 114769 50478490
Compulsive shopping 100.21 15.66 25 11840 693 50592566
Delusion 93.87 15.66 47 11818 10522 50582737
Pleurothotonus 89.91 15.66 26 11839 1275 50591984
Dopamine dysregulation syndrome 79.42 15.66 16 11849 160 50593099
Stereotypy 77.56 15.66 18 11847 364 50592895
Parkinsonism 74.63 15.66 38 11827 8809 50584450
Sudden onset of sleep 66.69 15.66 17 11848 515 50592744
Dementia 65.70 15.66 43 11822 15954 50577305
Akinesia 61.20 15.66 20 11845 1479 50591780
Fall 60.55 15.66 194 11671 334738 50258521
Stoma site discharge 60.20 15.66 19 11846 1256 50592003
Dystonia 58.83 15.66 36 11829 11890 50581369
Gambling disorder 57.24 15.66 18 11847 1176 50592083
Dropped head syndrome 55.74 15.66 11 11854 98 50593161
Abnormal behaviour 55.47 15.66 42 11823 19616 50573643
Torticollis 54.45 15.66 19 11846 1717 50591542
Myoclonus 50.12 15.66 35 11830 14435 50578824
Hyperkinesia 49.84 15.66 17 11848 1435 50591824
Stoma site erythema 49.33 15.66 15 11850 876 50592383
Fibroma 47.74 15.66 14 11851 721 50592538
Orthostatic hypotension 46.28 15.66 45 11820 29436 50563823
Gait disturbance 45.22 15.66 105 11760 149900 50443359
Camptocormia 44.62 15.66 11 11854 290 50592969
Speech disorder 44.44 15.66 48 11817 35500 50557759
Confusional state 44.34 15.66 119 11746 185809 50407450
Stoma site reaction 43.00 15.66 10 11855 204 50593055
Reduced facial expression 40.77 15.66 15 11850 1579 50591680
Product residue present 40.66 15.66 19 11846 3653 50589606
Agitation 40.50 15.66 56 11809 53328 50539931
Product complaint 40.33 15.66 28 11837 11438 50581821
Psychotic disorder 39.41 15.66 36 11829 21776 50571483
Jealous delusion 39.32 15.66 7 11858 33 50593226
Stoma site irritation 39.26 15.66 9 11856 172 50593087
Drug interaction 39.07 15.66 119 11746 199502 50393757
Ileus 38.96 15.66 29 11836 13200 50580059
Rash 38.45 15.66 28 11837 437443 50155816
Therapeutic product effect variable 38.34 15.66 13 11852 1077 50592182
Joint swelling 38.06 15.66 6 11859 245280 50347979
Vascular encephalopathy 37.04 15.66 10 11855 380 50592879
Posture abnormal 36.83 15.66 15 11850 2074 50591185
Hypersexuality 35.54 15.66 10 11855 444 50592815
Disorientation 34.37 15.66 42 11823 35442 50557817
Alopecia 33.79 15.66 8 11857 245039 50348220
Rheumatoid arthritis 33.67 15.66 4 11861 202546 50390713
Dysphagia 33.57 15.66 63 11802 77455 50515804
Aortic valve incompetence 33.49 15.66 19 11846 5457 50587802
Peripheral swelling 32.03 15.66 5 11860 205931 50387328
Eczema eyelids 31.59 15.66 7 11858 114 50593145
Restlessness 31.47 15.66 34 11831 25139 50568120
Ketonuria 30.70 15.66 9 11856 463 50592796
Somnolence 29.93 15.66 92 11773 154893 50438366
Stoma site pain 29.92 15.66 10 11855 793 50592466
Movement disorder 29.72 15.66 28 11837 17604 50575655
Tarsal tunnel syndrome 29.52 15.66 9 11856 530 50592729
Nasopharyngitis 29.29 15.66 5 11860 192922 50400337
Choking 28.13 15.66 20 11845 8478 50584781
Heat stroke 27.96 15.66 9 11856 634 50592625
Hypokinesia 27.79 15.66 23 11842 12194 50581065
Deep brain stimulation 27.68 15.66 5 11860 26 50593233
Device difficult to use 27.61 15.66 21 11844 9865 50583394
Aggression 27.24 15.66 29 11836 21087 50572172
Oromandibular dystonia 26.91 15.66 8 11857 432 50592827
Drug withdrawal syndrome 26.44 15.66 31 11834 25050 50568209
Anxiety 25.95 15.66 96 11769 177510 50415749
Therapeutic response shortened 25.88 15.66 18 11847 7371 50585888
Headache 25.71 15.66 50 11815 506485 50086774
Purpura senile 25.46 15.66 8 11857 521 50592738
Blood creatine phosphokinase increased 25.19 15.66 31 11834 26336 50566923
Pruritus 25.07 15.66 18 11847 283550 50309709
Device issue 25.01 15.66 27 11838 19945 50573314
Swelling 24.98 15.66 8 11857 200864 50392395
Hallucination, auditory 24.00 15.66 20 11845 10708 50582551
Resorption bone increased 23.97 15.66 9 11856 1002 50592257
Wrong product administered 23.46 15.66 15 11850 5345 50587914
Depressed level of consciousness 23.46 15.66 43 11822 51910 50541349
Coma 23.11 15.66 45 11820 56834 50536425
Pain 23.09 15.66 65 11800 578838 50014421
Diarrhoea 22.79 15.66 67 11798 588409 50004850
Paranoia 22.54 15.66 19 11846 10329 50582930
Psychomotor hyperactivity 22.18 15.66 18 11847 9283 50583976
Drug hypersensitivity 22.09 15.66 16 11849 250994 50342265
Vestibular disorder 21.99 15.66 9 11856 1260 50591999
Device use issue 21.42 15.66 10 11855 1919 50591340
Retroperitoneal fibrosis 20.89 15.66 6 11859 287 50592972
Orthostatic intolerance 20.65 15.66 8 11857 970 50592289
Cognitive disorder 20.53 15.66 37 11828 44086 50549173
Product use issue 20.35 15.66 5 11860 149470 50443789
Parkinsonism hyperpyrexia syndrome 20.31 15.66 5 11860 131 50593128
Hypersensitivity 19.88 15.66 13 11852 215148 50378111
Application site reaction 19.70 15.66 7 11858 667 50592592
Progressive supranuclear palsy 19.19 15.66 4 11861 48 50593211
Coronary artery dissection 19.18 15.66 7 11858 720 50592539
Cogwheel rigidity 19.08 15.66 9 11856 1768 50591491
Abdominal discomfort 18.82 15.66 16 11849 231625 50361634
Completed suicide 18.77 15.66 4 11861 131885 50461374
Exposure during pregnancy 18.66 15.66 3 11862 121012 50472247
Product administration error 18.56 15.66 23 11842 19676 50573583
Cross sensitivity reaction 18.20 15.66 9 11856 1960 50591299
Infection 18.05 15.66 9 11856 172945 50420314
Tension 18.02 15.66 10 11855 2752 50590507
Cerebral atrophy 17.99 15.66 12 11853 4589 50588670
Treatment failure 17.98 15.66 5 11860 137632 50455627
Hepatic enzyme increased 17.93 15.66 5 11860 137375 50455884
Fatigue 17.60 15.66 96 11769 707505 49885754
Glossodynia 17.52 15.66 3 11862 115566 50477693
Tongue necrosis 17.25 15.66 3 11862 12 50593247
Arthropathy 16.80 15.66 8 11857 157898 50435361
Balance disorder 16.60 15.66 45 11820 70545 50522714
Nuchal rigidity 16.57 15.66 6 11859 603 50592656
Ammonia increased 16.44 15.66 11 11854 4230 50589029
Mobility decreased 15.92 15.66 48 11817 79900 50513359
Pneumonia aspiration 15.72 15.66 27 11838 30977 50562282

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 374.28 15.32 178 12265 19883 29542201
Gambling disorder 323.70 15.32 84 12359 1491 29560593
On and off phenomenon 274.63 15.32 77 12366 1851 29560233
Dopamine dysregulation syndrome 268.44 15.32 54 12389 275 29561809
Hypersexuality 262.64 15.32 69 12374 1287 29560797
Hallucination 239.60 15.32 177 12266 44535 29517549
Impulse-control disorder 216.60 15.32 58 12385 1167 29560917
Parkinson's disease 187.66 15.32 53 12390 1308 29560776
Muscle rigidity 182.96 15.32 86 12357 9325 29552759
Hallucination, visual 153.03 15.32 89 12354 14926 29547158
Fall 118.65 15.32 242 12201 176936 29385148
Neuroleptic malignant syndrome 114.50 15.32 76 12367 16072 29546012
Freezing phenomenon 107.97 15.32 34 12409 1229 29560855
Bradykinesia 100.89 15.32 42 12401 3405 29558679
Akinesia 92.82 15.32 34 12409 1956 29560128
Gambling 78.95 15.32 18 12425 179 29561905
Dementia 78.14 15.32 53 12390 11605 29550479
Tremor 78.04 15.32 123 12320 73415 29488669
Confusional state 71.96 15.32 163 12280 127714 29434370
Sudden onset of sleep 71.95 15.32 19 12424 361 29561723
Orthostatic hypotension 69.50 15.32 65 12378 22564 29539520
Parkinsonism 68.49 15.32 41 12402 7237 29554847
Abnormal behaviour 66.40 15.32 64 12379 23063 29539021
Delusion 65.82 15.32 47 12396 11169 29550915
Obsessive-compulsive disorder 62.73 15.32 33 12410 4543 29557541
Gait disturbance 62.21 15.32 111 12332 73238 29488846
Dysphagia 61.20 15.32 94 12349 54832 29507252
Therapeutic product effect variable 58.75 15.32 24 12419 1853 29560231
Psychotic disorder 57.81 15.32 56 12387 20298 29541786
Compulsive shopping 57.29 15.32 16 12427 378 29561706
Delirium 54.93 15.32 75 12368 39322 29522762
Paraphilia 52.45 15.32 11 12432 71 29562013
Reduced facial expression 52.11 15.32 17 12426 689 29561395
Jealous delusion 51.98 15.32 13 12430 197 29561887
Agitation 47.85 15.32 81 12362 51223 29510861
Diarrhoea 47.81 15.32 42 12401 332656 29229428
Stoma site discharge 47.75 15.32 17 12426 900 29561184
Dystonia 46.34 15.32 36 12407 9713 29552371
Somnolence 43.34 15.32 111 12332 93844 29468240
Aggression 42.65 15.32 63 12380 35478 29526606
Hyperkinesia 41.85 15.32 18 12425 1581 29560503
Stoma site erythema 41.72 15.32 14 12429 620 29561464
Embedded device 40.70 15.32 11 12432 229 29561855
Fibroma 39.96 15.32 11 12432 246 29561838
Phlebitis infective 36.99 15.32 9 12434 121 29561963
Saliva discolouration 36.49 15.32 6 12437 6 29562078
Off label use 34.27 15.32 46 12397 300754 29261330
Febrile neutropenia 33.42 15.32 4 12439 112236 29449848
Cognitive disorder 33.13 15.32 45 12398 23454 29538630
Libido increased 32.44 15.32 12 12431 709 29561375
Restlessness 32.13 15.32 43 12400 22102 29539982
Compulsive sexual behaviour 31.59 15.32 9 12434 229 29561855
Marital problem 31.43 15.32 7 12436 62 29562022
Device use issue 31.22 15.32 9 12434 239 29561845
Persecutory delusion 30.94 15.32 16 12427 2125 29559959
Obsessive-compulsive personality disorder 30.65 15.32 8 12435 145 29561939
Stereotypy 29.77 15.32 11 12432 648 29561436
Hypertonia 29.51 15.32 19 12424 3810 29558274
Product cleaning inadequate 29.10 15.32 5 12438 8 29562076
Device dislocation 28.95 15.32 20 12423 4507 29557577
Compulsions 28.93 15.32 8 12435 182 29561902
Mobility decreased 28.51 15.32 44 12399 25736 29536348
Aortic valve incompetence 27.11 15.32 20 12423 4993 29557091
Deep brain stimulation 26.47 15.32 5 12438 17 29562067
Therapeutic response shortened 25.65 15.32 19 12424 4772 29557312
Pneumonia aspiration 25.39 15.32 51 12392 36686 29525398
Camptocormia 25.28 15.32 7 12436 160 29561924
Pleurothotonus 24.93 15.32 11 12432 1027 29561057
Speech disorder 24.42 15.32 39 12404 23477 29538607
Platelet count decreased 24.22 15.32 7 12436 104665 29457419
Motor dysfunction 24.14 15.32 20 12423 5910 29556174
Tension 23.98 15.32 13 12430 1900 29560184
Autonomic nervous system imbalance 23.96 15.32 14 12429 2362 29559722
Impulsive behaviour 23.79 15.32 13 12430 1930 29560154
Posture abnormal 23.76 15.32 13 12430 1934 29560150
Binge eating 23.63 15.32 6 12437 97 29561987
Product complaint 23.62 15.32 19 12424 5386 29556698
Balance disorder 23.56 15.32 49 12394 36121 29525963
Apathy 23.44 15.32 20 12423 6151 29555933
Abnormal dreams 23.42 15.32 21 12422 6899 29555185
Product residue present 23.10 15.32 14 12429 2525 29559559
Extrapyramidal disorder 22.13 15.32 25 12418 10806 29551278
Stoma site irritation 21.72 15.32 6 12437 136 29561948
Disorientation 21.63 15.32 42 12401 29473 29532611
Sleep attacks 21.55 15.32 6 12437 140 29561944
Hyperthermia 21.40 15.32 23 12420 9407 29552677
Device issue 21.32 15.32 21 12422 7759 29554325
Depression 20.99 15.32 81 12362 85066 29477018
Supine hypertension 20.97 15.32 7 12436 305 29561779
Device difficult to use 20.50 15.32 11 12432 1575 29560509
Pruritus 20.30 15.32 12 12431 116837 29445247
Movement disorder 19.85 15.32 23 12420 10214 29551870
Mesenteric artery thrombosis 18.95 15.32 7 12436 412 29561672
Device occlusion 18.94 15.32 17 12426 5591 29556493
Syncope 18.91 15.32 76 12367 81295 29480789
Stoma site inflammation 18.73 15.32 7 12436 426 29561658
Dependence 18.70 15.32 9 12434 1026 29561058
Illusion 18.69 15.32 8 12435 694 29561390
Psychomotor hyperactivity 18.58 15.32 20 12423 8193 29553891
Neutropenia 18.39 15.32 17 12426 131694 29430390
Wrong technique in device usage process 18.29 15.32 9 12434 1076 29561008
Postural reflex impairment 18.24 15.32 3 12440 3 29562081
Formication 18.02 15.32 10 12433 1530 29560554
Choking 17.97 15.32 15 12428 4476 29557608
Condition aggravated 17.92 15.32 114 12329 146181 29415903
Micrographia 17.03 15.32 3 12440 6 29562078
Economic problem 17.02 15.32 9 12434 1251 29560833
Malignant neoplasm progression 16.97 15.32 5 12438 73854 29488230
Anticholinergic syndrome 16.84 15.32 8 12435 886 29561198
Progressive supranuclear palsy 16.78 15.32 4 12439 49 29562035
Pancytopenia 16.76 15.32 7 12436 83161 29478923
Memory impairment 16.69 15.32 43 12400 36427 29525657
Stoma site reaction 16.58 15.32 5 12438 156 29561928
General physical health deterioration 16.41 15.32 86 12357 102771 29459313
Clonus 16.38 15.32 11 12432 2367 29559717
Obsessive thoughts 16.27 15.32 7 12436 615 29561469
Drug withdrawal syndrome 16.22 15.32 28 12415 17956 29544128
Soft tissue mass 16.12 15.32 7 12436 629 29561455
Sleep disorder 15.83 15.32 33 12410 24353 29537731
Blood creatine phosphokinase increased 15.67 15.32 45 12398 40599 29521485
Listless 15.56 15.32 9 12434 1489 29560595

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 552.93 14.12 255 18225 39133 64441119
Hallucination 329.76 14.12 224 18256 72564 64407688
Dopamine dysregulation syndrome 317.26 14.12 62 18418 417 64479835
On and off phenomenon 306.99 14.12 82 18398 2437 64477815
Impulse-control disorder 303.38 14.12 74 18406 1514 64478738
Hallucination, visual 269.60 14.12 140 18340 27694 64452558
Muscle rigidity 266.58 14.12 120 18360 17353 64462899
Gambling disorder 261.16 14.12 68 18412 1826 64478426
Hypersexuality 252.64 14.12 63 18417 1416 64478836
Parkinson's disease 247.68 14.12 63 18417 1538 64478714
Neuroleptic malignant syndrome 225.76 14.12 120 18360 24876 64455376
Bradykinesia 167.31 14.12 65 18415 6495 64473757
Akinesia 136.82 14.12 46 18434 3033 64477219
Parkinsonism 129.72 14.12 69 18411 14304 64465948
Delusion 128.34 14.12 74 18406 17940 64462312
Compulsive shopping 122.27 14.12 31 18449 746 64479506
Tremor 120.04 14.12 178 18302 148052 64332200
Fall 119.93 14.12 324 18156 416502 64063750
Freezing phenomenon 118.41 14.12 35 18445 1511 64478741
Dementia 116.09 14.12 73 18407 20693 64459559
Delirium 110.78 14.12 117 18363 69077 64411175
Pleurothotonus 108.68 14.12 36 18444 2266 64477986
Dystonia 102.16 14.12 65 18415 18800 64461452
Abnormal behaviour 99.11 14.12 80 18400 33542 64446710
Therapeutic product effect variable 90.98 14.12 29 18451 1615 64478637
Agitation 90.72 14.12 119 18361 88248 64392004
Confusional state 89.43 14.12 217 18263 260927 64219325
Orthostatic hypotension 89.34 14.12 87 18393 46651 64433601
Reduced facial expression 79.98 14.12 28 18452 2085 64478167
Torticollis 75.37 14.12 27 18453 2150 64478102
Sudden onset of sleep 75.21 14.12 20 18460 583 64479669
Stereotypy 73.05 14.12 21 18459 821 64479431
Hyperkinesia 71.25 14.12 27 18453 2519 64477733
Gait disturbance 69.81 14.12 153 18327 172002 64308250
Gambling 68.31 14.12 16 18464 273 64479979
Jealous delusion 66.68 14.12 15 18465 212 64480040
Psychotic disorder 65.39 14.12 64 18416 34514 64445738
Camptocormia 65.00 14.12 17 18463 464 64479788
Aortic valve incompetence 61.52 14.12 35 18445 8266 64471986
Diarrhoea 58.45 14.12 73 18407 722631 63757621
Aggression 58.21 14.12 69 18411 46163 64434089
Dysphagia 57.70 14.12 107 18373 106705 64373547
Deep brain stimulation 53.35 14.12 10 18470 52 64480200
Paraphilia 52.88 14.12 10 18470 55 64480197
Therapeutic response shortened 50.03 14.12 33 18447 10137 64470115
Restlessness 49.46 14.12 59 18421 39726 64440526
Obsessive-compulsive disorder 48.81 14.12 25 18455 4793 64475459
Drug withdrawal syndrome 48.43 14.12 52 18428 31239 64449013
Somnolence 48.32 14.12 148 18332 203497 64276755
Speech disorder 47.77 14.12 64 18416 48377 64431875
Stoma site discharge 47.66 14.12 18 18462 1664 64478588
Persecutory delusion 46.29 14.12 23 18457 4135 64476117
Posture abnormal 44.43 14.12 21 18459 3385 64476867
Blood creatine phosphokinase increased 42.62 14.12 67 18413 58491 64421761
Pneumonia aspiration 39.29 14.12 65 18415 59206 64421046
Disorientation 38.05 14.12 62 18418 55766 64424486
Fibroma 37.49 14.12 12 18468 677 64479575
Ileus 37.01 14.12 39 18441 22927 64457325
Progressive supranuclear palsy 36.26 14.12 8 18472 103 64480149
Rheumatoid arthritis 35.87 14.12 3 18477 164291 64315961
Joint swelling 35.46 14.12 9 18471 215373 64264879
Pruritus 35.38 14.12 23 18457 312377 64167875
Dropped head syndrome 34.76 14.12 9 18471 236 64480016
Febrile neutropenia 34.67 14.12 6 18474 187651 64292601
Product complaint 34.27 14.12 28 18452 11926 64468326
Peripheral swelling 33.93 14.12 9 18471 209144 64271108
Binge eating 33.64 14.12 10 18470 440 64479812
Drug interaction 33.31 14.12 197 18283 361886 64118366
Tricuspid valve incompetence 33.13 14.12 32 18448 16971 64463281
Off label use 32.94 14.12 84 18396 632722 63847530
Myoclonus 32.45 14.12 38 18442 25080 64455172
Hypertonia 32.27 14.12 21 18459 6304 64473948
Cognitive disorder 32.02 14.12 57 18423 55030 64425222
Stoma site pain 31.65 14.12 12 18468 1121 64479131
Pain 31.56 14.12 70 18410 553441 63926811
Apathy 31.55 14.12 26 18454 11206 64469046
Vascular encephalopathy 31.28 14.12 10 18470 562 64479690
Sinusitis 30.95 14.12 3 18477 145925 64334327
Fatigue 30.68 14.12 111 18369 748619 63731633
Product residue present 30.48 14.12 16 18464 3226 64477026
Parkinsonism hyperpyrexia syndrome 30.46 14.12 8 18472 222 64480030
Impulsive behaviour 30.45 14.12 15 18465 2648 64477604
Oromandibular dystonia 30.39 14.12 11 18469 902 64479350
Rash 29.53 14.12 54 18426 458495 64021757
Autonomic nervous system imbalance 29.49 14.12 17 18463 4115 64476137
Device use issue 29.25 14.12 13 18467 1820 64478432
Drug hypersensitivity 29.03 14.12 16 18464 237799 64242453
Eczema eyelids 28.70 14.12 7 18473 143 64480109
Headache 28.53 14.12 69 18411 529398 63950854
Tarsal tunnel syndrome 28.32 14.12 9 18471 496 64479756
Stoma site reaction 27.99 14.12 8 18472 306 64479946
Movement disorder 27.95 14.12 33 18447 21967 64458285
Anxiety 27.51 14.12 123 18357 202526 64277726
Cerebral atrophy 27.29 14.12 20 18460 7265 64472987
Serotonin syndrome 27.27 14.12 44 18436 39238 64441014
Stoma site erythema 27.13 14.12 11 18469 1228 64479024
Mitral valve incompetence 27.12 14.12 35 18445 25503 64454749
Urticaria 26.58 14.12 5 18475 147312 64332940
Hypokinesia 26.41 14.12 28 18452 16568 64463684
Stoma site irritation 26.13 14.12 7 18473 210 64480042
Hyperthermia 26.12 14.12 27 18453 15523 64464729
Extrapyramidal disorder 25.96 14.12 30 18450 19522 64460730
Alopecia 25.27 14.12 8 18472 165682 64314570
Paranoia 24.99 14.12 27 18453 16325 64463927
Obsessive-compulsive personality disorder 24.53 14.12 6 18474 124 64480128
Nasopharyngitis 24.20 14.12 13 18467 196060 64284192
Purpura senile 24.15 14.12 8 18472 503 64479749
Psychomotor hyperactivity 24.10 14.12 25 18455 14426 64465826
Product use issue 23.72 14.12 7 18473 151708 64328544
Product cleaning inadequate 23.62 14.12 4 18476 10 64480242
Postural reflex impairment 23.35 14.12 4 18476 11 64480241
Motor dysfunction 23.28 14.12 22 18458 11351 64468901
Retroperitoneal fibrosis 23.23 14.12 8 18472 567 64479685
Depressed level of consciousness 22.95 14.12 63 18417 81373 64398879
Compulsions 22.90 14.12 7 18473 339 64479913
Abdominal discomfort 22.63 14.12 12 18468 182310 64297942
Supine hypertension 22.61 14.12 7 18473 354 64479898
Resting tremor 22.47 14.12 10 18470 1404 64478848
Arthralgia 21.98 14.12 60 18420 442200 64038052
Mania 21.64 14.12 25 18455 16261 64463991
Dementia with Lewy bodies 21.61 14.12 8 18472 699 64479553
Aortic valve sclerosis 21.41 14.12 10 18470 1569 64478683
Marital problem 21.37 14.12 6 18474 215 64480037
Ketonuria 21.35 14.12 9 18471 1108 64479144
Orthostatic intolerance 21.29 14.12 10 18470 1590 64478662
Resorption bone increased 20.96 14.12 9 18471 1159 64479093
Kleptomania 20.72 14.12 4 18476 25 64480227
Syncope 20.13 14.12 94 18386 157541 64322711
Withdrawal syndrome 20.10 14.12 29 18451 23463 64456789
Pancytopenia 20.01 14.12 8 18472 143301 64336951
Mesenteric artery thrombosis 19.78 14.12 7 18473 538 64479714
Platelet count decreased 19.44 14.12 12 18468 167699 64312553
Stoma site inflammation 19.42 14.12 7 18473 567 64479685
Swelling 19.22 14.12 11 18469 160207 64320045
Heat stroke 19.07 14.12 9 18471 1446 64478806
Choking 18.98 14.12 19 18461 10519 64469733
Hyperreflexia 18.95 14.12 16 18464 7132 64473120
Formication 18.71 14.12 13 18467 4344 64475908
Delusion of replacement 18.66 14.12 5 18475 150 64480102
Hepatic enzyme increased 18.56 14.12 7 18473 129936 64350316
Drug intolerance 18.48 14.12 16 18464 187976 64292276
Cogwheel rigidity 18.42 14.12 11 18469 2842 64477410
Balance disorder 18.04 14.12 59 18421 83867 64396385
Sleep attacks 17.81 14.12 5 18475 179 64480073
Dysarthria 17.78 14.12 47 18433 59359 64420893
Tension 17.78 14.12 12 18468 3828 64476424
Asthma 17.68 14.12 3 18477 95222 64385030
Electrocardiogram J wave 17.56 14.12 4 18476 60 64480192
Lower respiratory tract infection 17.52 14.12 3 18477 94611 64385641
Ballismus 17.35 14.12 5 18475 197 64480055
Medical device site scab 17.32 14.12 3 18477 9 64480243
Dermatillomania 17.30 14.12 5 18475 199 64480053
Libido increased 17.30 14.12 9 18471 1781 64478471
Oral discomfort 16.71 14.12 16 18464 8390 64471862
Infection 16.69 14.12 17 18463 184863 64295389
Mitral valve disease 16.58 14.12 10 18470 2628 64477624
Neutropenia 16.51 14.12 27 18453 239597 64240655
Device dislocation 16.47 14.12 25 18455 21153 64459099
Device difficult to use 16.43 14.12 17 18463 9781 64470471
Chorea 16.36 14.12 9 18471 1991 64478261
Soft tissue mass 16.30 14.12 7 18473 902 64479350
Coronary artery dissection 16.29 14.12 7 18473 903 64479349
Femoral neck fracture 16.21 14.12 16 18464 8708 64471544
Hallucination, auditory 16.11 14.12 22 18458 16917 64463335
Nuchal rigidity 15.97 14.12 7 18473 948 64479304
Abnormal dreams 15.65 14.12 17 18463 10339 64469913
Hypersensitivity 15.63 14.12 20 18460 196432 64283820
Obsessive thoughts 15.55 14.12 7 18473 1010 64479242
Treatment failure 15.54 14.12 7 18473 116809 64363443
Granulocytopenia 15.53 14.12 17 18463 10423 64469829
Mobility decreased 15.53 14.12 57 18423 85783 64394469
Stomatitis 15.49 14.12 6 18474 109599 64370653
Illusion 15.48 14.12 8 18472 1562 64478690
Device issue 15.22 14.12 25 18455 22623 64457629
Vestibular disorder 15.22 14.12 9 18471 2284 64477968
Condition aggravated 15.06 14.12 168 18312 372258 64107994
Subileus 14.99 14.12 12 18468 4965 64475287
Micturition disorder 14.96 14.12 10 18470 3138 64477114
Dyspnoea 14.92 14.12 133 18347 718541 63761711
Influenza 14.78 14.12 6 18474 106525 64373727
Malignant neoplasm progression 14.64 14.12 7 18473 112864 64367388
Sudden death 14.62 14.12 23 18457 20073 64460179
Nocturia 14.60 14.12 17 18463 11148 64469104
Pyrexia 14.59 14.12 97 18383 558547 63921705
Listless 14.56 14.12 10 18470 3280 64476972
Altered state of consciousness 14.55 14.12 33 18447 37869 64442383
Device occlusion 14.50 14.12 16 18464 9897 64470355
Cross sensitivity reaction 14.35 14.12 10 18470 3357 64476895
Yawning 14.35 14.12 7 18473 1209 64479043
Injection site pain 14.32 14.12 7 18473 111401 64368851
Gait inability 14.22 14.12 35 18445 42333 64437919
Product physical issue 14.14 14.12 10 18470 3439 64476813

FDA Adverse Event Reporting System (Pediatric)

None

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 CS M0003647 Catecholamines
FDA CS M0370111 Amino Acids, Aromatic
FDA EPC N0000175570 Catecholamine
MeSH PA D015259 Dopamine Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D002316 Cardiotonic Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D020011 Protective Agents
MeSH PA D013566 Sympathomimetics
MeSH PA D018726 Anti-Dyskinesia Agents
MeSH PA D000978 Antiparkinson Agents
MeSH PA D002491 Central Nervous System Agents
FDA EPC N0000193220 Aromatic Amino Acid
CHEBI has role CHEBI:35219 plant growth inhibitors
CHEBI has role CHEBI:48407 antiparkinson agent
CHEBI has role CHEBI:48560 dopaminergic agents
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:50910 agente neurotoxico
CHEBI has role CHEBI:59174 haptens
CHEBI has role CHEBI:62215 allelochemicals
CHEBI has role CHEBI:66956 antidyskinetic agent
CHEBI has role CHEBI:75771 Mus musculus metabolites
CHEBI has role CHEBI:76924 plant metabolites
CHEBI has role CHEBI:77746 Homo sapiens metabolite
CHEBI has role CHEBI:35522 beta-adrenergic agonists
CHEBI has role CHEBI:35524 sympathomimetic
CHEBI has role CHEBI:38147 cardiotonic drugs
CHEBI has role CHEBI:76971 Escherichia coli metabolites

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
Restless legs off-label use 32914008 DOID:0050425
Age-related macular degeneration off-label use 267718000 DOID:10871
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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
23.75MG;95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 7094427 May 29, 2022 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
36.25MG;145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 7094427 May 29, 2022 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
48.75MG;195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 7094427 May 29, 2022 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
61.25MG;245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 7094427 May 29, 2022 TREATMENT OF PARKINSONS 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 PARKINSONS 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 PARKINSONS DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES
23.75MG;95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
23.75MG;95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
23.75MG;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
23.75MG;95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
23.75MG;95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
23.75MG;95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
23.75MG;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
23.75MG;95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
23.75MG;95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
23.75MG;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
23.75MG;95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9089607 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
23.75MG;95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9463246 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
23.75MG;95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9533046 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
23.75MG;95MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9901640 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
36.25MG;145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
36.25MG;145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
36.25MG;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
36.25MG;145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
36.25MG;145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
36.25MG;145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
36.25MG;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
36.25MG;145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
36.25MG;145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
36.25MG;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
36.25MG;145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9089607 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
36.25MG;145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9463246 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
36.25MG;145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9533046 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
36.25MG;145MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9901640 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
48.75MG;195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
48.75MG;195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
48.75MG;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
48.75MG;195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
48.75MG;195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
48.75MG;195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
48.75MG;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
48.75MG;195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
48.75MG;195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
48.75MG;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
48.75MG;195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9089607 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
48.75MG;195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9463246 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
48.75MG;195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9533046 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
48.75MG;195MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9901640 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
61.25MG;245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
61.25MG;245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
61.25MG;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
61.25MG;245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
61.25MG;245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
61.25MG;245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
61.25MG;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
61.25MG;245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
61.25MG;245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
61.25MG;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
61.25MG;245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9089607 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
61.25MG;245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9463246 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
61.25MG;245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9533046 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
61.25MG;245MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9901640 Dec. 26, 2028 TREATMENT OF PARKINSONS DISEASE
42MG INBRIJA ACORDA N209184 Dec. 21, 2018 RX POWDER INHALATION RE43711 Feb. 3, 2029 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES
25MG;100MG DHIVY AVION PHARMS N214869 Nov. 12, 2021 RX TABLET ORAL 11033521 March 28, 2039 METHOD OF TREATING PARKINSONS DISEASE BY ORALLY ADMINISTERING A FUNCTIONALLY MULTISCORED, BILAYERED TABLET HAVING CARBIDOPA—25 MG/LEVODOPA—100 MG
25MG;100MG DHIVY AVION PHARMS N214869 Nov. 12, 2021 RX TABLET ORAL 11033521 March 28, 2039 METHOD OF TREATING PARKINSONS DISEASE BY ORALLY ADMINISTERING SEGMENTS OF A FUNCTIONALLY MULTISCORED, BILAYERED TABLET HAVING CARBIDOPA—25 MG/LEVODOPA—100 MG, EACH SEGMENT HAVING CARBIDOPA—6.25 MG/LEVODOPA—25 MG
25MG;100MG DHIVY AVION PHARMS N214869 Nov. 12, 2021 RX TABLET ORAL 11033521 March 28, 2039 TREATMENT OF PARKINSONS DISEASE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
4.63MG/ML;20MG/ML DUOPA ABBVIE INC N203952 Jan. 9, 2015 RX SUSPENSION ENTERAL Jan. 9, 2022 TREATMENT OF MOTOR FLUCTUATIONS IN PATIENTS WITH ADVANCED PARKINSONS DISEASE

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
D(1A) dopamine receptor GPCR AGONIST WOMBAT-PK SCIENTIFIC LITERATURE
D(2) dopamine receptor GPCR AGONIST WOMBAT-PK SCIENTIFIC LITERATURE
Tyrosine-protein kinase Lck Kinase IC50 5.43 DRUG MATRIX
Large neutral amino acids transporter small subunit 1 Transporter IC50 4 CHEMBL
Tyrosine-protein kinase Fyn Kinase IC50 5.67 DRUG MATRIX
Epidermal growth factor receptor Kinase IC50 5.54 DRUG MATRIX
Arachidonate 15-lipoxygenase Enzyme IC50 5.65 DRUG MATRIX

External reference:

IDSource
4017790 VUID
N0000146151 NUI
D00059 KEGG_DRUG
4017790 VANDF
4019733 VANDF
C0023570 UMLSCUI
CHEBI:15765 CHEBI
CHEBI:18243 CHEBI
TY3 PDB_CHEM_ID
LDP PDB_CHEM_ID
CHEMBL1009 ChEMBL_ID
DB01235 DRUGBANK_ID
D007980 MESH_DESCRIPTOR_UI
6047 PUBCHEM_CID
2651 INN_ID
3639 IUPHAR_LIGAND_ID
46627O600J UNII
DB00988 DRUGBANK_ID
3628 RXNORM
1804 MMSL
4971 MMSL
6641 MMSL
d00216 MMSL
d00277 MMSL
001639 NDDF
004721 NDDF
15383004 SNOMEDCT_US
387086006 SNOMEDCT_US
412383006 SNOMEDCT_US
59187003 SNOMEDCT_US
65955006 SNOMEDCT_US
D004295 MESH_DESCRIPTOR_UI
681 PUBCHEM_CID
C0013030 UMLSCUI
D004298 MESH_DESCRIPTOR_UI
2417 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3915 TABLET 100 mg ORAL NDA 25 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3916 TABLET 100 mg ORAL NDA 25 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3917 TABLET 250 mg ORAL NDA 25 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-6722 TABLET 100 mg ORAL NDA 25 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-6723 TABLET 250 mg ORAL NDA 25 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-6724 TABLET 100 mg ORAL NDA 25 sections
Duopa HUMAN PRESCRIPTION DRUG LABEL 2 0074-3012 SUSPENSION 20 mg ENTERAL NDA 31 sections
Duopa HUMAN PRESCRIPTION DRUG LABEL 2 0074-3012 SUSPENSION 20 mg ENTERAL NDA 31 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0407 TABLET, FILM COATED 50 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0408 TABLET, FILM COATED 100 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0409 TABLET, FILM COATED 150 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0527 TABLET, FILM COATED 200 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0544 TABLET, FILM COATED 75 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0545 TABLET, FILM COATED 125 mg ORAL NDA 25 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0093-9701 TABLET 100 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0093-9701 TABLET 100 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0093-9702 TABLET 100 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0093-9702 TABLET 100 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2538 TABLET 100 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2538 TABLET 100 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2539 TABLET 100 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2539 TABLET 100 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2540 TABLET 250 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2540 TABLET 250 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0078 TABLET 100 mg ORAL ANDA 24 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0085 TABLET 100 mg ORAL ANDA 24 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0088 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 24 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0094 TABLET, EXTENDED RELEASE 200 mg ORAL ANDA 24 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-1133 TABLET 250 mg ORAL ANDA 24 sections
Carbidopa, Levodopa and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0378-8300 TABLET, FILM COATED 50 mg ORAL NDA authorized generic 24 sections