carbidopa 🐶 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 496 28860-95-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • carbidopa hydrate
  • carbidopa
  • lodosin
  • (S)-Carbidopa
  • lodosyn
  • alpha-Methyldopahydrazine
An inhibitor of DOPA DECARBOXYLASE that prevents conversion of LEVODOPA to dopamine. It is used in PARKINSON DISEASE to reduce peripheral adverse effects of LEVODOPA. It has no anti-parkinson activity by itself.
  • Molecular weight: 226.23
  • Formula: C10H14N2O4
  • CLOGP: -0.44
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 5
  • TPSA: 115.81
  • ALOGS: -1.78
  • ROTB: 4

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 2.50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 5.30 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 3.68 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
May 2, 1975 FDA MERCK SHARP DOHME

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
Hallucination 172.45 17.36 98 7149 46559 50551318
Parkinson's disease 167.58 17.36 38 7209 1157 50596720
Dyskinesia 146.43 17.36 74 7173 27787 50570090
Hallucination, visual 92.84 17.36 46 7201 16536 50581341
Tremor 91.99 17.36 97 7150 114806 50483071
Confusional state 67.51 17.36 106 7141 185822 50412055
Fall 57.44 17.36 139 7108 334793 50263084
Product complaint 50.28 17.36 27 7220 11439 50586438
Gambling disorder 47.86 17.36 14 7233 1180 50596697
Impulse-control disorder 46.05 17.36 12 7235 658 50597219
Drug interaction 45.58 17.36 93 7154 199528 50398349
Compulsive shopping 45.23 17.36 12 7235 706 50597171
Delirium 45.14 17.36 40 7207 38152 50559725
Muscle rigidity 42.69 17.36 23 7224 9806 50588071
Agitation 40.74 17.36 44 7203 53340 50544537
Parkinsonism 39.26 17.36 21 7226 8826 50589051
Abnormal behaviour 39.18 17.36 28 7219 19630 50578247
Delusion 38.43 17.36 22 7225 10547 50587330
Ileus 36.35 17.36 23 7224 13206 50584671
Sudden onset of sleep 34.03 17.36 9 7238 523 50597354
Orthostatic hypotension 33.10 17.36 30 7217 29451 50568426
Aortic valve incompetence 33.05 17.36 16 7231 5460 50592417
Neuroleptic malignant syndrome 32.21 17.36 20 7227 11110 50586767
Wrong product administered 30.37 17.36 15 7232 5345 50592532
Dementia 30.08 17.36 22 7225 15975 50581902
Depressed level of consciousness 29.85 17.36 37 7210 51916 50545961
Purpura senile 29.36 17.36 8 7239 521 50597356
Tarsal tunnel syndrome 29.21 17.36 8 7239 531 50597346
Resorption bone increased 28.32 17.36 9 7238 1002 50596875
Vascular encephalopathy 26.88 17.36 7 7240 383 50597494
Speech disorder 26.59 17.36 29 7218 35519 50562358
Psychotic disorder 26.07 17.36 23 7224 21789 50576088
Movement disorder 26.03 17.36 21 7226 17611 50580266
Hypersexuality 25.82 17.36 7 7240 447 50597430
Gait disturbance 25.31 17.36 62 7185 149943 50447934
Disorientation 23.21 17.36 27 7220 35457 50562420
Medication error 22.83 17.36 27 7220 36077 50561800
Aggression 22.74 17.36 21 7226 21095 50576782
Coronary artery dissection 22.57 17.36 7 7240 720 50597157
Vestibular disorder 22.46 17.36 8 7239 1261 50596616
Dysphagia 22.43 17.36 40 7207 77478 50520399
Blood creatine phosphokinase increased 22.36 17.36 23 7224 26344 50571533
Stereotypy 22.24 17.36 6 7241 376 50597501
Somnolence 21.96 17.36 60 7187 154925 50442952
On and off phenomenon 21.63 17.36 8 7239 1404 50596473
Off label use 21.28 17.36 22 7225 474404 50123473
Alopecia 20.41 17.36 5 7242 245042 50352835
Psychomotor hyperactivity 20.28 17.36 14 7233 9287 50588590
Freezing phenomenon 20.27 17.36 7 7240 1008 50596869
Bradykinesia 19.31 17.36 10 7237 3933 50593944
Rheumatoid arthritis 19.25 17.36 3 7244 202547 50395330
Application site reaction 18.88 17.36 6 7241 668 50597209
Tongue necrosis 18.73 17.36 3 7244 12 50597865
Joint swelling 18.58 17.36 6 7241 245280 50352597
Product administration error 18.20 17.36 18 7229 19681 50578196
Anxiety 17.88 17.36 61 7186 177545 50420332
Akinesia 17.61 17.36 7 7240 1492 50596385
Peripheral swelling 17.55 17.36 4 7243 205932 50391945

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
Parkinson's disease 207.36 16.73 52 7735 1309 29565431
Hallucination 192.49 16.73 129 7658 44583 29522157
Gambling disorder 161.77 16.73 44 7743 1531 29565209
Hypersexuality 158.71 16.73 42 7745 1314 29565426
Hallucination, visual 132.53 16.73 69 7718 14946 29551794
Dyskinesia 113.86 16.73 69 7718 19992 29546748
Muscle rigidity 105.87 16.73 51 7736 9360 29557380
Fall 100.10 16.73 172 7615 177006 29389734
Confusional state 77.18 16.73 128 7659 127749 29438991
On and off phenomenon 76.89 16.73 26 7761 1902 29564838
Sudden onset of sleep 65.31 16.73 16 7771 364 29566376
Neuroleptic malignant syndrome 63.18 16.73 44 7743 16104 29550636
Orthostatic hypotension 62.45 16.73 50 7737 22579 29544161
Gambling 58.87 16.73 13 7774 184 29566556
Abnormal behaviour 57.31 16.73 48 7739 23079 29543661
Delusion 57.05 16.73 36 7751 11180 29555560
Impulse-control disorder 54.74 16.73 18 7769 1207 29565533
Agitation 53.99 16.73 67 7720 51237 29515503
Dopamine dysregulation syndrome 52.24 16.73 13 7774 316 29566424
Somnolence 49.95 16.73 89 7698 93866 29472874
Tremor 40.79 16.73 71 7716 73467 29493273
Aggression 39.93 16.73 48 7739 35493 29531247
Psychotic disorder 39.91 16.73 37 7750 20317 29546423
Bradykinesia 39.72 16.73 19 7768 3428 29563312
Dementia 39.24 16.73 29 7758 11629 29555111
Dysphagia 38.54 16.73 59 7728 54867 29511873
Parkinsonism 36.10 16.73 23 7764 7255 29559485
Obsessive-compulsive disorder 34.63 16.73 19 7768 4557 29562183
Aortic valve incompetence 33.01 16.73 19 7768 4994 29561746
Product complaint 31.68 16.73 19 7768 5386 29561354
Delirium 31.49 16.73 45 7742 39352 29527388
Off label use 30.54 16.73 21 7766 300779 29265961
Libido increased 29.84 16.73 10 7777 711 29566029
Gait disturbance 29.75 16.73 62 7725 73287 29493453
Supine hypertension 28.72 16.73 8 7779 304 29566436
Disorientation 27.01 16.73 36 7751 29479 29537261
Syncope 23.31 16.73 60 7727 81311 29485429
Diarrhoea 22.58 16.73 33 7754 332665 29234075
Persecutory delusion 22.25 16.73 11 7776 2130 29564610
Mesenteric artery thrombosis 22.17 16.73 7 7780 412 29566328
Akinesia 20.02 16.73 10 7777 1980 29564760
Febrile neutropenia 19.74 16.73 3 7784 112237 29454503
Soft tissue mass 19.30 16.73 7 7780 629 29566111
Obsessive-compulsive personality disorder 19.15 16.73 5 7782 148 29566592
Illusion 18.63 16.73 7 7780 695 29566045
Serotonin syndrome 18.60 16.73 23 7764 17489 29549251
Micrographia 18.43 16.73 3 7784 6 29566734
Autonomic nervous system imbalance 18.35 16.73 10 7777 2366 29564374
Compulsions 18.08 16.73 5 7782 185 29566555
Tricuspid valve incompetence 17.90 16.73 16 7771 8378 29558362
Mania 17.46 16.73 16 7771 8647 29558093

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
Hallucination 283.12 15.74 171 11391 72617 64414553
Parkinson's disease 255.66 15.74 59 11503 1542 64485628
Dyskinesia 191.35 15.74 107 11455 39281 64447889
Hallucination, visual 187.31 15.74 94 11468 27740 64459430
Hypersexuality 146.05 15.74 37 11525 1442 64485728
Muscle rigidity 126.38 15.74 62 11500 17411 64469759
Confusional state 122.46 15.74 189 11373 260955 64226215
Gambling disorder 100.35 15.74 29 11533 1865 64485305
Fall 96.52 15.74 223 11339 416603 64070567
Agitation 94.90 15.74 97 11465 88270 64398900
Neuroleptic malignant syndrome 92.57 15.74 57 11505 24939 64462231
On and off phenomenon 88.05 15.74 28 11534 2491 64484679
Tremor 84.85 15.74 118 11444 148112 64339058
Abnormal behaviour 77.21 15.74 57 11505 33565 64453605
Delusion 74.23 15.74 44 11518 17970 64469200
Aortic valve incompetence 70.80 15.74 33 11529 8268 64478902
Impulse-control disorder 69.62 15.74 21 11541 1567 64485603
Orthostatic hypotension 68.60 15.74 61 11501 46677 64440493
Dopamine dysregulation syndrome 62.54 15.74 15 11547 464 64486706
Parkinsonism 58.93 15.74 35 11527 14338 64472832
Delirium 56.86 15.74 66 11496 69128 64418042
Dementia 56.39 15.74 39 11523 20727 64466443
Bradykinesia 52.62 15.74 25 11537 6535 64480635
Aggression 51.87 15.74 52 11510 46180 64440990
Somnolence 46.97 15.74 109 11453 203536 64283634
Psychotic disorder 46.54 15.74 43 11519 34535 64452635
Off label use 45.19 15.74 29 11533 632777 63854393
Product complaint 43.58 15.74 27 11535 11927 64475243
Gambling 42.68 15.74 10 11552 279 64486891
Disorientation 40.51 15.74 50 11512 55778 64431392
Sudden onset of sleep 39.96 15.74 11 11551 592 64486578
Tricuspid valve incompetence 39.41 15.74 29 11533 16974 64470196
Gait disturbance 37.34 15.74 90 11472 172065 64315105
Compulsive shopping 37.21 15.74 11 11551 766 64486404
Drug interaction 35.13 15.74 143 11419 361940 64125230
Dysphagia 33.68 15.74 65 11497 106747 64380423
Diarrhoea 32.23 15.74 50 11512 722654 63764516
Serotonin syndrome 31.47 15.74 37 11525 39245 64447925
Ileus 29.82 15.74 28 11534 22938 64464232
Mitral valve incompetence 29.14 15.74 29 11533 25509 64461661
Depressed level of consciousness 28.72 15.74 52 11510 81384 64405786
Akinesia 28.63 15.74 13 11549 3066 64484104
Tarsal tunnel syndrome 27.95 15.74 8 11554 497 64486673
Purpura senile 27.85 15.74 8 11554 503 64486667
Persecutory delusion 27.81 15.74 14 11548 4144 64483026
Syncope 27.55 15.74 76 11486 157559 64329611
Movement disorder 27 15.74 26 11536 21974 64465196
Obsessive-compulsive disorder 25.87 15.74 14 11548 4804 64482366
Supine hypertension 25.85 15.74 7 11555 354 64486816
Deep brain stimulation 25.56 15.74 5 11557 57 64487113
Speech disorder 25.35 15.74 37 11525 48404 64438766
Dementia with Lewy bodies 25.29 15.74 8 11554 699 64486471
Resorption bone increased 25.06 15.74 9 11553 1159 64486011
Blood creatine phosphokinase increased 24.05 15.74 40 11522 58518 64428652
Pain 23.96 15.74 39 11523 553472 63933698
Mesenteric artery thrombosis 23.00 15.74 7 11555 538 64486632
Vascular encephalopathy 22.67 15.74 7 11555 565 64486605
Autonomic nervous system imbalance 22.17 15.74 12 11550 4120 64483050
Obsessive-compulsive personality disorder 21.87 15.74 5 11557 125 64487045
Mania 21.42 15.74 20 11542 16266 64470904
Granulocytopenia 20.21 15.74 16 11546 10424 64476746
Soft tissue mass 19.49 15.74 7 11555 902 64486268
Coronary artery dissection 19.48 15.74 7 11555 903 64486267
Illusion 19.06 15.74 8 11554 1562 64485608
Aortic valve sclerosis 19.02 15.74 8 11554 1571 64485599
Dysstasia 18.81 15.74 22 11540 23193 64463977
Peripheral swelling 18.79 15.74 7 11555 209146 64278024
Posture abnormal 18.57 15.74 10 11552 3396 64483774
Cerebral atrophy 18.19 15.74 13 11549 7272 64479898
Mitral valve disease 17.99 15.74 9 11553 2629 64484541
Hallucinations, mixed 17.93 15.74 12 11550 6040 64481130
Psychomotor hyperactivity 17.58 15.74 17 11545 14434 64472736
Product use in unapproved indication 17.46 15.74 5 11557 176613 64310557
Restlessness 17.45 15.74 28 11534 39757 64447413
Febrile neutropenia 17.33 15.74 6 11556 187651 64299519
Balance disorder 17.24 15.74 43 11519 83883 64403287
Dystonia 17.19 15.74 19 11543 18846 64468324
Reduced facial expression 16.78 15.74 8 11554 2105 64485065
Intermittent claudication 16.75 15.74 9 11553 3045 64484125
Sinusitis 16.69 15.74 3 11559 145925 64341245
Mental status changes 16.62 15.74 35 11527 61127 64426043
Pruritus 16.52 15.74 19 11543 312381 64174789
Incoherent 16.18 15.74 12 11550 7106 64480064
Vestibular disorder 16.16 15.74 8 11554 2285 64484885
Abnormal dreams 16.15 15.74 14 11548 10342 64476828
Delusion of replacement 15.91 15.74 4 11558 151 64487019

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
CHEBI has role CHEBI:48407 antiparkinson agent
CHEBI has role CHEBI:48560 dopaminergic agents
CHEBI has role CHEBI:59321 aromatic-L-amino-acid decarboxylase inhibitors
CHEBI has role CHEBI:66956 antidyskinetic agent
MeSH PA D018726 Anti-Dyskinesia Agents
MeSH PA D000978 Antiparkinson Agents
MeSH PA D065105 Aromatic Amino Acid Decarboxylase Inhibitors
MeSH PA D002491 Central Nervous System Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D004791 Enzyme Inhibitors
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
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
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
Cataract surgery contraindication 110473004
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
Intraoperative floppy iris syndrome contraindication 418801006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.4 acidic
pKa2 10.49 acidic
pKa3 13.92 acidic
pKa4 7.18 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
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
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
Aromatic-L-amino-acid decarboxylase Enzyme INHIBITOR CHEMBL CHEMBL
Tyrosine-protein kinase Lck Kinase IC50 5.17 DRUG MATRIX
Tyrosine-protein kinase Fyn Kinase IC50 5.43 DRUG MATRIX
Lysine-specific demethylase 4E Enzyme Ki 5.70 CHEMBL

External reference:

IDSource
4017949 VUID
N0000146299 NUI
D00558 KEGG_DRUG
2019 RXNORM
C0006982 UMLSCUI
CHEBI:3395 CHEBI
142 PDB_CHEM_ID
CHEMBL1200748 ChEMBL_ID
CHEMBL1201236 ChEMBL_ID
DB00190 DRUGBANK_ID
D002230 MESH_DESCRIPTOR_UI
34359 PUBCHEM_CID
5159 IUPHAR_LIGAND_ID
MNX7R8C5VO UNII
31531 MMSL
4355 MMSL
71847 MMSL
d00184 MMSL
001085 NDDF
386107009 SNOMEDCT_US
73579000 SNOMEDCT_US
4017949 VANDF
38821-49-7 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3915 TABLET 10 mg ORAL NDA 25 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3916 TABLET 25 mg ORAL NDA 25 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3917 TABLET 25 mg ORAL NDA 25 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-6722 TABLET 10 mg ORAL NDA 25 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-6723 TABLET 25 mg ORAL NDA 25 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-6724 TABLET 25 mg ORAL NDA 25 sections
Duopa HUMAN PRESCRIPTION DRUG LABEL 2 0074-3012 SUSPENSION 4.63 mg ENTERAL NDA 31 sections
Duopa HUMAN PRESCRIPTION DRUG LABEL 2 0074-3012 SUSPENSION 4.63 mg ENTERAL NDA 31 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0407 TABLET, FILM COATED 12.50 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0408 TABLET, FILM COATED 25 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0409 TABLET, FILM COATED 37.50 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0527 TABLET, FILM COATED 50 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0544 TABLET, FILM COATED 18.75 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0545 TABLET, FILM COATED 31.25 mg ORAL NDA 25 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0093-9701 TABLET 10 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0093-9701 TABLET 10 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0093-9702 TABLET 25 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0093-9702 TABLET 25 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2538 TABLET 10 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2538 TABLET 10 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2539 TABLET 25 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2539 TABLET 25 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2540 TABLET 25 mg ORAL ANDA 11 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2540 TABLET 25 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0078 TABLET 10 mg ORAL ANDA 24 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0085 TABLET 25 mg ORAL ANDA 24 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0088 TABLET, EXTENDED RELEASE 25 mg ORAL ANDA 24 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0094 TABLET, EXTENDED RELEASE 50 mg ORAL ANDA 24 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-1133 TABLET 25 mg ORAL ANDA 24 sections
Carbidopa, Levodopa and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0378-8300 TABLET, FILM COATED 12.50 mg ORAL NDA authorized generic 24 sections