carbidopa indications/contra

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, preventing conversion of LEVODOPA to dopamine. It is used in PARKINSON DISEASE to reduce peripheral adverse effects of LEVODOPA. It has no antiparkinson actions 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

Drug dosage:

None

Approvals:

DateAgencyCompanyOrphan
May 2, 1975 FDA MERCK SHARP DOHME

FDA Adverse Event Reporting System

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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 738.59 35.58 164 2010 7121 3376564
Parkinson's disease 578.03 35.58 110 2064 2161 3381524
Hallucination 406.93 35.58 115 2059 13225 3370460
Fall 349.50 35.58 149 2025 58734 3324951
Drug ineffective 339.27 35.58 180 1994 115910 3267775
Tremor 318.62 35.58 114 2060 28030 3355655
Confusional state 317.13 35.58 123 2051 37875 3345810
On and off phenomenon 313.87 35.58 47 2127 183 3383502
Hallucination, visual 208.30 35.58 54 2120 4422 3379263
Drug effect decreased 195.57 35.58 64 2110 11905 3371780
Muscle rigidity 192.89 35.58 47 2127 2987 3380698
Hypersexuality 186.26 35.58 33 2141 420 3383265
Freezing phenomenon 168.20 35.58 27 2147 179 3383506
Gait disturbance 165.48 35.58 71 2103 27921 3355764
Dizziness 152.45 35.58 93 2081 76419 3307266
Dopamine dysregulation syndrome 152.43 35.58 24 2150 138 3383547
Orthostatic hypotension 151.04 35.58 43 2131 4993 3378692
Agitation 143.35 35.58 58 2116 19648 3364037
Delirium 143.20 35.58 48 2126 9580 3374105
Dysphagia 140.06 35.58 57 2117 19594 3364091
Neuroleptic malignant syndrome 138.03 35.58 39 2135 4402 3379283
Gambling disorder 136.49 35.58 26 2148 503 3383182
Somnolence 131.05 35.58 63 2111 32141 3351544
Drug interaction 127.93 35.58 70 2104 46742 3336943
Abnormal behaviour 125.72 35.58 44 2130 9984 3373701
Prescribed overdose 119.46 35.58 31 2143 2535 3381150
Nausea 118.70 35.58 98 2076 129547 3254138
Wrong technique in product usage process 117.29 35.58 48 2126 16703 3366982
Stoma site infection 112.45 35.58 17 2157 71 3383614
Product quality issue 110.80 35.58 53 2121 26682 3357003

Pharmacologic Action:

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SourceCodeDescription
CHEBI has role CHEBI:66956 antidyskinesia agent
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:48560 dopaminergic agent
FDA EPC N0000175754 Aromatic Amino Acid Decarboxylation Inhibitor
FDA MoA N0000175755 DOPA Decarboxylase Inhibitors
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

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Postencephalitic parkinsonism indication 19972008 DOID:14332
Parkinsonism indication 32798002 DOID:13548
Parkinson's disease indication 49049000 DOID:14330
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
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:2527
Cataract surgery contraindication 110473004
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
Intraoperative floppy iris syndrome contraindication 418801006
Restless legs off-label use 32914008 DOID:0050425

Acid dissociation constants calculated using MoKa v3.0.0

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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)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
12.5MG STALEVO 50 ORION PHARMA N021485 June 11, 2003 RX TABLET ORAL 6500867 June 29, 2020 TREATMENT OF PARKINSON'S DISEASE
18.75MG STALEVO 75 ORION PHARMA N021485 Aug. 29, 2008 RX TABLET ORAL 6500867 June 29, 2020 TREATMENT OF PARKINSON'S DISEASE
25MG STALEVO 100 ORION PHARMA N021485 June 11, 2003 RX TABLET ORAL 6500867 June 29, 2020 TREATMENT OF PARKINSON'S DISEASE
31.25MG STALEVO 125 ORION PHARMA N021485 Aug. 29, 2008 RX TABLET ORAL 6500867 June 29, 2020 TREATMENT OF PARKINSON'S DISEASE
37.5MG STALEVO 150 ORION PHARMA N021485 June 11, 2003 RX TABLET ORAL 6500867 June 29, 2020 TREATMENT OF PARKINSON'S DISEASE
50MG STALEVO 200 ORION PHARMA N021485 Aug. 2, 2007 RX TABLET ORAL 6500867 June 29, 2020 TREATMENT OF PARKINSON'S DISEASE
23.75MG 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
36.25MG 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
48.75MG 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
61.25MG 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
23.75MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
23.75MG 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
23.75MG 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 RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
23.75MG 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
23.75MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
23.75MG 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 RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
23.75MG 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
23.75MG 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 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
23.75MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9463246 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
23.75MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9533046 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
23.75MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9901640 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
36.25MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
36.25MG 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
36.25MG 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 RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
36.25MG 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
36.25MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
36.25MG 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 RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
36.25MG 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
36.25MG 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 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
36.25MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9463246 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
36.25MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9533046 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
36.25MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9901640 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
48.75MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
48.75MG 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
48.75MG 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 RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
48.75MG 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
48.75MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
48.75MG 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 RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
48.75MG 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
48.75MG 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 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
48.75MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9463246 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
48.75MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9533046 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
48.75MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9901640 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
61.25MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8377474 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
61.25MG 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
61.25MG 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 RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
61.25MG 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
61.25MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8454998 Dec. 26, 2028 TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
61.25MG 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 RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 8557283 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
61.25MG 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
61.25MG 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 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
61.25MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9463246 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
61.25MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL 9533046 Dec. 26, 2028 TREATMENT OF PARKINSON'S DISEASE
61.25MG 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)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
23.75MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL Jan. 7, 2018 NEW DOSAGE FORM
36.25MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL Jan. 7, 2018 NEW DOSAGE FORM
48.75MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL Jan. 7, 2018 NEW DOSAGE FORM
61.25MG RYTARY IMPAX LABS INC N203312 Jan. 7, 2015 RX CAPSULE, EXTENDED RELEASE ORAL Jan. 7, 2018 NEW DOSAGE FORM
4.63MG/ML DUOPA ABBVIE INC N203952 Jan. 9, 2015 RX SUSPENSION ENTERAL Jan. 9, 2018 NEW PRODUCT
4.63MG/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:

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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:

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IDSource
DB00190 DRUGBANK_ID
5159 IUPHAR_LIGAND_ID
4017949 VUID
N0000146299 NUI
C0006982 UMLSCUI
D00558 KEGG_DRUG
34359 PUBCHEM_CID
4017949 VANDF
71847 MMSL
N0000005697 NDFRT
N0000146299 NDFRT
001085 NDDF
2019 RXNORM
386107009 SNOMEDCT_US
73579000 SNOMEDCT_US
4355 MMSL
d00184 MMSL
CHEBI:3395 CHEBI
CHEMBL1200748 ChEMBL_ID
CHEMBL1201236 ChEMBL_ID
D002230 MESH_DESCRIPTOR_UI
MNX7R8C5VO UNII
38821-49-7 SECONDARY_CAS_RN
142 PDB_CHEM_ID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3915 TABLET 10 mg ORAL NDA 12 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3916 TABLET 25 mg ORAL NDA 12 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3917 TABLET 25 mg ORAL NDA 12 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3918 TABLET, EXTENDED RELEASE 25 mg ORAL NDA 12 sections
SINEMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-3919 TABLET, EXTENDED RELEASE 50 mg ORAL NDA 12 sections
Duopa HUMAN PRESCRIPTION DRUG LABEL 2 0074-3012 SUSPENSION 4.63 mg ENTERAL NDA 20 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0407 TABLET, FILM COATED 12.50 mg ORAL NDA 17 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0408 TABLET, FILM COATED 25 mg ORAL NDA 17 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0409 TABLET, FILM COATED 37.50 mg ORAL NDA 17 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0527 TABLET, FILM COATED 50 mg ORAL NDA 17 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0544 TABLET, FILM COATED 18.75 mg ORAL NDA 17 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0545 TABLET, FILM COATED 31.25 mg ORAL NDA 17 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0093-0292 TABLET 10 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0093-0293 TABLET 25 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0093-0294 TABLET 25 mg ORAL ANDA 11 sections
LODOSYN HUMAN PRESCRIPTION DRUG LABEL 1 0179-0125 TABLET 25 mg ORAL NDA 12 sections
Carbidopa HUMAN PRESCRIPTION DRUG LABEL 1 0179-0226 TABLET 25 mg ORAL NDA authorized generic 12 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2538 TABLET 10 mg ORAL ANDA 12 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2539 TABLET 25 mg ORAL ANDA 12 sections
Carbidopa and levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0228-2540 TABLET 25 mg ORAL ANDA 12 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0078 TABLET 10 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0085 TABLET 25 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0088 TABLET, EXTENDED RELEASE 25 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-0094 TABLET, EXTENDED RELEASE 50 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-1133 TABLET 25 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-5051 TABLET, ORALLY DISINTEGRATING 10 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-5052 TABLET, ORALLY DISINTEGRATING 25 mg ORAL ANDA 11 sections
Carbidopa and Levodopa HUMAN PRESCRIPTION DRUG LABEL 2 0378-5053 TABLET, ORALLY DISINTEGRATING 25 mg ORAL ANDA 11 sections
Carbidopa, Levodopa and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0378-8300 TABLET, FILM COATED 12.50 mg ORAL NDA authorized generic 16 sections
Carbidopa, Levodopa and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0378-8301 TABLET, FILM COATED 18.75 mg ORAL NDA authorized generic 16 sections