carbidopa 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
dopamine receptor agonists, dopamine derivatives, used as antiparkinsonism/prolactin inhibitors	496	28860-95-9

Description:

Molecule	Description
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

Molecule

Description

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:

Property	Value	Reference
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:

Date	Agency	Company	Orphan
May 2, 1975	FDA	MERCK SHARP DOHME

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Parkinson's disease	386.34	18.93	76	7237	1268	56283486
Hallucination	176.60	18.93	98	7215	49051	56235703
Dyskinesia	153.18	18.93	75	7238	29033	56255721
Tremor	97.47	18.93	98	7215	120991	56163763
Hallucination, visual	94.82	18.93	46	7267	17422	56267332
Confusional state	66.27	18.93	106	7207	208049	56076705
Fall	60.41	18.93	139	7174	357371	55927383
Product complaint	52.12	18.93	27	7286	11733	56273021
Gambling disorder	49.01	18.93	14	7299	1197	56283557
Drug interaction	48.71	18.93	93	7220	209662	56075092
Impulse-control disorder	46.31	18.93	12	7301	711	56284043
Compulsive shopping	46.24	18.93	12	7301	715	56284039
Delirium	44.80	18.93	40	7273	42477	56242277
Muscle rigidity	43.02	18.93	23	7290	10648	56274106
Parkinsonism	42.54	18.93	22	7291	9524	56275230
Agitation	42.53	18.93	44	7269	55992	56228762
Neuroleptic malignant syndrome	41.45	18.93	23	7290	11455	56273299
Abnormal behaviour	40.87	18.93	28	7285	20244	56264510
Delusion	39.21	18.93	22	7291	11193	56273561
Rheumatoid arthritis	38.43	18.93	3	7310	382601	55902153
Ileus	37.39	18.93	23	7290	13859	56270895
Sudden onset of sleep	34.55	18.93	9	7304	544	56284210
Aortic valve incompetence	34.16	18.93	16	7297	5596	56279158
Product administration error	33.22	18.93	25	7288	20904	56263850
Orthostatic hypotension	32.55	18.93	30	7283	33169	56251585
Wrong product administered	30.95	18.93	15	7298	5657	56279097
Dementia	30.62	18.93	22	7291	17136	56267618
Depressed level of consciousness	30.29	18.93	37	7276	56396	56228358
Purpura senile	30.13	18.93	8	7305	521	56284233
Tarsal tunnel syndrome	29.98	18.93	8	7305	531	56284223
Speech disorder	27.65	18.93	29	7284	37464	56247290
Vascular encephalopathy	27.48	18.93	7	7306	387	56284367
Resorption bone increased	27.30	18.93	9	7304	1241	56283513
Psychotic disorder	26.48	18.93	23	7290	23535	56261219
Movement disorder	26.26	18.93	21	7292	19177	56265577
Hypersexuality	26.16	18.93	7	7306	470	56284284
Gait disturbance	25.82	18.93	62	7251	163259	56121495
Disorientation	24.67	18.93	27	7286	36586	56248168
Off label use	24.27	18.93	22	7291	556158	55728596
Aggression	23.76	18.93	21	7292	21985	56262769
Somnolence	23.67	18.93	60	7253	163353	56121401
Dysphagia	23.65	18.93	40	7273	81907	56202847
Blood creatine phosphokinase increased	23.11	18.93	23	7290	27929	56256825
Alopecia	23.04	18.93	5	7308	293453	55991301
Vestibular disorder	22.89	18.93	8	7305	1317	56283437
Coronary artery dissection	22.78	18.93	7	7306	770	56283984
Stereotypy	22.23	18.93	6	7307	416	56284338
Medication error	21.49	18.93	27	7286	42308	56242446
On and off phenomenon	21.30	18.93	8	7305	1616	56283138
Psychomotor hyperactivity	20.82	18.93	14	7299	9806	56274948
Joint swelling	20.70	18.93	6	7307	289794	55994960
Freezing phenomenon	20.28	18.93	7	7306	1110	56283644
Application site reaction	19.35	18.93	6	7307	680	56284074
Tongue necrosis	19.02	18.93	3	7310	12	56284742

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Parkinson's disease	364.90	17.31	83	7824	1440	31687997
Hallucination	196.88	17.31	130	7777	46280	31643157
Gambling disorder	163.38	17.31	44	7863	1558	31687879
Hypersexuality	159.09	17.31	42	7865	1376	31688061
Hallucination, visual	132.75	17.31	69	7838	15725	31673712
Dyskinesia	117.26	17.31	70	7837	20840	31668597
Muscle rigidity	112.16	17.31	53	7854	9844	31679593
Fall	100.71	17.31	172	7735	185917	31503520
On and off phenomenon	83.85	17.31	28	7879	2082	31687355
Confusional state	78.33	17.31	128	7779	133206	31556231
Sudden onset of sleep	66.00	17.31	16	7891	368	31689069
Neuroleptic malignant syndrome	63.59	17.31	44	7863	16825	31672612
Orthostatic hypotension	62.02	17.31	50	7857	24069	31665368
Gambling	59.31	17.31	13	7894	188	31689249
Abnormal behaviour	58.32	17.31	48	7859	23780	31665657
Agitation	57.21	17.31	69	7838	54100	31635337
Delusion	56.61	17.31	36	7871	11961	31677476
Impulse-control disorder	54.97	17.31	18	7889	1258	31688179
Dopamine dysregulation syndrome	52.29	17.31	13	7894	333	31689104
Somnolence	49.77	17.31	89	7818	99356	31590081
Tremor	42.92	17.31	72	7835	76348	31613089
Aggression	41.82	17.31	49	7858	37242	31652195
Dementia	41.39	17.31	30	7877	12330	31677107
Bradykinesia	39.95	17.31	19	7888	3573	31685864
Dysphagia	38.77	17.31	59	7848	57617	31631820
Parkinsonism	38.74	17.31	24	7883	7612	31681825
Psychotic disorder	38.74	17.31	37	7870	22256	31667181
Off label use	34.74	17.31	22	7885	347252	31342185
Obsessive-compulsive disorder	34.24	17.31	19	7888	4918	31684519
Product complaint	32.25	17.31	19	7888	5505	31683932
Aortic valve incompetence	32.20	17.31	19	7888	5522	31683915
Delirium	31.62	17.31	45	7862	41376	31648061
Gait disturbance	30.88	17.31	63	7844	77432	31612005
Libido increased	30.17	17.31	10	7897	726	31688711
Supine hypertension	28.82	17.31	8	7899	317	31689120
Disorientation	27.39	17.31	36	7871	30708	31658729
Syncope	23.63	17.31	60	7847	85122	31604315
Mesenteric artery thrombosis	22.30	17.31	7	7900	427	31689010
Persecutory delusion	21.84	17.31	11	7896	2341	31687096
Diarrhoea	20.86	17.31	35	7872	352374	31337063
Febrile neutropenia	20.50	17.31	3	7904	121846	31567591
Akinesia	20.45	17.31	10	7897	1998	31687439
Obsessive-compulsive personality disorder	19.42	17.31	5	7902	148	31689289
Micrographia	18.60	17.31	3	7904	6	31689431
Autonomic nervous system imbalance	18.50	17.31	10	7897	2457	31686980
Illusion	18.44	17.31	7	7900	755	31688682
Serotonin syndrome	18.31	17.31	23	7884	18750	31670687
Compulsions	18.14	17.31	5	7902	193	31689244
Tricuspid valve incompetence	17.94	17.31	16	7891	8813	31680624
Soft tissue mass	17.82	17.31	7	7900	827	31688610
Mania	17.41	17.31	16	7891	9161	31680276

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Parkinson's disease	523.87	15.81	107	11608	1688	70915041
Hallucination	291.32	15.81	172	11543	76088	70840641
Dyskinesia	198.12	15.81	108	11607	40966	70875763
Hallucination, visual	189.92	15.81	94	11621	29243	70887486
Hypersexuality	147.03	15.81	37	11678	1526	70915203
Muscle rigidity	133.41	15.81	64	11651	18586	70898143
Confusional state	121.96	15.81	189	11526	284209	70632520
Neuroleptic malignant syndrome	102.64	15.81	60	11655	25947	70890782
Gambling disorder	102.04	15.81	29	11686	1909	70914820
Fall	99.28	15.81	223	11492	443873	70472856
Agitation	98.93	15.81	98	11617	93277	70823452
On and off phenomenon	95.82	15.81	30	11685	2756	70913973
Tremor	89.44	15.81	119	11596	155505	70761224
Abnormal behaviour	79.77	15.81	57	11658	34652	70882077
Delusion	75.04	15.81	44	11671	19121	70897608
Aortic valve incompetence	71.17	15.81	33	11682	8871	70907858
Impulse-control disorder	70.17	15.81	21	11694	1658	70915071
Orthostatic hypotension	67.55	15.81	61	11654	51682	70865047
Parkinsonism	64.83	15.81	37	11678	15288	70901441
Dopamine dysregulation syndrome	63.42	15.81	15	11700	475	70916254
Dementia	59.04	15.81	40	11675	22325	70894404
Delirium	57.20	15.81	66	11649	74548	70842181
Aggression	55.29	15.81	53	11662	48393	70868336
Bradykinesia	51.38	15.81	25	11690	7477	70909252
Off label use	50.84	15.81	30	11685	743030	70173699
Somnolence	48.78	15.81	109	11606	215497	70701232
Psychotic disorder	46.37	15.81	43	11672	37658	70879071
Product complaint	45.05	15.81	27	11688	12204	70904525
Gambling	43.19	15.81	10	11705	288	70916441
Disorientation	42.32	15.81	50	11665	57873	70858856
Sudden onset of sleep	40.43	15.81	11	11704	616	70916113
Tricuspid valve incompetence	40.32	15.81	29	11686	17788	70898941
Gait disturbance	38.99	15.81	91	11624	185015	70731714
Compulsive shopping	37.94	15.81	11	11704	777	70915952
Drug interaction	37.49	15.81	143	11572	381298	70535431
Dysphagia	34.93	15.81	65	11650	112769	70803960
Serotonin syndrome	33.52	15.81	38	11677	42076	70874653
Ileus	30.49	15.81	28	11687	24209	70892520
Diarrhoea	30.24	15.81	52	11663	783289	70133440
Mitral valve incompetence	30.03	15.81	29	11686	26699	70890030
Akinesia	29.44	15.81	13	11702	3118	70913611
Depressed level of consciousness	29.12	15.81	52	11663	87379	70829350
Syncope	29.09	15.81	76	11639	165633	70751096
Tarsal tunnel syndrome	28.59	15.81	8	11707	497	70916232
Purpura senile	28.50	15.81	8	11707	503	70916226
Persecutory delusion	27.80	15.81	14	11701	4503	70912226
Movement disorder	26.77	15.81	26	11689	24103	70892626
Speech disorder	26.45	15.81	37	11678	50543	70866186
Supine hypertension	26.08	15.81	7	11708	372	70916357
Deep brain stimulation	25.97	15.81	5	11710	57	70916672
Obsessive-compulsive disorder	25.52	15.81	14	11701	5356	70911373
Dementia with Lewy bodies	25.36	15.81	8	11707	753	70915976
Blood creatine phosphokinase increased	25.14	15.81	40	11675	61223	70855506
Pain	24.92	15.81	41	11674	628775	70287954
Resorption bone increased	24.28	15.81	9	11706	1376	70915353
Mesenteric artery thrombosis	23.27	15.81	7	11708	562	70916167
Vascular encephalopathy	23.10	15.81	7	11708	576	70916153
Autonomic nervous system imbalance	22.54	15.81	12	11703	4327	70912402
Obsessive-compulsive personality disorder	22.28	15.81	5	11710	125	70916604
Mania	21.91	15.81	20	11695	17154	70899575
Granulocytopenia	21.10	15.81	16	11699	10631	70906098
Peripheral swelling	20.08	15.81	7	11708	236556	70680173
Product use in unapproved indication	19.68	15.81	5	11710	207473	70709256
Aortic valve sclerosis	19.56	15.81	8	11707	1589	70915140
Coronary artery dissection	19.37	15.81	7	11708	997	70915732
Illusion	19.27	15.81	8	11707	1651	70915078
Abnormal dreams	18.97	15.81	15	11700	10588	70906141
Posture abnormal	18.83	15.81	10	11705	3586	70913143
Dysstasia	18.82	15.81	22	11693	25157	70891572
Soft tissue mass	18.82	15.81	7	11708	1081	70915648
Cerebral atrophy	18.73	15.81	13	11702	7534	70909195
Hallucinations, mixed	18.28	15.81	12	11703	6350	70910379
Sinusitis	18.28	15.81	3	11712	169192	70747537
Restlessness	17.96	15.81	28	11687	42100	70874629
Mental status changes	17.85	15.81	35	11680	63066	70853663
Psychomotor hyperactivity	17.82	15.81	17	11698	15416	70901313
Dystonia	17.79	15.81	19	11696	19687	70897042
Mitral valve disease	17.77	15.81	9	11706	2931	70913798
Joint swelling	17.56	15.81	10	11705	253201	70663528
Balance disorder	17.53	15.81	43	11672	90085	70826644
Febrile neutropenia	17.42	15.81	6	11709	204312	70712417
Pruritus	17.24	15.81	19	11696	345541	70571188
Drug intolerance	17.00	15.81	8	11707	225679	70691050
Intermittent claudication	16.86	15.81	9	11706	3264	70913465
Incoherent	16.78	15.81	12	11703	7294	70909435
Vestibular disorder	16.70	15.81	8	11707	2312	70914417
Alopecia	16.63	15.81	6	11709	198484	70718245
Reduced facial expression	16.59	15.81	8	11707	2344	70914385
Hepatic enzyme increased	16.48	15.81	3	11712	156987	70759742
Anxiety	16.43	15.81	76	11639	220254	70696475
Delusion of replacement	16.23	15.81	4	11711	151	70916578
Freezing phenomenon	16.06	15.81	7	11708	1627	70915102
Drug hypersensitivity	15.98	15.81	12	11703	262447	70654282

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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 | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Aromatic-L-amino-acid decarboxylase	Enzyme	P20711	DDC_HUMAN	INHIBITOR			CHEMBL	CHEMBL
Tyrosine-protein kinase Lck	Kinase	P06239	LCK_HUMAN		IC50	5.17	DRUG MATRIX
Tyrosine-protein kinase Fyn	Kinase	P06241	FYN_HUMAN		IC50	5.43	DRUG MATRIX
Lysine-specific demethylase 4E	Enzyme	B2RXH2	KDM4E_HUMAN		Ki	5.70	CHEMBL

External reference:

ID	Source
4017949	VUID
N0000146299	NUI
D00558	KEGG_DRUG
38821-49-7	SECONDARY_CAS_RN
2019	RXNORM
4017949	VANDF
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

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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	0378-0078	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	0378-0085	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