levodopa 🐶 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	1567	59-92-7

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
3.50	g	O
0.60	g	O
0.45	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	66 mg/mL	Bocci G, Oprea TI, Benet LZ
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:

Date	Agency	Company	Orphan
Sept. 19, 2019	EMA	Acorda Therapeutics Ireland Limited
June 4, 1970	FDA

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
Dyskinesia	439.40	15.40	184	12673	31818	63444347
Hallucination	249.79	15.40	149	12708	54668	63421497
On and off phenomenon	220.34	15.40	55	12802	1780	63474385
Muscle rigidity	187.94	15.40	75	12782	11425	63464740
Hallucination, visual	177.85	15.40	84	12773	19214	63456951
Parkinson's disease	168.93	15.40	41	12816	1178	63474987
Impulse-control disorder	159.19	15.40	36	12821	754	63475411
Freezing phenomenon	142.14	15.40	36	12821	1236	63474929
Bradykinesia	132.77	15.40	47	12810	5141	63471024
Tremor	123.86	15.40	143	12714	132096	63344069
Neuroleptic malignant syndrome	118.86	15.40	55	12802	12001	63464164
Delirium	109.65	15.40	87	12770	50454	63425711
Compulsive shopping	102.47	15.40	25	12832	734	63475431
Delusion	94.67	15.40	47	12810	11970	63464195
Pleurothotonus	92.75	15.40	26	12831	1323	63474842
Parkinsonism	82.74	15.40	41	12816	10398	63465767
Dopamine dysregulation syndrome	81.40	15.40	16	12841	164	63476001
Stereotypy	77.57	15.40	18	12839	424	63475741
Stoma site discharge	75.41	15.40	23	12834	1575	63474590
Dementia	72.51	15.40	46	12811	18748	63457417
Sudden onset of sleep	68.51	15.40	17	12840	536	63475629
Fall	67.48	15.40	203	12654	392131	63084034
Dystonia	66.60	15.40	39	12818	13780	63462385
Stoma site erythema	63.36	15.40	19	12838	1228	63474937
Gambling disorder	63.28	15.40	19	12838	1233	63474932
Akinesia	62.88	15.40	20	12837	1573	63474592
Fibroma	61.52	15.40	17	12840	820	63475345
Abnormal behaviour	60.02	15.40	43	12814	21383	63454782
Speech disorder	57.80	15.40	55	12802	40574	63435591
Torticollis	55.02	15.40	19	12838	1930	63474235
Hyperkinesia	53.54	15.40	18	12839	1686	63474479
Myoclonus	51.83	15.40	35	12822	15833	63460332
Product residue present	51.58	15.40	22	12835	3957	63472208
Gait disturbance	51.32	15.40	114	12743	183064	63293101
Dropped head syndrome	51.31	15.40	11	12846	178	63475987
Stoma site reaction	48.03	15.40	11	12846	244	63475921
Orthostatic hypotension	47.77	15.40	47	12810	36113	63440052
Therapeutic product effect variable	46.81	15.40	15	12842	1208	63474957
Joint swelling	46.08	15.40	6	12851	327660	63148505
Camptocormia	45.93	15.40	11	12846	298	63475867
Drug interaction	45.52	15.40	125	12732	229006	63247159
Rash	45.27	15.40	29	12828	560842	62915323
Confusional state	44.05	15.40	126	12731	236254	63239911
Stoma site irritation	43.74	15.40	10	12847	220	63475945
Product complaint	43.63	15.40	29	12828	12780	63463385
Reduced facial expression	43.51	15.40	16	12841	1950	63474215
Alopecia	43.33	15.40	8	12849	337528	63138637
Psychotic disorder	42.78	15.40	38	12819	25674	63450491
Ileus	42.27	15.40	30	12827	14695	63461470
Agitation	41.97	15.40	56	12801	59701	63416464
Jealous delusion	40.34	15.40	7	12850	33	63476132
Restlessness	38.37	15.40	38	12819	29415	63446750
Disorientation	37.41	15.40	43	12814	39409	63436756
Posture abnormal	37.36	15.40	15	12842	2317	63473848
Vascular encephalopathy	37.28	15.40	10	12847	431	63475734
Peripheral swelling	37.06	15.40	5	12852	265937	63210228
Dysphagia	36.71	15.40	65	12792	88520	63387645
Movement disorder	36.01	15.40	32	12825	21629	63454536
Hypersexuality	35.61	15.40	10	12847	512	63475653
Aortic valve incompetence	34.51	15.40	19	12838	5969	63470196
Somnolence	33.99	15.40	96	12761	178589	63297576
Deep brain stimulation	33.51	15.40	6	12851	35	63476130
Drug withdrawal syndrome	33.43	15.40	34	12823	27160	63449005
Stoma site pain	33.04	15.40	11	12846	999	63475166
Choking	32.76	15.40	22	12835	9857	63466308
Nasopharyngitis	32.67	15.40	6	12851	254251	63221914
Device difficult to use	32.03	15.40	24	12833	12772	63463393
Aggression	31.88	15.40	31	12826	23467	63452698
Eczema eyelids	30.66	15.40	7	12850	153	63476012
Tarsal tunnel syndrome	30.26	15.40	9	12848	565	63475600
Hypokinesia	30.21	15.40	24	12833	13912	63462253
Pruritus	30.07	15.40	18	12839	361435	63114730
Device issue	29.72	15.40	30	12827	23751	63452414
Headache	29.53	15.40	52	12805	633189	62842976
Ketonuria	29.12	15.40	9	12848	644	63475521
Swelling	28.66	15.40	10	12847	275368	63200797
Paranoia	27.24	15.40	21	12836	11658	63464507
Pain	26.89	15.40	70	12787	740558	62735607
Heat stroke	26.81	15.40	9	12848	839	63475326
Tension	26.74	15.40	13	12844	3162	63473003
Abdominal discomfort	26.65	15.40	16	12841	320869	63155296
Oromandibular dystonia	26.65	15.40	8	12849	519	63475646
Hypersensitivity	26.63	15.40	13	12844	292672	63183493
Cerebral atrophy	26.27	15.40	15	12842	5051	63471114
Wrong product administered	26.13	15.40	16	12841	6125	63470040
Purpura senile	26.12	15.40	8	12849	555	63475610
Device use issue	25.92	15.40	12	12845	2618	63473547
Glossodynia	25.79	15.40	3	12854	178873	63297292
Parkinsonism hyperpyrexia syndrome	25.63	15.40	6	12851	147	63476018
Hepatic enzyme increased	25.51	15.40	5	12852	202323	63273842
Hallucination, auditory	25.50	15.40	21	12836	12803	63463362
Arthropathy	25.35	15.40	8	12849	234784	63241381
Anxiety	25.33	15.40	99	12758	217442	63258723
Blood creatine phosphokinase increased	25.27	15.40	31	12826	30399	63445766
Rheumatoid arthritis	25.10	15.40	10	12847	253809	63222356
Drug hypersensitivity	25.10	15.40	16	12841	310671	63165494
Coma	25.09	15.40	46	12811	64318	63411847
Psychomotor hyperactivity	24.49	15.40	19	12838	10644	63465521
Diarrhoea	24.18	15.40	70	12787	715296	62760869
Depressed level of consciousness	23.73	15.40	44	12813	62034	63414131
Resorption bone increased	23.23	15.40	9	12848	1265	63474900
Resting tremor	23.14	15.40	8	12849	815	63475350
Delusion of parasitosis	22.54	15.40	4	12853	22	63476143
Vestibular disorder	22.22	15.40	9	12848	1422	63474743
Cognitive disorder	21.89	15.40	40	12817	55775	63420390
Exposure during pregnancy	21.48	15.40	3	12854	155544	63320621
Retroperitoneal fibrosis	21.44	15.40	6	12851	303	63475862
Product use issue	21.29	15.40	9	12848	220511	63255654
Infection	21.11	15.40	10	12847	229163	63247002
Therapeutic response shortened	20.63	15.40	18	12839	11870	63464295
Orthostatic intolerance	20.22	15.40	8	12849	1189	63474976
Application site reaction	19.97	15.40	7	12850	743	63475422
Labelled drug-disease interaction issue	19.85	15.40	4	12853	47	63476118
Cogwheel rigidity	19.45	15.40	9	12848	1961	63474204
Treatment failure	19.41	15.40	8	12849	199035	63277130
Off label use	19.30	15.40	71	12786	674391	62801774
Coronary artery dissection	19.02	15.40	7	12850	855	63475310
Product administration error	18.89	15.40	23	12834	22374	63453791
Progressive supranuclear palsy	18.82	15.40	4	12853	62	63476103
Device occlusion	18.81	15.40	14	12843	7373	63468792
Balance disorder	18.69	15.40	48	12809	84374	63391791
Cross sensitivity reaction	18.65	15.40	9	12848	2153	63474012
Wound	18.65	15.40	5	12852	163258	63312907
Hypophagia	18.51	15.40	27	12830	31232	63444933
Abnormal dreams	18.40	15.40	16	12841	10500	63465665
Parkinsonian gait	18.37	15.40	6	12851	513	63475652
Fatigue	18.02	15.40	106	12751	887922	62588243
Nasal mucosal discolouration	17.69	15.40	3	12854	12	63476153
Tongue necrosis	17.69	15.40	3	12854	12	63476153
Withdrawal syndrome	17.63	15.40	21	12836	19976	63456189
Completed suicide	17.53	15.40	4	12853	145669	63330496
Yawning	17.48	15.40	7	12850	1073	63475092
Urticaria	17.27	15.40	6	12851	165796	63310369
Bradyphrenia	17.26	15.40	13	12844	6967	63469198
Lower respiratory tract infection	17.25	15.40	3	12854	132304	63343861
Ammonia increased	16.97	15.40	11	12846	4645	63471520
Nuchal rigidity	16.88	15.40	6	12851	663	63475502
Stoma site hypergranulation	16.76	15.40	5	12852	317	63475848
Drug intolerance	16.57	15.40	23	12834	308638	63167527
Pneumonia aspiration	16.48	15.40	27	12830	34513	63441652
Stomatitis	16.32	15.40	4	12853	138721	63337444
Dysarthria	15.98	15.40	30	12827	42681	63433484
Serotonin syndrome	15.87	15.40	24	12833	28658	63447507
Erysipelas	15.83	15.40	13	12844	7892	63468273
Obsessive-compulsive disorder	15.81	15.40	10	12847	4050	63472115
Kleptomania	15.71	15.40	3	12854	26	63476139
Loss of consciousness	15.60	15.40	56	12801	118065	63358100

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
Dyskinesia	428.88	15.06	197	13283	22216	34921235
Gambling disorder	361.03	15.06	91	13389	1569	34941882
On and off phenomenon	310.58	15.06	88	13392	2409	34941042
Hypersexuality	286.13	15.06	74	13406	1419	34942032
Hallucination	271.45	15.06	195	13285	51303	34892148
Dopamine dysregulation syndrome	267.05	15.06	56	13424	400	34943051
Impulse-control disorder	232.48	15.06	61	13419	1240	34942211
Parkinson's disease	203.65	15.06	56	13424	1368	34942083
Muscle rigidity	202.67	15.06	93	13387	10425	34933026
Hallucination, visual	156.57	15.06	93	13387	17698	34925753
Neuroleptic malignant syndrome	130.39	15.06	83	13397	17851	34925600
Fall	126.90	15.06	256	13224	202629	34740822
Bradykinesia	123.38	15.06	49	13431	3844	34939607
Akinesia	123.10	15.06	42	13438	2142	34941309
Freezing phenomenon	120.77	15.06	38	13442	1498	34941953
Tremor	92.23	15.06	135	13345	82452	34860999
Gambling	85.16	15.06	19	13461	187	34943264
Dementia	81.41	15.06	56	13424	13692	34929759
Delusion	78.46	15.06	53	13427	12582	34930869
Sudden onset of sleep	77.47	15.06	20	13460	380	34943071
Orthostatic hypotension	72.51	15.06	68	13412	25851	34917600
Abnormal behaviour	70.79	15.06	66	13414	24903	34918548
Confusional state	70.55	15.06	165	13315	143995	34799456
Parkinsonism	70.14	15.06	42	13438	8096	34935355
Psychotic disorder	70.03	15.06	65	13415	24387	34919064
Gait disturbance	67.35	15.06	119	13361	85021	34858430
Dysphagia	65.33	15.06	99	13381	62282	34881169
Therapeutic product effect variable	61.10	15.06	26	13454	2430	34941021
Delirium	59.64	15.06	79	13401	43912	34899539
Obsessive-compulsive disorder	59.37	15.06	33	13447	5531	34937920
Compulsive shopping	58.28	15.06	16	13464	388	34943063
Jealous delusion	57.47	15.06	15	13465	298	34943153
Dystonia	54.55	15.06	40	13440	10805	34932646
Paraphilia	53.41	15.06	11	13469	71	34943380
Agitation	53.01	15.06	86	13394	57313	34886138
Stoma site discharge	51.86	15.06	19	13461	1194	34942257
Saliva discolouration	50.35	15.06	9	13471	23	34943428
Reduced facial expression	50.04	15.06	18	13462	1073	34942378
Aggression	49.80	15.06	68	13412	38896	34904555
Diarrhoea	47.94	15.06	48	13432	389864	34553587
Hyperkinesia	44.92	15.06	19	13461	1749	34941702
Somnolence	43.58	15.06	117	13363	110999	34832452
Binge eating	43.24	15.06	10	13470	117	34943334
Stoma site erythema	42.64	15.06	15	13465	838	34942613
Device use issue	42.49	15.06	14	13466	640	34942811
Off label use	41.66	15.06	61	13419	419463	34523988
Fibroma	40.77	15.06	12	13468	376	34943075
Postural reflex impairment	38.74	15.06	6	13474	3	34943448
Febrile neutropenia	38.54	15.06	4	13476	136845	34806606
Embedded device	38.15	15.06	11	13469	320	34943131
Restlessness	38.02	15.06	48	13432	25434	34918017
Phlebitis infective	37.77	15.06	9	13471	121	34943330
Cognitive disorder	36.54	15.06	50	13430	28643	34914808
Product cleaning inadequate	36.09	15.06	6	13474	8	34943443
Posture abnormal	34.54	15.06	17	13463	2222	34941229
Mobility decreased	33.19	15.06	49	13431	30079	34913372
Persecutory delusion	32.26	15.06	17	13463	2563	34940888
Compulsions	32.22	15.06	9	13471	233	34943218
Therapeutic response shortened	32.12	15.06	25	13455	7379	34936072
Impulsive behaviour	32.11	15.06	16	13464	2146	34941305
Marital problem	32.04	15.06	7	13473	62	34943389
Compulsive sexual behaviour	31.89	15.06	9	13471	242	34943209
Libido increased	31.52	15.06	12	13468	839	34942612
Obsessive-compulsive personality disorder	31.08	15.06	8	13472	150	34943301
Pleurothotonus	30.78	15.06	13	13467	1192	34942259
Abnormal dreams	29.48	15.06	24	13456	7554	34935897
Hypertonia	29.23	15.06	19	13461	4227	34939224
Stereotypy	29.20	15.06	11	13469	747	34942704
Speech disorder	28.62	15.06	42	13438	25644	34917807
Pneumonia aspiration	27.37	15.06	54	13426	41849	34901602
Apathy	27.06	15.06	22	13458	6910	34936541
Motor dysfunction	26.94	15.06	22	13458	6952	34936499
Device dislocation	26.89	15.06	21	13459	6228	34937223
Deep brain stimulation	26.68	15.06	5	13475	18	34943433
Tension	26.25	15.06	14	13466	2161	34941290
Camptocormia	25.89	15.06	7	13473	160	34943291
Product residue present	25.83	15.06	15	13465	2731	34940720
Aortic valve incompetence	25.75	15.06	20	13460	5884	34937567
Stoma site irritation	25.33	15.06	7	13473	174	34943277
Device difficult to use	25.08	15.06	15	13465	2882	34940569
Balance disorder	24.89	15.06	51	13429	40603	34902848
Device issue	24.21	15.06	24	13456	9753	34933698
Platelet count decreased	24.20	15.06	8	13472	119709	34823742
Autonomic nervous system imbalance	24.17	15.06	14	13466	2537	34940914
Product complaint	23.64	15.06	19	13461	5871	34937580
Disorientation	23.17	15.06	44	13436	33144	34910307
Pruritus	23.12	15.06	13	13467	141968	34801483
Movement disorder	23.09	15.06	26	13454	12222	34931229
Hyperthermia	22.63	15.06	24	13456	10553	34932898
Depression	22.21	15.06	85	13395	97013	34846438
Wrong technique in device usage process	21.90	15.06	11	13469	1501	34941950
Sleep attacks	21.83	15.06	6	13474	146	34943305
Parkinsonian gait	21.60	15.06	8	13472	518	34942933
Illusion	21.38	15.06	9	13471	818	34942633
Neutropenia	20.72	15.06	18	13462	156760	34786691
Supine hypertension	20.60	15.06	7	13473	352	34943099
Product packaging difficult to open	20.58	15.06	3	13477	0	34943451
Extrapyramidal disorder	20.38	15.06	25	13455	12855	34930596
Device occlusion	19.90	15.06	18	13462	6527	34936924
Choking	19.75	15.06	16	13464	4999	34938452
Anxiety	19.52	15.06	83	13397	99345	34844106
Malignant neoplasm progression	19.41	15.06	5	13475	88041	34855410
Syncope	19.25	15.06	78	13402	91373	34852078
Mesenteric artery thrombosis	19.07	15.06	7	13473	442	34943009
Drug withdrawal syndrome	18.67	15.06	30	13450	19804	34923647
Dependence	18.54	15.06	9	13471	1141	34942310
Listless	18.41	15.06	10	13470	1602	34941849
Stoma site inflammation	18.33	15.06	7	13473	494	34942957
Pancytopenia	18.13	15.06	7	13473	95150	34848301
Formication	17.80	15.06	10	13470	1709	34941742
Economic problem	17.45	15.06	9	13471	1298	34942153
Psychomotor hyperactivity	17.41	15.06	20	13460	9602	34933849
Memory impairment	17.33	15.06	46	13434	43272	34900179
Micrographia	17.29	15.06	3	13477	6	34943445
Progressive supranuclear palsy	17.13	15.06	4	13476	49	34943402
Paranoia	16.84	15.06	22	13458	12046	34931405
Arthralgia	16.53	15.06	25	13455	170016	34773435
Hyperreflexia	16.51	15.06	12	13468	3194	34940257
Clonus	15.80	15.06	11	13469	2739	34940712
Chorea	15.67	15.06	8	13472	1129	34942322
Torticollis	15.56	15.06	8	13472	1146	34942305
Obsessive thoughts	15.55	15.06	7	13473	748	34942703
Acute kidney injury	15.39	15.06	63	13417	304925	34638526
Blood creatine phosphokinase increased	15.35	15.06	45	13435	44812	34898639
Drug hypersensitivity	15.21	15.06	6	13474	80523	34862928
Sleep disorder	15.14	15.06	36	13444	31652	34911799
Condition aggravated	15.08	15.06	126	13354	192070	34751381

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
Dyskinesia	645.48	14.36	284	19794	44489	79679821
On and off phenomenon	386.76	14.36	101	19977	3139	79721171
Hallucination	385.22	14.36	250	19828	85495	79638815
Dopamine dysregulation syndrome	326.70	14.36	63	20015	454	79723856
Impulse-control disorder	325.29	14.36	78	20000	1696	79722614
Muscle rigidity	305.34	14.36	132	19946	19750	79704560
Gambling disorder	289.98	14.36	73	20005	1953	79722357
Hallucination, visual	282.40	14.36	146	19932	32583	79691727
Hypersexuality	272.90	14.36	67	20011	1613	79722697
Parkinson's disease	268.19	14.36	66	20012	1605	79722705
Neuroleptic malignant syndrome	249.50	14.36	127	19951	27432	79696878
Bradykinesia	205.31	14.36	77	20001	7966	79716344
Akinesia	172.12	14.36	54	20024	3258	79721052
Tremor	144.01	14.36	195	19883	169888	79554422
Delusion	142.11	14.36	79	19999	20344	79703966
Parkinsonism	137.31	14.36	72	20006	16512	79707798
Freezing phenomenon	137.28	14.36	40	20038	1874	79722436
Dementia	128.28	14.36	79	19999	24580	79699730
Fall	127.21	14.36	337	19741	487292	79237018
Compulsive shopping	124.74	14.36	31	20047	785	79723525
Pleurothotonus	118.25	14.36	38	20040	2478	79721832
Dystonia	117.57	14.36	71	20007	21328	79702982
Delirium	115.96	14.36	124	19954	84503	79639807
Abnormal behaviour	106.95	14.36	82	19996	36339	79687971
Therapeutic product effect variable	97.11	14.36	31	20047	1978	79722332
Agitation	96.21	14.36	122	19956	99593	79624717
Orthostatic hypotension	94.58	14.36	92	19986	56072	79668238
Confusional state	88.08	14.36	225	19853	317772	79406538
Reduced facial expression	83.62	14.36	30	20048	2735	79721575
Sudden onset of sleep	81.31	14.36	21	20057	623	79723687
Hyperkinesia	80.24	14.36	29	20049	2700	79721610
Gait disturbance	78.47	14.36	166	19912	207340	79516970
Psychotic disorder	77.66	14.36	72	20006	41330	79682980
Torticollis	76.35	14.36	27	20051	2360	79721950
Gambling	75.16	14.36	17	20061	283	79724027
Stereotypy	73.34	14.36	21	20057	924	79723386
Aggression	70.35	14.36	75	20003	50883	79673427
Jealous delusion	68.26	14.36	16	20062	314	79723996
Camptocormia	66.94	14.36	17	20061	471	79723839
Dysphagia	64.99	14.36	113	19965	122023	79602287
Speech disorder	64.57	14.36	74	20004	54371	79669939
Aortic valve incompetence	61.23	14.36	35	20043	9495	79714815
Diarrhoea	60.65	14.36	80	19998	880409	78843901
Drug withdrawal syndrome	58.67	14.36	57	20021	34661	79689649
Posture abnormal	57.13	14.36	25	20053	3841	79720469
Stoma site discharge	55.82	14.36	21	20057	2188	79722122
Restlessness	54.80	14.36	63	20015	46429	79677881
Somnolence	53.98	14.36	157	19921	238824	79485486
Therapeutic response shortened	53.90	14.36	39	20039	15824	79708486
Paraphilia	53.87	14.36	10	20068	57	79724253
Deep brain stimulation	53.29	14.36	10	20068	61	79724249
Binge eating	51.84	14.36	14	20064	495	79723815
Persecutory delusion	48.44	14.36	24	20054	4885	79719425
Obsessive-compulsive disorder	46.97	14.36	25	20053	5902	79718408
Drug interaction	45.61	14.36	216	19862	414967	79309343
Device use issue	44.41	14.36	19	20059	2765	79721545
Postural reflex impairment	44.40	14.36	7	20071	11	79724299
Fibroma	44.04	14.36	14	20064	881	79723429
Product residue present	43.14	14.36	20	20058	3516	79720794
Blood creatine phosphokinase increased	43.03	14.36	67	20011	66023	79658287
Joint swelling	42.94	14.36	10	20068	288636	79435674
Disorientation	42.78	14.36	65	20013	62711	79661599
Pneumonia aspiration	42.36	14.36	67	20011	66900	79657410
Off label use	41.42	14.36	106	19972	907109	78817201
Pruritus	41.41	14.36	24	20054	394624	79329686
Peripheral swelling	40.79	14.36	9	20069	269608	79454702
Ileus	38.70	14.36	40	20038	26171	79698139
Febrile neutropenia	38.60	14.36	6	20072	230993	79493317
Sinusitis	37.88	14.36	3	20075	195498	79528812
Impulsive behaviour	37.25	14.36	17	20061	2883	79721427
Product complaint	36.87	14.36	29	20049	13320	79710990
Rash	36.30	14.36	56	20022	578302	79146008
Pain	36.28	14.36	77	20001	703725	79020585
Cognitive disorder	36.26	14.36	64	20014	69862	79654448
Progressive supranuclear palsy	36.15	14.36	8	20070	120	79724190
Parkinsonism hyperpyrexia syndrome	35.80	14.36	9	20069	239	79724071
Movement disorder	35.65	14.36	39	20039	27220	79697090
Apathy	35.43	14.36	28	20050	12949	79711361
Stoma site erythema	34.84	14.36	14	20064	1739	79722571
Cerebral atrophy	34.84	14.36	23	20055	8052	79716258
Drug hypersensitivity	34.58	14.36	16	20062	298900	79425410
Myoclonus	33.47	14.36	38	20040	27622	79696688
Dropped head syndrome	32.93	14.36	9	20069	333	79723977
Tricuspid valve incompetence	32.62	14.36	32	20046	19680	79704630
Alopecia	32.50	14.36	9	20069	231346	79492964
Headache	32.46	14.36	73	20005	653699	79070611
Autonomic nervous system imbalance	32.44	14.36	18	20060	4612	79719698
Hypertonia	32.18	14.36	21	20057	7211	79717099
Vascular encephalopathy	31.71	14.36	10	20068	613	79723697
Abdominal discomfort	31.27	14.36	12	20066	250715	79473595
Serotonin syndrome	31.21	14.36	47	20031	44980	79679330
Paranoia	31.14	14.36	31	20047	19401	79704909
Product cleaning inadequate	30.95	14.36	5	20073	10	79724300
Urticaria	30.51	14.36	5	20073	185196	79539114
Stoma site pain	30.22	14.36	12	20066	1446	79722864
Oromandibular dystonia	30.20	14.36	11	20067	1047	79723263
Anxiety	29.98	14.36	133	19945	248379	79475931
Stoma site irritation	29.90	14.36	8	20070	273	79724037
Resting tremor	29.72	14.36	12	20066	1509	79722801
Rheumatoid arthritis	29.49	14.36	8	20070	208462	79515848
Contraindicated product administered	28.95	14.36	3	20075	157535	79566775
Tarsal tunnel syndrome	28.94	14.36	9	20069	527	79723783
Fatigue	28.50	14.36	129	19949	929598	78794712
Hypokinesia	27.98	14.36	29	20049	19031	79705279
Eczema eyelids	27.91	14.36	7	20071	184	79724126
Mitral valve incompetence	27.59	14.36	35	20043	28530	79695780
Hyperthermia	27.49	14.36	28	20050	18009	79706301
Nasopharyngitis	27.24	14.36	15	20063	253866	79470444
Stoma site reaction	26.95	14.36	8	20070	400	79723910
Compulsions	26.95	14.36	8	20070	400	79723910
Withdrawal syndrome	26.09	14.36	33	20045	26821	79697489
Hepatic enzyme increased	25.84	14.36	7	20071	182603	79541707
Extrapyramidal disorder	25.49	14.36	30	20048	22649	79701661
Psychomotor hyperactivity	25.39	14.36	26	20052	16823	79707487
Obsessive-compulsive personality disorder	25.08	14.36	6	20072	129	79724181
Drug intolerance	25.04	14.36	18	20060	264101	79460209
Purpura senile	24.88	14.36	8	20070	522	79723788
Motor dysfunction	24.53	14.36	24	20054	14709	79709601
Parkinsonian gait	23.91	14.36	9	20069	939	79723371
Arthralgia	23.63	14.36	70	20008	571733	79152577
Swelling	22.96	14.36	13	20065	216698	79507612
Retroperitoneal fibrosis	22.78	14.36	8	20070	685	79723625
Hyperreflexia	22.69	14.36	18	20060	8367	79715943
Choking	22.59	14.36	21	20057	12080	79712230
Supine hypertension	22.39	14.36	7	20071	417	79723893
Syncope	22.36	14.36	97	19981	179352	79544958
Depressed level of consciousness	22.26	14.36	64	20014	96588	79627722
Hypersensitivity	22.19	14.36	20	20058	262219	79462091
Delusion of parasitosis	22.16	14.36	4	20074	19	79724291
Marital problem	22.06	14.36	6	20072	218	79724092
Mania	21.94	14.36	25	20053	18235	79706075
Ketonuria	21.79	14.36	9	20069	1199	79723111
Abnormal dreams	21.69	14.36	20	20058	11392	79712918
Saliva discolouration	21.53	14.36	5	20073	94	79724216
Aortic valve sclerosis	21.50	14.36	10	20068	1770	79722540
Chorea	21.45	14.36	11	20067	2406	79721904
Kleptomania	21.23	14.36	4	20074	25	79724285
Dementia with Lewy bodies	21.22	14.36	8	20070	838	79723472
Arthropathy	21.22	14.36	9	20069	177102	79547208
Infection	20.98	14.36	18	20060	241694	79482616
Dysarthria	20.92	14.36	50	20028	67572	79656738
Device difficult to use	20.80	14.36	21	20057	13364	79710946
Orthostatic intolerance	20.76	14.36	10	20068	1914	79722396
Pancytopenia	20.55	14.36	8	20070	165737	79558573
Balance disorder	20.43	14.36	63	20015	98794	79625516
Tension	20.11	14.36	13	20065	4391	79719919
Stomatitis	20.07	14.36	6	20072	146751	79577559
Resorption bone increased	20.06	14.36	9	20069	1466	79722844
Device issue	19.79	14.36	29	20049	27079	79697231
Granulocytopenia	19.74	14.36	19	20059	11412	79712898
Mesenteric artery thrombosis	19.54	14.36	7	20071	635	79723675
Intentional product use issue	19.43	14.36	7	20071	152105	79572205
Product packaging difficult to open	19.06	14.36	4	20074	46	79724264
Stoma site inflammation	18.99	14.36	7	20071	689	79723621
Product use issue	18.98	14.36	15	20063	209807	79514503
Labelled drug-disease interaction issue	18.98	14.36	4	20074	47	79724263
Cogwheel rigidity	18.93	14.36	11	20067	3077	79721233
Delusion of replacement	18.88	14.36	5	20073	164	79724146
Heat stroke	18.83	14.36	9	20069	1694	79722616
Platelet count decreased	18.79	14.36	13	20065	194651	79529659
Illusion	18.64	14.36	9	20069	1732	79722578
Formication	18.56	14.36	13	20065	5010	79719300
Sleep attacks	18.43	14.36	5	20073	180	79724130
Lower respiratory tract infection	18.19	14.36	5	20073	129215	79595095
Electrocardiogram J wave	18.07	14.36	4	20074	60	79724250
Femoral neck fracture	18.01	14.36	17	20061	9967	79714343
Hallucination, auditory	17.88	14.36	24	20054	20669	79703641
Asthma	17.62	14.36	6	20072	135089	79589221
Dermatillomania	17.57	14.36	5	20073	215	79724095
Yawning	17.52	14.36	8	20070	1358	79722952
Medical device site scab	17.47	14.36	3	20075	10	79724300
Libido increased	17.45	14.36	9	20069	1992	79722318
Treatment failure	16.97	14.36	11	20067	170475	79553835
Pyrexia	16.90	14.36	101	19977	678608	79045702
Pericarditis	16.75	14.36	3	20075	104233	79620077
Listless	16.66	14.36	11	20067	3850	79720460
Oral discomfort	16.44	14.36	16	20062	9744	79714566
Device dislocation	16.44	14.36	26	20052	25944	79698366
Malignant neoplasm progression	16.15	14.36	7	20071	135983	79588327
Exposure during pregnancy	16.06	14.36	3	20075	101129	79623181
Mitral valve disease	16.00	14.36	10	20068	3187	79721123
Mobility decreased	15.95	14.36	67	20011	122108	79602202
Ballismus	15.94	14.36	5	20073	301	79724009
Hypomania	15.87	14.36	14	20064	7530	79716780
Nuchal rigidity	15.86	14.36	7	20071	1097	79723213
Product physical issue	15.86	14.36	11	20067	4174	79720136
Vestibular disorder	15.73	14.36	9	20069	2446	79721864
Obsessive thoughts	15.69	14.36	7	20071	1125	79723185
Incoherent	15.63	14.36	14	20064	7678	79716632
Coronary artery dissection	15.62	14.36	7	20071	1137	79723173
Device occlusion	15.55	14.36	17	20061	11849	79712461
Wound	15.43	14.36	5	20073	116174	79608136
Dyspnoea	15.36	14.36	140	19938	856885	78867425
Gallbladder necrosis	15.08	14.36	4	20074	132	79724178
Subileus	15.01	14.36	12	20066	5642	79718668
Sudden death	14.89	14.36	23	20055	22488	79701822
Soft tissue mass	14.83	14.36	7	20071	1281	79723029
Cross sensitivity reaction	14.64	14.36	10	20068	3702	79720608
Gait inability	14.53	14.36	40	20038	58877	79665433
Urinary retention	14.52	14.36	39	20039	56591	79667719

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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|

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
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 level	Dissociation constant	Type (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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
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
25MG;100MG	DHIVY	AVION PHARMS	N214869	Nov. 12, 2021	RX	TABLET	ORAL	11439613	March 28, 2039	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND SYMPTOMATIC PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
D(1A) dopamine receptor	GPCR	P21728	DRD1_HUMAN	AGONIST			WOMBAT-PK	SCIENTIFIC LITERATURE
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN	AGONIST			WOMBAT-PK	SCIENTIFIC LITERATURE
Tyrosine-protein kinase Lck	Kinase	P06239	LCK_HUMAN		IC50	5.43	DRUG MATRIX
Large neutral amino acids transporter small subunit 1	Transporter	Q01650	LAT1_HUMAN		IC50	4	CHEMBL
Tyrosine-protein kinase Fyn	Kinase	P06241	FYN_HUMAN		IC50	5.67	DRUG MATRIX
Epidermal growth factor receptor	Kinase	P00533	EGFR_HUMAN		IC50	5.54	DRUG MATRIX
Arachidonate 15-lipoxygenase	Enzyme		LOX15_RABIT		IC50	5.65	DRUG MATRIX

External reference:

ID	Source
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
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
C0013030	UMLSCUI
DB00988	DRUGBANK_ID
2417	INN_ID
D004298	MESH_DESCRIPTOR_UI
681	PUBCHEM_CID

Pharmaceutical products:

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