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

Stem definition	Drug id	CAS RN
dopamine receptor agonists, ergoline derivatives	2407	99755-59-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: rotigotine neupro leganto (S)-(-)-Rotigotine	Rotigotine is a non-ergoline dopamine agonist. The precise mechanism of action of rotigotine as a treatment for Parkinson's disease is unknown, although it is thought to be related to its ability to stimulate dopamine receptors within the caudate-putamen in the brain. The precise mechanism of action of rotigotine as a treatment for Restless Legs Syndrome is unknown but is thought to be related to its ability to stimulate dopamine receptors. Molecular weight: 315.48 Formula: C19H25NOS CLOGP: 4.54 LIPINSKI: 0 HAC: 2 HDO: 1 TPSA: 23.47 ALOGS: -4.54 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

rotigotine
neupro
leganto
(S)-(-)-Rotigotine

Rotigotine is a non-ergoline dopamine agonist. The precise mechanism of action of rotigotine as a treatment for Parkinson's disease is unknown, although it is thought to be related to its ability to stimulate dopamine receptors within the caudate-putamen in the brain. The precise mechanism of action of rotigotine as a treatment for Restless Legs Syndrome is unknown but is thought to be related to its ability to stimulate dopamine receptors.

Molecular weight: 315.48
Formula: C19H25NOS
CLOGP: 4.54
LIPINSKI: 0
HAC: 2
HDO: 1
TPSA: 23.47
ALOGS: -4.54
ROTB: 6

Status: OFP

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

Drug dosage:

Dose	Unit	Route
6	mg	TD

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	5.60 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.36 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	5.70 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	37 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.08 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	4 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
May 9, 2007	FDA	UCB INC

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	234.00	20.74	98	6752	31904	63450268
Product adhesion issue	222.16	20.74	59	6791	4660	63477512
On and off phenomenon	172.65	20.74	40	6810	1795	63480377
Application site pruritus	146.42	20.74	41	6809	3943	63478229
Stoma site pain	122.00	20.74	27	6823	983	63481189
Application site erythema	121.30	20.74	37	6813	4798	63477374
Device adhesion issue	114.87	20.74	36	6814	5105	63477067
Hallucination	114.18	20.74	72	6778	54745	63427427
Stoma site discharge	104.64	20.74	26	6824	1572	63480600
Fall	90.77	20.74	156	6694	392178	63089994
Muscle rigidity	86.57	20.74	36	6814	11464	63470708
Stoma site erythema	85.23	20.74	21	6829	1226	63480946
Freezing phenomenon	79.80	20.74	20	6830	1252	63480920
Tremor	79.54	20.74	84	6766	132155	63350017
Hallucination, visual	74.54	20.74	38	6812	19260	63462912
Dysphagia	69.39	20.74	65	6785	88520	63393652
Nocturia	66.42	20.74	27	6823	8114	63474058
Dopamine dysregulation syndrome	65.15	20.74	12	6838	168	63482004
Choking	64.63	20.74	28	6822	9851	63472321
Application site reaction	63.43	20.74	15	6835	735	63481437
Stoma site inflammation	58.55	20.74	13	6837	480	63481692
Dropped head syndrome	58.23	20.74	11	6839	178	63481994
Stoma site hypergranulation	58.18	20.74	12	6838	310	63481862
Orthostatic intolerance	56.47	20.74	15	6835	1182	63480990
Bradykinesia	55.71	20.74	21	6829	5167	63477005
Stoma site extravasation	52.28	20.74	11	6839	314	63481858
Therapeutic response shortened	50.57	20.74	25	6825	11863	63470309
Decreased interest	49.33	20.74	17	6833	3237	63478935
Loss of consciousness	47.43	20.74	61	6789	118060	63364112
Anosmia	46.70	20.74	20	6830	6840	63475332
Micturition urgency	46.27	20.74	22	6828	9589	63472583
Application site vesicles	44.76	20.74	13	6837	1422	63480750
Stoma site infection	42.26	20.74	11	6839	801	63481371
Oromandibular dystonia	41.76	20.74	10	6840	517	63481655
Drug dose titration not performed	41.43	20.74	10	6840	535	63481637
Sleep talking	40.03	20.74	11	6839	985	63481187
Somnolence	38.44	20.74	69	6781	178616	63303556
Compulsive shopping	38.14	20.74	10	6840	749	63481423
Middle insomnia	37.81	20.74	21	6829	12622	63469550
Application site rash	37.67	20.74	13	6837	2485	63479687
Nightmare	36.91	20.74	24	6826	19170	63463002
Sudden onset of sleep	36.21	20.74	9	6841	544	63481628
Delusion	36.04	20.74	20	6830	11997	63470175
Gait disturbance	35.96	20.74	68	6782	183110	63299062
Drooling	35.61	20.74	14	6836	3854	63478318
Akinesia	34.93	20.74	11	6839	1582	63480590
Depressed mood	34.36	20.74	31	6819	40160	63442012
Pneumonia aspiration	34.28	20.74	29	6821	34511	63447661
Application site irritation	33.91	20.74	11	6839	1739	63480433
Impulse-control disorder	33.03	20.74	9	6841	781	63481391
Product prescribing error	32.28	20.74	25	6825	26264	63455908
Gastrointestinal motility disorder	31.82	20.74	14	6836	5105	63477067
Antidiuretic hormone abnormality	31.55	20.74	5	6845	26	63482146
Wrong technique in product usage process	31.18	20.74	36	6814	62304	63419868
Dermatitis contact	29.45	20.74	17	6833	10991	63471181
Ageusia	28.46	20.74	18	6832	13710	63468462
Weight abnormal	28.30	20.74	9	6841	1335	63480837
Disturbance in attention	27.92	20.74	27	6823	38162	63444010
Sexual dysfunction	27.35	20.74	12	6838	4347	63477825
Anxiety	26.89	20.74	67	6783	217474	63264698
Hyperkinesia	26.21	20.74	9	6841	1695	63480477
Dystonia	25.88	20.74	17	6833	13802	63468370
Reduced facial expression	24.95	20.74	9	6841	1957	63480215
Altered state of consciousness	24.65	20.74	21	6829	25209	63456963
Device dislocation	24.31	20.74	21	6829	25684	63456488
Psychotic disorder	24.31	20.74	21	6829	25691	63456481
Device issue	23.66	20.74	20	6830	23761	63458411
Posture abnormal	23.45	20.74	9	6841	2323	63479849
Diarrhoea	23.09	20.74	26	6824	715340	62766832
Speech disorder	22.94	20.74	25	6825	40604	63441568
Joint swelling	22.71	20.74	4	6846	327662	63154510
Panic attack	22.67	20.74	19	6831	22312	63459860
Application site dermatitis	22.61	20.74	5	6845	181	63481991
Panic disorder	22.39	20.74	9	6841	2624	63479548
Constipation	21.48	20.74	63	6787	224880	63257292
Device occlusion	21.35	20.74	12	6838	7375	63474797
Application site hypersensitivity	21.28	20.74	5	6845	238	63481934
Device kink	20.92	20.74	8	6842	2046	63480126

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
On and off phenomenon	353.54	22.39	87	7706	2410	34946728
Hallucination	266.50	22.39	157	7636	51341	34897797
Dyskinesia	232.70	22.39	109	7684	22304	34926834
Freezing phenomenon	189.75	22.39	48	7745	1488	34947650
Impulse-control disorder	162.40	22.39	41	7752	1260	34947878
Product adhesion issue	153.99	22.39	41	7752	1559	34947579
Hallucination, visual	140.98	22.39	72	7721	17719	34931419
Stoma site discharge	135.56	22.39	35	7758	1178	34947960
Bradykinesia	110.37	22.39	39	7754	3854	34945284
Muscle rigidity	105.48	22.39	50	7743	10468	34938670
Stoma site erythema	92.34	22.39	24	7769	829	34948309
Delusion	91.06	22.39	48	7745	12587	34936551
Device dislocation	89.11	22.39	38	7755	6211	34942927
Application site erythema	88.15	22.39	29	7764	2307	34946831
Application site reaction	87.17	22.39	20	7773	405	34948733
Application site pruritus	84.29	22.39	25	7768	1412	34947726
Hypersexuality	83.35	22.39	25	7768	1468	34947670
Mobility decreased	80.49	22.39	61	7732	30067	34919071
Choking	79.89	22.39	33	7760	4982	34944156
Dysphagia	74.16	22.39	80	7713	62301	34886837
Fall	73.36	22.39	148	7645	202737	34746401
Poor quality sleep	70.00	22.39	35	7758	8221	34940917
Tremor	69.97	22.39	89	7704	82498	34866640
Stoma site pain	68.05	22.39	18	7775	666	34948472
Stoma site inflammation	63.56	22.39	16	7777	485	34948653
Nocturia	63.00	22.39	35	7758	10175	34938963
Middle insomnia	61.12	22.39	30	7763	6772	34942366
Dystonia	61.03	22.39	35	7758	10810	34938328
Akinesia	58.56	22.39	21	7772	2163	34946975
Sleep talking	57.46	22.39	15	7778	527	34948611
Micturition urgency	56.31	22.39	28	7765	6497	34942641
Device occlusion	56.23	22.39	28	7765	6517	34942621
Device kink	55.88	22.39	14	7779	416	34948722
Stoma site hypergranulation	55.62	22.39	12	7781	181	34948957
Balance disorder	55.19	22.39	56	7737	40598	34908540
Anosmia	52.54	22.39	23	7770	4001	34945137
Initial insomnia	51.26	22.39	21	7772	3103	34946035
Application site rash	50.65	22.39	15	7778	842	34948296
Memory impairment	50.47	22.39	55	7738	43263	34905875
Gastrointestinal motility disorder	48.02	22.39	19	7774	2565	34946573
Posture abnormal	47.05	22.39	18	7775	2221	34946917
Pneumonia aspiration	45.02	22.39	51	7742	41852	34907286
Abnormal dreams	44.09	22.39	25	7768	7553	34941585
Device issue	43.17	22.39	27	7766	9750	34939388
Depressed mood	42.70	22.39	35	7758	19282	34929856
Libido increased	42.15	22.39	13	7780	838	34948300
Gait disturbance	41.82	22.39	71	7722	85069	34864069
Application site vesicles	41.68	22.39	12	7781	610	34948528
Cognitive disorder	41.64	22.39	41	7752	28652	34920486
Speech disorder	41.62	22.39	39	7754	25647	34923491
Libido decreased	40.07	22.39	20	7773	4676	34944462
Reduced facial expression	38.98	22.39	13	7780	1078	34948060
Stoma site infection	38.55	22.39	12	7781	798	34948340
Fibroma	37.60	22.39	10	7783	378	34948760
Drooling	36.74	22.39	17	7776	3365	34945773
Therapeutic response shortened	36.66	22.39	22	7771	7382	34941756
Hyperkinesia	36.39	22.39	14	7779	1754	34947384
Psychomotor hyperactivity	36.13	22.39	24	7769	9598	34939540
Dropped head syndrome	35.70	22.39	8	7785	145	34948993
Anxiety	35.15	22.39	72	7721	99356	34849782
Musculoskeletal stiffness	34.36	22.39	47	7746	46633	34902505
Gambling disorder	33.65	22.39	13	7780	1647	34947491
Device connection issue	32.43	22.39	9	7784	400	34948738
Toxicity to various agents	31.12	22.39	4	7789	200358	34748780
Nightmare	29.57	22.39	25	7768	14366	34934772
Device breakage	29.55	22.39	13	7780	2287	34946851
Decreased interest	29.23	22.39	13	7780	2347	34946791
Enteral nutrition	28.86	22.39	6	7787	75	34949063
Gambling	28.24	22.39	7	7786	199	34948939
Dermatitis allergic	28.00	22.39	18	7775	6812	34942326
Application site irritation	27.72	22.39	9	7784	686	34948452
Device adhesion issue	27.54	22.39	13	7780	2691	34946447
Stoma site extravasation	27.42	22.39	6	7787	97	34949041
Tricuspid valve sclerosis	27.32	22.39	5	7788	30	34949108
Stoma site reaction	27.06	22.39	7	7786	237	34948901
Sexual dysfunction	26.80	22.39	17	7776	6286	34942852
Dementia	26.45	22.39	23	7770	13725	34935413
Stoma site haemorrhage	25.54	22.39	9	7784	881	34948257
Stoma site induration	25.25	22.39	5	7788	48	34949090
Skin swelling	25.23	22.39	10	7783	1355	34947783
Insomnia	24.31	22.39	64	7729	103843	34845295
Stoma site irritation	24.05	22.39	6	7787	175	34948963
Compulsive shopping	23.57	22.39	7	7786	397	34948741
Mucosal haemorrhage	23.55	22.39	10	7783	1615	34947523
Confusional state	23.43	22.39	78	7715	144082	34805056
Diarrhoea	23.14	22.39	32	7761	389880	34559258
Neuroleptic malignant syndrome	23.04	22.39	24	7769	17910	34931228
Stereotypy	23.03	22.39	8	7785	750	34948388
Device expulsion	22.84	22.39	5	7788	81	34949057
Somnolence	22.58	22.39	65	7728	111051	34838087
Therapeutic product effect variable	22.56	22.39	11	7782	2445	34946693

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
On and off phenomenon	435.77	19.13	100	11602	3140	79729546
Dyskinesia	381.00	19.13	167	11535	44606	79688080
Hallucination	283.63	19.13	169	11533	85576	79647110
Freezing phenomenon	214.68	19.13	51	11651	1863	79730823
Stoma site discharge	202.36	19.13	50	11652	2159	79730527
Hallucination, visual	178.87	19.13	90	11612	32639	79700047
Product adhesion issue	168.38	19.13	45	11657	2659	79730027
Stoma site pain	159.10	19.13	38	11664	1420	79731266
Muscle rigidity	155.55	19.13	70	11632	19812	79712874
Bradykinesia	142.36	19.13	51	11651	7992	79724694
Impulse-control disorder	141.77	19.13	36	11666	1738	79730948
Choking	139.17	19.13	56	11646	12045	79720641
Stoma site erythema	137.27	19.13	35	11667	1718	79730968
Application site erythema	136	19.13	44	11658	5066	79727620
Application site pruritus	135.72	19.13	41	11661	3769	79728917
Dysphagia	128.46	19.13	121	11581	122015	79610671
Nocturia	125.89	19.13	54	11648	13627	79719059
Fall	112.37	19.13	231	11471	487398	79245288
Micturition urgency	106.86	19.13	47	11655	12594	79720092
Stoma site hypergranulation	106.12	19.13	22	11680	423	79732263
Delusion	105.24	19.13	54	11648	20369	79712317
Anosmia	101.93	19.13	41	11661	8803	79723883
Tremor	101.78	19.13	125	11577	169958	79562728
Middle insomnia	99.09	19.13	48	11654	16021	79716665
Sleep talking	91.33	19.13	23	11679	1073	79731613
Decreased interest	90.96	19.13	30	11672	3667	79729019
Therapeutic response shortened	87.73	19.13	44	11658	15819	79716867
Stoma site inflammation	85.66	19.13	20	11682	676	79732010
Device dislocation	82.61	19.13	50	11652	25920	79706766
Dropped head syndrome	82.09	19.13	17	11685	325	79732361
Akinesia	81.99	19.13	27	11675	3285	79729401
Dopamine dysregulation syndrome	80.53	19.13	18	11684	499	79732187
Gastrointestinal motility disorder	79.71	19.13	31	11671	6091	79726595
Pneumonia aspiration	73.51	19.13	68	11634	66899	79665787
Device occlusion	71.81	19.13	35	11667	11831	79720855
Stoma site infection	70.16	19.13	20	11682	1500	79731186
Drooling	70.08	19.13	28	11674	5906	79726780
Stoma site extravasation	69.59	19.13	15	11687	350	79732336
Depressed mood	68.84	19.13	57	11645	48423	79684263
Hypersexuality	63.81	19.13	19	11683	1661	79731025
Application site reaction	63.25	19.13	16	11686	760	79731926
Sexual dysfunction	62.82	19.13	28	11674	7735	79724951
Initial insomnia	62.55	19.13	27	11675	6911	79725775
Speech disorder	61.13	19.13	56	11646	54389	79678297
Ageusia	60.69	19.13	35	11667	16597	79716089
Dystonia	59.94	19.13	38	11664	21361	79711325
Libido decreased	59.02	19.13	24	11678	5297	79727389
Reduced facial expression	58.38	19.13	20	11682	2745	79729941
Compulsive shopping	57.59	19.13	15	11687	801	79731885
Sudden onset of sleep	56.08	19.13	14	11688	630	79732056
Nightmare	55.71	19.13	39	11663	25822	79706864
Poor quality sleep	55.43	19.13	37	11665	22685	79710001
Disturbance in attention	54.61	19.13	51	11651	50750	79681936
Gait disturbance	54.43	19.13	104	11598	207402	79525284
Application site vesicles	53.45	19.13	16	11686	1424	79731262
Device kink	53.21	19.13	17	11685	1878	79730808
Drug dose titration not performed	52.89	19.13	14	11688	796	79731890
Posture abnormal	51.84	19.13	20	11682	3846	79728840
Loss of consciousness	51.40	19.13	90	11612	167853	79564833
Somnolence	51.06	19.13	110	11592	238871	79493815
Device issue	47.32	19.13	36	11666	27072	79705614
Application site rash	47.28	19.13	16	11686	2116	79730570
Balance disorder	47.10	19.13	65	11637	98792	79633894
Orthostatic intolerance	44.88	19.13	15	11687	1909	79730777
Anxiety	44.86	19.13	107	11595	248405	79484281
Hyperkinesia	43.41	19.13	16	11686	2713	79729973
Neuroleptic malignant syndrome	42.47	19.13	34	11668	27525	79705161
Mobility decreased	42.03	19.13	69	11633	122106	79610580
Toxicity to various agents	41.99	19.13	6	11696	421534	79311152
Memory impairment	41.02	19.13	65	11637	111669	79621017
Constipation	40.85	19.13	112	11590	282938	79449748
Panic disorder	38.42	19.13	15	11687	2977	79729709
Dementia	37.10	19.13	30	11672	24629	79708057
Dermatitis contact	37.04	19.13	22	11680	11011	79721675
Device connection issue	36.13	19.13	11	11691	1037	79731649
Insomnia	35.34	19.13	97	11605	245073	79487613
Diarrhoea	34.97	19.13	47	11655	880442	78852244
Abnormal dreams	33.80	19.13	21	11681	11391	79721295
Panic attack	33.38	19.13	28	11674	24188	79708498
Stress	33.00	19.13	49	11653	79563	79653123
Oromandibular dystonia	31.81	19.13	10	11692	1048	79731638
Weight abnormal	31.65	19.13	11	11691	1575	79731111
Joint swelling	31.48	19.13	3	11699	288643	79444043
Stoma site reaction	31.22	19.13	8	11694	400	79732286
Stoma site odour	30.66	19.13	6	11696	85	79732601
Headache	30.10	19.13	31	11671	653741	79078945
Agitation	29.91	19.13	53	11649	99662	79633024
Confusional state	29.46	19.13	108	11594	317889	79414797
Tricuspid valve sclerosis	29.41	19.13	5	11697	30	79732656
Libido increased	29.16	19.13	11	11691	1990	79730696
Gambling disorder	29.02	19.13	11	11691	2015	79730671
Stoma site irritation	28.98	19.13	7	11695	274	79732412
Sexually inappropriate behaviour	28.93	19.13	8	11694	537	79732149
Persecutory delusion	28.27	19.13	14	11688	4895	79727791
Restlessness	27.46	19.13	34	11668	46458	79686228
Drug titration error	26.87	19.13	9	11693	1153	79731533
Arthralgia	26.43	19.13	27	11675	571776	79160910
Sleep attacks	26.42	19.13	6	11696	179	79732507
Psychomotor hyperactivity	26.41	19.13	21	11681	16828	79715858
Sensory disturbance	26.26	19.13	20	11682	15057	79717629
Application site dermatitis	26.13	19.13	6	11696	188	79732498
Cognitive disorder	26.10	19.13	41	11661	69885	79662801
Bezoar	26.01	19.13	11	11691	2677	79730009
Antidiuretic hormone abnormality	25.28	19.13	5	11697	75	79732611
Fibroma	25.01	19.13	8	11694	887	79731799
Enteral nutrition	24.53	19.13	5	11697	88	79732598
Polycythaemia	24.30	19.13	10	11692	2274	79730412
Delirium	24.12	19.13	44	11658	84583	79648103
Febrile neutropenia	23.66	19.13	3	11699	230996	79501690
Application site irritation	23.30	19.13	9	11693	1735	79730951
Wrong technique in product usage process	23.10	19.13	40	11662	73835	79658851
Mucosal haemorrhage	23.10	19.13	10	11692	2576	79730110
Hallucination, auditory	22.66	19.13	21	11681	20672	79712014
Altered state of consciousness	22.66	19.13	30	11672	43792	79688894
Device colour issue	22.52	19.13	4	11698	32	79732654
Intentional medical device removal by patient	22.02	19.13	6	11696	381	79732305
Product administered at inappropriate site	21.92	19.13	11	11691	3954	79728732
Skin swelling	21.79	19.13	11	11691	4003	79728683
Withdrawal syndrome	21.53	19.13	23	11679	26831	79705855
Completed suicide	21.23	19.13	5	11697	245762	79486924
Application site discolouration	21.21	19.13	7	11695	857	79731829
Musculoskeletal stiffness	21.11	19.13	65	11637	174943	79557743
Cough	21.04	19.13	14	11688	366775	79365911
Device adhesion issue	20.90	19.13	13	11689	7062	79725624
Psychotic disorder	20.88	19.13	28	11674	41374	79691312
Camptocormia	20.64	19.13	6	11696	482	79732204
Product prescribing error	20.63	19.13	29	11673	44784	79687902
Stereotypy	20.59	19.13	7	11695	938	79731748
Parkinsonian gait	20.57	19.13	7	11695	941	79731745
Device breakage	20.46	19.13	15	11687	10660	79722026
Binge eating	20.39	19.13	6	11696	503	79732183
Stoma site pruritus	19.87	19.13	3	11699	7	79732679
Stoma site abscess	19.53	19.13	5	11697	249	79732437
Neutropenia	19.36	19.13	9	11693	287701	79444985
Mitral valve sclerosis	19.16	19.13	5	11697	269	79732417

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N04BC09	NERVOUS SYSTEM ANTI-PARKINSON DRUGS DOPAMINERGIC AGENTS Dopamine agonists
FDA MoA	N0000000117	Dopamine Agonists
MeSH PA	D015259	Dopamine Agents
MeSH PA	D018491	Dopamine Agonists
MeSH PA	D018377	Neurotransmitter Agents
FDA EPC	N0000175768	Nonergot Dopamine Agonist

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Restless legs	indication	32914008	DOID:0050425
Parkinson's disease	indication	49049000	DOID:14330
Dyskinesia	contraindication	9748009
Orthostatic hypotension	contraindication	28651003
Hypertensive disorder	contraindication	38341003	DOID:10763
Body fluid retention	contraindication	43498006
Chronic heart failure	contraindication	48447003
Acute nephropathy	contraindication	58574008
Magnetic resonance imaging	contraindication	113091000
Syncope	contraindication	271594007
Drowsy	contraindication	271782001
Peripheral edema	contraindication	271809000
Breastfeeding (mother)	contraindication	413712001

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.6	acidic
pKa2	8.87	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
1MG/24HR	NEUPRO	UCB INC	N021829	April 2, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8617591	July 22, 2023	A METHOD FOR THE TREATMENT OF A PATIENT SUFFERING FROM A DISEASE TREATABLE WITH ROTIGOTINE, COMPRISING APPLYING THE CLAIMED TRANSDERMAL DELIVERY SYSTEM (TDS) TO THE SKIN OF THE PATIENT
2MG/24HR	NEUPRO	UCB INC	N021829	May 9, 2007	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8617591	July 22, 2023	A METHOD FOR THE TREATMENT OF A PATIENT SUFFERING FROM A DISEASE TREATABLE WITH ROTIGOTINE, COMPRISING APPLYING THE CLAIMED TRANSDERMAL DELIVERY SYSTEM (TDS) TO THE SKIN OF THE PATIENT
3MG/24HR	NEUPRO	UCB INC	N021829	April 2, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8617591	July 22, 2023	A METHOD FOR THE TREATMENT OF A PATIENT SUFFERING FROM A DISEASE TREATABLE WITH ROTIGOTINE, COMPRISING APPLYING THE CLAIMED TRANSDERMAL DELIVERY SYSTEM (TDS) TO THE SKIN OF THE PATIENT
4MG/24HR	NEUPRO	UCB INC	N021829	May 9, 2007	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8617591	July 22, 2023	A METHOD FOR THE TREATMENT OF A PATIENT SUFFERING FROM A DISEASE TREATABLE WITH ROTIGOTINE, COMPRISING APPLYING THE CLAIMED TRANSDERMAL DELIVERY SYSTEM (TDS) TO THE SKIN OF THE PATIENT
6MG/24HR	NEUPRO	UCB INC	N021829	May 9, 2007	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8617591	July 22, 2023	A METHOD FOR THE TREATMENT OF A PATIENT SUFFERING FROM A DISEASE TREATABLE WITH ROTIGOTINE, COMPRISING APPLYING THE CLAIMED TRANSDERMAL DELIVERY SYSTEM (TDS) TO THE SKIN OF THE PATIENT
8MG/24HR	NEUPRO	UCB INC	N021829	April 2, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8617591	July 22, 2023	A METHOD FOR THE TREATMENT OF A PATIENT SUFFERING FROM A DISEASE TREATABLE WITH ROTIGOTINE, COMPRISING APPLYING THE CLAIMED TRANSDERMAL DELIVERY SYSTEM (TDS) TO THE SKIN OF THE PATIENT
1MG/24HR	NEUPRO	UCB INC	N021829	April 2, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8246979	Sept. 1, 2027	TREATMENT OF RESTLESS LEGS SYNDROME BY APPLICATION OF CLAIMED TRANSDERMAL DELIVERY SYSTEM
1MG/24HR	NEUPRO	UCB INC	N021829	April 2, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8246979	Sept. 1, 2027	TREATMENT OF SIGNS AND SYMPTOMS OF PARKINSONS DISEASE BY APPLICATION OF CLAIMED TRANSDERMAL SYSTEM
2MG/24HR	NEUPRO	UCB INC	N021829	May 9, 2007	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8246979	Sept. 1, 2027	TREATMENT OF RESTLESS LEGS SYNDROME BY APPLICATION OF CLAIMED TRANSDERMAL DELIVERY SYSTEM
2MG/24HR	NEUPRO	UCB INC	N021829	May 9, 2007	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8246979	Sept. 1, 2027	TREATMENT OF SIGNS AND SYMPTOMS OF PARKINSONS DISEASE BY APPLICATION OF CLAIMED TRANSDERMAL SYSTEM
3MG/24HR	NEUPRO	UCB INC	N021829	April 2, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8246979	Sept. 1, 2027	TREATMENT OF RESTLESS LEGS SYNDROME BY APPLICATION OF CLAIMED TRANSDERMAL DELIVERY SYSTEM
3MG/24HR	NEUPRO	UCB INC	N021829	April 2, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8246979	Sept. 1, 2027	TREATMENT OF SIGNS AND SYMPTOMS OF PARKINSONS DISEASE BY APPLICATION OF CLAIMED TRANSDERMAL SYSTEM
4MG/24HR	NEUPRO	UCB INC	N021829	May 9, 2007	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8246979	Sept. 1, 2027	TREATMENT OF RESTLESS LEGS SYNDROME BY APPLICATION OF CLAIMED TRANSDERMAL DELIVERY SYSTEM
4MG/24HR	NEUPRO	UCB INC	N021829	May 9, 2007	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8246979	Sept. 1, 2027	TREATMENT OF SIGNS AND SYMPTOMS OF PARKINSONS DISEASE BY APPLICATION OF CLAIMED TRANSDERMAL SYSTEM
6MG/24HR	NEUPRO	UCB INC	N021829	May 9, 2007	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8246979	Sept. 1, 2027	TREATMENT OF RESTLESS LEGS SYNDROME BY APPLICATION OF CLAIMED TRANSDERMAL DELIVERY SYSTEM
6MG/24HR	NEUPRO	UCB INC	N021829	May 9, 2007	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8246979	Sept. 1, 2027	TREATMENT OF SIGNS AND SYMPTOMS OF PARKINSONS DISEASE BY APPLICATION OF CLAIMED TRANSDERMAL SYSTEM
8MG/24HR	NEUPRO	UCB INC	N021829	April 2, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8246979	Sept. 1, 2027	TREATMENT OF RESTLESS LEGS SYNDROME BY APPLICATION OF CLAIMED TRANSDERMAL DELIVERY SYSTEM
8MG/24HR	NEUPRO	UCB INC	N021829	April 2, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	8246979	Sept. 1, 2027	TREATMENT OF SIGNS AND SYMPTOMS OF PARKINSONS DISEASE BY APPLICATION OF CLAIMED TRANSDERMAL SYSTEM

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(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN	AGONIST	Ki	10.22	IUPHAR	IUPHAR
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN	AGONIST	Ki	8.40	IUPHAR
D(1A) dopamine receptor	GPCR	P21728	DRD1_HUMAN	AGONIST	Ki	5.60	IUPHAR
D(4) dopamine receptor	GPCR	P21917	DRD4_HUMAN	AGONIST	Ki	7.26	CHEMBL
D(1B) dopamine receptor	GPCR	P21918	DRD5_HUMAN	AGONIST	Ki	6	IUPHAR
D(1A) dopamine receptor	GPCR		DRD1_BOVIN		Ki	6.30	CHEMBL
D(2) dopamine receptor	GPCR		DRD2_BOVIN		Ki	7.82	CHEMBL

External reference:

ID	Source
4025266	VUID
N0000171794	NUI
D05768	KEGG_DRUG
4025266	VANDF
C1700683	UMLSCUI
CHEBI:135351	CHEBI
R5F	PDB_CHEM_ID
CHEMBL1303	ChEMBL_ID
DB05271	DRUGBANK_ID
C047508	MESH_SUPPLEMENTAL_RECORD_UI
59227	PUBCHEM_CID
941	IUPHAR_LIGAND_ID
7897	INN_ID
87T4T8BO2E	UNII
616739	RXNORM
21751	MMSL
83818	MMSL
d05848	MMSL
011270	NDDF
421915002	SNOMEDCT_US
421924006	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Neupro	HUMAN PRESCRIPTION DRUG LABEL	1	50474-801	PATCH, EXTENDED RELEASE	1 mg	TRANSDERMAL	NDA	32 sections
Neupro	HUMAN PRESCRIPTION DRUG LABEL	1	50474-801	PATCH, EXTENDED RELEASE	1 mg	TRANSDERMAL	NDA	32 sections
Neupro	HUMAN PRESCRIPTION DRUG LABEL	1	50474-802	PATCH, EXTENDED RELEASE	2 mg	TRANSDERMAL	NDA	32 sections
Neupro	HUMAN PRESCRIPTION DRUG LABEL	1	50474-802	PATCH, EXTENDED RELEASE	2 mg	TRANSDERMAL	NDA	32 sections
Neupro	HUMAN PRESCRIPTION DRUG LABEL	1	50474-803	PATCH, EXTENDED RELEASE	3 mg	TRANSDERMAL	NDA	32 sections
Neupro	HUMAN PRESCRIPTION DRUG LABEL	1	50474-803	PATCH, EXTENDED RELEASE	3 mg	TRANSDERMAL	NDA	32 sections
Neupro	HUMAN PRESCRIPTION DRUG LABEL	1	50474-804	PATCH, EXTENDED RELEASE	4 mg	TRANSDERMAL	NDA	32 sections
Neupro	HUMAN PRESCRIPTION DRUG LABEL	1	50474-804	PATCH, EXTENDED RELEASE	4 mg	TRANSDERMAL	NDA	32 sections
Neupro	HUMAN PRESCRIPTION DRUG LABEL	1	50474-805	PATCH, EXTENDED RELEASE	6 mg	TRANSDERMAL	NDA	32 sections
Neupro	HUMAN PRESCRIPTION DRUG LABEL	1	50474-805	PATCH, EXTENDED RELEASE	6 mg	TRANSDERMAL	NDA	32 sections
Neupro	HUMAN PRESCRIPTION DRUG LABEL	1	50474-806	PATCH, EXTENDED RELEASE	8 mg	TRANSDERMAL	NDA	32 sections
Neupro	HUMAN PRESCRIPTION DRUG LABEL	1	50474-806	PATCH, EXTENDED RELEASE	8 mg	TRANSDERMAL	NDA	32 sections