rotigotine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
dopamine receptor agonists, ergoline derivatives 2407 99755-59-6

Description:

MoleculeDescription

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:

DoseUnitRoute
6 mg TD

ADMET properties:

PropertyValueReference
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 ยตM/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:

DateAgencyCompanyOrphan
May 9, 2007 FDA UCB INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.6 acidic
pKa2 8.87 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
D(2) dopamine receptor GPCR AGONIST Ki 10.22 IUPHAR IUPHAR
D(3) dopamine receptor GPCR AGONIST Ki 8.40 IUPHAR
D(1A) dopamine receptor GPCR AGONIST Ki 5.60 IUPHAR
D(4) dopamine receptor GPCR AGONIST Ki 7.26 CHEMBL
D(1B) dopamine receptor GPCR AGONIST Ki 6 IUPHAR
D(1A) dopamine receptor GPCR Ki 6.30 CHEMBL
D(2) dopamine receptor GPCR Ki 7.82 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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