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

Stem definitionDrug idCAS RN
4168 367514-87-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • SM-13496
  • latuda
  • lurasidone hydrochloride
  • lurasidone
  • lurasidone HCl
The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear. However, its efficacy in schizophrenia and bipolar depression could be mediated through a combination of central dopamine D2 and serotonin Type 2 (5HT2A) receptor antagonism.
  • Molecular weight: 492.68
  • Formula: C28H36N4O2S
  • CLOGP: 6.07
  • LIPINSKI: 1
  • HAC: 6
  • HDO: 0
  • TPSA: 56.75
  • ALOGS: -4.80
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
60 mg O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Oct. 28, 2010 FDA SUNOVION PHARMS INC
March 25, 2020 PMDA Sumitomo Dainippon Pharma Co., Ltd.

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
Blood prolactin abnormal 1222.69 21.45 245 12550 2834 63473393
Anosognosia 1195.72 21.45 242 12553 2954 63473273
Sexual dysfunction 1177.43 21.45 252 12543 4107 63472120
Disturbance in social behaviour 1119.13 21.45 238 12557 3755 63472472
Metabolic disorder 1071.77 21.45 251 12544 6252 63469975
Personality change 935.74 21.45 228 12567 6745 63469482
Dystonia 902.13 21.45 255 12540 13564 63462663
Dyskinesia 830.99 21.45 292 12503 31710 63444517
Sedation 808.94 21.45 301 12494 38508 63437719
Suicide attempt 680.80 21.45 302 12493 60616 63415611
Blood glucose increased 448.30 21.45 252 12543 83504 63392723
Completed suicide 334.16 21.45 258 12537 145415 63330812
Tardive dyskinesia 221.76 21.45 78 12717 8424 63467803
Mania 207.21 21.45 82 12713 12285 63463942
Akathisia 190.26 21.45 71 12724 9075 63467152
Insurance issue 151.41 21.45 54 12741 6067 63470160
Schizophrenia 146.04 21.45 60 12735 9892 63466335
Suicidal ideation 145.85 21.45 112 12683 62309 63413918
Serotonin syndrome 115.55 21.45 72 12723 28610 63447617
Hyperprolactinaemia 98.70 21.45 35 12760 3865 63472362
Condition aggravated 91.80 21.45 230 12565 401987 63074240
Blood prolactin increased 90.79 21.45 32 12763 3471 63472756
Adverse drug reaction 84.85 21.45 92 12703 79622 63396605
Drug ineffective 83.74 21.45 422 12373 1044343 62431884
Delusion 83.18 21.45 43 12752 11974 63464253
Galactorrhoea 81.83 21.45 31 12764 4124 63472103
Personality change due to a general medical condition 78.71 21.45 16 12779 198 63476029
Confabulation 72.30 21.45 16 12779 304 63475923
Depression 66.86 21.45 132 12663 196360 63279867
Hallucination, auditory 66.78 21.45 38 12757 12786 63463441
Persistent genital arousal disorder 62.96 21.45 14 12781 272 63475955
Psychotic disorder 61.89 21.45 47 12748 25665 63450562
Weight increased 58.14 21.45 148 12647 260644 63215583
Diarrhoea 57.30 21.45 37 12758 715329 62760898
Arthralgia 55.17 21.45 23 12772 569687 62906540
Distractibility 46.88 21.45 12 12783 432 63475795
Restlessness 46.17 21.45 42 12753 29411 63446816
Joint swelling 45.79 21.45 6 12789 327660 63148567
Psychotic symptom 43.29 21.45 15 12780 1546 63474681
Extrapyramidal disorder 42.80 21.45 29 12766 13255 63462972
Bipolar disorder 42.55 21.45 24 12771 7936 63468291
Mental disorder 38.75 21.45 36 12759 25883 63450344
Negative symptoms in schizophrenia 38.18 21.45 8 12787 116 63476111
Agitation 37.65 21.45 53 12742 59704 63416523
Therapy cessation 37.46 21.45 38 12757 30419 63445808
Alopecia 37.11 21.45 11 12784 337525 63138702
Tremor 36.93 21.45 82 12713 132157 63344070
Pain 34.89 21.45 60 12735 740568 62735659
Oculogyric crisis 34.46 21.45 13 12782 1708 63474519
Anxiety 34.28 21.45 109 12686 217432 63258795
Off label use 33.38 21.45 241 12554 674221 62802006
Psychomotor retardation 33.13 21.45 16 12779 3854 63472373
Rheumatoid arthritis 32.37 21.45 6 12789 253813 63222414
Depressed mood 32.02 21.45 40 12755 40151 63436076
Parkinsonism 31.76 21.45 22 12773 10417 63465810
Catatonia 30.92 21.45 16 12779 4461 63471766
Amenorrhoea 30.41 21.45 21 12774 9893 63466334
Anaemia 29.73 21.45 11 12784 293419 63182808
Pneumonia 29.71 21.45 29 12766 456738 63019489
Hyperthermia 29.52 21.45 20 12775 9136 63467091
Swelling 28.44 21.45 10 12785 275368 63200859
Drug interaction 28.40 21.45 106 12689 229025 63247202
Anger 28.28 21.45 22 12773 12434 63463793
Infection 28.00 21.45 6 12789 229167 63247060
Hallucination 27.90 21.45 44 12751 54773 63421454
Manic symptom 27.80 21.45 4 12791 3 63476224
Treatment failure 26.94 21.45 4 12791 199039 63277188
Nystagmus 26.01 21.45 16 12779 6204 63470023
Blood insulin increased 25.98 21.45 6 12789 139 63476088
Salivary hypersecretion 25.32 21.45 17 12778 7649 63468578
Somnolence 24.98 21.45 86 12709 178599 63297628
Apnoea 24.62 21.45 17 12778 8005 63468222
Abdominal discomfort 23.73 21.45 18 12777 320867 63155360
Hepatic enzyme increased 23.33 21.45 6 12789 202322 63273905
Mood altered 23.05 21.45 21 12774 14722 63461505
Metamyelocyte count increased 23.05 21.45 6 12789 231 63475996
Bruxism 22.64 21.45 12 12783 3513 63472714
Sedation complication 22.22 21.45 20 12775 13802 63462425
Personality disorder 21.91 21.45 14 12781 5797 63470430
Trismus 21.54 21.45 12 12783 3873 63472354
Crying 21.48 21.45 25 12770 23318 63452909

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
Anosognosia 367.59 30.05 72 5747 901 34950211
Blood prolactin abnormal 337.50 30.05 67 5752 902 34950210
Disturbance in social behaviour 288.90 30.05 66 5753 1785 34949327
Metabolic disorder 247.61 30.05 69 5750 4214 34946898
Sexual dysfunction 242.46 30.05 74 5745 6229 34944883
Dystonia 229.45 30.05 81 5738 10764 34940348
Dyskinesia 194.49 30.05 88 5731 22325 34928787
Personality change 179.28 30.05 56 5763 5083 34946029
Sedation 168.16 30.05 78 5741 20928 34930184
Suicide attempt 117.68 30.05 76 5743 39040 34912072
Akathisia 110.81 30.05 44 5775 8065 34943047
Mania 110.74 30.05 46 5773 9465 34941647
Tardive dyskinesia 88.21 30.05 34 5785 5756 34945356
Blood glucose increased 83.58 30.05 77 5742 66641 34884471
Suicidal ideation 78.30 30.05 60 5759 40328 34910784
Drug ineffective 69.83 30.05 199 5620 456552 34494560
Hallucination, auditory 67.54 30.05 35 5784 11882 34939230
Completed suicide 60.59 30.05 78 5741 98090 34853022
Extrapyramidal disorder 59.44 30.05 33 5786 12847 34938265
Psychotic disorder 53.31 30.05 39 5780 24413 34926699
Nail bed bleeding 50.93 30.05 12 5807 371 34950741
Neuroleptic malignant syndrome 49.36 30.05 33 5786 17901 34933211
Weight increased 48.33 30.05 68 5751 92965 34858147
Aggression 46.85 30.05 44 5775 38920 34912192
Irritability 39.92 30.05 33 5786 24657 34926455
Hypometabolism 39.45 30.05 8 5811 120 34950992
Off label use 38.24 30.05 154 5665 419370 34531742
Restlessness 36.97 30.05 32 5787 25450 34925662
Delusion 36.57 30.05 24 5795 12611 34938501
Insurance issue 34.74 30.05 13 5806 2026 34949086
Sedation complication 32.74 30.05 12 5807 1765 34949347
Myocarditis 32.50 30.05 23 5796 13659 34937453
Tremor 32.40 30.05 53 5766 82534 34868578
Insomnia 32.08 30.05 60 5759 103847 34847265
Agitation 31.33 30.05 43 5776 57356 34893756
Parasomnia 30.30 30.05 8 5811 396 34950716

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
Blood prolactin abnormal 1415.45 21.41 280 14439 3321 79726348
Anosognosia 1415.12 21.41 282 14437 3482 79726187
Disturbance in social behaviour 1285.39 21.41 273 14446 4697 79724972
Sexual dysfunction 1254.24 21.41 290 14429 7473 79722196
Metabolic disorder 1164.99 21.41 282 14437 8888 79720781
Personality change 1041.06 21.41 263 14456 9907 79719762
Dystonia 971.29 21.41 292 14427 21107 79708562
Dyskinesia 883.76 21.41 326 14393 44447 79685222
Sedation 847.59 21.41 329 14390 51566 79678103
Suicide attempt 717.55 21.41 335 14384 82597 79647072
Blood glucose increased 484.12 21.41 287 14432 114688 79614981
Completed suicide 349.17 21.41 318 14401 245449 79484220
Tardive dyskinesia 215.53 21.41 79 14640 10492 79719177
Akathisia 194.66 21.41 78 14641 13181 79716488
Mania 183.30 21.41 82 14637 18178 79711491
Insurance issue 179.41 21.41 59 14660 5674 79723995
Drug ineffective 148.15 21.41 485 14234 1080428 78649241
Schizophrenia 141.24 21.41 65 14654 15375 79714294
Adverse drug reaction 135.25 21.41 106 14613 66286 79663383
Suicidal ideation 124.31 21.41 107 14612 76233 79653436
Serotonin syndrome 102.89 21.41 77 14642 44950 79684719
Hyperprolactinaemia 99.21 21.41 36 14683 4640 79725029
Condition aggravated 97.00 21.41 255 14464 500869 79228800
Hallucination, auditory 95.61 21.41 55 14664 20638 79709031
Psychotic disorder 77.64 21.41 63 14656 41339 79688330
Delusion 67.94 21.41 44 14675 20379 79709290
Confabulation 66.65 21.41 16 14703 482 79729187
Personality change due to a general medical condition 66.52 21.41 14 14705 228 79729441
Persistent genital arousal disorder 64.43 21.41 14 14705 267 79729402
Psychotic symptom 61.86 21.41 22 14697 2675 79726994
Extrapyramidal disorder 61.40 21.41 43 14676 22636 79707033
Weight increased 59.56 21.41 147 14572 277239 79452430
Diarrhoea 58.92 21.41 46 14673 880443 78849226
Restlessness 53.98 21.41 54 14665 46438 79683231
Aggression 46.38 21.41 52 14667 50906 79678763
Pneumonia 46.03 21.41 33 14686 660213 79069456
Anaemia 45.34 21.41 13 14706 445002 79284667
Agitation 44.71 21.41 72 14647 99643 79630026
Neuroleptic malignant syndrome 43.54 21.41 38 14681 27521 79702148
Nail bed bleeding 42.75 21.41 12 14707 674 79728995
Sedation complication 40.77 21.41 29 14690 15640 79714029
Blood prolactin increased 40.19 21.41 18 14701 3993 79725676
Depression 38.41 21.41 107 14612 216683 79512986
Distractibility 37.34 21.41 11 14708 734 79728935
Negative symptoms in schizophrenia 37.25 21.41 8 14711 144 79729525
Off label use 36.13 21.41 288 14431 906927 78822742
Parkinsonism 34.86 21.41 27 14692 16557 79713112
General physical health deterioration 34.28 21.41 5 14714 275233 79454436
Tremor 33.18 21.41 87 14632 169996 79559673
Hypometabolism 32.34 21.41 7 14712 131 79729538
Galactorrhoea 32.24 21.41 15 14704 3631 79726038
Arthralgia 29.92 21.41 37 14682 571766 79157903
Irritability 29.21 21.41 37 14682 41107 79688562
Mental disorder 28.58 21.41 32 14687 31270 79698399
Suspected suicide 28.50 21.41 20 14699 10556 79719113
Antipsychotic drug level increased 27.95 21.41 16 14703 5941 79723728
Paranoia 27.14 21.41 25 14694 19407 79710262
Catatonia 27.01 21.41 18 14701 8738 79720931
Negative thoughts 26.83 21.41 10 14709 1389 79728280
Oculogyric crisis 25.66 21.41 12 14707 2940 79726729
Salivary hypersecretion 25.30 21.41 21 14698 14203 79715466
Bruxism 24.95 21.41 13 14706 4013 79725656
Myocarditis 24.77 21.41 25 14694 21708 79707961
Abdominal pain 23.94 21.41 22 14697 389547 79340122
Dyspnoea 23.18 21.41 81 14638 856944 78872725
Drug ineffective for unapproved indication 22.96 21.41 37 14682 51201 79678468
Infection 22.91 21.41 8 14711 241704 79487965
Hyperthermia 22.88 21.41 22 14697 18015 79711654
Swelling 22.66 21.41 6 14713 216705 79512964
Parasomnia 22.60 21.41 7 14712 554 79729115
Persecutory delusion 22.54 21.41 13 14706 4896 79724773
Bipolar disorder 21.76 21.41 15 14704 7692 79721977
Thrombocytopenia 21.59 21.41 11 14708 265248 79464421

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N05AE05 NERVOUS SYSTEM
PSYCHOLEPTICS
ANTIPSYCHOTICS
Indole derivatives
FDA EPC N0000175430 Atypical Antipsychotic
MeSH PA D018663 Adrenergic Agents
MeSH PA D058669 Adrenergic alpha-2 Receptor Antagonists
MeSH PA D000317 Adrenergic alpha-Antagonists
MeSH PA D018674 Adrenergic Antagonists
MeSH PA D014150 Antipsychotic Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D015259 Dopamine Agents
MeSH PA D018492 Dopamine Antagonists
MeSH PA D065127 Dopamine D2 Receptor Antagonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D058830 Serotonin 5-HT2 Receptor Antagonists
MeSH PA D018490 Serotonin Agents
MeSH PA D012702 Serotonin Antagonists
MeSH PA D014149 Tranquilizing Agents
CHEBI has role CHEBI:37887 adrenergic blockers
CHEBI has role CHEBI:48279 serotonin antagonists
CHEBI has role CHEBI:48561 dopaminergic antagonists
CHEBI has role CHEBI:65191 atypical antipsychotic agent

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

DiseaseRelationSNOMED_IDDOID
Schizophrenia indication 58214004 DOID:5419
Bipolar affective disorder, current episode depression indication 191627008 DOID:3312
Suicidal thoughts contraindication 6471006
Weight gain finding contraindication 8943002
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Lowered convulsive threshold contraindication 19260006
Orthostatic hypotension contraindication 28651003
Dysphagia contraindication 40739000
Hyperlipidemia contraindication 55822004 DOID:1168
Hepatic failure contraindication 59927004
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Leukopenia contraindication 84828003 DOID:615
Tardive dyskinesia contraindication 102449007
Seizure disorder contraindication 128613002
Impaired renal function disorder contraindication 197663003
Cerebrovascular accident contraindication 230690007
Disease of liver contraindication 235856003 DOID:409
Hyperprolactinemia contraindication 237662005 DOID:12700
Transient ischemic attack contraindication 266257000 DOID:224
Esophageal dysmotility contraindication 266434009 DOID:9192
Syncope contraindication 271594007
Neutropenic disorder contraindication 303011007 DOID:1227
Senile dementia with psychosis contraindication 371026009
Cardiovascular event risk contraindication 395112001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.38 Basic
pKa2 0.27 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
120MG LATUDA SUNOVION PHARMS INC N200603 April 26, 2012 RX TABLET ORAL 9174975 Feb. 20, 2024 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA
120MG LATUDA SUNOVION PHARMS INC N200603 April 26, 2012 RX TABLET ORAL 9815827 Feb. 20, 2024 TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
120MG LATUDA SUNOVION PHARMS INC N200603 April 26, 2012 RX TABLET ORAL 9815827 Feb. 20, 2024 TREATMENT OF SCHIZOPHRENIA
20MG LATUDA SUNOVION PHARMS INC N200603 Dec. 7, 2011 RX TABLET ORAL 9174975 Feb. 20, 2024 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA
20MG LATUDA SUNOVION PHARMS INC N200603 Dec. 7, 2011 RX TABLET ORAL 9815827 Feb. 20, 2024 TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
20MG LATUDA SUNOVION PHARMS INC N200603 Dec. 7, 2011 RX TABLET ORAL 9815827 Feb. 20, 2024 TREATMENT OF SCHIZOPHRENIA
40MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9174975 Feb. 20, 2024 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA
40MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9815827 Feb. 20, 2024 TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
40MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9815827 Feb. 20, 2024 TREATMENT OF SCHIZOPHRENIA
60MG LATUDA SUNOVION PHARMS INC N200603 July 12, 2013 RX TABLET ORAL 9174975 Feb. 20, 2024 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA
60MG LATUDA SUNOVION PHARMS INC N200603 July 12, 2013 RX TABLET ORAL 9815827 Feb. 20, 2024 TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
60MG LATUDA SUNOVION PHARMS INC N200603 July 12, 2013 RX TABLET ORAL 9815827 Feb. 20, 2024 TREATMENT OF SCHIZOPHRENIA
80MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9174975 Feb. 20, 2024 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA
80MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9815827 Feb. 20, 2024 TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
80MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9815827 Feb. 20, 2024 TREATMENT OF SCHIZOPHRENIA
120MG LATUDA SUNOVION PHARMS INC N200603 April 26, 2012 RX TABLET ORAL 9555027 May 26, 2026 TREATMENT OF SCHIZOPHRENIA
20MG LATUDA SUNOVION PHARMS INC N200603 Dec. 7, 2011 RX TABLET ORAL 9555027 May 26, 2026 TREATMENT OF SCHIZOPHRENIA
40MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9555027 May 26, 2026 TREATMENT OF SCHIZOPHRENIA
60MG LATUDA SUNOVION PHARMS INC N200603 July 12, 2013 RX TABLET ORAL 9555027 May 26, 2026 TREATMENT OF SCHIZOPHRENIA
80MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9555027 May 26, 2026 TREATMENT OF SCHIZOPHRENIA
120MG LATUDA SUNOVION PHARMS INC N200603 April 26, 2012 RX TABLET ORAL 9259423 May 23, 2031 TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
120MG LATUDA SUNOVION PHARMS INC N200603 April 26, 2012 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
120MG LATUDA SUNOVION PHARMS INC N200603 April 26, 2012 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA
20MG LATUDA SUNOVION PHARMS INC N200603 Dec. 7, 2011 RX TABLET ORAL 9259423 May 23, 2031 TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
20MG LATUDA SUNOVION PHARMS INC N200603 Dec. 7, 2011 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
20MG LATUDA SUNOVION PHARMS INC N200603 Dec. 7, 2011 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA
40MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9259423 May 23, 2031 TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
40MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
40MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA
60MG LATUDA SUNOVION PHARMS INC N200603 July 12, 2013 RX TABLET ORAL 9259423 May 23, 2031 TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
60MG LATUDA SUNOVION PHARMS INC N200603 July 12, 2013 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
60MG LATUDA SUNOVION PHARMS INC N200603 July 12, 2013 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA
80MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9259423 May 23, 2031 TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
80MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
80MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
D(2) dopamine receptor GPCR ANTAGONIST Ki 9.00 DRUG LABEL DRUG LABEL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 9.33 DRUG LABEL DRUG LABEL
5-hydroxytryptamine receptor 7 GPCR ANTAGONIST Ki 9.31 DRUG LABEL
Alpha-2C adrenergic receptor GPCR Ki 7.97 DRUG LABEL
Alpha-2A adrenergic receptor GPCR Ki 7.39 DRUG LABEL
5-hydroxytryptamine receptor 1A GPCR Ki 8.20 DRUG LABEL
D(2) dopamine receptor GPCR ANTAGONIST Ki 8.77 IUPHAR
5-hydroxytryptamine receptor 1A GPCR AGONIST Ki 8.17 IUPHAR
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 8.69 IUPHAR

External reference:

IDSource
D04820 KEGG_DRUG
367514-88-3 SECONDARY_CAS_RN
4030294 VANDF
4030301 VANDF
CHEBI:70735 CHEBI
CHEMBL1237021 ChEMBL_ID
CHEMBL1615372 ChEMBL_ID
7461 IUPHAR_LIGAND_ID
8247 INN_ID
DB08815 DRUGBANK_ID
22IC88528T UNII
1040027 RXNORM
177747 MMSL
27589 MMSL
365355 MMSL
d07705 MMSL
013606 NDDF
013607 NDDF
703115008 SNOMEDCT_US
703116009 SNOMEDCT_US
715585000 SNOMEDCT_US
C2003424 UMLSCUI
D000069056 MESH_DESCRIPTOR_UI
213046 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7355 TABLET, FILM COATED 20 mg ORAL ANDA 29 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7356 TABLET, FILM COATED 40 mg ORAL ANDA 29 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7357 TABLET, FILM COATED 60 mg ORAL ANDA 29 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7358 TABLET, FILM COATED 80 mg ORAL ANDA 29 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7359 TABLET, FILM COATED 120 mg ORAL ANDA 29 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-464 TABLET, FILM COATED 20 mg ORAL ANDA 24 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-464 TABLET, FILM COATED 20 mg ORAL ANDA 24 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-464 TABLET, FILM COATED 20 mg ORAL ANDA 24 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-465 TABLET, FILM COATED 40 mg ORAL ANDA 24 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-465 TABLET, FILM COATED 40 mg ORAL ANDA 24 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-465 TABLET, FILM COATED 40 mg ORAL ANDA 24 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-466 TABLET, FILM COATED 80 mg ORAL ANDA 24 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-466 TABLET, FILM COATED 80 mg ORAL ANDA 24 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-466 TABLET, FILM COATED 80 mg ORAL ANDA 24 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-467 TABLET, FILM COATED 120 mg ORAL ANDA 24 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-467 TABLET, FILM COATED 120 mg ORAL ANDA 24 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-467 TABLET, FILM COATED 120 mg ORAL ANDA 24 sections
Lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-509 TABLET, FILM COATED 60 mg ORAL ANDA 20 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-346 TABLET, FILM COATED 20 mg ORAL ANDA 30 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-347 TABLET, FILM COATED 40 mg ORAL ANDA 30 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-348 TABLET, FILM COATED 60 mg ORAL ANDA 30 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-349 TABLET, FILM COATED 80 mg ORAL ANDA 30 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-350 TABLET, FILM COATED 120 mg ORAL ANDA 30 sections
lurasidone hydrochloride Human Prescription Drug Label 1 33342-419 TABLET, FILM COATED 20 mg ORAL ANDA 31 sections
lurasidone hydrochloride Human Prescription Drug Label 1 33342-420 TABLET, FILM COATED 40 mg ORAL ANDA 31 sections
lurasidone hydrochloride Human Prescription Drug Label 1 33342-421 TABLET, FILM COATED 60 mg ORAL ANDA 31 sections
lurasidone hydrochloride Human Prescription Drug Label 1 33342-422 TABLET, FILM COATED 80 mg ORAL ANDA 31 sections
lurasidone hydrochloride Human Prescription Drug Label 1 33342-423 TABLET, FILM COATED 120 mg ORAL ANDA 31 sections
Lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43598-351 TABLET, FILM COATED 20 mg ORAL ANDA 28 sections
Lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43598-352 TABLET, FILM COATED 40 mg ORAL ANDA 28 sections