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 861.02 22.35 173 10149 2002 50592800
Anosognosia 838.56 22.35 170 10152 2064 50592738
Sexual dysfunction 828.66 22.35 180 10142 3112 50591690
Disturbance in social behaviour 772.02 22.35 166 10156 2728 50592074
Metabolic disorder 733.56 22.35 178 10144 5108 50589694
Dystonia 646.56 22.35 191 10131 11735 50583067
Personality change 641.76 22.35 162 10160 5483 50589319
Dyskinesia 584.94 22.35 218 10104 27643 50567159
Sedation 568.55 22.35 219 10103 30391 50564411
Suicide attempt 467.03 22.35 222 10100 51510 50543292
Blood glucose increased 288.67 22.35 180 10142 71144 50523658
Completed suicide 248.00 22.35 209 10113 131680 50463122
Tardive dyskinesia 220.92 22.35 75 10247 7204 50587598
Mania 166.93 22.35 68 10254 10848 50583954
Insurance issue 160.84 22.35 46 10276 2502 50592300
Akathisia 160.02 22.35 61 10261 8168 50586634
Schizophrenia 155.31 22.35 58 10264 7339 50587463
Suicidal ideation 125.39 22.35 98 10224 55287 50539515
Blood prolactin increased 90.35 22.35 31 10291 3068 50591734
Delusion 79.05 22.35 40 10282 10529 50584273
Condition aggravated 72.92 22.35 176 10146 296882 50297920
Hyperprolactinaemia 72.87 22.35 27 10295 3338 50591464
Confabulation 67.80 22.35 15 10307 281 50594521
Adverse drug reaction 67.49 22.35 69 10253 55153 50539649
Galactorrhoea 66.66 22.35 26 10296 3697 50591105
Persistent genital arousal disorder 64.56 22.35 14 10308 238 50594564
Hallucination, auditory 58.78 22.35 33 10289 10695 50584107
Depression 57.63 22.35 113 10209 165310 50429492
Psychotic disorder 54.57 22.35 41 10281 21771 50573031
Serotonin syndrome 54.29 22.35 43 10279 24670 50570132
Weight increased 52.00 22.35 122 10200 201769 50393033
Diarrhoea 48.83 22.35 30 10292 588446 50006356
Distractibility 47.77 22.35 12 10310 395 50594407
Restlessness 47.31 22.35 40 10282 25133 50569669
Drug ineffective 41.15 22.35 296 10026 819037 49775765
Arthralgia 39.75 22.35 20 10302 438682 50156120
Negative symptoms in schizophrenia 38.97 22.35 8 10314 103 50594699
Off label use 38.87 22.35 195 10127 474231 50120571
Psychotic symptom 38.77 22.35 13 10309 1199 50593603
Therapy cessation 38.28 22.35 36 10286 25975 50568827
Extrapyramidal disorder 36.00 22.35 25 10297 11745 50583057
Agitation 35.66 22.35 49 10273 53335 50541467
Psychomotor retardation 34.84 22.35 16 10306 3402 50591400
Personality change due to a general medical condition 33.82 22.35 7 10315 94 50594708
Oculogyric crisis 32.85 22.35 12 10310 1425 50593377
Tremor 32.36 22.35 72 10250 114831 50479971
Anxiety 32.02 22.35 94 10228 177512 50417290
Joint swelling 31.40 22.35 6 10316 245280 50349522
Depressed mood 30.25 22.35 36 10286 33987 50560815
Hyperthermia 29.96 22.35 19 10303 7677 50587125
Bipolar disorder 29.64 22.35 18 10304 6739 50588063
Somnolence 27.90 22.35 82 10240 154903 50439899
Anger 27.67 22.35 21 10301 11312 50583490
Parkinsonism 27.55 22.35 19 10303 8828 50585974
Catatonia 27.52 22.35 14 10308 3722 50591080
Drug interaction 26.35 22.35 95 10227 199526 50395276
Blood insulin increased 26.16 22.35 6 10316 133 50594669
Amenorrhoea 25.90 22.35 18 10304 8466 50586336
Rheumatoid arthritis 25.82 22.35 5 10317 202545 50392257
Alopecia 25.63 22.35 9 10313 245038 50349764
Hallucination 25.57 22.35 39 10283 46618 50548184
Anaemia 25.19 22.35 10 10312 252446 50342356
Nystagmus 24.87 22.35 15 10307 5546 50589256
Mental disorder 24.20 22.35 26 10296 21965 50572837
Apnoea 24.17 22.35 16 10306 6950 50587852
Metamyelocyte count increased 23.13 22.35 6 10316 225 50594577

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 323.10 29.95 62 4476 756 29569233
Blood prolactin abnormal 295.47 29.95 58 4480 802 29569187
Disturbance in social behaviour 256.01 29.95 58 4480 1644 29568345
Metabolic disorder 216.00 29.95 59 4479 3636 29566353
Sexual dysfunction 206.53 29.95 63 4475 5751 29564238
Dystonia 205.09 29.95 71 4467 9678 29560311
Dyskinesia 168.14 29.95 75 4463 19986 29550003
Sedation 152.03 29.95 67 4471 17338 29552651
Personality change 150.89 29.95 47 4491 4591 29565398
Akathisia 107.40 29.95 40 4498 6702 29563287
Suicide attempt 96.85 29.95 62 4476 34048 29535941
Mania 90.89 29.95 38 4500 8625 29561364
Tardive dyskinesia 79.38 29.95 30 4508 5228 29564761
Blood glucose increased 76.55 29.95 67 4471 58917 29511072
Suicidal ideation 67.51 29.95 50 4488 34666 29535323
Hallucination, auditory 62 29.95 30 4508 9563 29560426
Completed suicide 60.92 29.95 72 4466 90174 29479815
Drug ineffective 58.32 29.95 153 4385 363017 29206972
Psychotic disorder 57.72 29.95 37 4501 20317 29549672
Neuroleptic malignant syndrome 55.02 29.95 33 4505 16115 29553874
Extrapyramidal disorder 52.82 29.95 28 4510 10803 29559186
Off label use 52.62 29.95 131 4407 300669 29269320
Weight increased 41.80 29.95 55 4483 76612 29493377
Aggression 41.34 29.95 38 4500 35503 29534486
Insurance issue 36.78 29.95 11 4527 934 29569055
Delusion 35.83 29.95 22 4516 11194 29558795
Agitation 34.65 29.95 41 4497 51263 29518726
Restlessness 32.42 29.95 27 4511 22118 29547871
Tremor 31.48 29.95 47 4491 73491 29496498
Paranoia 30.59 29.95 19 4519 9858 29560131

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
Anosognosia 1075.60 22.00 213 11472 2592 64484455
Blood prolactin abnormal 1075.12 22.00 212 11473 2520 64484527
Disturbance in social behaviour 960.61 22.00 205 11480 3682 64483365
Sexual dysfunction 940.11 22.00 221 11464 6250 64480797
Metabolic disorder 861.46 22.00 213 11472 7484 64479563
Personality change 774.39 22.00 200 11485 8393 64478654
Dystonia 743.73 22.00 230 11455 18635 64468412
Dyskinesia 659.51 22.00 253 11432 39135 64447912
Sedation 636.30 22.00 250 11435 41212 64445835
Suicide attempt 534.10 22.00 259 11426 70748 64416299
Blood glucose increased 348.05 22.00 218 11467 97855 64389192
Completed suicide 274.59 22.00 265 11420 224149 64262898
Tardive dyskinesia 201.19 22.00 72 11613 9106 64477941
Insurance issue 179.69 22.00 50 11635 2776 64484271
Akathisia 171.23 22.00 68 11617 11442 64475605
Schizophrenia 152.37 22.00 62 11623 11106 64475941
Mania 145.35 22.00 67 11618 16219 64470828
Adverse drug reaction 110.33 22.00 80 11605 45384 64441663
Suicidal ideation 109.35 22.00 93 11592 66449 64420598
Drug ineffective 107.52 22.00 364 11321 839883 63647164
Hallucination, auditory 89.92 22.00 49 11636 16890 64470157
Condition aggravated 87.76 22.00 202 11483 372224 64114823
Hyperprolactinaemia 74.64 22.00 28 11657 4037 64483010
Psychotic disorder 73.04 22.00 56 11629 34522 64452525
Persistent genital arousal disorder 66.61 22.00 14 11671 231 64486816
Confabulation 63.02 22.00 15 11670 444 64486603
Delusion 61.07 22.00 39 11646 17975 64469072
Weight increased 53.75 22.00 119 11566 213229 64273818
Extrapyramidal disorder 53.40 22.00 37 11648 19515 64467532
Restlessness 52.20 22.00 49 11636 39736 64447311
Serotonin syndrome 50.81 22.00 48 11637 39234 64447813
Neuroleptic malignant syndrome 47.41 22.00 38 11647 24958 64462089
Agitation 46.48 22.00 68 11617 88299 64398748
Off label use 45.36 22.00 230 11455 632576 63854471
Diarrhoea 45.06 22.00 39 11646 722665 63764382
Psychotic symptom 43.94 22.00 16 11669 2122 64484925
Aggression 42.51 22.00 47 11638 46185 64440862
Blood prolactin increased 39.43 22.00 17 11668 3511 64483536
Negative symptoms in schizophrenia 39.29 22.00 8 11677 112 64486935
Distractibility 39.10 22.00 11 11674 635 64486412
Anaemia 35.82 22.00 12 11673 378668 64108379
Pneumonia 33.86 22.00 31 11654 559545 63927502
Personality change due to a general medical condition 31.71 22.00 7 11678 147 64486900
Tremor 31.07 22.00 77 11608 148153 64338894
Depression 30.13 22.00 87 11598 183204 64303843
Parkinsonism 29.73 22.00 23 11662 14350 64472697
Paranoia 29.19 22.00 24 11661 16328 64470719
Negative thoughts 27.59 22.00 10 11675 1308 64485739
Arthralgia 27.33 22.00 24 11661 442236 64044811
General physical health deterioration 26.55 22.00 3 11682 204422 64282625
Joint swelling 25.96 22.00 4 11681 215378 64271669
Galactorrhoea 24.88 22.00 12 11673 3207 64483840
Catatonia 24.59 22.00 16 11669 7604 64479443
Sedation complication 24.59 22.00 18 11667 10336 64476711
Oculogyric crisis 24.39 22.00 11 11674 2527 64484520
Hyperthermia 24.02 22.00 21 11664 15529 64471518
Parasomnia 23.59 22.00 7 11678 488 64486559
Infection 23.30 22.00 3 11682 184877 64302170
Prescribed underdose 23.26 22.00 22 11663 17993 64469054
Change in seizure presentation 22.14 22.00 6 11679 301 64486746

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
5-hydroxytryptamine receptor 1A GPCR AGONIST Ki 8.17 IUPHAR
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 8.69 IUPHAR
D(2) dopamine receptor GPCR ANTAGONIST Ki 8.77 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
213046 PUBCHEM_CID
1040027 RXNORM
177747 MMSL
27589 MMSL
d07705 MMSL
013606 NDDF
013607 NDDF
703115008 SNOMEDCT_US
703116009 SNOMEDCT_US
715585000 SNOMEDCT_US
D000069056 MESH_DESCRIPTOR_UI
C2003424 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 13668-466 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 46708-494 TABLET, FILM COATED 20 mg ORAL ANDA 31 sections
Lurasidone Hydrochloride Human Prescription Drug Label 1 46708-495 TABLET, FILM COATED 40 mg ORAL ANDA 31 sections
Lurasidone Hydrochloride Human Prescription Drug Label 1 46708-496 TABLET, FILM COATED 60 mg ORAL ANDA 31 sections
Lurasidone Hydrochloride Human Prescription Drug Label 1 46708-497 TABLET, FILM COATED 80 mg ORAL ANDA 31 sections
Lurasidone Hydrochloride Human Prescription Drug Label 1 46708-498 TABLET, FILM COATED 120 mg ORAL ANDA 31 sections
Lurasidone Hydrochloride Human Prescription Drug Label 1 62332-494 TABLET, FILM COATED 20 mg ORAL ANDA 31 sections
Lurasidone Hydrochloride Human Prescription Drug Label 1 62332-495 TABLET, FILM COATED 40 mg ORAL ANDA 31 sections
Lurasidone Hydrochloride Human Prescription Drug Label 1 62332-496 TABLET, FILM COATED 60 mg ORAL ANDA 31 sections
Lurasidone Hydrochloride Human Prescription Drug Label 1 62332-497 TABLET, FILM COATED 80 mg ORAL ANDA 31 sections
Lurasidone Hydrochloride Human Prescription Drug Label 1 62332-498 TABLET, FILM COATED 120 mg ORAL ANDA 31 sections
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 63402-302 TABLET, FILM COATED 20 mg ORAL NDA 32 sections
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 63402-304 TABLET, FILM COATED 40 mg ORAL NDA 32 sections
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 63402-306 TABLET, FILM COATED 60 mg ORAL NDA 32 sections
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 63402-308 TABLET, FILM COATED 80 mg ORAL NDA 32 sections
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 63402-312 TABLET, FILM COATED 120 mg ORAL NDA 32 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 65162-082 TABLET, COATED 60 mg ORAL ANDA 29 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 65162-879 TABLET, COATED 20 mg ORAL ANDA 29 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 65162-880 TABLET, COATED 40 mg ORAL ANDA 29 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 65162-881 TABLET, COATED 80 mg ORAL ANDA 29 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 65162-882 TABLET, COATED 120 mg ORAL ANDA 29 sections
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 70518-1812 TABLET, FILM COATED 60 mg ORAL NDA 31 sections
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 70518-1936 TABLET, FILM COATED 120 mg ORAL NDA 31 sections
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 70518-3010 TABLET, FILM COATED 80 mg ORAL NDA 31 sections