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

Stem definition	Drug id	CAS RN
	4168	367514-87-2

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
60	mg	O

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
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 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
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 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
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 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
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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	8.38	Basic
pKa2	0.27	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
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN	ANTAGONIST	Ki	9.00	DRUG LABEL	DRUG LABEL
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN	ANTAGONIST	Ki	9.33	DRUG LABEL	DRUG LABEL
5-hydroxytryptamine receptor 7	GPCR	P34969	5HT7R_HUMAN	ANTAGONIST	Ki	9.31	DRUG LABEL
Alpha-2C adrenergic receptor	GPCR	P18825	ADA2C_HUMAN		Ki	7.97	DRUG LABEL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN		Ki	7.39	DRUG LABEL
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Ki	8.20	DRUG LABEL
D(2) dopamine receptor	GPCR		DRD2_RAT	ANTAGONIST	Ki	8.77	IUPHAR
5-hydroxytryptamine receptor 1A	GPCR		5HT1A_RAT	AGONIST	Ki	8.17	IUPHAR
5-hydroxytryptamine receptor 2A	GPCR		5HT2A_RAT	ANTAGONIST	Ki	8.69	IUPHAR

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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