Latuda
(Lurasidone)ApprovedSmall molecule
Lurasidone is used to treat schizophrenia and bipolar depression. It helps reduce symptoms like hallucinations, delusions, and depressed mood by affecting certain chemicals in the brain.[2] Latuda is currently approved and in use across 9 indications[4].[1]
Latuda is one of 313 small molecule programs targeting Bipolar I Disorder. It is currently in Approved.
9
Indications
50
Total Trials
2
Active Trials
312
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
10
Patents
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
583 competitors in Schizophrenia
#DrugCompanyPhaseTrials
1Latuda
SSunovion Respiratory Development Inc.
Approved
Celexa
AbbViePreclinical
Resotran
TakedaPreclinical
Zocor
OOrganon and Co
Preclinical
Depakote
AbbViePreclinical
Ibrance
PfizerPreclinical
Comtan
Orion Corporation, Orion PharmaPreclinical
Vivarin
HHikma Pharmaceuticals LLC
Preclinical
Compazine
GGlaxo Dba Glaxosmithkline
Preclinical
Rapamune
PPrism Pharmaceuticals
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Schizophrenia18 trials
Show 15 more trials
Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in Unmedicated Schizophrenia
Completed·—·Phase 4·NCT03304457·100 enrolled
Major Depressive Disorder3 trials
Bipolar Depression3 trials
Depression3 trials
Cognitive impairment2 trials
14 more indications
Bipolar I Disorder2 trials
Oral2 trials
Bipolar Disorder2 trials
Sleep Quality1 trial
Randomized1 trial
Cognitive Function1 trial
Regulatory
FDA Approval Timeline[5]
Dec 7, 2011
LATUDA
NDA NDA200603
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Latuda drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Lurasidone. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Latuda. U.S. Food & Drug Administration.
- [7]
Details
Drug Info
Quick Facts
Patent Landscape[6]
Patent Cliff
Nov 26, 2026
Earliest patent expiration — generic entry possible after this date
Patent #Expires
8729085May 26, 2026
9555027May 26, 2026
9907794May 26, 2026
8883794May 26, 2026
9907794*PEDNov 26, 2026
5 more patents
8883794*PEDNov 26, 2026
8729085*PEDNov 26, 2026
9259423May 23, 2031
9827242May 23, 2031
9259423*PEDNov 23, 2031