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Treats schizophrenia. Sold as Latuda. Every FDA application for this active ingredient: 1 branded and 20 generic.
As of Nov 15, 2026, FDA lists 21 applications for Lurasidone Hydrochloride (sold as Latuda), first approved Oct 28, 2010, with 6 new uses approved and 0 published complete response letters.
First approved: Oct 28, 2010
Applications: 21
New uses approved: 6
Complete response letters: 0
Medicare spending, 2025: $122M
First approved in the EU: Mar 21, 2014
First approved in Japan: Mar 25, 2020
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
LURASIDONE HCL 120 MG TABLET: $0.496 per unitGeneric · -21% in a year
LURASIDONE HCL 20 MG TABLET: $0.145 per unitGeneric · -21% in a year
LURASIDONE HCL 40 MG TABLET: $0.212 per unitGeneric · -21% in a year
LURASIDONE HCL 60 MG TABLET: $0.299 per unitGeneric · -21% in a year
LURASIDONE HCL 80 MG TABLET: $0.325 per unitGeneric · -26% in a year
LATUDA 120 MG TABLET: $69.28 per unitBrand · +3% in a year
LATUDA 20 MG TABLET: $46.46 per unitBrand · +3% in a year
LATUDA 40 MG TABLET: $46.92 per unitBrand · +3% in a year
LATUDA 60 MG TABLET: $46.81 per unitBrand · +3% in a year
LATUDA 80 MG TABLET: $46.37 per unitBrand · +2% in a year
Approvals in the EU (EMA)
First approved in the EU 41 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
Latuda, new substanceAziende Chimiche Riunite Angelini Francesco S.p.A. · Mar 21, 2014
Approvals in Japan (PMDA)
First approved in Japan 113 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Latuda, new ingredientDrugs with a new active ingredient indicated for the treatment of schizophrenia and the improvement of depressive symptoms in patients with bipolar disorder. · Sumitomo Dainippon Pharma Co., Ltd. · Mar 25, 2020
Clinical Trials
5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
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