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Treats schizophrenia. Sold as Secuado. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Asenapine (sold as Secuado), first approved Oct 11, 2019, with 0 new uses approved and 0 published complete response letters.
First approved: Oct 11, 2019
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $27.7M
First approved in the EU: Sep 1, 2010
First approved in Japan: Mar 28, 2016
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Asenapine Maleate
Part D
$14.3M
-19%
9,481
Secuado
Part D
$7.1M
+16%
872
Saphris
Part D
$6.4M
-11%
776
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
ASENAPINE 10 MG TABLET SL: $2.36 per unitGeneric · -5% in a year
ASENAPINE 2.5 MG TABLET SL: $3.10 per unitGeneric · +1% in a year
ASENAPINE 5 MG TABLET SL: $2.09 per unitGeneric · -7% in a year
SECUADO 3.8 MG/24 HR PATCH: $49.11 per unitBrand · +5% in a year
SECUADO 5.7 MG/24 HR PATCH: $49.05 per unitBrand · +7% in a year
SECUADO 7.6 MG/24 HR PATCH: $48.83 per unitBrand · +5% in a year
Approvals in the EU (EMA)
First approved in the EU 109 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
First approved in Japan 42 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Sycrest Sublingual, new ingredientDrugs with a new active ingredient indicated for the treatment of schizophrenia. · Meiji Seika Pharma Co., Ltd. · Mar 28, 2016
Clinical Trials
1 open or ongoing study names 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
