Lumateperone Tosylate

Treats schizophrenia. Sold as Caplyta. Every FDA application for this active ingredient: 1 branded and 2 generic.

As of Nov 15, 2026, FDA lists 3 applications for Lumateperone Tosylate (sold as Caplyta), first approved Dec 20, 2019, with 5 new uses approved and 0 published complete response letters.

First approved: Dec 20, 2019
Applications: 3
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $351M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Caplyta	Part D	$351M	+31%	35,880

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

CAPLYTA 10.5 MG CAPSULE: $57.22 per unitBrand · +5% in a year
CAPLYTA 21 MG CAPSULE: $57.20 per unitBrand · +5% in a year
CAPLYTA 42 MG CAPSULE: $57.24 per unitBrand · +5% in a year

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 20, 2019	CaplytaNDA 209500 · New molecular entity	Intra-Cellular	7	Marketed
—	Lumateperone TosylateANDA 219142	Hetero Labs Limited	0	Discontinued
—	Lumateperone TosylateANDA 219248	Msn Laboratories Private Ltd	0	Discontinued

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