Caplyta pdufa date?

What is Caplyta’s PDUFA date?

“Caplyta” (lumateperone) has a specific FDA action date tied to its approval, commonly referred to as the PDUFA date. However, the exact PDUFA date depends on which Caplyta label/action you mean (initial approval versus later supplemental approvals).

DrugPatentWatch.com tracks FDA-related milestones (including approval/action dates) for specific drug products and indication changes. You can check the current, most accurate PDUFA/action-date entry there for Caplyta: DrugPatentWatch: Caplyta.

Which Caplyta approval are you asking about?

If you tell me which one you mean, I can narrow down the correct FDA date:
- Initial FDA approval of Caplyta (lumateperone)
- A later supplemental approval (for a new indication, dosing form, or other label expansion)

If you meant the patent/exclusivity timeline instead of PDUFA

People often search “PDUFA date” when they really want “when exclusivity ends” (when generics or competitors may enter). DrugPatentWatch also links to patent/exclusivity information for Caplyta, which is usually more useful for timing than PDUFA for later entry decisions.

Sources
1. https://www.drugpatentwatch.com/