Caplyta - (10.5 and 21 mg ; Capsule, Oral)

Generic Name	Lumateperone Tosylate	Innovator	Intra-Cellular
Dosage	10.5 and 21 mg ; Capsule, Oral	Branded US Sales	Less Than $1000 mn
Probable FTF	More Than 5	Known Para IV Filers	More Than 5
Other ANDA developers	Less Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	CAPLYTA is an atypical antipsychotic indicated for the treatment of: • Schizophrenia in adults. • Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate.
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
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Chronology Of Events

Caplyta - (42 mg ; Capsule, Oral)

Generic Name	Lumateperone Tosylate	Innovator	Intra-Cellular
Dosage	42 mg ; Capsule, Oral	Branded US Sales	Less Than $1000 mn
Probable FTF	More Than 5	Known Para IV Filers	More Than 5
Other ANDA developers	Less Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	CAPLYTA is an atypical antipsychotic indicated for the treatment of: • Schizophrenia in adults. • Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate.
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
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*****	*** \ *********	*** **, ****	*******	****	*** ****** *** ****
** *****'*	*** \ *********	*** **, ****	*******	****	*** ****** *** ****

Chronology Of Events