Lybalvi - (5mg ; Eq 10mg Base,10 mg ; Eq 10 mg Base, 15 mg ; Eq 10 mg Base , 20 mg ; Eq 10mg Base ; Tablet)

Generic Name	Olanzapine; Samidorphan L- Malate	Innovator	Alkermes
Dosage	5mg ; Eq 10mg Base,10 mg ; Eq 10 mg Base, 15 mg ; Eq 10 mg Base , 20 mg ; Eq 10mg Base ; Tablet	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	Less Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, indicated for the treatment of: • Schizophrenia in adults • Bipolar I disorder in adults o Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate o Maintenance monotherapy treatment
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