LYBALVI — Competitive Intelligence Brief

LYBALVI (LYBALVI) competitive landscape: 1 comparator, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Atypical antipsychotic with opioid antagonist. Area: Psychiatry.

marketed Atypical antipsychotic with opioid antagonist D2 dopamine receptor, 5-HT7 serotonin receptor, mu-opioid receptor Psychiatry Small molecule

Target snapshot

LYBALVI (LYBALVI) — Alkermes, Inc.. LYBALVI is a combination of lurasidone (an atypical antipsychotic) and samidorphan (an opioid antagonist) that blocks dopamine and serotonin receptors while antagonizing opioid receptors to reduce antipsychotic-induced weight gain.

Comparator set (1 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
LYBALVI TARGET	LYBALVI	Alkermes, Inc.	marketed	Atypical antipsychotic with opioid antagonist	D2 dopamine receptor, 5-HT7 serotonin receptor, mu-opioid receptor
Olanzapine-samidorphan + exercise	Olanzapine-samidorphan + exercise	New York State Psychiatric Institute	marketed	Atypical antipsychotic with opioid antagonist	Dopamine receptors, serotonin receptors (olanzapine); mu-opioid receptor (samidorphan)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Atypical antipsychotic with opioid antagonist class)

1. Alkermes, Inc. · 1 drug in this class
2. New York State Psychiatric Institute · 1 drug in this class