Who are OLZ/SAM's main competitors?

Direct comparators (same drug class / molecular target / therapeutic area): Lybalvi, SAMIDORPHAN L-MALATE, Caplyta, Nuplazid, Rexulti, Vraylar.

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Every 30 minutes from primary sources (FDA, EMA, MHRA, PMDA, ClinicalTrials.gov, USPTO). Subscribe to the RSS feed below for push alerts.

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Last reviewed 2026-05-13 · How we verify

OLZ/SAM — Competitive Intelligence Brief

OLZ/SAM (OLZ/SAM) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Atypical antipsychotic. Area: Psychiatry.

phase 3 Atypical antipsychotic Serotonin 5-HT2A receptor, Dopamine D2 receptor, μ-opioid receptor Psychiatry Small molecule Live · refreshed every 30 min

Target snapshot

OLZ/SAM (OLZ/SAM) — Alkermes, Inc.. OLZ/SAM is an oral, fixed-dose combination of olanzapine and samidorphan, a partial agonist at the μ-opioid receptor.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
OLZ/SAM TARGET	OLZ/SAM	Alkermes, Inc.	phase 3	Atypical antipsychotic	Serotonin 5-HT2A receptor, Dopamine D2 receptor, μ-opioid receptor
Lybalvi	SAMIDORPHAN	Alkermes Inc	marketed	Atypical Antipsychotic [EPC]	Mu-type opioid receptor	2021-01-01
SAMIDORPHAN L-MALATE	SAMIDORPHAN L-MALATE		marketed	Atypical Antipsychotic [EPC]	dopamine and serotonin type 2 (5HT2) receptors, opioid receptors	2021-01-01
Caplyta	LUMATEPERONE	Intra-Cellular	marketed	Atypical Antipsychotic [EPC]	5-hydroxytryptamine receptor 2A	2019-01-01
Nuplazid	PIMAVANSERIN	Acadia Pharms Inc	marketed	Atypical Antipsychotic	5-hydroxytryptamine receptor 2A	2016-01-01
Rexulti	BREXPIPRAZOLE	Otsuka	marketed	Atypical Antipsychotic [EPC]	D(2) dopamine receptor	2015-01-01
Vraylar	CARIPRAZINE	AbbVie	marketed	Atypical Antipsychotic [EPC]	D(3) dopamine receptor	2015-01-01

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)

2031-08-23 — Lybalvi · 11351166 · US
2031-08-23 — Lybalvi · 11241425 · US
2031-08-23 — Lybalvi · 9126977 · US
2031-08-23 — Lybalvi · 10300054 · US
2031-08-23 — Lybalvi · 10716785 · US
2031-08-23 — Lybalvi · 11185541 · US
2031-08-23 — Lybalvi · 9517235 · US
2031-08-30 — Lybalvi · 9119848 · US
2032-02-13 — Lybalvi · 8778960 · US

Sponsor landscape (Atypical antipsychotic class)

Shanghai Mental Health Center · 10 drugs in this class
AstraZeneca · 6 drugs in this class
Otsuka Pharmaceutical Development & Commercialization, Inc. · 5 drugs in this class
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · 4 drugs in this class
Eli Lilly and Company · 4 drugs in this class
Otsuka Pharmaceutical Co., Ltd. · 3 drugs in this class
Medical University of Vienna · 2 drugs in this class
Organon and Co · 2 drugs in this class
Chengdu Kanghong Pharmaceutical Group Co., Ltd. · 2 drugs in this class
H. Lundbeck A/S · 2 drugs in this class

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Cite this brief

Drug Landscape (2026). OLZ/SAM — Competitive Intelligence Brief. https://druglandscape.com/ci/olz-sam. Accessed 2026-05-13.

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