Naltrexone intramuscular suspension — Competitive Intelligence Brief

Naltrexone intramuscular suspension (Naltrexone intramuscular suspension) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid receptor antagonist. Area: Psychiatry.

phase 3 Opioid receptor antagonist Opioid receptor Psychiatry Small molecule

Target snapshot

Naltrexone intramuscular suspension (Naltrexone intramuscular suspension) — University of Oslo. Naltrexone is an opioid receptor antagonist that blocks the action of opioids at their receptor sites.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Naltrexone intramuscular suspension TARGET	Naltrexone intramuscular suspension	University of Oslo	phase 3	Opioid receptor antagonist	Opioid receptor
Lybalvi	SAMIDORPHAN	Alkermes Inc	marketed	Atypical Antipsychotic [EPC]	Mu-type opioid receptor	2021-01-01
Korsuva	DIFELIKEFALIN	Vifor Intl	marketed	Kappa Opioid Receptor Agonist	Kappa-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
Olinvyk	OLICERIDINE	Trevena	marketed		Mu-type opioid receptor	2020-01-01
BENZHYDROCODONE	BENZHYDROCODONE		marketed	Opioid analgesic combination; full mu-opioid agonist with non-opioid analgesic	Mu-opioid receptors (primary); delta and kappa opioid receptors (secondary); central nervous system pain pathways	2018-01-01
Symproic	NALDEMEDINE	Bdsi	marketed	Opioid Antagonist	Mu-type opioid receptor	2017-01-01

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 (Opioid receptor antagonist class)

1. Albert Einstein Healthcare Network · 1 drug in this class
2. Cephalon · 1 drug in this class
3. Leiden University Medical Center · 1 drug in this class
4. New York State Psychiatric Institute · 1 drug in this class
5. Paion UK Ltd. · 1 drug in this class
6. Pocket Naloxone Corp · 1 drug in this class
7. State University of New York - Upstate Medical University · 1 drug in this class
8. Texas Tech University · 1 drug in this class
9. The Scripps Research Institute · 1 drug in this class
10. University of North Carolina, Chapel Hill · 1 drug in this class