Who are High Dose ALKS 5461's main competitors?

No direct comparators detected in our index.

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Last reviewed 2026-06-10 · How we verify

High Dose ALKS 5461 — Competitive Intelligence Brief

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

High Dose ALKS 5461 (High Dose ALKS 5461) competitive landscape: 0 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid receptor partial agonist / antagonist combination. Area: Pain Management / Psychiatry.

phase 3 Opioid receptor partial agonist / antagonist combination Mu-opioid receptor (partial agonist via buprenorphine; antagonist via samidorphan) Pain Management / Psychiatry Small molecule Live · refreshed every 30 min

Target snapshot

High Dose ALKS 5461 (High Dose ALKS 5461) — Alkermes, Inc.. ALKS 5461 is a combination of buprenorphine and samidorphan that acts as a partial mu-opioid receptor agonist while blocking opioid-induced side effects through antagonism at the opioid receptor.

Comparator set

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
High Dose ALKS 5461 TARGET	High Dose ALKS 5461	Alkermes, Inc.	phase 3	Opioid receptor partial agonist / antagonist combination	Mu-opioid receptor (partial agonist via buprenorphine; antagonist via 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 (Opioid receptor partial agonist / antagonist combination class)

Alkermes, Inc. · 1 drug in this class

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Cite this brief

Drug Landscape (2026). High Dose ALKS 5461 — Competitive Intelligence Brief. https://druglandscape.com/ci/high-dose-alks-5461. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing