Who are High Bup/Nal Dose's main competitors?

Direct comparators (same drug class / molecular target / therapeutic area): Buprenorphine Naloxone, Suboxone (SCH 000484), Buprenorphine, Naloxone Drug Combination, Zubsolv sublingual tablets, Low Dose ALKS 5461, NTX/BUP.

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Last reviewed 2026-06-10 · How we verify

High Bup/Nal Dose — Competitive Intelligence Brief

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

High Bup/Nal Dose (High Bup/Nal Dose) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid agonist-antagonist combination. Area: Psychiatry / Addiction Medicine.

phase 3 Opioid agonist-antagonist combination Mu-opioid receptor (buprenorphine); opioid receptors (naloxone antagonism) Psychiatry / Addiction Medicine Small molecule Live · refreshed every 30 min

Target snapshot

High Bup/Nal Dose (High Bup/Nal Dose) — New York State Psychiatric Institute. A combination of buprenorphine (partial opioid agonist) and naloxone (opioid antagonist) at higher doses to treat opioid use disorder with improved efficacy and safety.

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
High Bup/Nal Dose TARGET	High Bup/Nal Dose	New York State Psychiatric Institute	phase 3	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine); opioid receptors (naloxone antagonism)
Buprenorphine Naloxone	Buprenorphine Naloxone	Johns Hopkins University	marketed	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine as partial agonist; naloxone as antagonist)
Suboxone (SCH 000484)	Suboxone (SCH 000484)	Merck Sharp & Dohme LLC	marketed	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine); opioid receptors (naloxone)
Buprenorphine, Naloxone Drug Combination	Buprenorphine, Naloxone Drug Combination	The University of Texas Health Science Center, Houston	marketed	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine as partial agonist; naloxone as antagonist)
Zubsolv sublingual tablets	Zubsolv sublingual tablets	Indivior Inc.	marketed	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine); opioid receptors (naloxone antagonism)
Low Dose ALKS 5461	Low Dose ALKS 5461	Alkermes, Inc.	phase 3	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine component); opioid receptor antagonism (samidorphan component)
NTX/BUP	NTX/BUP	Alkermes, Inc.	phase 3	Opioid agonist-antagonist combination	Mu-opioid receptor (μ-OR)

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 agonist-antagonist combination class)

New York State Psychiatric Institute · 2 drugs in this class
Elite Laboratories, Inc · 2 drugs in this class
Alkermes, Inc. · 2 drugs in this class
Merck Sharp & Dohme LLC · 1 drug in this class
Orexo AB · 1 drug in this class
The University of Texas Health Science Center, Houston · 1 drug in this class
Indivior Inc. · 1 drug in this class
Johns Hopkins University · 1 drug in this class

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Cite this brief

Drug Landscape (2026). High Bup/Nal Dose — Competitive Intelligence Brief. https://druglandscape.com/ci/high-bup-nal-dose. Accessed 2026-06-10.

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