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NTX/BUP — Competitive Intelligence Brief
phase 3
Opioid agonist-antagonist combination
Mu-opioid receptor (μ-OR)
Psychiatry / Addiction Medicine
Small molecule
Live · refreshed every 30 min
Target snapshot
NTX/BUP (NTX/BUP) — Alkermes, Inc.. NTX/BUP is a fixed-dose combination of naltrexone (an opioid antagonist) and buprenorphine (a partial opioid agonist) that reduces opioid cravings and withdrawal symptoms while blocking euphoric effects of additional opioid use.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| NTX/BUP TARGET | NTX/BUP | Alkermes, Inc. | phase 3 | Opioid agonist-antagonist combination | Mu-opioid receptor (μ-OR) | |
| Zubsolv sublingual tablets | Zubsolv sublingual tablets | Indivior Inc. | marketed | Opioid agonist-antagonist combination | Mu-opioid receptor (buprenorphine); opioid receptors (naloxone antagonism) | |
| 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) | |
| Buprenorphine Naloxone | Buprenorphine Naloxone | Johns Hopkins University | marketed | Opioid agonist-antagonist combination | Mu-opioid receptor (buprenorphine as partial agonist; naloxone as antagonist) | |
| Oxycodone Naltrexone (a) | Oxycodone Naltrexone (a) | Elite Laboratories, Inc | phase 3 | Opioid agonist-antagonist combination | Mu-opioid receptor (oxycodone agonist); opioid receptors (naltrexone antagonist) | |
| Oxycodone Naltrexone (b) | Oxycodone Naltrexone (b) | Elite Laboratories, Inc | phase 3 | Opioid agonist-antagonist combination | Mu-opioid receptor (oxycodone); opioid receptors (naltrexone antagonism) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
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). NTX/BUP — Competitive Intelligence Brief. https://druglandscape.com/ci/ntx-bup. Accessed 2026-06-10.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing