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Buprenorphine (Subutex) — Competitive Intelligence Brief
marketed
Partial opioid agonist
Mu-opioid receptor (μ-OR)
Psychiatry / Addiction Medicine
Small molecule
Live · refreshed every 30 min
Target snapshot
Buprenorphine (Subutex) (Buprenorphine (Subutex)) — Indivior Inc.. Buprenorphine is a partial opioid agonist that binds to mu-opioid receptors in the brain, reducing cravings and withdrawal symptoms while producing a lower risk of overdose compared to full opioid agonists.
Comparator set (3 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| Buprenorphine (Subutex) TARGET | Buprenorphine (Subutex) | Indivior Inc. | marketed | Partial opioid agonist | Mu-opioid receptor (μ-OR) | |
| Subutex | Buprenorphine Hydrochloride | Indivior | marketed | partial opioid agonist | mu-opioid receptor, kappa-opioid receptor | 1981-01-01 |
| Subutex | BUPRENORPHINE | Purdue Pharma Lp | marketed | Partial Opioid Agonist | mu-opioid receptor, kappa-opioid receptor | 1981-01-01 |
| PBO-N/PBO-B | PBO-N/PBO-B | Alkermes, Inc. | phase 3 | partial opioid agonist | mu-opioid receptor |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
- — Subutex · 8236755 · Formulation · US
- — Subutex · 8236292 · Formulation · US
- — Subutex · 8147866 · Formulation · US
- — Subutex · 9655843 · Formulation · US
- — Subutex · 9782402 · Formulation · US
- — Subutex · 9827241 · Formulation · US
- — Subutex · 10198218 · Method of Use · US
- — Subutex · 10592168 · Method of Use · US
- — Subutex · 9498432 · Formulation · US
- — Subutex · 9272044 · Method of Use · US
- — Subutex · 10558394 · Formulation · US
- — Subutex · 8975270 · Formulation · US
- — Subutex · 8921387 · Formulation · US
- — Subutex · 11135215 · Formulation · US
- — Subutex · 12318379 · Formulation · US
- — Subutex · 12161640 · Formulation · US
- — Subutex · 11110084 · Formulation · US
- — Subutex · 10912772 · Method of Use · US
- — Subutex · 9937164 · Formulation · US
- — Subutex · 9901539 · Method of Use · US
- — Subutex · 11000520 · Method of Use · US
- — Subutex · 11839611 · Method of Use · US
- — Subutex · 10646484 · Method of Use · US
Sponsor landscape (Partial opioid agonist class)
- Indivior Inc. · 1 drug in this class
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Cite this brief
Drug Landscape (2026). Buprenorphine (Subutex) — Competitive Intelligence Brief. https://druglandscape.com/ci/buprenorphine-subutex. Accessed 2026-06-10.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing