Last reviewed · How we verify
Placebo First, then ORADUR® — Competitive Intelligence Brief
phase 3
Opioid partial agonist
Opioid receptors
Pain management
Small molecule
Live · refreshed every 30 min
Target snapshot
Placebo First, then ORADUR® (Placebo First, then ORADUR®) — Orient Pharma Co., Ltd.. ORADUR is a sustained-release formulation of buprenorphine.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| Placebo First, then ORADUR® TARGET | Placebo First, then ORADUR® | Orient Pharma Co., Ltd. | phase 3 | Opioid partial agonist | Opioid receptors | |
| SAMIDORPHAN L-MALATE | SAMIDORPHAN L-MALATE | marketed | Atypical Antipsychotic [EPC] | dopamine and serotonin type 2 (5HT2) receptors, opioid receptors | 2021-01-01 | |
| 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 | |
| NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | marketed | kappa opioid receptors, mu opioid receptors | 1979-01-01 | ||
| Methadone Hydrochloride | METHADONE | Specgx Llc | marketed | Opioid Agonist | mu-opioid receptors, NMDA receptor | 1947-01-01 |
| morphine ,ketorolac | morphine ,ketorolac | Jose Antonio Bernia Gil | marketed | Opioid analgesic + NSAID combination | Opioid receptors (μ, δ, κ); COX-1 and COX-2 enzymes | |
| Naloxone Hydrochloride | Naloxone Hydrochloride | Pfizer Inc. | marketed | Mixed opioid agonist-antagonist with opioid antagonist | Opioid receptors (mu, kappa) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
- — Naloxone Hydrochloride · 7731686 · Formulation · US
- — Naloxone Hydrochloride · 10960155 · Formulation · US
- — Naloxone Hydrochloride · 11590286 · Formulation · US
- — Naloxone Hydrochloride · 9238108 · Formulation · US
- — Naloxone Hydrochloride · 8206360 · Formulation · US
- — Naloxone Hydrochloride · 9724471 · Formulation · US
- — Naloxone Hydrochloride · 7947017 · Formulation · US
- — Naloxone Hydrochloride · 7749194 · Formulation · US
- — Naloxone Hydrochloride · 8231573 · Formulation · US
- — Naloxone Hydrochloride · 8226610 · Formulation · US
- — Naloxone Hydrochloride · 8021344 · Formulation · US
- — Naloxone Hydrochloride · 9814838 · Formulation · US
- — Naloxone Hydrochloride · 8939943 · Formulation · US
- — Naloxone Hydrochloride · 9022022 · Formulation · US
- — Naloxone Hydrochloride · 10322239 · Method of Use · US
- — Naloxone Hydrochloride · 9474869 · Formulation · US
- — Naloxone Hydrochloride · 10143792 · Method of Use · US
- — Naloxone Hydrochloride · 10143972 · Method of Use · US
- — Naloxone Hydrochloride · 8627816 · Formulation · US
- — Naloxone Hydrochloride · 12458591 · Method of Use · US
- — Naloxone Hydrochloride · 11806428 · Formulation · US
- — Naloxone Hydrochloride · 11020343 · Method of Use · US
- — Naloxone Hydrochloride · 9517307 · Formulation · US
- — Naloxone Hydrochloride · 11135155 · Formulation · US
- — Naloxone Hydrochloride · 11617713 · Formulation · US
- — Naloxone Hydrochloride · 11628139 · Formulation · US
- — Naloxone Hydrochloride · 10973814 · Formulation · US
- — Naloxone Hydrochloride · 10722510 · Formulation · US
- — Naloxone Hydrochloride · 11975096 · Formulation · US
- — Naloxone Hydrochloride · 12414915 · Formulation · US
Sponsor landscape (Opioid partial agonist class)
- Brigham and Women's Hospital · 1 drug in this class
- Orexo AB · 1 drug in this class
- Orient Pharma Co., Ltd. · 1 drug in this class
- Rutgers, The State University of New Jersey · 1 drug in this class
- Yih-Ing Hser · 1 drug in this class
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Cite this brief
Drug Landscape (2026). Placebo First, then ORADUR® — Competitive Intelligence Brief. https://druglandscape.com/ci/placebo-first-then-oradur. Accessed 2026-05-16.
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