Last reviewed · How we verify
OROS hydromorphone HCl — Competitive Intelligence Brief
marketed
Opioid agonist
Mu-opioid receptor
Pain Management
Small molecule
Live · refreshed every 30 min
Target snapshot
OROS hydromorphone HCl (OROS hydromorphone HCl) — Janssen-Cilag International NV. OROS hydromorphone HCl is an extended-release opioid agonist that binds to mu-opioid receptors in the central nervous system to provide sustained pain relief.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| OROS hydromorphone HCl TARGET | OROS hydromorphone HCl | Janssen-Cilag International NV | marketed | Opioid agonist | Mu-opioid receptor | |
| 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 | |
| Dilaudid-Hp | HYDROMORPHONE | Fresenius Kabi | marketed | Opioid Agonist | mu-opioid receptor | 1984-01-01 |
| Dilaudid-Hp | Hydromorphone Hydrochloride | Fresenius Kabi | marketed | Opioid agonist | Mu-opioid receptor | 1984-01-01 |
| Subutex | BUPRENORPHINE | Purdue Pharma Lp | marketed | Partial Opioid Agonist | mu-opioid receptor, kappa-opioid receptor | 1981-01-01 |
| Subutex | Buprenorphine Hydrochloride | Indivior | marketed | partial opioid agonist | mu-opioid receptor, kappa-opioid receptor | 1981-01-01 |
| Levo-Dromoran | LEVORPHANOL | Bausch Health | marketed | Opioid Agonist | mu-opioid receptor | 1953-01-01 |
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 (Opioid agonist class)
- University of British Columbia · 3 drugs in this class
- Ciusss de L'Est de l'Île de Montréal · 2 drugs in this class
- Kaohsiung Veterans General Hospital. · 2 drugs in this class
- Nycomed · 2 drugs in this class
- Rigshospitalet, Denmark · 2 drugs in this class
- University Hospital, Ghent · 2 drugs in this class
- Fundación Universitaria de Ciencias de la Salud · 2 drugs in this class
- Erasme University Hospital · 2 drugs in this class
- Cephalon · 2 drugs in this class
- Corporacion Parc Tauli · 1 drug in this class
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Push every new event for this competitive set into your RSS reader, IFTTT/Zapier workflow, or email digest:
- OROS hydromorphone HCl CI watch — RSS
- OROS hydromorphone HCl CI watch — Atom
- OROS hydromorphone HCl CI watch — JSON
- OROS hydromorphone HCl alone — RSS
- Whole Opioid agonist class — RSS
Cite this brief
Drug Landscape (2026). OROS hydromorphone HCl — Competitive Intelligence Brief. https://druglandscape.com/ci/oros-hydromorphone-hcl. Accessed 2026-05-16.
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