Hydromorphone
As of the edition of 20 October 2026, Hydromorphone is a small molecule: marketed, first approved in 1984 (US); acts on OPRM1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Dilaudid-Hp
- First approved
- 11 January 1984 (US)
- Approvals on record
- 39 in 4 regions
- Holder of the most recent approval
- Hikma Pharmaceuticals; 8 holders in all
- Registered trials
- 115, 22 stopped early
- Disease areas
- Nervous system; Chemically induced; Mental health; Cancer; Blood and lymph; Digestive system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Hydromorphone.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| OPRM1 | Mu-type opioid receptor | P35372 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 21 | 12 | 1 | 4 |
| Phase 1 | 15 | 10 | 1 | 4 |
| Phase 2 | 21 | 12 | 4 | 2 |
| Phase 3 | 23 | 16 | 1 | 5 |
| Phase 4 | 35 | 21 | 5 | 7 |
| All trials | 115 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Purdue Pharma | Applicant and Lead sponsor of trials | 1984 to now |
| Byk-Mallinckrodt CIL | Later holder and Lead sponsor of trials | 2002 to now |
| Pfizer | Later holder | 2011 to now |
| Fresenius Kabi | Acquired holder | 2017 to now |
| Rhodes Pharmaceuticals | Acquired holder | 2017 to now |
| Specgx | Acquired holder | 2018 to now |
| Hikma Pharmaceuticals | Later holder | 2023 to now |