Oxymorphone
As of the edition of 20 October 2026, Oxymorphone is a small molecule: marketed, first approved in 1982 (US); acts on OPRD1, OPRK1 and OPRM1; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1982
- Kind
- Small molecule
- Brand name
- Opana
- First approved
- 1 January 1982 (US)
- Approvals on record
- 19 in 1 region
- Holder of the most recent approval
- Endo; 2 holders in all
- Registered trials
- 21, 5 stopped early
- Disease areas
- Cancer; Bones, joints and muscles; Nervous system; Blood and lymph; Immune system; Skin and connective tissue
US protection
US protection ends in 2029.
The last listed US drug-substance patent ends in 2029. The application that gives this date is held by Endo.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product21 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 21 listings behind itRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 0 |
| Phase 1 | 3 | 2 | 0 | 1 |
| Phase 3 | 12 | 9 | 0 | 3 |
| Phase 4 | 3 | 2 | 0 | 1 |
| All trials | 21 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Endo | Acquired holder, Later holder and Lead sponsor of trials | 2001 to now |
| Dupont Merck | Earlier holder |