Oxycodone
As of the edition of 20 October 2026, Oxycodone is a small molecule: marketed, first approved in 1982 (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 2012
- Kind
- Small molecule
- Brand name
- Percodan
- First approved
- 1 January 1982 (US)
- Approvals on record
- 68 in 5 regions
- Holder of the most recent approval
- Protega Pharmaceuticals; 16 holders in all
- Withdrawn from market
- 1 January 2013 (in some regions)
- Registered trials
- 277, 31 stopped early
- Disease areas
- Cancer; Nervous system; Chemically induced; Mental health; Injuries; Bones, joints and muscles
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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Oxycodone.
See the 2 companies 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 | 59 | 32 | 7 | 9 |
| Phase 1 | 58 | 51 | 2 | 2 |
| Phase 2 | 24 | 15 | 4 | 4 |
| Phase 3 | 55 | 44 | 1 | 7 |
| Phase 4 | 81 | 52 | 8 | 9 |
| All trials | 277 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Purdue Pharma | Applicant and Lead sponsor of trials | 1995 to now |
| Hikma Pharmaceuticals | Later holder | 1998 to now |
| VistaPharm | Later holder and Lead sponsor of trials | 2012 to now |
| Shionogi | Applicant | 2012 to now |
| Collegium Pharmaceutical | Later holder and Lead sponsor of trials | 2013 to now |
| Specgx | Acquired holder | 2018 to now |
| Genus Life Sciences | Acquired holder | 2018 to now |
| Zydus Worldwide DMCC | Acquired holder | 2019 to now |
| Protega Pharmaceuticals | Acquired holder | 2024 to now |
| Knoa Pharma | Acquired holder | 2026 to now |