Hydrocodone
As of the edition of 20 October 2026, Hydrocodone is a small molecule: marketed, first approved in 1987 (US); acts on OPRD1, OPRK1 and 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 1997
- Kind
- Small molecule
- Brand name
- Tussionex Pennkinetic
- First approved
- 31 December 1987 (US)
- Approvals on record
- 32 in 2 regions
- Holder of the most recent approval
- ECI PHARMACEUTICALS LLC; 12 holders in all
- Registered trials
- 63, 9 stopped early
- Disease areas
- Nervous system; Bones, joints and muscles; Injuries; Cancer; Mental health; Chemically induced
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
9 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product9 company-target rows are on route B because of Hydrocodone.
See the 9 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 2 | 1 | 2 |
| Phase 1 | 15 | 11 | 0 | 4 |
| Phase 2 | 12 | 10 | 1 | 1 |
| Phase 3 | 22 | 20 | 1 | 1 |
| Phase 4 | 9 | 6 | 0 | 1 |
| All trials | 63 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| UCB | Applicant and Lead sponsor of trials | 2002 to now |
| Teva | Later holder and Lead sponsor of trials | 2010 to now |
| Purdue Pharma | Later holder and Lead sponsor of trials | 2011 to now |
| Recro Gainesville | Acquired holder | 2021 to now |
| Knoa Pharma | Acquired holder | 2026 to now |