Codeine
As of the edition of 20 October 2026, Codeine is a small molecule: marketed, first approved in 1940 (ES); acts on OPRD1, OPRK1 and OPRM1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1983
- Kind
- Small molecule
- Brand name
- Soma Compound W/ Codeine
- First approved
- 1 December 1940 (ES)
- Approvals on record
- 24 in 5 regions
- Holder of the most recent approval
- MAINPOINTE PHARMACEUTICALS LLC; 17 holders in all
- Withdrawn from market
- 1 January 1985 (in some regions)
- Registered trials
- 36, 3 stopped early
- Disease areas
- Infections; Lungs and airways; Bones, joints and muscles; Mental health; Chemically induced; Injuries
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
8 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product8 company-target rows are on route B because of Codeine.
See the 8 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 | 3 | 0 | 1 |
| Phase 1 | 11 | 11 | 0 | 0 |
| Phase 2 | 4 | 3 | 1 | 0 |
| Phase 3 | 3 | 1 | 0 | 2 |
| Phase 4 | 13 | 12 | 0 | 0 |
| All trials | 36 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant | 1982 to now |
| Purdue Pharma | Later holder | 1995 to now |
| Hikma Pharmaceuticals | Applicant, Later holder and Lead sponsor of trials | 2006 to now |