Morphine
As of the edition of 20 October 2026, Morphine is a small molecule: marketed, first approved in 1982 (CH); acts on OPRM1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1991
- Kind
- Small molecule
- Brand name
- Duramorph Pf
- First approved
- 29 March 1982 (CH)
- Approvals on record
- 81 in 4 regions
- Holder of the most recent approval
- Pfizer; 18 holders in all
- Registered trials
- 381, 50 stopped early
- Disease areas
- Nervous system; Cancer; Bones, joints and muscles; Mental health; Heart and blood vessels; Chemically induced
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
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 Morphine.
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 | 129 | 82 | 22 | 16 |
| Phase 1 | 29 | 23 | 0 | 3 |
| Phase 2 | 50 | 31 | 4 | 6 |
| Phase 3 | 56 | 31 | 5 | 12 |
| Phase 4 | 117 | 75 | 10 | 13 |
| All trials | 381 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Mundipharm | Applicant | 1982 to now |
| Purdue Frederick | Later holder | 1987 to now |
| Hikma Pharmaceuticals | Acquired holder, Later holder and Lead sponsor of trials | 1991 to now |
| Purdue Pharma | Applicant | 1991 to now |
| Abbott | Later holder | 1992 to now |
| Byk-Mallinckrodt CIL | Later holder and Lead sponsor of trials | 1996 to now |
| Pfizer | Acquired holder, Later holder and Lead sponsor of trials | 2001 to now |
| SkyePharma | Later holder | 2004 to now |
| Egalet | Later holder and Lead sponsor of trials | 2007 to now |
| Lannett | Later holder | 2011 to now |
| Pacira Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2012 to now |
| Xanodyne Pharmaceuticals | Acquired holder | 2012 to now |
| Fresenius Kabi | Acquired holder | 2016 to now |
| AbbVie | Acquired holder | 2016 to now |
| Specgx | Acquired holder | 2018 to now |
| Zydus Worldwide DMCC | Acquired holder | 2019 to now |
| Chartwell Molecular | Acquired holder | 2022 to now |
| Ohemo Life Sciences | Acquired holder | 2023 to now |
| Knoa Pharma | Acquired holder | 2026 to now |