Methadone
As of the edition of 20 October 2026, Methadone is a small molecule: marketed, first approved in 1952 (ES); acts on OPRM1.
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
- Westadone
- First approved
- 1 May 1952 (ES)
- Approvals on record
- 17 in 5 regions
- Holder of the most recent approval
- Teikoku Seiyaku; 9 holders in all
- Registered trials
- 142, 26 stopped early
- Disease areas
- Mental health; Chemically induced; Infections; Nervous system; Cancer; Urinary and reproductive
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 Methadone.
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 | 28 | 16 | 3 | 4 |
| Phase 1 | 33 | 25 | 4 | 2 |
| Phase 2 | 19 | 10 | 1 | 8 |
| Phase 3 | 27 | 13 | 8 | 3 |
| Phase 4 | 35 | 17 | 7 | 9 |
| All trials | 142 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Knight Therapeutics | Applicant | 2000 to now |
| Sandoz | Acquired holder | 2005 to now |
| Viatris | Acquired holder | 2011 to now |
| Teikoku Seiyaku | Applicant | 2012 to now |
| Specgx | Acquired holder | 2018 to now |
| Hikma Pharmaceuticals | Acquired holder and Later holder | 2019 to now |
| Byk-Mallinckrodt CIL | Later holder | |
| Eli Lilly | Earlier holder | |
| Vitarine Pharmaceuticals | Later holder |