Dexmethylphenidate
As of the edition of 20 October 2026, Dexmethylphenidate is a small molecule: marketed, first approved in 2001 (US); acts on SLC6A2 and SLC6A3; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2001
- Kind
- Small molecule
- Brand name
- Focalin
- First approved
- 13 November 2001 (US)
- Approvals on record
- 14 in 1 region
- Holder of the most recent approval
- Collegium Pharmaceutical; 2 holders in all
- Registered trials
- 15, 0 stopped early
- Disease areas
- Mental health; Cancer; Chemically induced; Nervous system
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Collegium Pharmaceutical holds a later exclusivity on its own new formulation or combination product, ending 2037; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Dexmethylphenidate.
See the 2 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 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 3 | 3 | 0 | 0 |
| Phase 3 | 5 | 4 | 0 | 0 |
| Phase 4 | 5 | 5 | 0 | 0 |
| All trials | 15 |