Methylphenidate
As of the edition of 20 October 2026, Methylphenidate is a small molecule: marketed, first approved in 1981 (ES); acts on SLC6A2 and SLC6A3.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Ritalin
- First approved
- 1 May 1981 (ES)
- Approvals on record
- 70 in 6 regions
- Holder of the most recent approval
- Neuraxpharm Pharmaceuticals; 17 holders in all
- Registered trials
- 310, 32 stopped early
- Disease areas
- Mental health; Nervous system; Chemically induced; Cancer; Blood and lymph; Heart and blood vessels
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
11 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product11 company-target rows are on route B because of Methylphenidate.
See the 11 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 | 69 | 41 | 9 | 3 |
| Phase 1 | 34 | 26 | 5 | 1 |
| Phase 2 | 42 | 24 | 6 | 9 |
| Phase 3 | 63 | 45 | 7 | 7 |
| Phase 4 | 102 | 63 | 12 | 12 |
| All trials | 310 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Applicant, Later holder and Lead sponsor of trials | 2000 to now |
| Byk-Mallinckrodt CIL | Later holder | 2002 to now |
| Takeda | Later holder and Lead sponsor of trials | 2004 to now |
| Noven Therapeutics | Acquired holder and Lead sponsor of trials | 2004 to now |
| Pfizer | Later holder and Lead sponsor of trials | 2009 to now |
| Rhodes Pharmaceuticals | Later holder and Lead sponsor of trials | 2010 to now |
| Nextwave Pharmaceuticals | Later holder | 2012 to now |
| Collegium Pharmaceutical | Later holder and Lead sponsor of trials | 2013 to now |
| Purdue Pharma | Later holder and Lead sponsor of trials | 2017 to now |
| Aytu BioPharma | Later holder | 2017 to now |
| Specgx | Acquired holder | 2018 to now |
| Nextwave Pharmaceuticals Inc A Sub Of Tris Pharma | Acquired holder | 2019 to now |
| Osmotica Pharmaceutical | Later holder | 2022 to now |
| Sandoz | Acquired holder | 2023 to now |
| Ironshore Pharmaceuticals Inc A Wholly Owned Sub Of Collegium Pharmaceutical | Acquired holder | 2024 to now |
| Neuraxpharm Pharmaceuticals | Applicant | 2025 to now |
| Knoa Pharma | Acquired holder | 2026 to now |
| Lannett | Acquired holder | 2026 to now |
| Novartis | Earlier holder |