Dextroamphetamine
As of the edition of 20 October 2026, Dextroamphetamine is a small molecule: marketed, first approved in 1982 (US); acts on SLC18A2, SLC6A2 and SLC6A3; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Dexedrine Spansule
- First approved
- 1 January 1982 (US)
- Approvals on record
- 33 in 5 regions
- Holder of the most recent approval
- Medice Arzneimittel Puetter Gmbh & Co. Kg; 9 holders in all
- Registered trials
- 40, 5 stopped early
- Disease areas
- Mental health; Chemically induced; Nervous system; Heart and blood vessels; Cancer; Inherited and neonatal
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Dextroamphetamine.
See the 3 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 | 8 | 4 | 1 | 1 |
| Phase 1 | 13 | 11 | 1 | 1 |
| Phase 2 | 10 | 9 | 0 | 1 |
| Phase 3 | 2 | 1 | 0 | 0 |
| Phase 4 | 7 | 3 | 0 | 2 |
| All trials | 40 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Knight Therapeutics | Applicant | 1992 to now |
| Amneal Pharmaceuticals | Acquired holder | 2017 to now |
| Noven Therapeutics | Later holder | 2022 to now |
| GSK | Earlier holder |