Apomorphine
As of the edition of 20 October 2026, Apomorphine is a small molecule: marketed, first approved in 1988 (CH); acts on DRD2, DRD3 and DRD4; 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 2012
- Kind
- Small molecule
- Brand name
- Apokyn
- First approved
- 6 January 1988 (CH)
- Approvals on record
- 11 in 4 regions
- Holder of the most recent approval
- Mdd Us Operations Llc A Sub Of Supernus Pharmaceuticals; 6 holders in all
- Withdrawn from market
- 28 May 2006 (in some regions)
- Registered trials
- 37, 3 stopped early
- Disease areas
- Nervous system; Mental health; Chemically induced; Eye; Lungs and airways
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.
Mdd Us Operations Llc A Sub Of Supernus Pharmaceuticals holds a later exclusivity on its own new formulation or combination product, ending 2028; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Apomorphine.
See the 1 company-target row 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 | 6 | 4 | 2 | 0 |
| Phase 2 | 10 | 5 | 0 | 2 |
| Phase 3 | 16 | 13 | 2 | 0 |
| Phase 4 | 5 | 3 | 0 | 1 |
| All trials | 37 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sumitomo Pharma | Acquired holder, Later holder and Lead sponsor of trials | 2014 to now |
| Supernus Pharmaceuticals | Acquired holder | 2020 to now |
| Mdd Us Operations Llc A Sub Of Supernus Pharmaceuticals | Later holder | 2025 to now |