Risperidone
As of the edition of 20 October 2026, Risperidone is a small molecule: marketed, first approved in 1993 (US); acts on DRD2 and HTR2A; 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 2022
- Kind
- Small molecule
- Brand name
- Risperdal
- First approved
- 29 December 1993 (US)
- Approvals on record
- 45 in 8 regions
- Holder of the most recent approval
- Laboratorios Farmaceuticos Rovi; 10 holders in all
- Registered trials
- 320, 31 stopped early
- Disease areas
- Mental health; Nervous system; Chemically induced; Inherited and neonatal; Nutrition and metabolism; Heart and blood vessels
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.
Laboratorios Farmaceuticos Rovi holds a later exclusivity on its own new formulation or combination product, ending 2027; 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 Risperidone.
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 not stated | 64 | 41 | 1 | 8 |
| Phase 1 | 40 | 32 | 2 | 2 |
| Phase 2 | 36 | 28 | 2 | 5 |
| Phase 3 | 84 | 75 | 1 | 7 |
| Phase 4 | 96 | 74 | 5 | 9 |
| All trials | 320 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant, Later holder and Lead sponsor of trials | 1993 to now |
| Teva | Later holder and Lead sponsor of trials | 2001 to now |
| Indivior | Later holder and Lead sponsor of trials | 2010 to now |
| Laboratorios Farmacéuticos Rovi | Applicant | 2022 to now |
| Shandong Luye Pharmaceutical | Later holder | 2023 to now |
| Laboratorios Farmaceuticos Rovi | Later holder | 2024 to now |