Data updated: Mar 29, 2026
RISVAN
RISPERIDONE
Approved 2024-03-29
1
Indication
--
Phase 3 Trials
1
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2024-03-29
- Routes
- INTRAMUSCULAR
- Dosage Forms
- FOR SUSPENSION, EXTENDED RELEASE
RISVAN Approval History
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What RISVAN Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RISVAN FDA Label Details
ProRISVAN Patents & Exclusivity
Latest Patent: May 2031
Exclusivity: Mar 2027
Patents (56 active)
US11752092
Expires May 31, 2031
US11241377
Expires May 31, 2031
US11173110
Expires May 31, 2031
US11007139
Expires May 31, 2031
US10195138
Expires May 31, 2031
US10182982
Expires May 31, 2031
US11759416
Expires May 31, 2031
US11752094
Expires May 31, 2031
US10085936
Expires May 31, 2031
US10881605
Expires May 31, 2031
+ 46 more patents
Exclusivity
NP
Until Mar 2027
NP
Until Mar 2027
NP
Until Mar 2027
NP
Until Mar 2027
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.