Data updated: Mar 10, 2026
NUPLAZID
PIMAVANSERIN TARTRATE
Approved 2016-04-29
3
Indications
--
Phase 3 Trials
1
Priority Reviews
9
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2016-04-29
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
NUPLAZID Approval History
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What NUPLAZID Treats
3 FDA approvalsOriginally approved for its first indication in 2016 . Covers 3 distinct patient populations.
- Other (3)
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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.
NUPLAZID FDA Label Details
ProNUPLAZID Patents & Exclusivity
Latest Patent: Aug 2038
Patents (23 active)
US10849891
Expires Aug 27, 2038
US11452721
Expires Aug 27, 2038
US10449185
Expires Aug 27, 2038
US10646480
Expires Aug 27, 2038
US10517860
Expires Mar 23, 2037
US10953000
Expires Mar 23, 2037
US7601740
Expires Apr 29, 2030
US7732615
Expires Jun 3, 2028
US7659285
Expires Aug 24, 2026
+ 13 more patents
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.