TheraRadar
Data updated: May 26, 2026

BYSANTI (milsaperidone)

CNS Approved 2026-02-20
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2026-02-20
Patent Cliff
2044

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

VANDA PHARMS INC
Active Ingredient: MILSAPERIDONE

BYSANTI Approval History

Original
New Indication
New Form
Label Update
7 FDA actions from 2026 to 2026
Feb 2026 ORIGINAL
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What BYSANTI Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT06830044 VP-VHX-896-3201 Ph 3 recruiting Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

BYSANTI FDA Label Details

BYSANTI Patents & Exclusivity

Latest Patent: May 2044
Exclusivity: Feb 2031

Patents (9 active)

US12478619 Expires May 31, 2044
US9074254 Expires Dec 28, 2031
US9074256 Expires Feb 10, 2031
US9072742 Expires Jan 16, 2031
US9074255 Expires Dec 17, 2030
US8999638 Expires Oct 28, 2030
US10563259 Expires Jul 24, 2030
US9157121 Expires Apr 5, 2030
US10570453 Expires Mar 28, 2028

Exclusivity

NCE Until Feb 2031
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Source: FDA Orange Book

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Deep insights for BYSANTI

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2044
  • • 882 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA220358 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.