TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

INGREZZA SPRINKLE

VALBENAZINE TOSYLATE
Approved 2024-04-30
1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Prescription
First Approved
2024-04-30
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Active Ingredient: VALBENAZINE TOSYLATE

INGREZZA SPRINKLE Approval History

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What INGREZZA SPRINKLE Treats

3 indications

INGREZZA SPRINKLE is approved for 3 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Tardive Dyskinesia
  • Chorea
  • Huntington's Disease
Source: FDA Label

INGREZZA SPRINKLE Competitors

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5 other drugs also target VMAT2. Compare mechanisms, indications, and trial activity.

Drug = Competitor name Company = Manufacturer N indic. = FDA-approved indications โ†’ Date = Patent/exclusivity expiry

Competitors share the same molecular target (VMAT2). Earlier expiry dates signal biosimilar/generic opportunities.

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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

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.

INGREZZA SPRINKLE FDA Label Details

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INGREZZA SPRINKLE Patents & Exclusivity

Latest Patent: Aug 2040
Exclusivity: Aug 2026

Patents (297 active)

US10940141 Expires Aug 10, 2040
US11026931 Expires Aug 14, 2039
US11654142 Expires Nov 14, 2038
US11311532 Expires Sep 18, 2038
US11026939 Expires Sep 18, 2038
US11439629 Expires Oct 10, 2037
US11040029 Expires Oct 10, 2037
US10993941 Expires Oct 10, 2037
US10952997 Expires Oct 10, 2037
US10912771 Expires Oct 10, 2037
+ 287 more patents

Exclusivity

I-925 Until Aug 2026
I-925 Until Aug 2026
I-925 Until Aug 2026
I-925 Until Aug 2026
I-925 Until Aug 2026
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.