TheraRadar
Data updated: May 26, 2026

INGREZZA SPRINKLE (valbenazine tosylate)

Genetic Support Trial Activity: Stable 5 active trials
CNS Approved 2024-04-30

INGREZZA SPRINKLE is indicated for the treatment of Tardive Dyskinesia; Chorea; Huntington's Disease.

Source: FDA Label • NEUROCRINE

Development Insights

Neurocrine Biosciences conducting 15 trials (83%)
12 indications explored (Broad Platform)
schizophrenia (4 trials)
tardive dyskinesia (4 trials)
tourette syndrome (4 trials)
1
Indication
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2024-04-30
Patent Cliff
2040

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE

Companies

Active Ingredient: VALBENAZINE TOSYLATE

INGREZZA SPRINKLE Approval History

2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2024 to 2026
Apr 2026 SUPPL
Label · Labeling
Apr 2024 ORIGINAL
New Form · Type 3 - New Dosage Form

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 Target & Pathway

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Target

VMAT2 ()

INGREZZA SPRINKLE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to INGREZZA SPRINKLE

3 of 5

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AUSTEDO
DEUTETRABENAZINE
3 shared
Teva
Shared indications:
ChoreaHuntington's DiseaseTardive Dyskinesia
AUSTEDO XR
DEUTETRABENAZINE
3 shared
Teva
Shared indications:
ChoreaHuntington's DiseaseTardive Dyskinesia
INGREZZA
VALBENAZINE TOSYLATE
2 shared
NEUROCRINE
Shared indications:
Tardive DyskinesiaHuntington's Disease
🔬

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

Indications & Usage

FDA Label (PDF)

INGREZZA SPRINKLE is indicated for the treatment of Tardive Dyskinesia; Chorea; Huntington's Disease.

View full patent landscape →
22 OB patents · 9 families · 375 international docs across 36 countries

INGREZZA SPRINKLE Patents & Exclusivity

Latest Patent: Aug 2040
Exclusivity: Aug 2026

Patents (22 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
US10874648 Expires Oct 10, 2037
US10857148 Expires Oct 10, 2037
US10857137 Expires Oct 10, 2037
US10906903 Expires Dec 22, 2036
US10919892 Expires Dec 22, 2036
US10906902 Expires Dec 22, 2036
US10851104 Expires Oct 28, 2036
US10851103 Expires Oct 28, 2036
US10844058 Expires Oct 28, 2036
US10065952 Expires Oct 28, 2036
US8039627 Expires Apr 11, 2031
US8357697 Expires Nov 8, 2027

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
I-925 Until Aug 2026
I-925 Until Aug 2026
I-925 Until Aug 2026
I-925 Until Aug 2026
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for INGREZZA SPRINKLE

Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2040
  • 297 active patents

Trial Analysis

  • 18 total trials
  • Stage: Stable

Competitive Landscape

  • 5 similar drugs
  • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment