TheraRadar
Data updated: May 26, 2026

EVEKEO ODT (amphetamine sulfate)

CNS Approved 2019-01-30
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
7
Years on Market

Details

Status
Discontinued
First Approved
2019-01-30
Patent Cliff
2037

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET, ORALLY DISINTEGRATING

Companies

AZURITY
Active Ingredient: AMPHETAMINE SULFATE

EVEKEO ODT Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
25 FDA actions from 2019 to 2023 · 1 indication expansions
Oct 2023 SUPPL
Label · Labeling
FDA Letter Label
Sep 2022 SUPPL
Label · Labeling
FDA Letter Label
Feb 2022 SUPPL
Label · Labeling
FDA Letter Label

What EVEKEO ODT Treats

2 FDA approvals

Originally approved for its first indication in 2019 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03659929 results posted AR19.004 Ph 3 completed Adult Attention Deficit Hyperactivity Disorder (ADHD) Study With Amphetamine Sulfate
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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.

EVEKEO ODT FDA Label Details

View full patent landscape →
3 OB patents · 1 families · 8 international docs across 1 countries

EVEKEO ODT Patents & Exclusivity

Latest Patent: Mar 2037

Patents (3 active)

US11896562 Expires Mar 10, 2037
US10441554 Expires Mar 10, 2037
US11160772 Expires Mar 10, 2037
Source: FDA Orange Book

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Deep insights for EVEKEO ODT

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2037
  • • 70 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: NDA209905 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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