TheraRadar
Data updated: Jun 28, 2026

EVEKEO ODT (amphetamine sulfate) · AZURITY

CNS Approved 2019-01-30

EVEKEO ODT is FDA-approved to treat 3 conditions (same as AMPHETAMINE SULFATE).

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

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
Sep 2022 SUPPL
Label · Labeling
Feb 2022 SUPPL
Label · Labeling

What EVEKEO ODT Treats

3 indications

EVEKEO ODT is approved for 3 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as AMPHETAMINE SULFATE (same active ingredient).

Source: FDA Label
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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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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.

EVEKEO ODT FDA Label Details

Indications & Usage

FDA Label (PDF)

EVEKEO ODT is FDA-approved to treat 3 conditions — same approved indications as AMPHETAMINE SULFATE.

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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Revenue Insights

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  • 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

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