TheraRadar
Data updated: Jun 28, 2026

ADZENYS ER (amphetamine) · NEOS THERAPS INC

CNS Approved 2017-09-15

ADZENYS ER is FDA-approved to treat 1 condition (same as ADZENYS XR-ODT).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Discontinued
First Approved
2017-09-15
Patent Cliff
2032

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
SUSPENSION, EXTENDED RELEASE

Companies

NEOS THERAPS INC
Active Ingredient: AMPHETAMINE

ADZENYS ER Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2017 to 2022
Feb 2022 SUPPL
Label · Labeling
FDA Letter Label
Sep 2017 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What ADZENYS ER Treats

1 indications

ADZENYS ER is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as ADZENYS XR-ODT (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

4 trials
Trial Sponsor ID Phase Status Title
NCT03242772 results posted Pro00085179 1P50HD093074-01 Ph 2 terminated Impact of Combined Medication and Behavioral Treatment for ASD & ADHD
NCT02959892 results posted TAK-041-1002 U1111-1184-1947, 2016-002346-23 Ph 1 completed A Single-Dose Positron Emission Tomography (PET) Study to Determine the Effect of TAK-041 on Amphetamine-Induced Dopamine Release in the Central Nervous System (CNS)
NCT02020408 results posted 090661 R01MH092793 Ph 4 completed Monoamine Contributions to Neurocircuitry in Eating Disorders
NCT00733993 results posted DA09262 P50DA009262, DPMCDA Ph 1, Ph 2 completed Caffeine and Cocaine
🔬

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.

ADZENYS ER FDA Label Details

Indications & Usage

FDA Label (PDF)

ADZENYS ER is FDA-approved to treat 1 condition — same approved indications as ADZENYS XR-ODT.

View full patent landscape →
3 OB patents · 1 families · 20 international docs across 3 countries

ADZENYS ER Patents & Exclusivity

Latest Patent: Jun 2032

Patents (3 active)

US8709491 Expires Jun 28, 2032
US9017731 Expires Jun 28, 2032
US9265737 Expires Jun 28, 2032
Source: FDA Orange Book

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Deep insights for ADZENYS ER

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2032
  • • 3 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: NDA204325 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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