Adzenys Er

(Amphetamine)

ApprovedSmall molecule

AAzurity Pharmaceuticals

Adzenys Er is one of 48 small molecule programs targeting Substance Abuse. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Substance AbuseActive, not recruiting

InfusionCompleted

Eating DisorderCompleted

Substance AbusePreclinical

Active, not recruiting

InfusionPreclinical

Completed

Eating DisorderApproved

Completed

Competition

Competitive Landscape

19 competitors in Substance Abuse

#DrugCompanyPhaseTrials

Exelon

Namenda

Strattera

1 4

Abilify

Otsuka

Approved

1 5

Chantix

PPrism Pharmaceuticals

Approved

—6

Wellbutrin

GGlaxo Dba Glaxosmithkline

Oxycontin

Mirapex

Adzenys Er

AAzurity Pharmaceuticals

Approved

1 10

Revia

Teva

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Eating Disorder1 trial

Monoamine Contributions to Neurocircuitry in Eating Disorders

Completed·UUniversity of California, San Diego·Phase 4·NCT02020408·88 enrolled

Caffeine1 trial

Caffeine and Cocaine

Completed·VVirginia Commonwealth University·Phase 1/2·NCT00733993·23 enrolled

Substance Abuse1 trial

A Study on Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT04132557·430,000 enrolled

Tobacco1 trial

Imaging Extrastriatal Dopamine Release in Tobacco Smokers and Nonsmokers

Completed·YYale University··NCT02348385·49 enrolled

Central Nervous System1 trial

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)

Completed· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 1·NCT02959892·12 enrolled

5 more indications

ESS1 trial

Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing

Completed·UUniversity Hospital, Basel, Switzerland·Phase 1·NCT03019822·28 enrolled

Infusion1 trial

Test-retest Reproducibility of [11C]PHNO PET Using the Constant Infusion Paradigm

Completed·YYale University·N/A·NCT01699607·10 enrolled

Medication1 trial

Impact of Combined Medication and Behavioral Treatment for ASD & ADHD

Terminated·—·Phase 2·NCT03242772·18 enrolled

Children1 trial

Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years

Completed·TTris Pharma, Inc.·Phase 4·NCT03610464·5 enrolled

Attention1 trial

Amphetamine Extended Release Tablets and Driving Performance in Subjects With Attention Deficit/Hyperactivity Disorder (ADHD)

Completed·TTris Pharma, Inc.·Phase 2·NCT04027361·41 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 27, 2016

ADZENYS XR-ODT

NDA NDA204326

Sep 15, 2017

ADZENYS ER

NDA NDA204325

Apr 16, 2021

EVEKEO ODT

NDA NDA209905

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Amphetamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Amphetamine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Amphetamine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209905). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Adzenys Er. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Azurity Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAzurity Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Jun 28, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8840924Apr 9, 2026

9839619Jun 28, 2032

9265737Jun 28, 2032

9017731Jun 28, 2032

8709491Jun 28, 2032

3 more patents

11160772Mar 10, 2037

10441554Mar 10, 2037

11896562Mar 10, 2037

Adzenys Er

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Eating Disorder1 trial

Caffeine1 trial

Substance Abuse1 trial

Tobacco1 trial

Central Nervous System1 trial

ESS1 trial

Infusion1 trial

Medication1 trial

Children1 trial

Attention1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News