NDAORALSUSPENSION, EXTENDED RELEASE
Approved
Oct 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
DYANAVEL XR (amphetamine) by Teva is non-catecholamine sympathomimetic amines with cns stimulant activity. Approved for attention-deficit/hyperactivity disorder. First approved in 2015.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DYANAVEL XR is an extended-release oral suspension of amphetamine, a central nervous system stimulant approved for ADHD as its primary indication. The drug works through non-catecholamine sympathomimetic mechanisms, though the precise therapeutic action in ADHD remains incompletely understood. Off-label use extends to methamphetamine use disorder, stimulant use disorder, PTSD, autism spectrum disorder, depression, and cognitive enhancement.
$0.483MPart D
Peak10.3 years to LOEProduct is in peak commercial phase with minimal Part D penetration ($483K annual spend), suggesting limited market adoption relative to competitive alternatives and a smaller brand team footprint.
Mechanism of Action
non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known.
Pharmacologic Class:
Central Nervous System Stimulant
Indications (1)
Clinical Trials (20)
A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
Started Feb 2026
40 enrolled
Methamphetamine IntoxicationMethamphetamine DisordersMethamphetamine Abuse
Maternal Outcomes With Methamphetamine Use and Cardiac Assessment for Rural Dissemination (MOM CARD)
Started Feb 2026
35 enrolled
Methamphetamine Abuse
Methamphetamine Use Disorder Support in Heart Failure Pilot Study
Started Nov 2025
50 enrolled
Heart FailureMethamphetamine Use Disorder
Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder
Started Sep 2024
20 enrolled
Methamphetamine Use Disorder
Rural Community Peer Partnerships for Improving Methamphetamine-Associated Heart Failure Screening and Engagement
Started Aug 2024
200 enrolled
Methamphetamine UseHeart Failure
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.