NDAORALTABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
Approved
Jan 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
7/8 — Comprehensive
ADZENYS XR-ODT (amphetamine extended-release) by Therapeutic Solutions International is non-catecholamine sympathomimetic amines with cns stimulant activity. Approved for attention deficit hyperactivity disorder (adhd) in patients 6 years, older [see clinical studies ( )], older. First approved in 2016.
Drug data last refreshed 17h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADZENYS XR-ODT is an orally disintegrating extended-release tablet formulation of amphetamine indicated for ADHD in patients 6 years and older. It works as a CNS stimulant by blocking reuptake of norepinephrine and dopamine into presynaptic neurons, increasing monoamine release into extraneuronal space. The exact mechanism of therapeutic action in ADHD remains not fully understood.
$0.001BPart D
Peak5.6 years to LOEProduct is at peak lifecycle stage with minimal market penetration (1,972 Part D claims in 2023); small team size expected for niche formulation with low uptake versus generic competitors.
Mechanism of Action
non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal…
Pharmacologic Class:
Central Nervous System Stimulant
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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.