AZSTARYS
Peakserdexmethylphenidate and dexmethylphenidate
NDAORALCAPSULE
Approved
Mar 2021
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
6/8 — Strong
AZSTARYS (serdexmethylphenidate and dexmethylphenidate) is dexmethylphenidate. Approved for attention deficit hyperactivity disorder (adhd) in patients 6 years of age, older. First approved in 2021.
Drug data last refreshed 4d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AZSTARYS is an oral capsule combining serdexmethylphenidate and dexmethylphenidate, a CNS stimulant approved in 2021 for ADHD in patients 6 years and older. The mechanism of therapeutic action in ADHD is not fully understood, though dexmethylphenidate is thought to affect dopamine and norepinephrine pathways. This dual-component formulation represents a novel approach to sustained ADHD symptom management.
$0.001BPart D
Peak11.6 years to LOEProduct is at peak lifecycle with minimal Part D uptake ($1M, 3,223 claims in 2023), suggesting early commercial stage or narrow market penetration requiring focused market development efforts.
Mechanism of Action
dexmethylphenidate. Dexmethylphenidate HCl is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD is not known.
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.