NDAORALSOLUTION
Approved
Jun 2025
Lifecycle
Launch
Competitive Pressure
0/100
Data completeness
4/8 — Partial
ARYNTA (lisdexamfetamine dimesylate oral) by R-Pharm US is dextroamphetamine. Approved for (): attention deficit hyperactivity disorder (adhd) in adults, older () lisdexamfetamine dimesylate capsules are not indicated for weight loss. First approved in 2025.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ARYNTA is a lisdexamfetamine dimesylate oral solution approved for ADHD in adults. It is a prodrug of dextroamphetamine that acts as a CNS stimulant to improve attention and reduce hyperactivity symptoms. The exact mechanism in ADHD is not fully elucidated, but amphetamines enhance catecholamine activity in the central nervous system.
Launch14.3 years to LOE
As a newly launched product with zero competitive pressure, ARYNTA represents a greenfield opportunity for commercial team expansion and rapid market penetration.
Mechanism of Action
dextroamphetamine. Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD and BED is not known.
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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.