NDAORALTABLET, EXTENDED RELEASE
Approved
Jan 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
XANAX XR (alprazolam) by Viatris is 1,4 benzodiazepine. First approved in 2003.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XANAX XR (alprazolam) is an extended-release benzodiazepine indicated for acute treatment of generalized anxiety disorder and panic disorder. It works by binding to GABA-A receptors in the brain, enhancing inhibitory neurotransmission to reduce anxiety and panic symptoms. Peak plasma concentration occurs 1–2 hours post-dose, with a mean elimination half-life of approximately 11.2 hours in healthy adults.
$0.295MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D spending; brand team focus likely shifting toward generic transition strategy and cost-containment positioning.
Mechanism of Action
1,4 benzodiazepine. Alprazolam exerts its effect for the acute treatment of generalized anxiety disorder and panic disorder through binding to the benzodiazepine site of gamma-aminobutyric acid-A (GABAA) receptors in the brain and enhances GABA-mediated synaptic inhibition. 12.3 Pharmacokinetics…
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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.