NDAORALTABLET, EXTENDED RELEASE
Approved
Sep 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
KAPVAY (clonidine hydrochloride) by Teva is clinical pharmacology clonidine stimulates alpha-adrenoreceptors in the brain stem. First approved in 2009.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KAPVAY is an extended-release oral tablet formulation of clonidine hydrochloride, an alpha-2 adrenergic agonist approved by FDA in 2009. It reduces sympathetic nervous system outflow by stimulating alpha-adrenoreceptors in the brainstem, resulting in decreased blood pressure, heart rate, and peripheral resistance. The drug is indicated for attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult populations.
$0.008BPart D
LOE ApproachingProduct is approaching loss of exclusivity with minimal Medicare Part D penetration, signaling a small and declining commercial footprint requiring defensive strategy.
Mechanism of Action
CLINICAL PHARMACOLOGY Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. Clonidine hydrochloride…
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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.