NDAORALTABLET
Approved
Feb 2011
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
1
Data completeness
7/8 — Comprehensive
EDARBI (azilsartan kamedoxomil) by R-Pharm US is angiotensin-converting enzymes (ace, kinase ii). Approved for hypertension in adults, to lower blood pressure, hypertension and 1 more indications. First approved in 2011.
Drug data last refreshed 43m ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EDARBI (azilsartan kamedoxomil) is an oral angiotensin II receptor blocker (ARB) approved in 2011 for treating hypertension in adults and heart failure. It selectively blocks AT1 receptors to prevent angiotensin II-mediated vasoconstriction and aldosterone secretion, independent of ACE inhibition pathways. The prodrug is rapidly converted to active azilsartan during absorption.
$37MPart D
LOE ApproachingDeclining
1.6 years to LOEWith ~1.7 years until LOE (2028), the brand team is transitioning from growth defense to managed decline, likely reducing commercial headcount and shifting focus to key accounts and specialty segments.
Mechanism of Action
angiotensin-converting enzymes (ACE, kinase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Azilsartan…
Indications (4)
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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.