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 17h 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 for hypertension and heart failure in adults. It selectively blocks AT1 receptors to reduce vasoconstriction and aldosterone secretion, lowering blood pressure independent of ACE inhibition. The prodrug is rapidly converted to active azilsartan during absorption.
$37MPart D
LOE ApproachingDeclining
1.4 years to LOEEDARBI faces patent expiration in 1.5 years (March 2028), signaling imminent loss-of-exclusivity; brand teams should expect downsizing and transition to lifecycle management or defensive strategies.
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.