NDAORALTABLET
Approved
Dec 2011
Lifecycle
Peak
Competitive Pressure
8/100
Data completeness
6/8 — Strong
EDARBYCLOR (azilsartan kamedoxomil and chlorthalidone) by R-Pharm US is regulation. Approved for hypertension, to lower blood pressure: in patients not adequately controlled with monotherapy ( ), nonfatal cardiovascular events and 6 more indications. First approved in 2011.
Drug data last refreshed 16h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EDARBYCLOR is a fixed-dose combination tablet containing azilsartan kamedoxomil (an angiotensin II receptor blocker) and chlorthalidone (a thiazide-like diuretic). It is indicated for hypertension treatment in patients not adequately controlled on monotherapy, and reduces risk of nonfatal cardiovascular events including stroke and myocardial infarction. The dual mechanism blocks angiotensin II-mediated vasoconstriction while promoting sodium and water excretion to lower blood pressure.
$27MPart D
Peak4.7 years to LOEProduct remains in peak commercial stage with $27M Part D spending but faces approaching patent expiry; brand team will shift focus toward lifecycle extension and competitive positioning.
Mechanism of Action
regulation. Azilsartan medoxomil Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzymes (ACE, kinase II). Angiotensin II is the principle pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of…
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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.