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 6h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EDARBYCLOR is a fixed-dose combination tablet containing azilsartan medoxomil (an angiotensin II receptor blocker) and chlorthalidone (a thiazide-like diuretic) for oral administration. It treats hypertension by blocking angiotensin II-mediated vasoconstriction and reducing blood volume through diuresis. The combination is indicated for patients not adequately controlled on monotherapy and reduces risk of nonfatal cardiovascular events including stroke and myocardial infarction.
$27MPart D
PeakStable
4.9 years to LOEProduct is in peak revenue phase with stable commercial demand; moderate-sized brand team focused on maintenance and formulary positioning rather than growth initiatives.
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.