NDAORALTABLET
Approved
Apr 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
BENICAR (olmesartan medoxomil) by Jubilant Therapeutics is (ace, kininase ii). First approved in 2002.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BENICAR (olmesartan medoxomil) is an oral angiotensin II receptor blocker (ARB) approved in 2002 for hypertension management. It selectively blocks AT1 receptors in vascular smooth muscle, preventing angiotensin II-mediated vasoconstriction and aldosterone release. The mechanism is independent of ACE inhibition, making it distinct from ACE inhibitor classes.
$0.015BPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with modest Part D footprint; commercial teams likely focused on managed care retention and generic transition planning rather than growth initiatives.
Mechanism of Action
(ACE, kininase 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. Olmesartan blocks the vasoconstrictor effects of…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Combination Therapy in Patients With Hypertension Not Controlled With Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy
Started Apr 2013
344 enrolled
Essential Hypertension
Long-Term Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Hypertension and Kidney Disease
Started Mar 2011
153 enrolled
Safety
Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients
Started Jun 2010
615 enrolled
Hypertension
Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Moderate to Severe Hypertension.
Started Jan 2010
1,071 enrolled
Essential Hypertension
Safety and Tolerability of Azilsartan Medoxomil Plus Chlorthalidone Compared to Olmesartan Medoxomil Plus Hydrochlorothiazide in Participants With Essential Hypertension
Started Oct 2009
837 enrolled
Essential Hypertension
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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.