NDAORALCAPSULE
Approved
Mar 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
6/8 — Strong
LOTREL (amlodipine besylate and benazepril hydrochloride) by Novartis is angiotensin-converting enzyme (ace) in human subjects and in animals. Approved for hypertension in patients not adequately controlled on monotherapy with either agent, hypertension, hypertension. First approved in 1995.
Drug data last refreshed 4d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOTREL is a fixed-dose oral combination of amlodipine besylate (a calcium channel blocker) and benazepril hydrochloride (an ACE inhibitor) used to treat hypertension in patients inadequately controlled on monotherapy. The combination works synergistically by reducing vascular resistance through calcium channel inhibition while simultaneously suppressing the renin-angiotensin-aldosterone system.
$3MPart D
LOE ApproachingDeclining
LOTREL is approaching loss of exclusivity with minimal Part D spending ($3M) and declining claims, signaling a contracting team requiring focus on generic transition management.
Mechanism of Action
angiotensin-converting enzyme (ACE) in human subjects and in animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results…
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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.