NDAORALCAPSULE
Approved
Mar 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
Drug data last refreshed 11h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOTREL is a fixed-dose combination of amlodipine besylate (a calcium channel blocker) and benazepril hydrochloride (an ACE inhibitor) indicated for hypertension management. This oral capsule combines two complementary mechanisms to reduce blood pressure in patients who require dual antihypertensive therapy. It has been a cornerstone antihypertensive since its 1995 approval.
$0.003BPart D
LOE ApproachingDeclining
Declining Part D spending and LOE approaching signal a mature franchise with shrinking commercial teams and reduced field headcount.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Fed Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg
Started May 2004
64 enrolled
Healhty
Fasting Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg
Started May 2004
54 enrolled
Healthy
Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM)
Started Jan 2004
357 enrolled
HypertensionDiabetesProteinuria
Career Relevance
LOTREL offers limited career growth given its LOE-approaching status and minimal linked job openings; roles are primarily defensive and focused on maximizing remaining patent value. Professionals joining this franchise should expect stable but declining headcount and resource allocation as the product transitions to generic competition.
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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.