NDAORALTABLET
Approved
Jun 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
LOTENSIN (benazepril hydrochloride) by Bausch Health is angiotensin-converting enzyme (ace) in human subjects and animals. First approved in 1991.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Lotensin (benazepril hydrochloride) is an oral ACE inhibitor approved in 1991 for hypertension management. It works by inhibiting angiotensin-converting enzyme, reducing angiotensin II production and decreasing vasopressor activity and aldosterone secretion. The drug is effective across renin-angiotensin profiles and maintains efficacy even in low-renin hypertension patients.
LOE Approaching
Lotensin faces LOE with moderate competitive pressure (30/100), signaling contraction of brand team infrastructure and shift toward generic support roles.
Mechanism of Action
angiotensin-converting enzyme (ACE) in human subjects and animals. Benazeprilat has much greater ACE inhibitory activity than does benazepril. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) Conditions
Started Apr 2005
48 enrolled
Healthy
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting Conditions
Started Mar 2004
54 enrolled
Healthy
Fed Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg
Started Dec 2002
24 enrolled
Healthy
Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg
Started Nov 2002
56 enrolled
Healthy
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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.