Last reviewed · How we verify
BENAZEPRIL HYDROCHLORIDE
Benazepril Hydrochloride is a marketed drug primarily indicated for hypertension. A key strength is its patent protection, which extends until 2028, providing a strong barrier to generic competition. The primary risk is the eventual patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | BENAZEPRIL HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1991 |
Approved indications
- Hypertension
Boxed warnings
- WARNING: FETAL TOXICITY When pregnancy is detected, discontinue benazepril hydrochloride tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 )]. WARNING-FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue benazepril hydrochloride tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )
Common side effects
- headache
- dizziness
- somnolence
- postural dizziness
Key clinical trials
- Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets (PHASE1)
- Study of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS) (PHASE2)
- Benazepril HCl 40 mg Tablets, Fasting (PHASE1)
- Fasting Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg (PHASE1)
- Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg (PHASE1)
- Fed Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg (PHASE1)
- Fed Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg (PHASE1)
- Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BENAZEPRIL HYDROCHLORIDE CI brief — competitive landscape report
- BENAZEPRIL HYDROCHLORIDE updates RSS · CI watch RSS