Benazepril Hydrochloride

Treats hypertension. Sold as Lotensin. Every FDA application for this active ingredient: 1 branded and 12 generic.

As of Nov 15, 2026, FDA lists 13 applications for Benazepril Hydrochloride (sold as Lotensin), first approved Jun 25, 1991, with 1 new use approved and 0 published complete response letters.

First approved: Jun 25, 1991
Applications: 13
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $20.9M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Benazepril HCl	Part D	$20.9M	-6%	507,019

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

BENAZEPRIL HCL 10 MG TABLET: $0.062 per unitGeneric · +5% in a year
BENAZEPRIL HCL 20 MG TABLET: $0.078 per unitGeneric · +3% in a year
BENAZEPRIL HCL 40 MG TABLET: $0.099 per unitGeneric · +2% in a year
BENAZEPRIL HCL 5 MG TABLET: $0.048 per unitGeneric · -4% in a year

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Bioequivalence Study of Sacubitril Alisartan Amlodipine TabletsPrimary Hypertension · Shenzhen Salubris Pharmaceuticals Co., Ltd.	Phase 1	Not yet recruiting	Mar 20, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jun 25, 1991	LotensinNDA 19851 · New molecular entity	Validus Pharms	44	Marketed
Feb 11, 2004	Benazepril HydrochlorideANDA 76118	Prinston Inc	10	Marketed
Feb 11, 2004	Benazepril HydrochlorideANDA 76211	Teva	14	Marketed
Feb 11, 2004	Benazepril HydrochlorideANDA 76267	Heritage Pharma	2	Marketed
Feb 11, 2004	Benazepril HydrochlorideANDA 76333	Ani Pharms	2	Marketed
Feb 11, 2004	Benazepril HydrochlorideANDA 76344	Sun Pharm Inds Ltd	9	Marketed
Feb 11, 2004	Benazepril HydrochlorideANDA 76402	Chartwell Rx	9	Marketed
Feb 11, 2004	Benazepril HydrochlorideANDA 76430	Rising	8	Discontinued
Feb 11, 2004	Benazepril HydrochlorideANDA 76476	Genpharm	0	Discontinued
Feb 3, 2006	Benazepril HydrochlorideANDA 76820	Amneal Pharms	9	Marketed
Mar 8, 2006	Benazepril HydrochlorideANDA 77128	Macleods Pharms	11	Marketed
May 22, 2008	Benazepril HydrochlorideANDA 78212	Aurobindo Pharma	13	Marketed
May 23, 2008	Benazepril HydrochlorideANDA 78848	Zydus Lifesciences	4	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA