Lisinopril

Treats hypertension. Sold as Prinivil, Zestril, Qbrelis. Every FDA application for this active ingredient: 3 branded and 20 generic.

As of Nov 14, 2026, FDA lists 23 applications for Lisinopril (sold as Prinivil, Zestril, Qbrelis), first approved Dec 29, 1987, with 7 new uses approved and 0 published complete response letters.

First approved: Dec 29, 1987
Applications: 23
New uses approved: 7
Complete response letters: 0
Medicare spending, 2025: $258M

Medicare Spending

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


Lisinopril	Part D	$254M	+0%	8,629,941
Qbrelis	Part D	$2.8M	+27%	281
Zestril	Part D	$2.0M	-36%	580

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

LISINOPRIL 10 MG TABLET: $0.018 per unitGeneric · -2% in a year
LISINOPRIL 2.5 MG TABLET: $0.014 per unitGeneric · -4% in a year
LISINOPRIL 20 MG TABLET: $0.025 per unitGeneric · -5% in a year
LISINOPRIL 30 MG TABLET: $0.051 per unitGeneric · -6% in a year
LISINOPRIL 40 MG TABLET: $0.046 per unitGeneric · -1% in a year
LISINOPRIL 5 MG TABLET: $0.014 per unitGeneric · -3% in a year
ZESTRIL 10 MG TABLET: $12.52 per unitBrand · new this year
QBRELIS 1 MG/ML SOLUTION: $4.49 per MLBrand · +3% in a year

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

ZestrilDrugs with a new additional pediatric dosage. · AstraZeneca K.K. · Jun 22, 2012

Clinical Trials

16 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Pharmacologic Therapies to Mitigate Radiation- Associated Heart DiseaseChest Wall Tumor, Breast Cancer · UNC Lineberger Comprehensive Cancer Center	Phase 2	Recruiting	Jul 6, 2026
The Effect Of Lisinopril On PolycythemiaPolycythemia · Mayo Clinic	Phase 4	Recruiting	May 18, 2026
Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite AthletesSafety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes · Enhanced Emirates Limited	Not applicable	Enrolling by invitation	May 6, 2026
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)Chronic Kidney Disease, Type 2 Diabetes · Baylor Research Institute	Phase 4	Enrolling by invitation	Apr 23, 2026
The Assessment of Partial Guideline-Directed Medical Therapy Down Titration in Heart Failure in Remission.Heart Failure · Ziekenhuis Oost-Limburg	Phase 4	Recruiting	Apr 7, 2026
Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort StudyPost-stroke Pneumonia · First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	—	Not yet recruiting	Dec 4, 2025
Effect of Smartphone Application (MED-AD) on Medication Adherence Among Patients With Cardiovascular Disease in OmanIschemic Cardiovascular Disease, Hypertension · Sultan Qaboos University	Not applicable	Enrolling by invitation	Apr 30, 2025
A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate CancerProstate Cancer, Radiation Toxicity · University of Rochester	Early phase 1	Recruiting	Sep 7, 2022

Applications

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


Dec 29, 1987	PrinivilNDA 19558 · New molecular entity	Merck	60	Discontinued
May 19, 1988	ZestrilNDA 19777 · New formulation or manufacturer	Twi Pharms	61	Marketed
Jul 1, 2002	LisinoprilANDA 75743	Prinston	16	Marketed
Jul 1, 2002	LisinoprilANDA 75752	Heritage Pharma	16	Discontinued
Jul 1, 2002	LisinoprilANDA 75783	Teva	7	Discontinued
Jul 1, 2002	LisinoprilANDA 75903	Annora Pharma	9	Marketed
Jul 1, 2002	LisinoprilANDA 75944	Sun Pharm Inds Ltd	16	Marketed
Jul 1, 2002	LisinoprilANDA 75994	Chartwell Rx	14	Marketed
Jul 1, 2002	LisinoprilANDA 75999	Rising	7	Discontinued
Jul 1, 2002	LisinoprilANDA 76059	Watson Labs	6	Marketed
Jul 1, 2002	LisinoprilANDA 76063	Hikma	28	Discontinued
Jul 1, 2002	LisinoprilANDA 76071	Strides Pharma	12	Discontinued
Jul 1, 2002	LisinoprilANDA 76164	Prinston Inc	6	Marketed
Sep 30, 2002	LisinoprilANDA 76102	Heritage	9	Marketed
Sep 9, 2005	LisinoprilANDA 77321	Lupin	12	Marketed
Feb 22, 2006	LisinoprilANDA 77622	Aurobindo	12	Marketed
Apr 19, 2007	LisinoprilANDA 78402	Wockhardt Bio AG	5	Marketed
Jul 30, 2013	LisinoprilANDA 202554	Accord Hlthcare	5	Discontinued
Oct 29, 2013	LisinoprilANDA 203508	Invagen Pharms	5	Marketed
Jul 29, 2016	QbrelisNDA 208401 · New dosage form	Azurity	1	Marketed
Sep 15, 2020	LisinoprilANDA 212041	Sciegen Pharms	0	Marketed
Mar 4, 2021	LisinoprilANDA 208920	Sciegen Pharms	0	Marketed
Aug 20, 2026	LisinoprilANDA 218419	Annora Pharma	0	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