Drug facts

Molecule

Lisinopril

Generics already compete: 11 makers on the market. 73 A-rated products from 11 makers substitute at the counter.

Prinivil was first approved by the FDA on 12/29/1987 under NDA 019558; the application holder is Merck Research Laboratories Div Merck Co Inc. The Orange Book lists NDA 019558 as discontinued.

The latest NADAC for LISINOPRIL 10 MG TABLET is $0.02 per unit (as of 10/28/2026).

Holder Merck Research Laboratories Div Merck Co IncApplication NDA 019558Approved 12/29/1987

01Patents and exclusivity

When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.

Latest patent
No Prinivil patent listed in the Orange Book
Orange Book
Later patents, other products
Qbrelis 11/06/2035
Orange Book

02Competition

Generics
11 generic makers
Orange Book
First generic approved
07/01/2002
Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Lisinopril profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages
NADAC
$0.02 per unitLISINOPRIL 10 MG TABLET, mid-priced of 6 strengths, as of 10/28/2026
CMS NADAC
Latest recall
11/15/2024Class II, Lisinopril, Evaric Pharmaceuticals Inc.
FDA enforcement

04Product

Application holder
Merck Research Laboratories Div Merck Co Inc
Orange Book
Application
NDA 019558
Orange Book
First approved
12/29/1987
Orange Book
Dosage forms
solution; tablet
Routes
oral
Other brand names
QbrelisZestril
Status
NDA 019558 discontinued
Orange Book

Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.