Drug facts

Molecule

Hydrochlorothiazide and Losartan (Hyzaar)

Generics already compete: 11 makers on the market. 32 A-rated products from 11 makers substitute at the counter.

Hyzaar was first approved by the FDA on 04/28/1995 under NDA 020387; the application holder is Organon LLC A Sub of Organon and Co.

The latest NADAC for LOSARTAN-HYDROCHLOROTHIAZIDE 100-12.5 MG TAB is $0.08 per unit (as of 10/28/2026).

Holder Organon LLC A Sub of Organon and CoApplication NDA 020387Approved 04/28/1995

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 Hyzaar patent listed in the Orange Book
Orange Book

02Competition

Generics
11 generic makers
Orange Book
First generic approved
01/06/2010
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 Hydrochlorothiazide and Losartan profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages
NADAC
$0.08 per unitLOSARTAN-HYDROCHLOROTHIAZIDE 100-12.5 MG TAB, mid-priced of 3 strengths, as of 10/28/2026
CMS NADAC
Latest recall
05/07/2024Class II, Losartan Potassium and Hydrochlorothiazide, Macleods Pharma USA, Inc
FDA enforcement

04Product

Application holder
Organon LLC A Sub of Organon and Co
Orange Book
Application
NDA 020387
Orange Book
First approved
04/28/1995
Orange Book
Dosage forms
tablet
Routes
oral

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