Drug facts
MoleculeLosartan (Cozaar)
Generics already compete: 16 makers on the market. 48 A-rated products from 16 makers substitute at the counter.
Cozaar was first approved by the FDA on 04/14/1995 under NDA 020386; the application holder is Organon LLC A Sub of Organon and Co.
The latest NADAC for LOSARTAN POTASSIUM 50 MG TAB is $0.03 per unit (as of 10/28/2026).
Holder Organon LLC A Sub of Organon and CoApplication NDA 020386Approved 04/14/1995
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 Cozaar patent listed in the Orange Book Orange Book
- Later patents, other products
- Arbli 10/07/2041 Orange Book
02Competition
- Generics
- 16 generic makers Orange Book
- First generic approved
- 04/06/2010 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 Losartan profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.03 per unitLOSARTAN POTASSIUM 50 MG TAB, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 06/26/2023Class II, Losartan Potassium, Strides Pharma Inc. FDA enforcement
04Product
- Application holder
- Organon LLC A Sub of Organon and Co Orange Book
- Application
- NDA 020386 Orange Book
- First approved
- 04/14/1995 Orange Book
- Dosage forms
- suspension; tablet
- Routes
- oral
- Other brand names
- Arbli
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.