Drug facts
MoleculeEzetimibe (Zetia)
Generics already compete: 11 makers on the market. 11 A-rated products from 11 makers substitute at the counter.
Zetia was first approved by the FDA on 10/25/2002 under NDA 021445; the application holder is Organon LLC A Sub of Organon and Co.
The latest NADAC for EZETIMIBE 10 MG TABLET is $0.07 per unit (as of 10/28/2026).
Holder Organon LLC A Sub of Organon and CoApplication NDA 021445Approved 10/25/2002
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 listed protection expired 04/30/2026
ExclusivityPatent onlyOpen to generics
Today
Approved10/25/2002
Last patent04/30/2026
2003200720112015201920232027
- Latest patent
- 04/30/2026Zetia Orange Book
02Competition
- Generics
- 11 generic makers Orange Book
- First generic approved
- 06/26/2015 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 Ezetimibe profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.07 per unitEZETIMIBE 10 MG TABLET, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Organon LLC A Sub of Organon and Co Orange Book
- Application
- NDA 021445 Orange Book
- First approved
- 10/25/2002 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.