Drug facts
BrandZituvimet (Metformin and Sitagliptin)
No generic metformin and sitagliptin is approved; no Zituvimet patent or exclusivity is listed in the Orange Book.
Zituvimet was first approved by the FDA on 11/03/2023 under NDA 216743; the application holder is Zydus Lifesciences Global Fze.
The latest NADAC for ZITUVIMET XR 50-500 MG TABLET is $5.01 per unit (as of 10/28/2026).
Holder Zydus Lifesciences Global FzeApplication NDA 216743Approved 11/03/2023
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 Zituvimet patent listed in the Orange Book Orange Book
02Competition
- Generics
- No generic approved 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 Zituvimet profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $5.01 per unitZITUVIMET XR 50-500 MG TABLET, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Zydus Lifesciences Global Fze Orange Book
- Application
- NDA 216743 Orange Book
- First approved
- 11/03/2023 Orange Book
- Dosage forms
- tablet
- Routes
- oral
- Other brand names
- Zituvimet XR
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.