Drug facts
MoleculeSitagliptin (Januvia)
Generics already compete: 3 makers on the market. 9 A-rated products from 3 makers substitute at the counter.
Januvia was first approved by the FDA on 10/16/2006 under NDA 021995; the application holder is Merck Sharp and Dohme LLC.
The latest NADAC for SITAGLIPTIN PHOSPHATE 50 MG TABLET is $3.72 per unit (as of 10/28/2026).
Holder Merck Sharp and Dohme LLCApplication NDA 021995Approved 10/16/2006
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.
205days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved10/16/2006
Last patent05/24/2027
20072010201320162019202220252028
- Latest patent
- 05/24/2027Januvia Orange Book
02Competition
- Generics
- 3 generic makers Orange Book
- Staged generics
- 16 passed FDA review, awaiting market entry FDA
- First generic approved
- 12/30/2025 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 Sitagliptin profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $3.72 per unitSITAGLIPTIN PHOSPHATE 50 MG TABLET, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Merck Sharp and Dohme LLC Orange Book
- Application
- NDA 021995 Orange Book
- First approved
- 10/16/2006 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.