Drug facts
BrandGemtesa (Vibegron)
No generic vibegron is approved; the latest Gemtesa patent or exclusivity in the Orange Book runs to 07/06/2042.
Gemtesa was first approved by the FDA on 12/23/2020 under NDA 213006; the application holder is Sumitomo Pharma America Inc.
The latest NADAC for GEMTESA 75 MG TABLET is $16.46 per unit (as of 10/28/2026).
Holder Sumitomo Pharma America IncApplication NDA 213006Approved 12/23/2020
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.
5,728days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved12/23/2020
Exclusivity ends12/18/2027
Last patent07/06/2042
202120252029203320372041
- Latest patent
- 07/06/2042Gemtesa Orange Book
- Exclusivity
- 12/18/2027Gemtesa 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 Gemtesa profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $16.46 per unitGEMTESA 75 MG TABLET, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Sumitomo Pharma America Inc Orange Book
- Application
- NDA 213006 Orange Book
- First approved
- 12/23/2020 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.