Drug facts
BrandJardiance (Empagliflozin)
No generic empagliflozin has an active Orange Book listing (a generic was first approved 08/03/2022); the latest Jardiance patent or exclusivity in the Orange Book runs to 12/11/2034. 7 staged generic applications passed FDA review and wait on patents or exclusivity.
Jardiance was first approved by the FDA on 08/01/2014 under NDA 204629; the application holder is Boehringer Ingelheim Pharmaceuticals Inc.
The latest NADAC for JARDIANCE 10 MG TABLET is $11.19 per unit (as of 10/28/2026).
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.
2,963days until the latest patent expires
- Latest patent
- 12/11/2034Jardiance Orange Book
- Exclusivity
- 12/20/2026Jardiance Orange Book
02Competition
- Generics
- No active generic listing in the Orange Book Orange Book
- Staged generics
- 7 passed FDA review, awaiting market entry FDA
- First generic approved
- 08/03/2022 Orange Book
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $11.19 per unitJARDIANCE 10 MG TABLET, as of 10/28/2026 CMS NADAC
- Latest recall
- 03/09/2023Class II, Empagliflozin, Boehringer Ingelheim Pharmaceuticals, Inc. FDA enforcement
04Product
- Application holder
- Boehringer Ingelheim Pharmaceuticals Inc Orange Book
- Application
- NDA 204629 Orange Book
- First approved
- 08/01/2014 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.