Drug facts
BrandKisqali (Ribociclib)
No generic ribociclib is approved; the latest Kisqali patent or exclusivity in the Orange Book runs to 10/14/2036. 1 staged generic application passed FDA review and waits on patents or exclusivity.
Kisqali was first approved by the FDA on 03/13/2017 under NDA 209092; the application holder is Novartis Pharmaceuticals Corp.
The latest NADAC for KISQALI 600 MG DAILY DOSE is $289.72 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.
3,636days until the latest patent expires
- Latest patent
- 10/14/2036Kisqali Orange Book
- Exclusivity
- 01/01/2030Kisqali Orange Book
02Competition
- Generics
- No generic approved Orange Book
- Staged generics
- 1 passed FDA review, awaiting market entry FDA
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $289.72 per unitKISQALI 600 MG DAILY DOSE, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Novartis Pharmaceuticals Corp Orange Book
- Application
- NDA 209092 Orange Book
- First approved
- 03/13/2017 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.