Drug facts
BrandIbrance (Palbociclib)
No generic palbociclib has an active Orange Book listing (a generic was first approved 06/05/2024); the latest NDA 207103 patent or exclusivity in the Orange Book runs to 08/08/2034. 10 staged generic applications passed FDA review and wait on patents or exclusivity.
Ibrance was first approved by the FDA on 02/03/2015 under NDA 207103; the application holder is Pfizer Inc.
Holder Pfizer IncApplication NDA 207103Approved 02/03/2015
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.
2,839days until the latest NDA 207103 patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved02/03/2015
Exclusivity ends06/24/2029
Last patent08/08/2034
2016201920222025202820312034
- Latest patent
- 08/08/2034Ibrance Orange Book
- Exclusivity
- 06/24/2029Ibrance Orange Book
- Later patents, other products
- Ibrance (NDA 212436) 02/19/2037 Orange Book
02Competition
- Generics
- No active generic listing in the Orange Book Orange Book
- Staged generics
- 10 passed FDA review, awaiting market entry FDA
- First generic approved
- 06/05/2024 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 Ibrance profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Pfizer Inc Orange Book
- Application
- NDA 207103 Orange Book
- First approved
- 02/03/2015 Orange Book
- Dosage forms
- capsule
- 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.