Drug facts
MoleculeCarfilzomib (Kyprolis)
Generics already compete: 2 makers on the market. 2 A-rated products from 2 makers substitute at the counter.
Kyprolis was first approved by the FDA on 07/20/2012 under NDA 202714; the application holder is Onyx Pharmaceuticals Inc A Wholly Owned Sub of Amgen Inc.
Holder Onyx Pharmaceuticals Inc A Wholly Owned Sub of Amgen IncApplication NDA 202714Approved 07/20/2012
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.
5,477days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved07/20/2012
Exclusivity ends11/22/2028
Last patent10/29/2041
20132017202120252029203320372041
- Latest patent
- 10/29/2041Kyprolis Orange Book
- Exclusivity
- 11/22/2028Kyprolis Orange Book
02Competition
- Generics
- 2 generic makers Orange Book
- Staged generics
- 3 passed FDA review, awaiting market entry FDA
- First generic approved
- 09/09/2019 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 Carfilzomib profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Onyx Pharmaceuticals Inc A Wholly Owned Sub of Amgen Inc Orange Book
- Application
- NDA 202714 Orange Book
- First approved
- 07/20/2012 Orange Book
- Dosage forms
- powder
- Routes
- intravenous
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.