Drug facts
MoleculeFerric Carboxymaltose (Injectafer)
Generics already compete: 2 makers on the market. 3 A-rated products from 2 makers substitute at the counter.
Injectafer was first approved by the FDA on 07/25/2013 under NDA 203565; the application holder is American Regent Inc.
Holder American Regent IncApplication NDA 203565Approved 07/25/2013
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.
472days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved07/25/2013
Exclusivity ends05/31/2026
Last patent02/15/2028
201420172020202320262029
- Latest patent
- 02/15/2028Injectafer Orange Book
- Exclusivity
- 05/31/2026Injectafer Orange Book
02Competition
- Generics
- 2 generic makers Orange Book
- First generic approved
- 06/25/2026 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 Ferric Carboxymaltose profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- American Regent Inc Orange Book
- Application
- NDA 203565 Orange Book
- First approved
- 07/25/2013 Orange Book
- Dosage forms
- solution
- 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.