Drug facts
BrandMonoferric (Ferric Derisomaltose)
No generic ferric derisomaltose is approved; the latest Monoferric patent or exclusivity in the Orange Book runs to 06/22/2036.
Monoferric was first approved by the FDA on 01/16/2020 under NDA 208171; the application holder is Pharmacosmos As.
Holder Pharmacosmos AsApplication NDA 208171Approved 01/16/2020
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.
3,522days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved01/16/2020
Last patent06/22/2036
202120242027203020332036
- Latest patent
- 06/22/2036Monoferric Orange Book
02Competition
- Generics
- No generic approved 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 Monoferric profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Pharmacosmos As Orange Book
- Application
- NDA 208171 Orange Book
- First approved
- 01/16/2020 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.