Drug facts
BrandFirmagon (Degarelix)
No generic degarelix is approved; the latest Firmagon patent or exclusivity in the Orange Book runs to 04/27/2032. 1 staged generic application passed FDA review and waits on patents or exclusivity.
Firmagon was first approved by the FDA on 12/24/2008 under NDA 022201; the application holder is Ferring Pharmaceuticals Inc.
The most recent FDA recall on record is a Class II recall dated 04/13/2022.
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.
2,005days until the latest patent expires
- Latest patent
- 04/27/2032Firmagon 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
- Latest recall
- 04/13/2022Class II, Firmagon, Mckesson Medical-Surgical Inc. Corporate Office FDA enforcement
04Product
- Application holder
- Ferring Pharmaceuticals Inc Orange Book
- Application
- NDA 022201 Orange Book
- First approved
- 12/24/2008 Orange Book
- Dosage forms
- powder
- Routes
- subcutaneous
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.