Drug facts
BrandNubeqa (Darolutamide)
No generic darolutamide is approved; the latest Nubeqa patent or exclusivity in the Orange Book runs to 06/17/2042.
Nubeqa was first approved by the FDA on 07/30/2019 under NDA 212099; the application holder is Bayer Healthcare Pharmaceuticals Inc.
Holder Bayer Healthcare Pharmaceuticals IncApplication NDA 212099Approved 07/30/2019
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.
5,709days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved07/30/2019
Exclusivity ends06/03/2028
Last patent06/17/2042
2020202420282032203620402044
- Latest patent
- 06/17/2042Nubeqa Orange Book
- Exclusivity
- 06/03/2028Nubeqa 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 Nubeqa profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Bayer Healthcare Pharmaceuticals Inc Orange Book
- Application
- NDA 212099 Orange Book
- First approved
- 07/30/2019 Orange Book
- Dosage forms
- tablet
- 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.