Drug facts
MoleculeApalutamide (Erleada)
Generics already compete: 1 maker on the market. 1 A-rated product from 1 maker substitute at the counter.
Erleada was first approved by the FDA on 02/14/2018 under NDA 210951; the application holder is Janssen Biotech Inc.
Holder Janssen Biotech IncApplication NDA 210951Approved 02/14/2018
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.
5,189days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved02/14/2018
Last patent01/14/2041
2019202320272031203520392043
- Latest patent
- 01/14/2041Erleada Orange Book
02Competition
- Generics
- 1 generic maker Orange Book
- First generic approved
- 03/17/2025 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 Apalutamide profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Janssen Biotech Inc Orange Book
- Application
- NDA 210951 Orange Book
- First approved
- 02/14/2018 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.