Drug facts
MoleculeEnzalutamide (Xtandi)
Generics already compete: 1 maker on the market. 2 A-rated products from 1 maker substitute at the counter.
Xtandi was first approved by the FDA on 08/31/2012 under NDA 203415; the application holder is Astellas Pharma US Inc.
Holder Astellas Pharma US IncApplication NDA 203415Approved 08/31/2012
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.
3,768days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved08/31/2012
Exclusivity ends11/17/2026
Last patent02/23/2037
2013201720212025202920332037
- Latest patent
- 02/23/2037Xtandi Orange Book
- Exclusivity
- 11/17/2026Xtandi Orange Book
02Competition
- Generics
- 1 generic maker Orange Book
- Staged generics
- 3 passed FDA review, awaiting market entry FDA
- First generic approved
- 05/14/2021 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 Enzalutamide profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Astellas Pharma US Inc Orange Book
- Application
- NDA 203415 Orange Book
- First approved
- 08/31/2012 Orange Book
- Dosage forms
- capsule; 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.