Drug facts
BrandBreo Ellipta (Fluticasone and Vilanterol)
No generic fluticasone and vilanterol is approved; the latest Breo Ellipta patent or exclusivity in the Orange Book runs to 04/11/2031.
Breo Ellipta was first approved by the FDA on 05/10/2013 under NDA 204275; the application holder is Glaxo Group Ltd England Dba Glaxosmithkline.
The latest NADAC for BREO ELLIPTA 200-25 MCG INHALR is $5.35 per unit (as of 10/28/2026).
Holder Glaxo Group Ltd England Dba GlaxosmithklineApplication NDA 204275Approved 05/10/2013
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.
1,623days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved05/10/2013
Exclusivity ends11/13/2026
Last patent04/11/2031
2014201720202023202620292032
- Latest patent
- 04/11/2031Breo Ellipta Orange Book
- Exclusivity
- 11/13/2026Breo Ellipta 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 Breo Ellipta profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $5.35 per unitBREO ELLIPTA 200-25 MCG INHALR, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Glaxo Group Ltd England Dba Glaxosmithkline Orange Book
- Application
- NDA 204275 Orange Book
- First approved
- 05/10/2013 Orange Book
- Dosage forms
- powder
- Routes
- inhalation
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.