Drug facts
BrandBreztri Aerosphere (Budesonide, Formoterol and Glycopyrrolate)
No generic budesonide, formoterol and glycopyrrolate is approved; the latest Breztri Aerosphere patent or exclusivity in the Orange Book runs to 10/05/2038.
Breztri Aerosphere was first approved by the FDA on 07/23/2020 under NDA 212122; the application holder is Astrazeneca AB.
The latest NADAC for BREZTRI AEROSPHERE 160-9-4.8 MCG is $61.27 per gram (as of 10/28/2026).
Holder Astrazeneca ABApplication NDA 212122Approved 07/23/2020
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.
4,357days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved07/23/2020
Exclusivity ends04/27/2029
Last patent10/05/2038
2021202420272030203320362039
- Latest patent
- 10/05/2038Breztri Aerosphere Orange Book
- Exclusivity
- 04/27/2029Breztri Aerosphere 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 Breztri Aerosphere profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $61.27 per gramBREZTRI AEROSPHERE 160-9-4.8 MCG, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Astrazeneca AB Orange Book
- Application
- NDA 212122 Orange Book
- First approved
- 07/23/2020 Orange Book
- Dosage forms
- aerosol, metered
- 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.