Drug facts
BrandSymbicort Aerosphere (Budesonide and Formoterol)
No generic budesonide and formoterol is approved; the latest Symbicort Aerosphere patent or exclusivity in the Orange Book runs to 05/28/2030.
Symbicort Aerosphere was first approved by the FDA on 04/28/2023 under NDA 216579; the application holder is Astrazeneca Pharmaceuticals LP.
The latest NADAC for BUDESONIDE-FORMOTEROL 80-4.5 is $15.53 per gram (as of 10/28/2026).
Holder Astrazeneca Pharmaceuticals LPApplication NDA 216579Approved 04/28/2023
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.
1,305days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved04/28/2023
Exclusivity ends04/27/2029
Last patent05/28/2030
20242026202820302032
- Latest patent
- 05/28/2030Symbicort Aerosphere Orange Book
- Exclusivity
- 04/27/2029Symbicort 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 Symbicort Aerosphere profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $15.53 per gramBUDESONIDE-FORMOTEROL 80-4.5, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Astrazeneca Pharmaceuticals LP Orange Book
- Application
- NDA 216579 Orange Book
- First approved
- 04/28/2023 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.