FDA Orange Book
Is there a generic for Symbicort Aerosphere?
Symbicort Aerosphere contains budesonide and formoterol. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Symbicort Aerosphere (budesonide and formoterol). The Orange Book shows its last listed patent expires May 28, 2030 and its last listed exclusivity ends April 27, 2029.
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Symbicort Aerosphere products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, metered, inhalation | 0.08MG/INH;0.0048MG/INH | Marketed (Rx) | None | 0 | None |
| aerosol, metered, inhalation | 0.16MG/INH;0.0048MG/INH | Marketed (Rx) | None | 0 | None |
NDA 216579, held by ASTRAZENECA PHARMACEUTICALS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Symbicort Aerosphere patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9415009 | May 28, 2030 | Method of use | U-4513 | 216579 |
| 10716753 | May 28, 2030 | Drug product | U-4513 | 216579 |
| 10716753 | May 28, 2030 | Drug product | U-3203 | 216579 |
| 9415009 | May 28, 2030 | Method of use | U-3203 | 216579 |
Symbicort Aerosphere exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NS | New strength | April 27, 2029 | 216579 |
| I-988 | New indication | April 27, 2029 | 216579 |
Questions
Is there a generic for Symbicort Aerosphere?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Symbicort Aerosphere (budesonide and formoterol). The Orange Book shows its last listed patent expires May 28, 2030 and its last listed exclusivity ends April 27, 2029.
What is the generic name for Symbicort Aerosphere?
The active ingredient in Symbicort Aerosphere is budesonide and formoterol, per the FDA Orange Book.
When does the Symbicort Aerosphere patent expire?
The last patent listed for Symbicort Aerosphere in the Orange Book expires May 28, 2030. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.