FDA Orange Book
Is there a generic for Breztri Aerosphere?
Breztri Aerosphere contains budesonide, glycopyrrolate 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 Breztri Aerosphere (budesonide, glycopyrrolate and formoterol). The Orange Book shows its last listed patent expires October 5, 2038 and its last listed exclusivity ends April 27, 2029.
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Breztri Aerosphere products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, metered, inhalation | 0.16MG/INH;0.0048MG/INH;0.009MG/INH | Marketed (Rx) | None | 0 | None |
| aerosol, metered, inhalation | 0.16MG/INH;0.0048MG/INH;0.018MG/INH | Marketed (Rx) | None | 0 | None |
NDA 212122, held by ASTRAZENECA AB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Breztri Aerosphere patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8703806 | May 28, 2030 | Method of use | U-2889 | 212122 |
| 8808713 | May 28, 2030 | Drug product | U-2889 | 212122 |
| 8324266 | May 28, 2030 | Method of use | U-2889 | 212122 |
| 9415009 | May 28, 2030 | Method of use | U-2889 | 212122 |
| 10716753 | May 28, 2030 | Drug product | U-2889 | 212122 |
| 9463161 | May 28, 2030 | Drug product | U-2889 | 212122 |
| 8324266 | May 28, 2030 | Method of use | U-4503 | 212122 |
| 8703806 | May 28, 2030 | Method of use | U-4503 | 212122 |
| 8808713 | May 28, 2030 | Drug product | U-4503 | 212122 |
| 9415009 | May 28, 2030 | Method of use | U-4503 | 212122 |
| 9463161 | May 28, 2030 | Drug product | U-4503 | 212122 |
| 10716753 | May 28, 2030 | Drug product | U-4503 | 212122 |
| 8815258 | March 17, 2031 | Method of use | U-2889 | 212122 |
| 8815258 | March 17, 2031 | Method of use | U-4503 | 212122 |
| 11833292 | October 5, 2038 | Drug product | None | 212122 |
| 11331442 | October 5, 2038 | Drug product | None | 212122 |
Breztri Aerosphere exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NS | New strength | April 27, 2029 | 212122 |
Breztri Aerosphere NDC codes
Questions
Is there a generic for Breztri Aerosphere?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Breztri Aerosphere (budesonide, glycopyrrolate and formoterol). The Orange Book shows its last listed patent expires October 5, 2038 and its last listed exclusivity ends April 27, 2029.
What is the generic name for Breztri Aerosphere?
The active ingredient in Breztri Aerosphere is budesonide, glycopyrrolate and formoterol, per the FDA Orange Book.
When does the Breztri Aerosphere patent expire?
The last patent listed for Breztri Aerosphere in the Orange Book expires October 5, 2038. 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.