FDA Orange Book
Is there a generic for Bevespi Aerosphere?
Bevespi Aerosphere contains 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 Bevespi Aerosphere (glycopyrrolate and formoterol). The Orange Book shows its last listed patent expires March 17, 2031.
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Bevespi Aerosphere products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, metered, inhalation | 0.0048MG/INH;0.0090MG/INH | Marketed (Rx) | None | 0 | None |
NDA 208294, 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.
Bevespi Aerosphere patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8324266 | May 28, 2030 | Method of use | U-2889 | 208294 |
| 10716753 | May 28, 2030 | Drug product | U-2889 | 208294 |
| 9415009 | May 28, 2030 | Method of use | U-2889 | 208294 |
| 8703806 | May 28, 2030 | Method of use | U-2889 | 208294 |
| 8808713 | May 28, 2030 | Drug product | U-2889 | 208294 |
| 9463161 | May 28, 2030 | Drug product | U-2889 | 208294 |
| 8815258 | March 17, 2031 | Method of use | U-2889 | 208294 |
Bevespi Aerosphere NDC codes
Questions
Is there a generic for Bevespi Aerosphere?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Bevespi Aerosphere (glycopyrrolate and formoterol). The Orange Book shows its last listed patent expires March 17, 2031.
What is the generic name for Bevespi Aerosphere?
The active ingredient in Bevespi Aerosphere is glycopyrrolate and formoterol, per the FDA Orange Book.
When does the Bevespi Aerosphere patent expire?
The last patent listed for Bevespi Aerosphere in the Orange Book expires March 17, 2031. 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.