FDA Orange Book

Is there a generic for Alvesco?

Alvesco contains ciclesonide. 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 Alvesco (ciclesonide). The Orange Book shows its last listed patent expires February 1, 2028.

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Alvesco products in the Orange Book

Alvesco products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
aerosol, metered, inhalation0.08MG/INHMarketed (Rx)None0None
aerosol, metered, inhalation0.16MG/INHMarketed (Rx)None0None

NDA 021658, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Alvesco patents

Patents listed for Alvesco
PatentExpiresCoversUse codeNDA
8371292February 1, 2028Method of useU-1355021658

Alvesco NDC codes

Questions

Is there a generic for Alvesco?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Alvesco (ciclesonide). The Orange Book shows its last listed patent expires February 1, 2028.

What is the generic name for Alvesco?

The active ingredient in Alvesco is ciclesonide, per the FDA Orange Book.

When does the Alvesco patent expire?

The last patent listed for Alvesco in the Orange Book expires February 1, 2028. 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.

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