FDA Orange Book
Is there a generic for Omnaris?
Omnaris 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 Omnaris (ciclesonide). The Orange Book shows its last listed patent expires February 1, 2028.
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Omnaris products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, nasal | 0.05MG/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 022004, 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.
Omnaris patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8371292 | February 1, 2028 | Method of use | U-1356 | 022004 |
Omnaris NDC codes
Questions
Is there a generic for Omnaris?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Omnaris (ciclesonide). The Orange Book shows its last listed patent expires February 1, 2028.
What is the generic name for Omnaris?
The active ingredient in Omnaris is ciclesonide, per the FDA Orange Book.
When does the Omnaris patent expire?
The last patent listed for Omnaris 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.