FDA Orange Book
Is there a generic for Kovanaze?
Kovanaze contains oxymetazoline and tetracaine. 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 Kovanaze (oxymetazoline and tetracaine). The Orange Book shows its last listed patent expires April 2, 2030.
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Kovanaze products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, nasal | 0.1MG/SPRAY;6MG/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 208032, held by ST RENATUS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Kovanaze patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9308191 | April 2, 2030 | Drug product | U-1876 | 208032 |
| 8580282 | April 2, 2030 | Drug product | U-1876 | 208032 |
Questions
Is there a generic for Kovanaze?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Kovanaze (oxymetazoline and tetracaine). The Orange Book shows its last listed patent expires April 2, 2030.
What is the generic name for Kovanaze?
The active ingredient in Kovanaze is oxymetazoline and tetracaine, per the FDA Orange Book.
When does the Kovanaze patent expire?
The last patent listed for Kovanaze in the Orange Book expires April 2, 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.