FDA Orange Book
Is there a generic for Xtoro?
Xtoro contains finafloxacin. 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 Xtoro (finafloxacin). The Orange Book shows its last listed patent expires November 21, 2033.
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Xtoro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension/drops, otic | 0.3% | Marketed (Rx) | None | 0 | None |
NDA 206307, held by FONSECA BIOSCIENCES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xtoro patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9119859 | July 2, 2030 | Method of use | U-1679 | 206307 |
| 9993483 | July 2, 2030 | Drug product | None | 206307 |
| 8536167 | August 8, 2031 | Method of use | U-1679 | 206307 |
| 9504691 | November 21, 2033 | Drug product | U-1679 | 206307 |
Xtoro NDC codes
Questions
Is there a generic for Xtoro?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xtoro (finafloxacin). The Orange Book shows its last listed patent expires November 21, 2033.
What is the generic name for Xtoro?
The active ingredient in Xtoro is finafloxacin, per the FDA Orange Book.
When does the Xtoro patent expire?
The last patent listed for Xtoro in the Orange Book expires November 21, 2033. 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.