FDA Orange Book
Is there a generic for Otovel?
Otovel contains ciprofloxacin and fluocinolone acetonide. 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 Otovel (ciprofloxacin and fluocinolone acetonide). The Orange Book shows its last listed patent expires March 24, 2030.
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Otovel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, otic | EQ 0.3% BASE;0.025% | Marketed (Rx) | None | 0 | None |
NDA 208251, held by LABORATORIOS SALVAT SA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Otovel patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8932610 | March 24, 2030 | Drug product | U-1578 | 208251 |
Questions
Is there a generic for Otovel?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Otovel (ciprofloxacin and fluocinolone acetonide). The Orange Book shows its last listed patent expires March 24, 2030.
What is the generic name for Otovel?
The active ingredient in Otovel is ciprofloxacin and fluocinolone acetonide, per the FDA Orange Book.
When does the Otovel patent expire?
The last patent listed for Otovel in the Orange Book expires March 24, 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.