FDA Orange Book
Is there a generic for Clotic?
Clotic contains clotrimazole. 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 Clotic (clotrimazole). The Orange Book shows its last listed patent expires May 26, 2042 and its last listed exclusivity ends September 26, 2037.
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Clotic products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, otic | 1% | Marketed (Rx) | None | 0 | None |
NDA 217628, held by CARWIN PHARMACEUTICAL ASSOCIATES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Clotic patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12246006 | May 26, 2042 | Drug product | U-4276 | 217628 |
Clotic exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | September 26, 2028 | 217628 |
| ODE-549 | Orphan drug exclusivity | September 26, 2032 | 217628 |
| GAIN | Generating Antibiotic Incentives Now | September 26, 2033 | 217628 |
| GAIN | Generating Antibiotic Incentives Now | September 26, 2037 | 217628 |
Clotic NDC codes
Questions
Is there a generic for Clotic?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Clotic (clotrimazole). The Orange Book shows its last listed patent expires May 26, 2042 and its last listed exclusivity ends September 26, 2037.
What is the generic name for Clotic?
The active ingredient in Clotic is clotrimazole, per the FDA Orange Book.
When does the Clotic patent expire?
The last patent listed for Clotic in the Orange Book expires May 26, 2042. 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.