FDA Orange Book
Is there a generic for Luzu?
Luzu contains luliconazole. 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 Luzu (luliconazole). The Orange Book shows its last listed patent expires April 28, 2034.
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Luzu products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 1% | Marketed (Rx) | None | 0 | None |
NDA 204153, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Luzu patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9012484 | September 6, 2033 | Drug substance, Drug product | U-540 | 204153 |
| 9453006 | September 6, 2033 | Drug substance | None | 204153 |
| 9199977 | September 6, 2033 | Drug substance, Drug product | None | 204153 |
| 8980931 | April 28, 2034 | Drug product | None | 204153 |
Luzu NDC codes
Questions
Is there a generic for Luzu?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Luzu (luliconazole). The Orange Book shows its last listed patent expires April 28, 2034.
What is the generic name for Luzu?
The active ingredient in Luzu is luliconazole, per the FDA Orange Book.
When does the Luzu patent expire?
The last patent listed for Luzu in the Orange Book expires April 28, 2034. 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.