FDA Orange Book
Generic for Naftin
Naftin contains naftifine. 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
Yes. The generic name for Naftin is naftifine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Naftin products the Orange Book lists.
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Naftin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 1% | Discontinued | None | 1 | None |
| cream, topical | 2% | Marketed (Rx) | AB | 2 | AB |
| gel, topical | 1% | Discontinued | None | 0 | None |
| gel, topical | 2% | Marketed (Rx) | AB | 1 | AB |
NDA 019599, 019356, 204286, held by LEGACY PHARMA INC SEZC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic naftifine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMA CANADA INC | 206901 | AB (A-rated, therapeutically equivalent) | January 6, 2016 | 2% |
| SUN PHARMA CANADA INC | 205975 | None (No TE code listed) | September 8, 2016 | 1% |
| SUN PHARMA CANADA INC | 208201 | AB (A-rated, therapeutically equivalent) | April 10, 2019 | 2% |
| XIROMED PHARMA ESPANA SL | 210038 | AB (A-rated, therapeutically equivalent) | September 22, 2020 | 2% |
Naftin patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9161914 | January 31, 2033 | Method of use | U-540 | 204286 |
| 10729667 | January 31, 2033 | Drug product | None | 204286 |
| 8778365 | January 31, 2033 | Drug product | None | 204286 |
| 10695303 | January 31, 2033 | Drug product | None | 204286 |
| 10166206 | January 31, 2033 | Drug product | None | 204286 |
| 10166205 | January 31, 2033 | Drug product | None | 204286 |
Naftin NDC codes
Questions
Is there a generic for Naftin?
Yes. The generic name for Naftin is naftifine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Naftin products the Orange Book lists.
What is the generic name for Naftin?
The active ingredient in Naftin is naftifine, per the FDA Orange Book.
When does the Naftin patent expire?
The last patent listed for Naftin in the Orange Book expires January 31, 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.