FDA Orange Book
Is there a generic for Aklief?
Aklief contains trifarotene. 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 Aklief (trifarotene). The Orange Book shows its last listed patent expires May 30, 2033.
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Aklief products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.005% | Marketed (Rx) | None | 0 | None |
NDA 211527, held by GALDERMA LABORATORIES LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Aklief patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7807708 | July 19, 2031 | Drug substance, Drug product | None | 211527 |
| 9084778 | May 30, 2033 | Drug product | U-134 | 211527 |
| 9498465 | May 30, 2033 | Drug product | U-1033 | 211527 |
Aklief NDC codes
Questions
Is there a generic for Aklief?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Aklief (trifarotene). The Orange Book shows its last listed patent expires May 30, 2033.
What is the generic name for Aklief?
The active ingredient in Aklief is trifarotene, per the FDA Orange Book.
When does the Aklief patent expire?
The last patent listed for Aklief in the Orange Book expires May 30, 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.