FDA Orange Book
Is there a generic for Adquey?
Adquey contains difamilast. 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 Adquey (difamilast). The Orange Book shows its last listed patent expires December 31, 2036 and its last listed exclusivity ends February 12, 2031.
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Adquey products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| ointment, topical | 1% | Marketed (Rx) | None | 0 | None |
NDA 219474, held by ACROTECH BIOPHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Adquey patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE46792 | March 1, 2028 | Drug substance, Drug product | U-4445 | 219474 |
| 10588893 | December 31, 2036 | Drug substance, Drug product | None | 219474 |
Adquey exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | February 12, 2031 | 219474 |
Adquey NDC codes
Questions
Is there a generic for Adquey?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Adquey (difamilast). The Orange Book shows its last listed patent expires December 31, 2036 and its last listed exclusivity ends February 12, 2031.
What is the generic name for Adquey?
The active ingredient in Adquey is difamilast, per the FDA Orange Book.
When does the Adquey patent expire?
The last patent listed for Adquey in the Orange Book expires December 31, 2036. 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.