FDA Orange Book
Is there a generic for Leqselvi?
Leqselvi contains deuruxolitinib. 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 Leqselvi (deuruxolitinib). The Orange Book shows its last listed patent expires October 10, 2044 and its last listed exclusivity ends July 25, 2029.
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Leqselvi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 8MG BASE | Marketed (Rx) | None | 0 | None |
NDA 217900, held by SUN PHARMACEUTICAL INDUSTRIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Leqselvi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10561659 | May 4, 2037 | Method of use | U-3976 | 217900 |
| 12076323 | May 4, 2037 | Method of use | U-3976 | 217900 |
| 11919907 | May 21, 2041 | Drug product | U-3976 | 217900 |
| 12285432 | August 11, 2042 | Method of use | U-3976 | 217900 |
| 12247034 | May 10, 2044 | Drug substance, Drug product | None | 217900 |
| 12364699 | October 10, 2044 | Method of use | U-3976 | 217900 |
Leqselvi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | July 25, 2029 | 217900 |
Leqselvi NDC codes
Questions
Is there a generic for Leqselvi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Leqselvi (deuruxolitinib). The Orange Book shows its last listed patent expires October 10, 2044 and its last listed exclusivity ends July 25, 2029.
What is the generic name for Leqselvi?
The active ingredient in Leqselvi is deuruxolitinib, per the FDA Orange Book.
When does the Leqselvi patent expire?
The last patent listed for Leqselvi in the Orange Book expires October 10, 2044. 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.