FDA Orange Book
Is there a generic for Sotyktu?
Sotyktu contains deucravacitinib. 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 Sotyktu (deucravacitinib). The Orange Book shows its last listed patent expires February 11, 2043 and its last listed exclusivity ends March 6, 2029.
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Sotyktu products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 6MG | Marketed (Rx) | None | 0 | None |
NDA 214958, held by BRISTOL MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Sotyktu patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE47929 | November 7, 2033 | Drug substance, Drug product | U-4452 | 214958 |
| 11021475 | November 7, 2033 | Method of use | U-3434 | 214958 |
| RE47929 | November 7, 2033 | Drug substance, Drug product | U-3434 | 214958 |
| 10000480 | November 7, 2033 | Drug substance, Drug product | None | 214958 |
| 12734169 | September 18, 2040 | Drug product | U-3434 | 214958 |
| 12734169 | September 18, 2040 | Drug product | U-4452 | 214958 |
| 12521390 | February 11, 2043 | Drug product | U-3434 | 214958 |
| 12521390 | February 11, 2043 | Drug product | U-4451 | 214958 |
Sotyktu exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 9, 2027 | 214958 |
| I-986 | New indication | March 6, 2029 | 214958 |
Sotyktu NDC codes
Questions
Is there a generic for Sotyktu?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sotyktu (deucravacitinib). The Orange Book shows its last listed patent expires February 11, 2043 and its last listed exclusivity ends March 6, 2029.
What is the generic name for Sotyktu?
The active ingredient in Sotyktu is deucravacitinib, per the FDA Orange Book.
When does the Sotyktu patent expire?
The last patent listed for Sotyktu in the Orange Book expires February 11, 2043. 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.