FDA Orange Book
Is there a generic for Lupkynis?
Lupkynis contains voclosporin. 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 Lupkynis (voclosporin). The Orange Book shows its last listed patent expires December 7, 2037 and its last listed exclusivity ends January 22, 2026.
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Lupkynis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 7.9MG | Marketed (Rx) | None | 0 | None |
NDA 213716, held by AURINIA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lupkynis patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7332472 | October 17, 2027 | Drug substance, Drug product | U-3056 | 213716 |
| 11622991 | December 7, 2037 | Method of use | U-3056 | 213716 |
| 10286036 | December 7, 2037 | Method of use | U-3056 | 213716 |
Lupkynis exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | January 22, 2026 | 213716 |
Lupkynis NDC codes
Questions
Is there a generic for Lupkynis?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lupkynis (voclosporin). The Orange Book shows its last listed patent expires December 7, 2037 and its last listed exclusivity ends January 22, 2026.
What is the generic name for Lupkynis?
The active ingredient in Lupkynis is voclosporin, per the FDA Orange Book.
When does the Lupkynis patent expire?
The last patent listed for Lupkynis in the Orange Book expires December 7, 2037. 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.