FDA Orange Book
Is there a generic for Joenja?
Joenja contains leniolisib. 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 Joenja (leniolisib). The Orange Book shows its last listed patent expires February 19, 2032 and its last listed exclusivity ends March 24, 2030.
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Joenja products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 40MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 50MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 70MG BASE | Marketed (Rx) | None | 0 | None |
NDA 217759, held by PHARMING TECHNOLOGIES BV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Joenja patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8653092 | February 19, 2032 | Drug substance, Drug product | None | 217759 |
Joenja exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | March 24, 2028 | 217759 |
| NS | New strength | September 11, 2029 | 217759 |
| NPP | New patient population | September 11, 2029 | 217759 |
| ODE* | See the Orange Book exclusivity code list | March 24, 2030 | 217759 |
| ODE-430 | Orphan drug exclusivity | March 24, 2030 | 217759 |
Joenja NDC codes
Questions
Is there a generic for Joenja?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Joenja (leniolisib). The Orange Book shows its last listed patent expires February 19, 2032 and its last listed exclusivity ends March 24, 2030.
What is the generic name for Joenja?
The active ingredient in Joenja is leniolisib, per the FDA Orange Book.
When does the Joenja patent expire?
The last patent listed for Joenja in the Orange Book expires February 19, 2032. 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.