FDA Orange Book
Is there a generic for Litfulo?
Litfulo contains ritlecitinib. 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 Litfulo (ritlecitinib). The Orange Book shows its last listed patent expires October 17, 2041 and its last listed exclusivity ends June 23, 2028.
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Litfulo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 50MG BASE | Marketed (Rx) | None | 0 | None |
NDA 215830, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Litfulo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12077533 | December 3, 2034 | Method of use | U-3994 | 215830 |
| 9617258 | December 3, 2034 | Drug substance, Drug product | None | 215830 |
| 12116368 | October 17, 2041 | Drug substance | None | 215830 |
Litfulo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | June 23, 2028 | 215830 |
Litfulo NDC codes
Questions
Is there a generic for Litfulo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Litfulo (ritlecitinib). The Orange Book shows its last listed patent expires October 17, 2041 and its last listed exclusivity ends June 23, 2028.
What is the generic name for Litfulo?
The active ingredient in Litfulo is ritlecitinib, per the FDA Orange Book.
When does the Litfulo patent expire?
The last patent listed for Litfulo in the Orange Book expires October 17, 2041. 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.