FDA Orange Book
Generic for Leustatin
Leustatin contains cladribine. 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
Yes. The generic name for Leustatin is cladribine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Leustatin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1MG/ML | Discontinued | None | 3 | AP |
NDA 020229, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cladribine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 075405 | AP (A-rated, therapeutically equivalent) | February 28, 2000 | 1MG/ML |
| FRESENIUS KABI USA LLC | 076571 | AP (A-rated, therapeutically equivalent) | April 22, 2004 | 1MG/ML |
| HISUN PHARMACEUTICAL (HANGZHOU) CO LTD | 210856 | AP (A-rated, therapeutically equivalent) | November 25, 2019 | 1MG/ML |
Questions
Is there a generic for Leustatin?
Yes. The generic name for Leustatin is cladribine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Leustatin?
The active ingredient in Leustatin is cladribine, per the FDA Orange Book.
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.