FDA Orange Book
Is there a generic for Khapzory?
Khapzory contains levoleucovorin. 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 Khapzory (levoleucovorin). The Orange Book shows its last listed patent expires March 25, 2039.
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Khapzory products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 175MG/VIAL | Marketed (Rx) | None | 0 | None |
| powder, intravenous | 300MG/VIAL | Discontinued | None | 0 | None |
NDA 211226, held by ACROTECH BIOPHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Khapzory patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11541012 | March 25, 2039 | Drug product | None | 211226 |
Khapzory NDC codes
Questions
Is there a generic for Khapzory?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Khapzory (levoleucovorin). The Orange Book shows its last listed patent expires March 25, 2039.
What is the generic name for Khapzory?
The active ingredient in Khapzory is levoleucovorin, per the FDA Orange Book.
When does the Khapzory patent expire?
The last patent listed for Khapzory in the Orange Book expires March 25, 2039. 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.