FDA Orange Book
Is there a generic for Harliku?
Harliku contains nitisinone. 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 Harliku (nitisinone). The Orange Book shows its last listed exclusivity ends June 10, 2032.
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Harliku products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 2MG | Marketed (Rx) | None | 0 | None |
NDA 209449, held by CYCLE PHARMACEUTICALS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Harliku exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-529 | Orphan drug exclusivity | June 10, 2032 | 209449 |
Harliku NDC codes
Questions
Is there a generic for Harliku?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Harliku (nitisinone). The Orange Book shows its last listed exclusivity ends June 10, 2032.
What is the generic name for Harliku?
The active ingredient in Harliku is nitisinone, 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.