FDA Orange Book
Is there a generic for Nityr?
Nityr 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 Nityr (nitisinone). The Orange Book shows its last listed patent expires January 5, 2035.
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Nityr products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 2MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 5MG | 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.
Nityr patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10328029 | January 5, 2035 | Drug product | U-1836 | 209449 |
Nityr NDC codes
Questions
Is there a generic for Nityr?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nityr (nitisinone). The Orange Book shows its last listed patent expires January 5, 2035.
What is the generic name for Nityr?
The active ingredient in Nityr is nitisinone, per the FDA Orange Book.
When does the Nityr patent expire?
The last patent listed for Nityr in the Orange Book expires January 5, 2035. 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.