FDA Orange Book
Is there a generic for Nulibry?
Nulibry contains fosdenopterin. 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 Nulibry (fosdenopterin). The Orange Book shows its last listed patent expires April 9, 2029 and its last listed exclusivity ends February 26, 2028.
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Nulibry products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 9.5MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 214018, held by SENTYNL THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Nulibry patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7504095 | April 9, 2029 | Drug product | U-3092 | 214018 |
Nulibry exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | February 26, 2026 | 214018 |
| ODE-342 | Orphan drug exclusivity | February 26, 2028 | 214018 |
Nulibry NDC codes
Questions
Is there a generic for Nulibry?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nulibry (fosdenopterin). The Orange Book shows its last listed patent expires April 9, 2029 and its last listed exclusivity ends February 26, 2028.
What is the generic name for Nulibry?
The active ingredient in Nulibry is fosdenopterin, per the FDA Orange Book.
When does the Nulibry patent expire?
The last patent listed for Nulibry in the Orange Book expires April 9, 2029. 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.