FDA Orange Book
Is there a generic for Cytalux?
Cytalux contains pafolacianine. 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 Cytalux (pafolacianine). The Orange Book shows its last listed patent expires November 29, 2035 and its last listed exclusivity ends November 29, 2028.
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Cytalux products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 214907, held by ON TARGET LABORATORIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cytalux patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9333270 | August 26, 2033 | Drug substance, Drug product | U-3291 | 214907 |
| 10881747 | August 26, 2033 | Drug substance, Drug product | U-3291 | 214907 |
| 9789208 | August 26, 2033 | Drug substance, Drug product | U-3291 | 214907 |
| 9341629 | August 26, 2033 | Drug substance, Drug product | None | 214907 |
| 9254341 | October 4, 2033 | Drug substance, Drug product | None | 214907 |
| 9061057 | November 29, 2035 | Drug substance, Drug product | U-3291 | 214907 |
Cytalux exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | November 29, 2026 | 214907 |
| ODE-390 | Orphan drug exclusivity | November 29, 2028 | 214907 |
Cytalux NDC codes
Questions
Is there a generic for Cytalux?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cytalux (pafolacianine). The Orange Book shows its last listed patent expires November 29, 2035 and its last listed exclusivity ends November 29, 2028.
What is the generic name for Cytalux?
The active ingredient in Cytalux is pafolacianine, per the FDA Orange Book.
When does the Cytalux patent expire?
The last patent listed for Cytalux in the Orange Book expires November 29, 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.