FDA Orange Book
Is there a generic for Gozellix?
Gozellix contains gallium ga-68 gozetotide. 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 Gozellix (gallium ga-68 gozetotide). The Orange Book shows its last listed patent expires July 28, 2035.
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Gozellix products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | N/A | Marketed (Rx) | None | 0 | None |
NDA 219592, held by TELIX INNOVATIONS SA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Gozellix patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11027031 | July 28, 2035 | Method of use | U-3317 | 219592 |
Questions
Is there a generic for Gozellix?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Gozellix (gallium ga-68 gozetotide). The Orange Book shows its last listed patent expires July 28, 2035.
What is the generic name for Gozellix?
The active ingredient in Gozellix is gallium ga-68 gozetotide, per the FDA Orange Book.
When does the Gozellix patent expire?
The last patent listed for Gozellix in the Orange Book expires July 28, 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.