FDA Orange Book
Is there a generic for Axumin?
Axumin contains fluciclovine f-18. 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 Axumin (fluciclovine f-18). The Orange Book shows its last listed patent expires April 23, 2042.
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Axumin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 9-221mCi/ML | Marketed (Rx) | None | 0 | None |
NDA 208054, held by BLUE EARTH DIAGNOSTICS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Axumin patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9387266 | November 28, 2026 | Method of use | U-1879 | 208054 |
| 10953112 | November 28, 2026 | Method of use | U-1879 | 208054 |
| 10010632 | November 28, 2026 | Drug product | None | 208054 |
| 10124079 | December 30, 2035 | Method of use | U-2450 | 208054 |
| 10716868 | December 30, 2035 | Method of use | U-2450 | 208054 |
| 10967077 | December 30, 2035 | Method of use | U-2450 | 208054 |
| 10933147 | December 30, 2035 | Method of use | U-2450 | 208054 |
| 11980674 | April 23, 2042 | Method of use | U-2450 | 208054 |
Axumin NDC codes
Questions
Is there a generic for Axumin?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Axumin (fluciclovine f-18). The Orange Book shows its last listed patent expires April 23, 2042.
What is the generic name for Axumin?
The active ingredient in Axumin is fluciclovine f-18, per the FDA Orange Book.
When does the Axumin patent expire?
The last patent listed for Axumin in the Orange Book expires April 23, 2042. 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.