FDA Orange Book · active-ingredient family
Fluciclovine f-18
Fluciclovine f-18 is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:AXUMIN · NDA 208054
1
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AXUMINRLD | BLUE EARTH | NDA 208054 | — | May 27, 2016 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9387266 | Nov 28, 2026 | in 5 mo | U-1879 |
| 10953112 | Nov 28, 2026 | in 5 mo | U-1879 |
| 10010632 | Nov 28, 2026 | in 5 mo | Product |
| 10124079 | Dec 30, 2035 | in 9 yr 8 mo | U-2450 |
| 10716868 | Dec 30, 2035 | in 9 yr 8 mo | U-2450 |
| 10967077 | Dec 30, 2035 | in 9 yr 8 mo | U-2450 |
| 10933147 | Dec 30, 2035 | in 9 yr 8 mo | U-2450 |
| 11980674 | Apr 23, 2042 | in 16 yr 1 mo | U-2450 |
Fluciclovine f-18 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
