Orange Book product · Brand (NDA)
AXUMIN
FLUCICLOVINE F-18
At a glance
May 27, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 27, 2016
10 yr 3 mo ago
Today
Patent 10010632 expires
Listed drug product patent expiration.
Nov 28, 2026
in 5 mo
Patent 10953112 expires
Listed method-of-use patent (U-1879) expiration.
Nov 28, 2026
in 5 mo
Patent 9387266 expires
Listed method-of-use patent (U-1879) expiration.
Nov 28, 2026
in 5 mo
Patent 10124079 expires
Listed method-of-use patent (U-2450) expiration.
Dec 30, 2035
in 9 yr 8 mo
Patent 10716868 expires
Listed method-of-use patent (U-2450) expiration.
Dec 30, 2035
in 9 yr 8 mo
Patent 10933147 expires
Listed method-of-use patent (U-2450) expiration.
Dec 30, 2035
in 9 yr 8 mo
Patent 10967077 expires
Listed method-of-use patent (U-2450) expiration.
Dec 30, 2035
in 9 yr 8 mo
Patent 11980674 expires
Listed method-of-use patent (U-2450) expiration.
Apr 23, 2042
in 16 yr 1 mo
Pharmaceutical detail
Active ingredient
FLUCICLOVINE F-18
Strength
9-221mCi/ML
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 208054
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10010632 | Nov 28, 2026 | in 5 mo | Product |
| 10953112 | Nov 28, 2026 | in 5 mo | U-1879 |
| 9387266 | Nov 28, 2026 | in 5 mo | U-1879 |
| 10124079 | Dec 30, 2035 | in 9 yr 8 mo | U-2450 |
| 10716868 | Dec 30, 2035 | in 9 yr 8 mo | U-2450 |
| 10933147 | Dec 30, 2035 | in 9 yr 8 mo | U-2450 |
| 10967077 | Dec 30, 2035 | in 9 yr 8 mo | U-2450 |
| 11980674 | Apr 23, 2042 | in 16 yr 1 mo | U-2450 |
