Orange Book product · Brand (NDA)
POSLUMA
FLOTUFOLASTAT F-18 GALLIUM
At a glance
May 25, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 25, 2023
3 yr 1 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 25, 2028
in 2 yr
Patent 12390540 expires
Listed drug substance patent expiration.
Aug 23, 2038
in 12 yr 4 mo
Patent 11413360 expires
Listed drug substance patent expiration.
Nov 22, 2038
in 12 yr 7 mo
Patent 11413360 expires
Listed drug substance patent expiration.
Nov 22, 2038
in 12 yr 7 mo
Patent 12357711 expires
Listed drug substance patent expiration.
Nov 22, 2038
in 12 yr 7 mo
Patent 12377176 expires
Listed drug substance patent expiration.
Nov 22, 2038
in 12 yr 7 mo
Patent 12036290 expires
Listed drug product patent expiration.
Nov 27, 2041
in 15 yr 8 mo
Patent 12036290 expires
Listed drug product patent expiration.
Nov 27, 2041
in 15 yr 8 mo
Patent 12427207 expires
Listed drug product patent expiration.
Nov 27, 2041
in 15 yr 8 mo
Pharmaceutical detail
Active ingredient
FLOTUFOLASTAT F-18 GALLIUM
Strength
25ML (8-158mCi/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 216023
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.
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
May 25, 2028
in 2 yr
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12390540 | Aug 23, 2038 | in 12 yr 4 mo | Substance |
| 11413360 | Nov 22, 2038 | in 12 yr 7 mo | SubstanceU-3614 |
| 11413360 | Nov 22, 2038 | in 12 yr 7 mo | SubstanceU-3615 |
| 12357711 | Nov 22, 2038 | in 12 yr 7 mo | Substance |
| 12377176 | Nov 22, 2038 | in 12 yr 7 mo | Substance |
| 12036290 | Nov 27, 2041 | in 15 yr 8 mo | ProductU-3614 |
| 12036290 | Nov 27, 2041 | in 15 yr 8 mo | ProductU-3615 |
| 12427207 | Nov 27, 2041 | in 15 yr 8 mo | Product |

