Orange Book product · Brand (NDA)
FLYRCADO
FLURPIRIDAZ F-18
At a glance
Sep 27, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 27, 2024
1 yr 9 mo ago
Patent 9161997 expires
Listed drug substance patent expiration.
Feb 04, 2026
5 mo ago
Patent 7344702 expires
Listed drug substance patent expiration.
May 26, 2026
24 d ago
Today
Patent 8226929 expires
Listed method-of-use patent (U-4011) expiration.
Jun 21, 2028
in 2 yr
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 27, 2029
in 3 yr 4 mo
Patent 9603951 expires
Listed method-of-use patent (U-4011) expiration.
May 02, 2031
in 4 yr 11 mo
Patent 8936777 expires
Listed method-of-use patent (U-4011) expiration.
Jun 30, 2031
in 5 yr 1 mo
Patent 9687571 expires
Listed drug product patent expiration.
Nov 01, 2032
in 6 yr 6 mo
Patent 12527884 expires
Listed drug product patent expiration.
May 13, 2042
in 16 yr 2 mo
Pharmaceutical detail
Active ingredient
FLURPIRIDAZ F-18
Strength
5-55mCi/ML
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 215168
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)
Sep 27, 2029
in 3 yr 4 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9161997 | Feb 04, 2026 | 5 mo ago | SubstanceProductU-4011 |
| 7344702 | May 26, 2026 | 24 d ago | Substance |
| 8226929 | Jun 21, 2028 | in 2 yr | U-4011 |
| 9603951 | May 02, 2031 | in 4 yr 11 mo | U-4011 |
| 8936777 | Jun 30, 2031 | in 5 yr 1 mo | U-4011 |
| 9687571 | Nov 01, 2032 | in 6 yr 6 mo | ProductU-4011 |
| 12527884 | May 13, 2042 | in 16 yr 2 mo | ProductU-4406 |
