Orange Book product · Brand (NDA)
PYLARIFY
PIFLUFOLASTAT F-18
At a glance
May 26, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 26, 2021
5 yr 2 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 26, 2026
24 d ago
Today
Patent 8487129 expires
Listed drug substance patent expiration.
Nov 07, 2027
in 1 yr 5 mo
Patent 12070513 expires
Listed drug substance patent expiration.
Jul 31, 2029
in 3 yr 2 mo
Patent 9861713 expires
Listed drug substance patent expiration.
Jul 31, 2029
in 3 yr 2 mo
Patent 8778305 expires
Listed drug substance patent expiration.
Sep 21, 2030
in 4 yr 4 mo
Patent 10947197 expires
Listed drug substance patent expiration.
Jun 09, 2037
in 11 yr 2 mo
Patent 11851407 expires
Listed drug substance patent expiration.
Jun 09, 2037
in 11 yr 2 mo
Pharmaceutical detail
Active ingredient
PIFLUFOLASTAT F-18
Strength
50ML (1-80mCi/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 214793
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 26, 2026
24 d ago
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8487129 | Nov 07, 2027 | in 1 yr 5 mo | SubstanceProduct |
| 12070513 | Jul 31, 2029 | in 3 yr 2 mo | SubstanceProductU-3130 |
| 9861713 | Jul 31, 2029 | in 3 yr 2 mo | SubstanceProductU-3130 |
| 8778305 | Sep 21, 2030 | in 4 yr 4 mo | SubstanceProductU-3130 |
| 10947197 | Jun 09, 2037 | in 11 yr 2 mo | SubstanceProductU-3130 |
| 11851407 | Jun 09, 2037 | in 11 yr 2 mo | SubstanceProductU-3130 |
