Orange Book product · Brand (NDA)
PLUVICTO
LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
At a glance
Mar 23, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 23, 2022
4 yr 4 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 23, 2027
in 9 mo
Exclusivity ends · I-965
New indication exclusivity (3 years)
Mar 28, 2028
in 1 yr 10 mo
Patent 10406240 expires
Listed drug substance patent expiration.
Aug 15, 2028
in 2 yr 2 mo
Patent 11318121 expires
Listed drug substance patent expiration.
Aug 15, 2028
in 2 yr 2 mo
Patent 11951190 expires
Listed method-of-use patent (U-4169) expiration.
Nov 12, 2035
in 9 yr 6 mo
Patent 10398791 expires
Listed drug substance patent expiration.
Mar 23, 2036
in 9 yr 11 mo
Patent 12208102 expires
Listed method-of-use patent (U-4169) expiration.
Sep 18, 2041
in 15 yr 6 mo
Pharmaceutical detail
Active ingredient
LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
Strength
27mCi/ML
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 215833
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 (2)
- NCENew chemical entity exclusivity (5 years)
Mar 23, 2027
in 9 mo
- I-965New indication exclusivity (3 years)
Mar 28, 2028
in 1 yr 10 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10406240 | Aug 15, 2028 | in 2 yr 2 mo | SubstanceProductU-4169 |
| 11318121 | Aug 15, 2028 | in 2 yr 2 mo | SubstanceProductU-4169 |
| 11951190 | Nov 12, 2035 | in 9 yr 6 mo | U-4169 |
| 10398791 | Mar 23, 2036 | in 9 yr 11 mo | SubstanceProduct |
| 12208102 | Sep 18, 2041 | in 15 yr 6 mo | U-4169 |
