Orange Book product · Brand (NDA)
LUMISIGHT
PEGULICIANINE ACETATE
At a glance
Apr 17, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 17, 2024
2 yr 2 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Apr 17, 2029
in 2 yr 10 mo
Patent 11592396 expires
Listed drug substance patent expiration.
Sep 01, 2030
in 4 yr 3 mo
Patent 9155471 expires
Listed method-of-use patent (U-3890) expiration.
Oct 12, 2031
in 5 yr 5 mo
Patent 10285759 expires
Listed method-of-use patent (U-3890) expiration.
Dec 08, 2031
in 5 yr 7 mo
Patent 9032965 expires
Listed method-of-use patent (U-3890) expiration.
Dec 08, 2031
in 5 yr 7 mo
Patent 9532835 expires
Listed method-of-use patent (U-3890) expiration.
Dec 08, 2031
in 5 yr 7 mo
Patent 9763577 expires
Listed drug substance patent expiration.
Sep 14, 2034
in 8 yr 4 mo
Pharmaceutical detail
Active ingredient
PEGULICIANINE ACETATE
Strength
EQ 39MG BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 214511
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)
Apr 17, 2029
in 2 yr 10 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11592396 | Sep 01, 2030 | in 4 yr 3 mo | Substance |
| 9155471 | Oct 12, 2031 | in 5 yr 5 mo | U-3890 |
| 10285759 | Dec 08, 2031 | in 5 yr 7 mo | U-3890 |
| 9032965 | Dec 08, 2031 | in 5 yr 7 mo | U-3890 |
| 9532835 | Dec 08, 2031 | in 5 yr 7 mo | U-3890 |
| 9763577 | Sep 14, 2034 | in 8 yr 4 mo | SubstanceProductU-3890 |
