Orange Book product · Brand (NDA)
REDEMPLO
PLOZASIRAN SODIUM
At a glance
Nov 18, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 18, 2025
7 mo ago
Today
Exclusivity ends · ODE-541
Orphan-drug exclusivity (7 years)
Nov 18, 2032
in 6 yr 6 mo
Patent 10294474 expires
Listed drug substance patent expiration.
Mar 07, 2037
in 10 yr 10 mo
Patent 11174481 expires
Listed drug substance patent expiration.
Mar 07, 2037
in 10 yr 10 mo
Patent 10597657 expires
Listed drug substance patent expiration.
Sep 10, 2038
in 12 yr 5 mo
Patent 11214801 expires
Listed drug substance patent expiration.
Sep 10, 2038
in 12 yr 5 mo
Patent 12365899 expires
Listed drug substance patent expiration.
Sep 10, 2038
in 12 yr 5 mo
Pharmaceutical detail
Active ingredient
PLOZASIRAN SODIUM
Strength
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 219947
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)
- ODE-541Orphan-drug exclusivity (7 years)
Nov 18, 2032
in 6 yr 6 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10294474 | Mar 07, 2037 | in 10 yr 10 mo | SubstanceProductU-4360 |
| 11174481 | Mar 07, 2037 | in 10 yr 10 mo | SubstanceProduct |
| 10597657 | Sep 10, 2038 | in 12 yr 5 mo | SubstanceProductU-4360 |
| 11214801 | Sep 10, 2038 | in 12 yr 5 mo | SubstanceProductU-4360 |
| 12365899 | Sep 10, 2038 | in 12 yr 5 mo | SubstanceProductU-4360 |
