Orange Book product · Brand (NDA)
QFITLIA
FITUSIRAN SODIUM
At a glance
Mar 28, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 28, 2025
1 yr 3 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 28, 2030
in 3 yr 10 mo
Exclusivity ends · ODE-510
Orphan-drug exclusivity (7 years)
Mar 28, 2032
in 5 yr 10 mo
Exclusivity ends · ODE-511
Orphan-drug exclusivity (7 years)
Mar 28, 2032
in 5 yr 10 mo
Patent 9376680 expires
Listed drug substance patent expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9127274 expires
Listed drug substance patent expiration.
Mar 22, 2033
in 6 yr 10 mo
Patent 11091759 expires
Listed method-of-use patent (U-4165) expiration.
Dec 07, 2036
in 10 yr 7 mo
Pharmaceutical detail
Active ingredient
FITUSIRAN SODIUM
Strength
EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 219019
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 (3)
- NCENew chemical entity exclusivity (5 years)
Mar 28, 2030
in 3 yr 10 mo
- ODE-510Orphan-drug exclusivity (7 years)
Mar 28, 2032
in 5 yr 10 mo
- ODE-511Orphan-drug exclusivity (7 years)
Mar 28, 2032
in 5 yr 10 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9376680 | Mar 15, 2033 | in 6 yr 10 mo | SubstanceProductU-4165 |
| 9127274 | Mar 22, 2033 | in 6 yr 10 mo | SubstanceProductU-4165 |
| 11091759 | Dec 07, 2036 | in 10 yr 7 mo | U-4165 |
