Orange Book product · Brand (NDA)
GIVLAARI
GIVOSIRAN SODIUM
At a glance
Nov 20, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 20, 2019
6 yr 8 mo ago
Today
Exclusivity ends · ODE-273
Orphan-drug exclusivity (7 years)
Nov 20, 2026
in 5 mo
Patent 10131907 expires
Listed drug substance patent expiration.
Aug 24, 2028
in 2 yr 3 mo
Patent 8828956 expires
Listed drug substance patent expiration.
Dec 04, 2028
in 2 yr 6 mo
Patent 8106022 expires
Listed drug substance patent expiration.
Dec 12, 2029
in 3 yr 6 mo
Patent 10125364 expires
Listed drug substance patent expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9631193 expires
Listed method-of-use patent (U-2672) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9133461 expires
Listed drug substance patent expiration.
Nov 30, 2033
in 7 yr 7 mo
Patent 10119143 expires
Listed drug substance patent expiration.
Oct 03, 2034
in 8 yr 5 mo
Patent 11028392 expires
Listed drug substance patent expiration.
Oct 03, 2034
in 8 yr 5 mo
Pharmaceutical detail
Active ingredient
GIVOSIRAN SODIUM
Strength
EQ 189MG BASE/ML (EQ 189MG BASE/ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 212194
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-273Orphan-drug exclusivity (7 years)
Nov 20, 2026
in 5 mo
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10131907 | Aug 24, 2028 | in 2 yr 3 mo | SubstanceProductU-2672 |
| 8828956 | Dec 04, 2028 | in 2 yr 6 mo | SubstanceProductU-2672 |
| 8106022 | Dec 12, 2029 | in 3 yr 6 mo | SubstanceProductU-2672 |
| 10125364 | Mar 15, 2033 | in 6 yr 10 mo | SubstanceProductU-2672 |
| 9631193 | Mar 15, 2033 | in 6 yr 10 mo | U-2672 |
| 9133461 | Nov 30, 2033 | in 7 yr 7 mo | SubstanceProductU-2672 |
| 10119143 | Oct 03, 2034 | in 8 yr 5 mo | SubstanceProductU-2672 |
| 11028392 | Oct 03, 2034 | in 8 yr 5 mo | SubstanceProductU-2672 |
