Orange Book product · Brand (NDA)
AMVUTTRA
VUTRISIRAN SODIUM
At a glance
Jun 13, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 13, 2022
4 yr 1 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jun 13, 2027
in 1 yr
Exclusivity ends · I-964
New indication exclusivity (3 years)
Mar 20, 2028
in 1 yr 9 mo
Patent 10131907 expires
Listed drug substance patent expiration.
Aug 24, 2028
in 2 yr 3 mo
Patent 10806791 expires
Listed drug substance patent expiration.
Dec 04, 2028
in 2 yr 6 mo
Patent 8828956 expires
Listed drug substance patent expiration.
Dec 04, 2028
in 2 yr 6 mo
Patent 9370581 expires
Listed drug substance patent expiration.
Dec 04, 2028
in 2 yr 6 mo
Exclusivity ends · ODE-212
Orphan-drug exclusivity (7 years)
Jun 13, 2029
in 3 yr
Patent 8106022 expires
Listed drug substance patent expiration.
Dec 12, 2029
in 3 yr 6 mo
Exclusivity ends · ODE-527
Orphan-drug exclusivity (7 years)
Mar 20, 2032
in 5 yr 10 mo
Patent 10570391 expires
Listed drug substance patent expiration.
Nov 16, 2032
in 6 yr 6 mo
Patent 9399775 expires
Listed drug substance patent expiration.
Nov 16, 2032
in 6 yr 6 mo
Patent 10612024 expires
Listed drug substance patent expiration.
Aug 14, 2035
in 9 yr 3 mo
Patent 11401517 expires
Listed drug substance patent expiration.
Aug 14, 2035
in 9 yr 3 mo
Patent 10208307 expires
Listed drug substance patent expiration.
Jul 28, 2036
in 10 yr 3 mo
Patent 10683501 expires
Listed drug substance patent expiration.
Jul 28, 2036
in 10 yr 3 mo
Patent 11286486 expires
Listed drug substance patent expiration.
Jul 28, 2036
in 10 yr 3 mo
Patent 12049628 expires
Listed drug substance patent expiration.
Jul 28, 2036
in 10 yr 3 mo
Pharmaceutical detail
Active ingredient
VUTRISIRAN SODIUM
Strength
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 215515
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 (4)
- NCENew chemical entity exclusivity (5 years)
Jun 13, 2027
in 1 yr
- I-964New indication exclusivity (3 years)
Mar 20, 2028
in 1 yr 9 mo
- ODE-212Orphan-drug exclusivity (7 years)
Jun 13, 2029
in 3 yr
- ODE-527Orphan-drug exclusivity (7 years)
Mar 20, 2032
in 5 yr 10 mo
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10131907 | Aug 24, 2028 | in 2 yr 3 mo | SubstanceProductU-3396 |
| 10806791 | Dec 04, 2028 | in 2 yr 6 mo | Substance |
| 8828956 | Dec 04, 2028 | in 2 yr 6 mo | SubstanceProductU-3396 |
| 9370581 | Dec 04, 2028 | in 2 yr 6 mo | SubstanceProductU-3396 |
| 8106022 | Dec 12, 2029 | in 3 yr 6 mo | SubstanceProductU-3396 |
| 10570391 | Nov 16, 2032 | in 6 yr 6 mo | SubstanceProductU-3396 |
| 9399775 | Nov 16, 2032 | in 6 yr 6 mo | SubstanceProductU-3396 |
| 10612024 | Aug 14, 2035 | in 9 yr 3 mo | SubstanceProductU-3396 |
| 11401517 | Aug 14, 2035 | in 9 yr 3 mo | SubstanceProductU-3396 |
| 10208307 | Jul 28, 2036 | in 10 yr 3 mo | SubstanceProductU-3396 |
| 10683501 | Jul 28, 2036 | in 10 yr 3 mo | SubstanceProductU-3396 |
| 11286486 | Jul 28, 2036 | in 10 yr 3 mo | SubstanceProductU-3396 |
| 12049628 | Jul 28, 2036 | in 10 yr 3 mo | SubstanceProductU-3396 |
