Orange Book product · Brand (NDA)
ONPATTRO
PATISIRAN SODIUM
At a glance
Aug 10, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 10, 2018
8 yr ago
Exclusivity ends · M-270
New use / labeling-change exclusivity (3 years)
Jan 13, 2026
5 mo ago
Today
Patent 8642076 expires
Listed drug product patent expiration.
Oct 03, 2027
in 1 yr 4 mo
Patent 11141378 expires
Listed drug product patent expiration.
Apr 15, 2029
in 2 yr 10 mo
Patent 8058069 expires
Listed drug product patent expiration.
Apr 15, 2029
in 2 yr 10 mo
Patent 8492359 expires
Listed drug product patent expiration.
Apr 15, 2029
in 2 yr 10 mo
Patent 8822668 expires
Listed drug product patent expiration.
Apr 15, 2029
in 2 yr 10 mo
Patent 9364435 expires
Listed drug product patent expiration.
Apr 15, 2029
in 2 yr 10 mo
Patent 10240152 expires
Listed drug substance patent expiration.
Oct 20, 2029
in 3 yr 5 mo
Patent 8741866 expires
Listed method-of-use patent (U-2378) expiration.
Oct 20, 2029
in 3 yr 5 mo
Patent 9234196 expires
Listed drug product patent expiration.
Oct 20, 2029
in 3 yr 5 mo
Patent 8802644 expires
Listed drug product patent expiration.
Oct 21, 2030
in 4 yr 5 mo
Patent 8158601 expires
Listed drug product patent expiration.
Nov 10, 2030
in 4 yr 6 mo
Patent 8168775 expires
Listed drug substance patent expiration.
Aug 10, 2032
in 6 yr 3 mo
Patent 11079379 expires
Listed drug substance patent expiration.
Aug 27, 2035
in 9 yr 4 mo
Pharmaceutical detail
Active ingredient
PATISIRAN SODIUM
Strength
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 210922
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)
- M-270New use / labeling-change exclusivity (3 years)
Jan 13, 2026
5 mo ago
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8642076 | Oct 03, 2027 | in 1 yr 4 mo | Product |
| 11141378 | Apr 15, 2029 | in 2 yr 10 mo | Product |
| 8058069 | Apr 15, 2029 | in 2 yr 10 mo | Product |
| 8492359 | Apr 15, 2029 | in 2 yr 10 mo | Product |
| 8822668 | Apr 15, 2029 | in 2 yr 10 mo | ProductU-2378 |
| 9364435 | Apr 15, 2029 | in 2 yr 10 mo | ProductU-2378 |
| 10240152 | Oct 20, 2029 | in 3 yr 5 mo | SubstanceProductU-2378 |
| 8741866 | Oct 20, 2029 | in 3 yr 5 mo | U-2378 |
| 9234196 | Oct 20, 2029 | in 3 yr 5 mo | ProductU-2378 |
| 8802644 | Oct 21, 2030 | in 4 yr 5 mo | ProductU-2378 |
| 8158601 | Nov 10, 2030 | in 4 yr 6 mo | ProductU-2378 |
| 8168775 | Aug 10, 2032 | in 6 yr 3 mo | SubstanceProductU-2378 |
| 11079379 | Aug 27, 2035 | in 9 yr 4 mo | SubstanceProductU-2378 |
