FDA Orange Book · active-ingredient family
Patisiran sodium
Patisiran sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ONPATTRO · NDA 210922
1
Brand (NDA)
0
Generics (ANDA)
13
Listed patents
1
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ONPATTRORLD | ALNYLAM PHARMS INC | NDA 210922 | — | Aug 10, 2018 |
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 |
| 8822668 | Apr 15, 2029 | in 2 yr 10 mo | ProductU-2378 |
| 9364435 | Apr 15, 2029 | in 2 yr 10 mo | ProductU-2378 |
| 11141378 | Apr 15, 2029 | in 2 yr 10 mo | Product |
| 8492359 | Apr 15, 2029 | in 2 yr 10 mo | Product |
| 8058069 | Apr 15, 2029 | in 2 yr 10 mo | Product |
| 9234196 | Oct 20, 2029 | in 3 yr 5 mo | ProductU-2378 |
| 8741866 | Oct 20, 2029 | in 3 yr 5 mo | U-2378 |
| 10240152 | Oct 20, 2029 | in 3 yr 5 mo | SubstanceProductU-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 |
Patisiran sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
