VUTRISIRAN SODIUM | N215515 | ALNYLAM PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alnylam Pharmaceuticals, Inc. FDA-2026-P-7229 Alnylam Pharmaceuticals, Inc., the sponsor of NDA 215515 for AMVUTTRA (vutrisiran) injection, filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA decline to approve any abbreviated new drug application under Section 505(j) or Section 505( | 505(q) | 2026-06-30 | Open | Alnylam Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8106022 | Dec 12, 2029 | — | Yes | Yes | — | |
| 8828956 | Dec 4, 2028 | — | Yes | Yes | — | |
| 9370581 | Dec 4, 2028 | — | Yes | Yes | — | |
| 9399775 | Nov 16, 2032 | — | Yes | Yes | — | |
| 10131907 | Aug 24, 2028 | — | Yes | Yes | — | |
| 10208307 | Jul 28, 2036 | — | Yes | Yes | — | |
| 10570391 | Nov 16, 2032 | — | Yes | Yes | — | |
| 10612024 | Aug 14, 2035 | — | Yes | Yes | — | |
| 10683501 | Jul 28, 2036 | — | Yes | Yes | — | |
| 10806791 | Dec 4, 2028 | — | Yes | — | — | — |
| 11286486 | Jul 28, 2036 | — | Yes | Yes | — | |
| 11401517 | Aug 14, 2035 | — | Yes | Yes | — | |
| 12049628 | Jul 28, 2036 | — | Yes | Yes | — |
| Code | Date | Status |
|---|---|---|
| I-964 | Mar 20, 2028 | Active |
| NCE | Jun 13, 2027 | < 1 year |
| ODE-212 | Jun 13, 2029 | Active |
| ODE-527 | Mar 20, 2032 | Active |
New: New record