# AMVUTTRA — FDA application NDA215515

Informational only - not investment advice.

Application NDA215515 · type NDA · FDA status: approved · original approval 2022-06-13

Listed sponsor: ALNYLAM PHARMS INC · [ALNY company profile](/company/ALNY/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | AMVUTTRA | VUTRISIRAN SODIUM | SOLUTION | SUBCUTANEOUS | EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 10131907, product 001; listed patent expiry date: 2028-08-24.
- Patent 10806791, product 001; listed patent expiry date: 2028-12-04.
- Patent 8828956, product 001; listed patent expiry date: 2028-12-04.
- Patent 9370581, product 001; listed patent expiry date: 2028-12-04.
- Patent 8106022, product 001; listed patent expiry date: 2029-12-12.
- Patent 10570391, product 001; listed patent expiry date: 2032-11-16.
- Patent 9399775, product 001; listed patent expiry date: 2032-11-16.
- Patent 10612024, product 001; listed patent expiry date: 2035-08-14.
- Patent 11401517, product 001; listed patent expiry date: 2035-08-14.
- Patent 10208307, product 001; listed patent expiry date: 2036-07-28.
- Patent 10683501, product 001; listed patent expiry date: 2036-07-28.
- Patent 11286486, product 001; listed patent expiry date: 2036-07-28.
- Patent 12049628, product 001; listed patent expiry date: 2036-07-28.
- Exclusivity NCE, product 001; listed exclusivity date: 2027-06-13.
- Exclusivity I-964, product 001; listed exclusivity date: 2028-03-20.
- Exclusivity ODE-212, product 001; listed exclusivity date: 2029-06-13.
- Exclusivity ODE-527, product 001; listed exclusivity date: 2032-03-20.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- VUTRISIRAN SODIUM · UNII 28O0WP6Z1P · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/ALNY/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA215515. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.