# ONPATTRO — FDA application NDA210922

Informational only - not investment advice.

Application NDA210922 · type NDA · FDA status: approved · original approval 2018-08-10

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 | ONPATTRO | PATISIRAN SODIUM | SOLUTION | INTRAVENOUS | EQ 10MG BASE/5ML (EQ 2MG BASE/ML) | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 8642076, product 001; listed patent expiry date: 2027-10-03.
- Patent 11141378, product 001; listed patent expiry date: 2029-04-15.
- Patent 8058069, product 001; listed patent expiry date: 2029-04-15.
- Patent 8492359, product 001; listed patent expiry date: 2029-04-15.
- Patent 8822668, product 001; listed patent expiry date: 2029-04-15.
- Patent 9364435, product 001; listed patent expiry date: 2029-04-15.
- Patent 10240152, product 001; listed patent expiry date: 2029-10-20.
- Patent 8741866, product 001; listed patent expiry date: 2029-10-20.
- Patent 9234196, product 001; listed patent expiry date: 2029-10-20.
- Patent 8802644, product 001; listed patent expiry date: 2030-10-21.
- Patent 8158601, product 001; listed patent expiry date: 2030-11-10.
- Patent 8168775, product 001; listed patent expiry date: 2032-08-10.
- Patent 11079379, product 001; listed patent expiry date: 2035-08-27.
- Exclusivity M-270, product 001; listed exclusivity date: 2026-01-13.

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

- PATISIRAN SODIUM · UNII WO0YM16LKG · 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:NDA210922. FDA data retrieved 2026-08-07.

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