# GIVLAARI — FDA application NDA212194

Informational only - not investment advice.

Application NDA212194 · type NDA · FDA status: approved · original approval 2019-11-20

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 | GIVLAARI | GIVOSIRAN SODIUM | SOLUTION | SUBCUTANEOUS | EQ 189MG BASE/ML (EQ 189MG BASE/ML) | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 10131907, product 001; listed patent expiry date: 2028-08-24.
- Patent 8828956, product 001; listed patent expiry date: 2028-12-04.
- Patent 8106022, product 001; listed patent expiry date: 2029-12-12.
- Patent 10125364, product 001; listed patent expiry date: 2033-03-15.
- Patent 9631193, product 001; listed patent expiry date: 2033-03-15.
- Patent 9133461, product 001; listed patent expiry date: 2033-11-30.
- Patent 10119143, product 001; listed patent expiry date: 2034-10-03.
- Patent 11028392, product 001; listed patent expiry date: 2034-10-03.
- Exclusivity ODE-273, product 001; listed exclusivity date: 2026-11-20.

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

- GIVOSIRAN SODIUM · UNII 5XE21E41RT · 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:NDA212194. FDA data retrieved 2026-08-07.

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