# OXLUMO — FDA application NDA214103

Informational only - not investment advice.

Application NDA214103 · type NDA · FDA status: approved · original approval 2020-11-23

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 | OXLUMO | LUMASIRAN SODIUM | SOLUTION | SUBCUTANEOUS | EQ 94.5MG BASE/0.5ML (EQ 94.5MG 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 8828956, product 001; listed patent expiry date: 2028-12-04.
- Patent 8106022, product 001; listed patent expiry date: 2029-12-12.
- Patent 10435692, product 001; listed patent expiry date: 2034-12-26.
- Patent 10465195, product 001; listed patent expiry date: 2034-12-26.
- Patent 10487330, product 001; listed patent expiry date: 2034-12-26.
- Patent 11060093, product 001; listed patent expiry date: 2034-12-26.
- Patent 9828606, product 001; listed patent expiry date: 2034-12-26.
- Patent 10612024, product 001; listed patent expiry date: 2035-08-14.
- Patent 10612027, product 001; listed patent expiry date: 2035-08-14.
- Patent 11401517, product 001; listed patent expiry date: 2035-08-14.
- Patent 10478500, product 001; listed patent expiry date: 2035-10-09.
- Patent 11446380, product 001; listed patent expiry date: 2035-10-09.
- Patent 11261447, product 001; listed patent expiry date: 2038-11-20.
- Exclusivity ODE-339, product 001; listed exclusivity date: 2027-11-23.
- Exclusivity ODE-415, product 001; listed exclusivity date: 2029-10-06.

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

- LUMASIRAN SODIUM · UNII 67P6XH37HD · 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:NDA214103. FDA data retrieved 2026-08-07.

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