# TRYNGOLZA (AUTOINJECTOR) — FDA application NDA218614

Informational only - not investment advice.

Application NDA218614 · type NDA · FDA status: approved · original approval 2024-12-19

Listed sponsor: IONIS PHARMS INC · [IONS company profile](/company/IONS/) · 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 | TRYNGOLZA (AUTOINJECTOR) | OLEZARSEN SODIUM | SOLUTION | SUBCUTANEOUS | EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) | Prescription | not listed | Yes |
| 002 | TRYNGOLZA (AUTOINJECTOR) | OLEZARSEN SODIUM | SOLUTION | SUBCUTANEOUS | EQ 50MG BASE/0.8ML (EQ 50MG BASE/0.8ML) | Prescription | not listed | not listed |

## Orange Book patent and exclusivity listings

- Patent 9157082, product 001; listed patent expiry date: 2032-04-27.
- Patent 9593333, product 001; listed patent expiry date: 2034-02-14.
- Patent 12509684, product 001; listed patent expiry date: 2034-05-01.
- Patent 9127276, product 001; listed patent expiry date: 2034-05-01.
- Patent 9163239, product 001; listed patent expiry date: 2034-05-01.
- Patent 9181549, product 001; listed patent expiry date: 2034-05-01.
- Exclusivity ODE-515, product 001; listed exclusivity date: 2031-12-19.

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

- OLEZARSEN SODIUM · UNII NSY2BY6PSB · 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/IONS/)
- [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:NDA218614. FDA data retrieved 2026-08-07.

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