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TRYNGOLZA (AUTOINJECTOR) — FDA application NDA218614

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

Listed sponsor: IONIS PHARMS INC · IONS company profile · exact_unique

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

FDA application facts

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001TRYNGOLZA (AUTOINJECTOR)OLEZARSEN SODIUMSOLUTIONSUBCUTANEOUSEQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)Prescriptionnot listedYes
002TRYNGOLZA (AUTOINJECTOR)OLEZARSEN SODIUMSOLUTIONSUBCUTANEOUSEQ 50MG BASE/0.8ML (EQ 50MG BASE/0.8ML)Prescriptionnot listednot listed

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Orange Book patent and exclusivity listings

ListingProductDescriptive dateFlags/code
Patent 9157082001listed patent expiry date: 2032-04-27U-4050
Patent 9593333001listed patent expiry date: 2034-02-14U-4050
Patent 12509684001listed patent expiry date: 2034-05-01U-4050
Patent 9127276001listed patent expiry date: 2034-05-01drug substance
Patent 9163239001listed patent expiry date: 2034-05-01drug substance
Patent 9181549001listed patent expiry date: 2034-05-01drug substance
Exclusivity ODE-515001listed exclusivity date: 2031-12-19FDA code as listed
NDA218614 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA218614 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA218614 FDA listing datesDescriptive regulatory dates only; no relationship to revenue or future sales is stated or implied.Source: Drugs@FDA and FDA Orange Book.Listed dateDated listing marker0.001.002.002024-12-191.002031-12-191.002032-04-271.002034-02-141.002034-05-011.00

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

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

Related pages

Sponsor company · FDA-approved application index

Peer clusters: No published peer-cluster link for this sponsor.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

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