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LIVDELZI — FDA application NDA217899

Application NDA217899 · type NDA · FDA status: approved · original approval 2024-08-14

Listed sponsor: GILEAD SCIENCES INC · GILD 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
001LIVDELZISELADELPAR LYSINECAPSULEORALEQ 10MG BASEPrescriptionnot listedYes

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 7301050001listed patent expiry date: 2026-08-02drug substance, drug product
Patent 7709682001listed patent expiry date: 2026-09-13drug substance
Patent 10272058001listed patent expiry date: 2035-03-19U-1854
Patent 11406611001listed patent expiry date: 2035-03-19U-1854
Patent 11596614001listed patent expiry date: 2035-03-19U-1854
Patent 9486428001listed patent expiry date: 2035-03-19U-1854
Exclusivity NCE001listed exclusivity date: 2029-08-14FDA code as listed
Exclusivity ODE-486001listed exclusivity date: 2031-08-14FDA code as listed
NDA217899 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA217899 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA217899 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 marker0.001.002.002024-08-141.002026-08-021.002026-09-131.002029-08-141.002031-08-141.002035-03-191.00

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: Large-cap biopharma

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.