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SUNLENCA — FDA application NDA215973

Application NDA215973 · type NDA · FDA status: approved · original approval 2022-12-22

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
001SUNLENCALENACAPAVIR SODIUMSOLUTIONSUBCUTANEOUSEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)Prescriptionnot 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 9951043001listed patent expiry date: 2034-02-28drug substance, drug product, U-3507
Patent 10071985001listed patent expiry date: 2037-08-17drug substance, drug product
Patent 10654827001listed patent expiry date: 2037-08-17U-3507
Patent 11267799001listed patent expiry date: 2038-08-16drug substance
Patent 12594267001listed patent expiry date: 2039-07-15drug product
Patent 11944611001listed patent expiry date: 2041-08-28U-3507
Exclusivity NCE001listed exclusivity date: 2027-12-22FDA code as listed
NDA215973 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA215973 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA215973 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 marker0.001.002.002022-12-221.002027-12-221.002034-02-281.002037-08-171.002038-08-161.002039-07-151.002041-08-281.00

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.