grepcent public filings, reorganized for comparison

SOVALDI — FDA application NDA212480

Application NDA212480 · type NDA · FDA status: approved · original approval 2019-08-28

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
001SOVALDISOFOSBUVIRPELLETSORAL150MG/PACKETPrescriptionnot listedYes
002SOVALDISOFOSBUVIRPELLETSORAL200MG/PACKETPrescriptionnot 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 8334270001listed patent expiry date: 2028-03-21drug substance, drug product, U-1470
Patent 8334270002listed patent expiry date: 2028-03-21drug substance, drug product, U-1470
Patent 8580765001listed patent expiry date: 2028-03-21drug substance, drug product, U-1470
Patent 8580765002listed patent expiry date: 2028-03-21drug substance, drug product, U-1470
Patent 9085573001listed patent expiry date: 2028-03-21drug substance, drug product, U-1470
Patent 9085573002listed patent expiry date: 2028-03-21drug substance, drug product, U-1470
Patent 8334270001listed patent expiry date: 2028-09-21pediatric extension
Patent 8334270002listed patent expiry date: 2028-09-21pediatric extension
Patent 8580765001listed patent expiry date: 2028-09-21pediatric extension
Patent 8580765002listed patent expiry date: 2028-09-21pediatric extension
Patent 9085573001listed patent expiry date: 2028-09-21pediatric extension
Patent 9085573002listed patent expiry date: 2028-09-21pediatric extension
Patent 7964580001listed patent expiry date: 2029-03-26drug substance, drug product, U-1470
Patent 7964580002listed patent expiry date: 2029-03-26drug substance, drug product, U-1470
Patent 8633309001listed patent expiry date: 2029-03-26drug substance, drug product, U-1470
Patent 8633309002listed patent expiry date: 2029-03-26drug substance, drug product, U-1470
Patent 8889159001listed patent expiry date: 2029-03-26drug product, U-1470
Patent 8889159002listed patent expiry date: 2029-03-26drug product, U-1470
Patent 7964580001listed patent expiry date: 2029-09-26pediatric extension
Patent 7964580002listed patent expiry date: 2029-09-26pediatric extension
Patent 8633309001listed patent expiry date: 2029-09-26pediatric extension
Patent 8633309002listed patent expiry date: 2029-09-26pediatric extension
Patent 8889159001listed patent expiry date: 2029-09-26pediatric extension
Patent 8889159002listed patent expiry date: 2029-09-26pediatric extension
Patent 9284342001listed patent expiry date: 2030-09-13drug substance, drug product, U-1470
Patent 9284342002listed patent expiry date: 2030-09-13drug substance, drug product, U-1470
Patent 8618076001listed patent expiry date: 2030-12-11drug substance, drug product, U-1470
Patent 8618076002listed patent expiry date: 2030-12-11drug substance, drug product, U-1470
Patent 9284342001listed patent expiry date: 2031-03-13pediatric extension
Patent 9284342002listed patent expiry date: 2031-03-13pediatric extension
Patent 8618076001listed patent expiry date: 2031-06-11pediatric extension
Patent 8618076002listed patent expiry date: 2031-06-11pediatric extension
Exclusivity ODE-258001listed exclusivity date: 2026-08-28FDA code as listed
Exclusivity ODE-258002listed exclusivity date: 2026-08-28FDA code as listed
NDA212480 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA212480 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA212480 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 marker0.001.002.002019-08-281.002026-08-281.002028-03-211.002028-09-211.002029-03-261.002029-09-261.002030-09-131.002030-12-111.002031-03-131.002031-06-111.00

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.