grepcent public filings, reorganized for comparison

TYBOST — FDA application NDA203094

Application NDA203094 · type NDA · FDA status: approved · original approval 2014-09-24

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
001TYBOSTCOBICISTATTABLETORAL150MGDiscontinuednot listedYes
002TYBOSTCOBICISTATTABLETORAL90MGDiscontinuednot 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 8148374001listed patent expiry date: 2029-09-03drug substance, drug product, U-1279
Patent 8148374002listed patent expiry date: 2029-09-03drug substance, drug product, U-1279
Patent 8148374001listed patent expiry date: 2030-03-03pediatric extension
Patent 8148374002listed patent expiry date: 2030-03-03pediatric extension
Patent 10039718001listed patent expiry date: 2032-10-06drug product
Patent 10039718002listed patent expiry date: 2032-10-06drug product
Patent 10039718001listed patent expiry date: 2033-04-06pediatric extension
Patent 10039718002listed patent expiry date: 2033-04-06pediatric extension
Exclusivity ODE-260001listed exclusivity date: 2026-08-22FDA code as listed
NDA203094 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA203094 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA203094 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 marker0.001.002.002014-09-241.002026-08-221.002029-09-031.002030-03-031.002032-10-061.002033-04-061.00

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.