grepcent public filings, reorganized for comparison

STRIBILD — FDA application NDA203100

Application NDA203100 · type NDA · FDA status: approved · original approval 2012-08-27

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
001STRIBILDCOBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLETORAL150MG;150MG;200MG;300MGPrescriptionnot 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 7176220001listed patent expiry date: 2026-08-27drug substance, drug product, U-257
Patent 7635704001listed patent expiry date: 2026-10-26drug substance, drug product, U-257
Patent 8981103001listed patent expiry date: 2026-10-26drug substance, drug product
Patent 7176220001listed patent expiry date: 2027-02-27pediatric extension
Patent 7635704001listed patent expiry date: 2027-04-26pediatric extension
Patent 8981103001listed patent expiry date: 2027-04-26pediatric extension
Patent 8148374001listed patent expiry date: 2029-09-03drug substance, drug product, U-1279
Patent 9891239001listed patent expiry date: 2029-09-03drug product, U-257
Patent 8148374001listed patent expiry date: 2030-03-03pediatric extension
Patent 9891239001listed patent expiry date: 2030-03-03pediatric extension
Patent 8633219001listed patent expiry date: 2030-04-30drug product, U-257
Patent 8633219001listed patent expiry date: 2030-10-30pediatric extension
Patent 10039718001listed patent expiry date: 2032-10-06drug product
Patent 10039718001listed patent expiry date: 2033-04-06pediatric extension
NDA203100 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA203100 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA203100 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 marker0.001.002.002012-08-271.002026-08-271.002026-10-261.002027-02-271.002027-04-261.002029-09-031.002030-03-031.002030-04-301.002030-10-301.002032-10-061.002033-04-061.00

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.