grepcent public filings, reorganized for comparison

GENVOYA — FDA application NDA207561

Application NDA207561 · type NDA · FDA status: approved · original approval 2015-11-05

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
001GENVOYACOBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATETABLETORAL150MG;150MG;200MG;EQ 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 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 8754065001listed patent expiry date: 2032-08-15drug substance, drug product, U-257
Patent 9296769001listed patent expiry date: 2032-08-15drug substance, drug product, U-257
Patent 10039718001listed patent expiry date: 2032-10-06drug product
Patent 8754065001listed patent expiry date: 2033-02-15pediatric extension
Patent 9296769001listed patent expiry date: 2033-02-15pediatric extension
Patent 10039718001listed patent expiry date: 2033-04-06pediatric extension
NDA207561 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA207561 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA207561 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 marker0.001.002.00

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.