grepcent public filings, reorganized for comparison

DESCOVY — FDA application NDA208215

Application NDA208215 · type NDA · FDA status: approved · original approval 2016-04-04

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
001DESCOVYEMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATETABLETORAL200MG;EQ 25MG BASEPrescriptionABYes
002DESCOVYEMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATETABLETORAL120MG;EQ 15MG 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 8754065001listed patent expiry date: 2032-08-15drug substance, drug product, U-1259
Patent 8754065001listed patent expiry date: 2032-08-15drug substance, drug product, U-1663
Patent 8754065001listed patent expiry date: 2032-08-15drug substance, drug product, U-257
Patent 8754065002listed patent expiry date: 2032-08-15drug substance, drug product, U-1663
Patent 9296769001listed patent expiry date: 2032-08-15drug substance, drug product, U-257
Patent 9296769001listed patent expiry date: 2032-08-15drug substance, drug product, U-1259
Patent 9296769001listed patent expiry date: 2032-08-15drug substance, drug product, U-1663
Patent 9296769002listed patent expiry date: 2032-08-15drug substance, drug product, U-1663
Patent 8754065001listed patent expiry date: 2033-02-15pediatric extension
Patent 8754065002listed patent expiry date: 2033-02-15pediatric extension
Patent 9296769001listed patent expiry date: 2033-02-15pediatric extension
Patent 9296769002listed patent expiry date: 2033-02-15pediatric extension
Patent 12629338001listed patent expiry date: 2036-06-29drug product
Patent 12648911001listed patent expiry date: 2036-06-29U-1663
Patent 12648911001listed patent expiry date: 2036-06-29U-1259
Patent 12661323001listed patent expiry date: 2036-06-29drug product
Patent 12661323002listed patent expiry date: 2036-06-29drug product
Exclusivity M-316001listed exclusivity date: 2028-06-20FDA code as listed
Exclusivity M-316002listed exclusivity date: 2028-06-20FDA code as listed
Exclusivity ODE-457002listed exclusivity date: 2029-01-07FDA code as listed
NDA208215 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA208215 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA208215 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 marker0.001.002.002016-04-041.002028-06-201.002029-01-071.002032-08-151.002033-02-151.002036-06-291.00

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.