grepcent public filings, reorganized for comparison

BIKTARVY — FDA application NDA210251

Application NDA210251 · type NDA · FDA status: approved · original approval 2018-02-07

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
001BIKTARVYBICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATETABLETORALEQ 50MG BASE;200MG;EQ 25MG BASEPrescriptionnot listedYes
002BIKTARVYBICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATETABLETORALEQ 30MG BASE;120MG;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-257
Patent 8754065002listed 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 9296769002listed patent expiry date: 2032-08-15drug substance, drug product, U-257
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 9216996001listed patent expiry date: 2033-12-19drug substance, drug product
Patent 9216996002listed patent expiry date: 2033-12-19drug substance, drug product
Patent 9732092001listed patent expiry date: 2033-12-19drug substance, drug product
Patent 9732092002listed patent expiry date: 2033-12-19drug substance, drug product
Patent 10385067001listed patent expiry date: 2035-06-19U-257
Patent 10385067002listed patent expiry date: 2035-06-19U-257
Patent 9708342001listed patent expiry date: 2035-06-19drug substance, drug product
Patent 9708342002listed patent expiry date: 2035-06-19drug substance, drug product
Patent 10548846001listed patent expiry date: 2036-11-08drug product
Patent 11744802001listed patent expiry date: 2036-11-08drug product
Patent 12594244001listed patent expiry date: 2036-11-08drug product, U-257
Patent 12594244002listed patent expiry date: 2036-11-08drug product, U-257
Exclusivity ODE-256001listed exclusivity date: 2026-06-18FDA code as listed
Exclusivity I-942001listed exclusivity date: 2027-02-23FDA code as listed
Exclusivity I-942002listed exclusivity date: 2027-02-23FDA code as listed
Exclusivity M-305001listed exclusivity date: 2027-04-24FDA code as listed
Exclusivity ODE-378002listed exclusivity date: 2028-10-07FDA code as listed
Exclusivity ODE-468001listed exclusivity date: 2031-02-23FDA code as listed
Exclusivity ODE-468002listed exclusivity date: 2031-02-23FDA code as listed
Exclusivity ODE-540001listed exclusivity date: 2032-07-30FDA code as listed
Exclusivity ODE-540002listed exclusivity date: 2032-07-30FDA code as listed
NDA210251 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA210251 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA210251 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 marker0.001.002.002018-02-071.002026-06-181.002027-02-231.002027-04-241.002028-10-071.002031-02-231.002032-07-301.002032-08-151.002033-02-151.002033-12-191.002035-06-191.002036-11-081.00

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.