# BIKTARVY — FDA application NDA210251

Informational only - not investment advice.

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

Listed sponsor: GILEAD SCIENCES INC · [GILD company profile](/company/GILD/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | BIKTARVY | BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | TABLET | ORAL | EQ 50MG BASE;200MG;EQ 25MG BASE | Prescription | not listed | Yes |
| 002 | BIKTARVY | BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | TABLET | ORAL | EQ 30MG BASE;120MG;EQ 15MG BASE | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 8754065, product 001; listed patent expiry date: 2032-08-15.
- Patent 8754065, product 002; listed patent expiry date: 2032-08-15.
- Patent 9296769, product 001; listed patent expiry date: 2032-08-15.
- Patent 9296769, product 002; listed patent expiry date: 2032-08-15.
- Patent 8754065, product 001; listed patent expiry date: 2033-02-15.
- Patent 8754065, product 002; listed patent expiry date: 2033-02-15.
- Patent 9296769, product 001; listed patent expiry date: 2033-02-15.
- Patent 9296769, product 002; listed patent expiry date: 2033-02-15.
- Patent 9216996, product 001; listed patent expiry date: 2033-12-19.
- Patent 9216996, product 002; listed patent expiry date: 2033-12-19.
- Patent 9732092, product 001; listed patent expiry date: 2033-12-19.
- Patent 9732092, product 002; listed patent expiry date: 2033-12-19.
- Patent 10385067, product 001; listed patent expiry date: 2035-06-19.
- Patent 10385067, product 002; listed patent expiry date: 2035-06-19.
- Patent 9708342, product 001; listed patent expiry date: 2035-06-19.
- Patent 9708342, product 002; listed patent expiry date: 2035-06-19.
- Patent 10548846, product 001; listed patent expiry date: 2036-11-08.
- Patent 11744802, product 001; listed patent expiry date: 2036-11-08.
- Patent 12594244, product 001; listed patent expiry date: 2036-11-08.
- Patent 12594244, product 002; listed patent expiry date: 2036-11-08.
- Exclusivity ODE-256, product 001; listed exclusivity date: 2026-06-18.
- Exclusivity I-942, product 001; listed exclusivity date: 2027-02-23.
- Exclusivity I-942, product 002; listed exclusivity date: 2027-02-23.
- Exclusivity M-305, product 001; listed exclusivity date: 2027-04-24.
- Exclusivity ODE-378, product 002; listed exclusivity date: 2028-10-07.
- Exclusivity ODE-468, product 001; listed exclusivity date: 2031-02-23.
- Exclusivity ODE-468, product 002; listed exclusivity date: 2031-02-23.
- Exclusivity ODE-540, product 001; listed exclusivity date: 2032-07-30.
- Exclusivity ODE-540, product 002; listed exclusivity date: 2032-07-30.

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

- BICTEGRAVIR SODIUM · UNII 4L5MP1Y7W7 · no lmmol compound match
- EMTRICITABINE · UNII G70B4ETF4S · no lmmol compound match
- TENOFOVIR ALAFENAMIDE FUMARATE · UNII FWF6Q91TZO · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/GILD/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA210251. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.