# STRIBILD — FDA application NDA203100

Informational only - not investment advice.

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

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 | STRIBILD | COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET | ORAL | 150MG;150MG;200MG;300MG | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 7176220, product 001; listed patent expiry date: 2026-08-27.
- Patent 7635704, product 001; listed patent expiry date: 2026-10-26.
- Patent 8981103, product 001; listed patent expiry date: 2026-10-26.
- Patent 7176220, product 001; listed patent expiry date: 2027-02-27.
- Patent 7635704, product 001; listed patent expiry date: 2027-04-26.
- Patent 8981103, product 001; listed patent expiry date: 2027-04-26.
- Patent 8148374, product 001; listed patent expiry date: 2029-09-03.
- Patent 9891239, product 001; listed patent expiry date: 2029-09-03.
- Patent 8148374, product 001; listed patent expiry date: 2030-03-03.
- Patent 9891239, product 001; listed patent expiry date: 2030-03-03.
- Patent 8633219, product 001; listed patent expiry date: 2030-04-30.
- Patent 8633219, product 001; listed patent expiry date: 2030-10-30.
- Patent 10039718, product 001; listed patent expiry date: 2032-10-06.
- Patent 10039718, product 001; listed patent expiry date: 2033-04-06.

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

- COBICISTAT · UNII LW2E03M5PG · [lmmol compound ZCIGNRJZKPOIKD-CQXVEOKZSA-N](https://lmmol.com/compound/ZCIGNRJZKPOIKD-CQXVEOKZSA-N)
- ELVITEGRAVIR · UNII 4GDQ854U53 · no lmmol compound match
- EMTRICITABINE · UNII G70B4ETF4S · no lmmol compound match
- TENOFOVIR DISOPROXIL FUMARATE · UNII OTT9J7900I · 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:NDA203100. FDA data retrieved 2026-08-07.

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