# DESCOVY — FDA application NDA208215

Informational only - not investment advice.

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

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 | DESCOVY | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | TABLET | ORAL | 200MG;EQ 25MG BASE | Prescription | AB | Yes |
| 002 | DESCOVY | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | TABLET | ORAL | 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 001; listed patent expiry date: 2032-08-15.
- 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 001; 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 12629338, product 001; listed patent expiry date: 2036-06-29.
- Patent 12648911, product 001; listed patent expiry date: 2036-06-29.
- Patent 12648911, product 001; listed patent expiry date: 2036-06-29.
- Patent 12661323, product 001; listed patent expiry date: 2036-06-29.
- Patent 12661323, product 002; listed patent expiry date: 2036-06-29.
- Exclusivity M-316, product 001; listed exclusivity date: 2028-06-20.
- Exclusivity M-316, product 002; listed exclusivity date: 2028-06-20.
- Exclusivity ODE-457, product 002; listed exclusivity date: 2029-01-07.

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

- 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:NDA208215. FDA data retrieved 2026-08-07.

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