# EPCLUSA — FDA application NDA214187

Informational only - not investment advice.

Application NDA214187 · type NDA · FDA status: approved · original approval 2021-06-10

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 | EPCLUSA | SOFOSBUVIR; VELPATASVIR | PELLETS | ORAL | 150MG;37.5MG/PACKET | Prescription | not listed | Yes |
| 002 | EPCLUSA | SOFOSBUVIR; VELPATASVIR | PELLETS | ORAL | 200MG;50MG/PACKET | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 8334270, product 001; listed patent expiry date: 2028-03-21.
- Patent 8334270, product 002; listed patent expiry date: 2028-03-21.
- Patent 8580765, product 001; listed patent expiry date: 2028-03-21.
- Patent 8580765, product 002; listed patent expiry date: 2028-03-21.
- Patent 8735372, product 001; listed patent expiry date: 2028-03-21.
- Patent 8735372, product 002; listed patent expiry date: 2028-03-21.
- Patent 9085573, product 001; listed patent expiry date: 2028-03-21.
- Patent 9085573, product 002; listed patent expiry date: 2028-03-21.
- Patent 8334270, product 001; listed patent expiry date: 2028-09-21.
- Patent 8334270, product 002; listed patent expiry date: 2028-09-21.
- Patent 8580765, product 001; listed patent expiry date: 2028-09-21.
- Patent 8580765, product 002; listed patent expiry date: 2028-09-21.
- Patent 8735372, product 001; listed patent expiry date: 2028-09-21.
- Patent 8735372, product 002; listed patent expiry date: 2028-09-21.
- Patent 9085573, product 001; listed patent expiry date: 2028-09-21.
- Patent 9085573, product 002; listed patent expiry date: 2028-09-21.
- Patent 7964580, product 001; listed patent expiry date: 2029-03-26.
- Patent 7964580, product 002; listed patent expiry date: 2029-03-26.
- Patent 8633309, product 001; listed patent expiry date: 2029-03-26.
- Patent 8633309, product 002; listed patent expiry date: 2029-03-26.
- Patent 8889159, product 001; listed patent expiry date: 2029-03-26.
- Patent 8889159, product 002; listed patent expiry date: 2029-03-26.
- Patent 7964580, product 001; listed patent expiry date: 2029-09-26.
- Patent 7964580, product 002; listed patent expiry date: 2029-09-26.
- Patent 8633309, product 001; listed patent expiry date: 2029-09-26.
- Patent 8633309, product 002; listed patent expiry date: 2029-09-26.
- Patent 8889159, product 001; listed patent expiry date: 2029-09-26.
- Patent 8889159, product 002; listed patent expiry date: 2029-09-26.
- Patent 9284342, product 001; listed patent expiry date: 2030-09-13.
- Patent 9284342, product 002; listed patent expiry date: 2030-09-13.
- Patent 8618076, product 001; listed patent expiry date: 2030-12-11.
- Patent 8618076, product 002; listed patent expiry date: 2030-12-11.
- Patent 9284342, product 001; listed patent expiry date: 2031-03-13.
- Patent 9284342, product 002; listed patent expiry date: 2031-03-13.
- Patent 8618076, product 001; listed patent expiry date: 2031-06-11.
- Patent 8618076, product 002; listed patent expiry date: 2031-06-11.
- Patent 8575135, product 001; listed patent expiry date: 2032-11-16.
- Patent 8575135, product 002; listed patent expiry date: 2032-11-16.
- Patent 8921341, product 001; listed patent expiry date: 2032-11-16.
- Patent 8921341, product 002; listed patent expiry date: 2032-11-16.
- Patent 8940718, product 001; listed patent expiry date: 2032-11-16.
- Patent 8940718, product 002; listed patent expiry date: 2032-11-16.
- Patent 8575135, product 001; listed patent expiry date: 2033-05-16.
- Patent 8575135, product 002; listed patent expiry date: 2033-05-16.
- Patent 8921341, product 001; listed patent expiry date: 2033-05-16.
- Patent 8921341, product 002; listed patent expiry date: 2033-05-16.
- Patent 8940718, product 001; listed patent expiry date: 2033-05-16.
- Patent 8940718, product 002; listed patent expiry date: 2033-05-16.
- Patent 11116783, product 001; listed patent expiry date: 2034-01-30.
- Patent 11116783, product 002; listed patent expiry date: 2034-01-30.
- Patent 11707479, product 001; listed patent expiry date: 2034-01-30.
- Patent 11707479, product 002; listed patent expiry date: 2034-01-30.
- Patent 11116783, product 001; listed patent expiry date: 2034-07-30.
- Patent 11116783, product 002; listed patent expiry date: 2034-07-30.
- Patent 11707479, product 001; listed patent expiry date: 2034-07-30.
- Patent 11707479, product 002; listed patent expiry date: 2034-07-30.
- Exclusivity ODE*, product 002; listed exclusivity date: 2027-03-19.
- Exclusivity PED, product 002; listed exclusivity date: 2027-09-19.
- Exclusivity ODE-376, product 001; listed exclusivity date: 2028-06-10.
- Exclusivity PED, product 001; listed exclusivity date: 2028-12-10.

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

- SOFOSBUVIR · UNII WJ6CA3ZU8B · no lmmol compound match
- VELPATASVIR · UNII KCU0C7RS7Z · 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:NDA214187. FDA data retrieved 2026-08-07.

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