EPCLUSA — FDA application NDA214187
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
| 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 |
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
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 8334270 | 001 | listed patent expiry date: 2028-03-21 | drug substance, drug product, U-1470 |
| Patent 8334270 | 002 | listed patent expiry date: 2028-03-21 | drug substance, drug product, U-1470 |
| Patent 8580765 | 001 | listed patent expiry date: 2028-03-21 | drug substance, drug product, U-1470 |
| Patent 8580765 | 002 | listed patent expiry date: 2028-03-21 | drug substance, drug product, U-1470 |
| Patent 8735372 | 001 | listed patent expiry date: 2028-03-21 | U-1470 |
| Patent 8735372 | 002 | listed patent expiry date: 2028-03-21 | U-1470 |
| Patent 9085573 | 001 | listed patent expiry date: 2028-03-21 | drug substance, drug product, U-1470 |
| Patent 9085573 | 002 | listed patent expiry date: 2028-03-21 | drug substance, drug product, U-1470 |
| Patent 8334270 | 001 | listed patent expiry date: 2028-09-21 | pediatric extension |
| Patent 8334270 | 002 | listed patent expiry date: 2028-09-21 | pediatric extension |
| Patent 8580765 | 001 | listed patent expiry date: 2028-09-21 | pediatric extension |
| Patent 8580765 | 002 | listed patent expiry date: 2028-09-21 | pediatric extension |
| Patent 8735372 | 001 | listed patent expiry date: 2028-09-21 | pediatric extension |
| Patent 8735372 | 002 | listed patent expiry date: 2028-09-21 | pediatric extension |
| Patent 9085573 | 001 | listed patent expiry date: 2028-09-21 | pediatric extension |
| Patent 9085573 | 002 | listed patent expiry date: 2028-09-21 | pediatric extension |
| Patent 7964580 | 001 | listed patent expiry date: 2029-03-26 | drug substance, drug product, U-1470 |
| Patent 7964580 | 002 | listed patent expiry date: 2029-03-26 | drug substance, drug product, U-1470 |
| Patent 8633309 | 001 | listed patent expiry date: 2029-03-26 | drug substance, drug product, U-1470 |
| Patent 8633309 | 002 | listed patent expiry date: 2029-03-26 | drug substance, drug product, U-1470 |
| Patent 8889159 | 001 | listed patent expiry date: 2029-03-26 | drug product, U-1470 |
| Patent 8889159 | 002 | listed patent expiry date: 2029-03-26 | drug product, U-1470 |
| Patent 7964580 | 001 | listed patent expiry date: 2029-09-26 | pediatric extension |
| Patent 7964580 | 002 | listed patent expiry date: 2029-09-26 | pediatric extension |
| Patent 8633309 | 001 | listed patent expiry date: 2029-09-26 | pediatric extension |
| Patent 8633309 | 002 | listed patent expiry date: 2029-09-26 | pediatric extension |
| Patent 8889159 | 001 | listed patent expiry date: 2029-09-26 | pediatric extension |
| Patent 8889159 | 002 | listed patent expiry date: 2029-09-26 | pediatric extension |
| Patent 9284342 | 001 | listed patent expiry date: 2030-09-13 | drug substance, drug product, U-1470 |
| Patent 9284342 | 002 | listed patent expiry date: 2030-09-13 | drug substance, drug product, U-1470 |
| Patent 8618076 | 001 | listed patent expiry date: 2030-12-11 | drug substance, drug product, U-1470 |
| Patent 8618076 | 002 | listed patent expiry date: 2030-12-11 | drug substance, drug product, U-1470 |
| Patent 9284342 | 001 | listed patent expiry date: 2031-03-13 | pediatric extension |
| Patent 9284342 | 002 | listed patent expiry date: 2031-03-13 | pediatric extension |
| Patent 8618076 | 001 | listed patent expiry date: 2031-06-11 | pediatric extension |
| Patent 8618076 | 002 | listed patent expiry date: 2031-06-11 | pediatric extension |
| Patent 8575135 | 001 | listed patent expiry date: 2032-11-16 | drug substance, drug product, U-1470 |
| Patent 8575135 | 002 | listed patent expiry date: 2032-11-16 | drug substance, drug product, U-1470 |
| Patent 8921341 | 001 | listed patent expiry date: 2032-11-16 | drug substance, drug product, U-1470 |
| Patent 8921341 | 002 | listed patent expiry date: 2032-11-16 | drug substance, drug product, U-1470 |
| Patent 8940718 | 001 | listed patent expiry date: 2032-11-16 | drug substance, drug product, U-1470 |
| Patent 8940718 | 002 | listed patent expiry date: 2032-11-16 | drug substance, drug product, U-1470 |
| Patent 8575135 | 001 | listed patent expiry date: 2033-05-16 | pediatric extension |
| Patent 8575135 | 002 | listed patent expiry date: 2033-05-16 | pediatric extension |
| Patent 8921341 | 001 | listed patent expiry date: 2033-05-16 | pediatric extension |
| Patent 8921341 | 002 | listed patent expiry date: 2033-05-16 | pediatric extension |
| Patent 8940718 | 001 | listed patent expiry date: 2033-05-16 | pediatric extension |
| Patent 8940718 | 002 | listed patent expiry date: 2033-05-16 | pediatric extension |
| Patent 11116783 | 001 | listed patent expiry date: 2034-01-30 | drug product, U-1470 |
| Patent 11116783 | 002 | listed patent expiry date: 2034-01-30 | drug product, U-1470 |
| Patent 11707479 | 001 | listed patent expiry date: 2034-01-30 | drug product, U-1470 |
| Patent 11707479 | 002 | listed patent expiry date: 2034-01-30 | drug product, U-1470 |
| Patent 11116783 | 001 | listed patent expiry date: 2034-07-30 | pediatric extension |
| Patent 11116783 | 002 | listed patent expiry date: 2034-07-30 | pediatric extension |
| Patent 11707479 | 001 | listed patent expiry date: 2034-07-30 | pediatric extension |
| Patent 11707479 | 002 | listed patent expiry date: 2034-07-30 | pediatric extension |
| Exclusivity ODE* | 002 | listed exclusivity date: 2027-03-19 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2027-09-19 | FDA code as listed |
| Exclusivity ODE-376 | 001 | listed exclusivity date: 2028-06-10 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2028-12-10 | FDA code as listed |
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 · 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.