VOSEVI — FDA application NDA209195
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 | VOSEVI | SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR | TABLET | ORAL | 400MG;100MG;100MG | 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-2040 |
| Patent 8334270 | 001 | listed patent expiry date: 2028-03-21 | drug substance, drug product, U-2039 |
| Patent 8580765 | 001 | listed patent expiry date: 2028-03-21 | drug substance, drug product, U-2040 |
| Patent 8580765 | 001 | listed patent expiry date: 2028-03-21 | drug substance, drug product, U-2039 |
| Patent 8735372 | 001 | listed patent expiry date: 2028-03-21 | drug substance, drug product, U-2040 |
| Patent 8735372 | 001 | listed patent expiry date: 2028-03-21 | drug substance, drug product, U-2039 |
| Patent 8957046 | 001 | listed patent expiry date: 2028-03-21 | U-2040 |
| Patent 8957046 | 001 | listed patent expiry date: 2028-03-21 | U-2039 |
| Patent 9085573 | 001 | listed patent expiry date: 2028-03-21 | drug substance, drug product, U-2040 |
| Patent 9085573 | 001 | listed patent expiry date: 2028-03-21 | drug substance, drug product, U-2039 |
| Patent 8334270 | 001 | listed patent expiry date: 2028-09-21 | pediatric extension |
| Patent 8580765 | 001 | listed patent expiry date: 2028-09-21 | pediatric extension |
| Patent 8735372 | 001 | listed patent expiry date: 2028-09-21 | pediatric extension |
| Patent 9085573 | 001 | listed patent expiry date: 2028-09-21 | pediatric extension |
| Patent 7964580 | 001 | listed patent expiry date: 2029-03-26 | drug substance, drug product, U-2039 |
| Patent 7964580 | 001 | listed patent expiry date: 2029-03-26 | drug substance, drug product, U-2040 |
| Patent 8633309 | 001 | listed patent expiry date: 2029-03-26 | drug substance, drug product, U-2039 |
| Patent 8633309 | 001 | listed patent expiry date: 2029-03-26 | drug substance, drug product, U-2040 |
| Patent 8889159 | 001 | listed patent expiry date: 2029-03-26 | drug substance, drug product, U-2040 |
| Patent 8889159 | 001 | listed patent expiry date: 2029-03-26 | drug substance, drug product, U-2039 |
| Patent 7964580 | 001 | listed patent expiry date: 2029-09-26 | pediatric extension |
| Patent 8633309 | 001 | listed patent expiry date: 2029-09-26 | pediatric extension |
| Patent 8889159 | 001 | listed patent expiry date: 2029-09-26 | pediatric extension |
| Patent 9284342 | 001 | listed patent expiry date: 2030-09-13 | drug substance, drug product, U-2040 |
| Patent 9284342 | 001 | listed patent expiry date: 2030-09-13 | drug substance, drug product, U-2039 |
| Patent 8618076 | 001 | listed patent expiry date: 2030-12-11 | drug substance, drug product, U-2040 |
| Patent 8618076 | 001 | listed patent expiry date: 2030-12-11 | drug substance, drug product, U-2039 |
| Patent 9284342 | 001 | listed patent expiry date: 2031-03-13 | pediatric extension |
| Patent 8618076 | 001 | listed patent expiry date: 2031-06-11 | pediatric extension |
| Patent 8575135 | 001 | listed patent expiry date: 2032-11-16 | drug substance, drug product, U-2040 |
| Patent 8575135 | 001 | listed patent expiry date: 2032-11-16 | drug substance, drug product, U-2039 |
| Patent 8921341 | 001 | listed patent expiry date: 2032-11-16 | drug substance, drug product, U-2040 |
| Patent 8921341 | 001 | listed patent expiry date: 2032-11-16 | drug substance, drug product, U-2039 |
| Patent 8940718 | 001 | listed patent expiry date: 2032-11-16 | drug substance, drug product, U-2039 |
| Patent 8940718 | 001 | listed patent expiry date: 2032-11-16 | drug substance, drug product, U-2040 |
| Patent 9868745 | 001 | listed patent expiry date: 2032-11-16 | drug substance, drug product |
| Patent 8575135 | 001 | listed patent expiry date: 2033-05-16 | pediatric extension |
| Patent 8921341 | 001 | listed patent expiry date: 2033-05-16 | pediatric extension |
| Patent 8940718 | 001 | listed patent expiry date: 2033-05-16 | pediatric extension |
| Patent 11116783 | 001 | listed patent expiry date: 2034-01-30 | drug product, U-2039 |
| Patent 11116783 | 001 | listed patent expiry date: 2034-01-30 | drug product, U-2040 |
| Patent 9296782 | 001 | listed patent expiry date: 2034-07-17 | drug substance, drug product |
| Patent 11116783 | 001 | listed patent expiry date: 2034-07-30 | pediatric extension |
| Patent 10912814 | 001 | listed patent expiry date: 2037-06-01 | drug product |
| Patent 11338007 | 001 | listed patent expiry date: 2037-06-01 | drug product, U-2039 |
| Patent 11338007 | 001 | listed patent expiry date: 2037-06-01 | drug product, U-2040 |
| Patent 11338007 | 001 | listed patent expiry date: 2037-12-01 | pediatric extension |
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
- VOXILAPREVIR · UNII 0570F37359 · 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.