Home Applications 209195 Application 209195
Type NDA
Sponsor GILEAD SCIENCES INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VOSEVI SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR TABLET;ORAL 400MG;100MG;100MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209195-001 VOSEVI SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18
Orange Book patents# Current patent rows page 1 of 1 · 47 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209195-001 8334270 2028-03-21 U-2039 Drug substance, Drug product 2017-07-28 N209195-001 8334270 2028-03-21 U-2040 Drug substance, Drug product 2017-07-28 N209195-001 8580765 2028-03-21 U-2039 Drug substance, Drug product 2017-07-28 N209195-001 8580765 2028-03-21 U-2040 Drug substance, Drug product 2017-07-28 N209195-001 8735372 2028-03-21 U-2039 Drug substance, Drug product 2017-07-28 N209195-001 8735372 2028-03-21 U-2040 Drug substance, Drug product 2017-07-28 N209195-001 8957046 2028-03-21 U-2039 2021-03-06 N209195-001 8957046 2028-03-21 U-2040 2021-03-06 N209195-001 9085573 2028-03-21 U-2039 Drug substance, Drug product 2017-07-28 N209195-001 9085573 2028-03-21 U-2040 Drug substance, Drug product 2017-07-28 N209195-001 8334270*PED 2028-09-21 Pediatric extension N209195-001 8580765*PED 2028-09-21 Pediatric extension N209195-001 8735372*PED 2028-09-21 Pediatric extension N209195-001 9085573*PED 2028-09-21 Pediatric extension N209195-001 7964580 2029-03-26 U-2039 Drug substance, Drug product 2017-07-28 N209195-001 7964580 2029-03-26 U-2040 Drug substance, Drug product 2017-07-28 N209195-001 8633309 2029-03-26 U-2039 Drug substance, Drug product 2017-07-28 N209195-001 8633309 2029-03-26 U-2040 Drug substance, Drug product 2017-07-28 N209195-001 8889159 2029-03-26 U-2039 Drug substance, Drug product 2017-07-28 N209195-001 8889159 2029-03-26 U-2040 Drug substance, Drug product 2017-07-28 N209195-001 7964580*PED 2029-09-26 Pediatric extension N209195-001 8633309*PED 2029-09-26 Pediatric extension N209195-001 8889159*PED 2029-09-26 Pediatric extension N209195-001 9284342 2030-09-13 U-2039 Drug substance, Drug product 2017-07-28 N209195-001 9284342 2030-09-13 U-2040 Drug substance, Drug product 2017-07-28 N209195-001 8618076 2030-12-11 U-2039 Drug substance, Drug product 2017-07-28 N209195-001 8618076 2030-12-11 U-2040 Drug substance, Drug product 2017-07-28 N209195-001 9284342*PED 2031-03-13 Pediatric extension N209195-001 8618076*PED 2031-06-11 Pediatric extension N209195-001 8575135 2032-11-16 U-2039 Drug substance, Drug product 2017-07-28 N209195-001 8575135 2032-11-16 U-2040 Drug substance, Drug product 2017-07-28 N209195-001 8921341 2032-11-16 U-2039 Drug substance, Drug product 2017-07-28 N209195-001 8921341 2032-11-16 U-2040 Drug substance, Drug product 2017-07-28 N209195-001 8940718 2032-11-16 U-2039 Drug substance, Drug product 2017-07-28 N209195-001 8940718 2032-11-16 U-2040 Drug substance, Drug product 2017-07-28 N209195-001 9868745 2032-11-16 Drug substance, Drug product 2018-02-06 N209195-001 8575135*PED 2033-05-16 Pediatric extension N209195-001 8921341*PED 2033-05-16 Pediatric extension N209195-001 8940718*PED 2033-05-16 Pediatric extension N209195-001 11116783 2034-01-30 U-2039 Drug product 2021-10-01 N209195-001 11116783 2034-01-30 U-2040 Drug product 2021-10-01 N209195-001 9296782 2034-07-17 Drug substance, Drug product 2017-07-28 N209195-001 11116783*PED 2034-07-30 Pediatric extension N209195-001 10912814 2037-06-01 Drug product 2021-03-09 N209195-001 11338007 2037-06-01 U-2039 Drug product 2022-06-17 N209195-001 11338007 2037-06-01 U-2040 Drug product 2022-06-17 N209195-001 11338007*PED 2037-12-01 Pediatric extension
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209195-001 VOSEVI 400MG;100MG;100MG TABLET / ORAL RLD, RS 2017-07-18 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 47 · 1,854 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209195-001 8334270 2028-03-21 U-2040 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8334270 2028-03-21 U-2039 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8580765 2028-03-21 U-2040 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8580765 2028-03-21 U-2039 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8735372 2028-03-21 U-2040 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8735372 2028-03-21 U-2039 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8957046 2028-03-21 U-2040 2021-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8957046 2028-03-21 U-2039 2021-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 9085573 2028-03-21 U-2040 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 9085573 2028-03-21 U-2039 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8334270*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8580765*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8735372*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 9085573*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 7964580 2029-03-26 U-2039 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 7964580 2029-03-26 U-2040 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8633309 2029-03-26 U-2039 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8633309 2029-03-26 U-2040 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8889159 2029-03-26 U-2040 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8889159 2029-03-26 U-2039 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 7964580*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8633309*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8889159*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 9284342 2030-09-13 U-2040 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 9284342 2030-09-13 U-2039 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8618076 2030-12-11 U-2040 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8618076 2030-12-11 U-2039 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 9284342*PED 2031-03-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8618076*PED 2031-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8575135 2032-11-16 U-2040 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8575135 2032-11-16 U-2039 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8921341 2032-11-16 U-2040 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8921341 2032-11-16 U-2039 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8940718 2032-11-16 U-2039 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8940718 2032-11-16 U-2040 Drug substance, Drug product 2017-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 9868745 2032-11-16 Drug substance, Drug product 2018-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8575135*PED 2033-05-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8921341*PED 2033-05-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 8940718*PED 2033-05-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209195-001 11116783 2034-01-30 U-2039 Drug product 2021-10-01 011fe1cb6892…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vosevi SOFOSBUVIR, VELPATASVIR, AND VOXILAPREVIR Gilead Sciences, Inc. 17ffc094-8ca7-45d2-80d8-fd043bc9a221 2025-07-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 209195 application number: NDA209195 ndc (product): 61958-2401
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61958-2401 Vosevi SOFOSBUVIR, VELPATASVIR, and VOXILAPREVIR Gilead Sciences, Inc. NDA Current 61958-2401 Vosevi SOFOSBUVIR, VELPATASVIR, and VOXILAPREVIR Gilead Sciences, Inc. NDA Current 61958-2401 Vosevi SOFOSBUVIR, VELPATASVIR, and VOXILAPREVIR Gilead Sciences, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 60970 SUPPL 2019-11-19 60883 SUPPL 2019-11-19 60203 SUPPL 2019-10-02 60161 SUPPL 2019-09-30 50395 SUPPL 2017-11-13 50377 SUPPL 2017-11-13 49650 ORIG 2017-09-01 49031 ORIG 2017-07-21 49016 ORIG 2017-07-19