Home Applications 208341 Application 208341
Type NDA
Sponsor GILEAD SCIENCES INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EPCLUSA SOFOSBUVIR; VELPATASVIR TABLET;ORAL 400MG;100MG Yes Yes 002 EPCLUSA SOFOSBUVIR; VELPATASVIR TABLET;ORAL 200MG;50MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208341-001 EPCLUSA SOFOSBUVIR; VELPATASVIR 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 N208341-002 EPCLUSA SOFOSBUVIR; VELPATASVIR 200MG;50MG TABLET / ORAL RLD 2020-03-19
Orange Book patents# Current patent rows page 1 of 1 · 60 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208341-001 8334270 2028-03-21 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8580765 2028-03-21 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8735372 2028-03-21 U-1470 2016-07-15 N208341-001 9085573 2028-03-21 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8334270*PED 2028-09-21 Pediatric extension N208341-001 8580765*PED 2028-09-21 Pediatric extension N208341-001 8735372*PED 2028-09-21 Pediatric extension N208341-001 9085573*PED 2028-09-21 Pediatric extension N208341-001 7964580 2029-03-26 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8633309 2029-03-26 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8889159 2029-03-26 U-1470 Drug product 2016-07-15 N208341-001 7964580*PED 2029-09-26 Pediatric extension N208341-001 8633309*PED 2029-09-26 Pediatric extension N208341-001 8889159*PED 2029-09-26 Pediatric extension N208341-001 9284342 2030-09-13 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8618076 2030-12-11 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 9284342*PED 2031-03-13 Pediatric extension N208341-001 8618076*PED 2031-06-11 Pediatric extension N208341-001 8575135 2032-11-16 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8921341 2032-11-16 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8940718 2032-11-16 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8575135*PED 2033-05-16 Pediatric extension N208341-001 8921341*PED 2033-05-16 Pediatric extension N208341-001 8940718*PED 2033-05-16 Pediatric extension N208341-001 10086011 2034-01-30 U-1470 2018-10-23 N208341-001 11116783 2034-01-30 U-1470 Drug product 2021-10-01 N208341-001 9757406 2034-01-30 Drug product 2017-09-26 N208341-001 10086011*PED 2034-07-30 Pediatric extension N208341-001 11116783*PED 2034-07-30 Pediatric extension N208341-001 9757406*PED 2034-07-30 Pediatric extension N208341-002 8334270 2028-03-21 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8580765 2028-03-21 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8735372 2028-03-21 U-1470 2020-04-16 N208341-002 9085573 2028-03-21 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8334270*PED 2028-09-21 Pediatric extension N208341-002 8580765*PED 2028-09-21 Pediatric extension N208341-002 8735372*PED 2028-09-21 Pediatric extension N208341-002 9085573*PED 2028-09-21 Pediatric extension N208341-002 7964580 2029-03-26 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8633309 2029-03-26 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8889159 2029-03-26 U-1470 Drug product 2020-04-16 N208341-002 7964580*PED 2029-09-26 Pediatric extension N208341-002 8633309*PED 2029-09-26 Pediatric extension N208341-002 8889159*PED 2029-09-26 Pediatric extension N208341-002 9284342 2030-09-13 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8618076 2030-12-11 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 9284342*PED 2031-03-13 Pediatric extension N208341-002 8618076*PED 2031-06-11 Pediatric extension N208341-002 8575135 2032-11-16 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8921341 2032-11-16 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8940718 2032-11-16 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8575135*PED 2033-05-16 Pediatric extension N208341-002 8921341*PED 2033-05-16 Pediatric extension N208341-002 8940718*PED 2033-05-16 Pediatric extension N208341-002 10086011 2034-01-30 U-1470 2020-04-16 N208341-002 11116783 2034-01-30 U-1470 Drug product 2021-10-01 N208341-002 9757406 2034-01-30 Drug product 2020-04-16 N208341-002 10086011*PED 2034-07-30 Pediatric extension N208341-002 11116783*PED 2034-07-30 Pediatric extension N208341-002 9757406*PED 2034-07-30 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 · 78 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 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 87673890dc5c…
Observed Orange Book patent history# Patent history page 1 of 56 · 2,204 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 N208341-001 8334270 2028-03-21 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8580765 2028-03-21 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8735372 2028-03-21 U-1470 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 9085573 2028-03-21 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8334270*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8580765*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8735372*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 9085573*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 7964580 2029-03-26 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8633309 2029-03-26 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8889159 2029-03-26 U-1470 Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 7964580*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8633309*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8889159*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 9284342 2030-09-13 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8618076 2030-12-11 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 9284342*PED 2031-03-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8618076*PED 2031-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8575135 2032-11-16 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8921341 2032-11-16 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8940718 2032-11-16 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8575135*PED 2033-05-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8921341*PED 2033-05-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8940718*PED 2033-05-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 10086011 2034-01-30 U-1470 2018-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 11116783 2034-01-30 U-1470 Drug product 2021-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 9757406 2034-01-30 Drug product 2017-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 10086011*PED 2034-07-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 11116783*PED 2034-07-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 9757406*PED 2034-07-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 8334270 2028-03-21 U-1470 Drug substance, Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 8580765 2028-03-21 U-1470 Drug substance, Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 8735372 2028-03-21 U-1470 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 9085573 2028-03-21 U-1470 Drug substance, Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 8334270*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 8580765*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 8735372*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 9085573*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 7964580 2029-03-26 U-1470 Drug substance, Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 8633309 2029-03-26 U-1470 Drug substance, Drug product 2020-04-16 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 14 · 531 observed states.
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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 22 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61958-2201 Epclusa Velpatasvir and Sofosbuvir Gilead Sciences, Inc. NDA Current 61958-2201 Epclusa Velpatasvir and Sofosbuvir Gilead Sciences, Inc. NDA Current 61958-2201 Epclusa Velpatasvir and Sofosbuvir Gilead Sciences, Inc. NDA Current 61958-2201 Epclusa Velpatasvir and Sofosbuvir Gilead Sciences, Inc. NDA Current 61958-2201 Epclusa Velpatasvir and Sofosbuvir Gilead Sciences, Inc. NDA Current 61958-2201 Epclusa Velpatasvir and Sofosbuvir Gilead Sciences, Inc. NDA Current 61958-2201 Epclusa Velpatasvir and Sofosbuvir Gilead Sciences, Inc. NDA Current 61958-2201 Epclusa Velpatasvir and Sofosbuvir Gilead Sciences, Inc. NDA Current 61958-2201 Epclusa Velpatasvir and Sofosbuvir Gilead Sciences, Inc. NDA Current 61958-2203 Epclusa Velpatasvir and Sofosbuvir Gilead Sciences, Inc. NDA Current 61958-2203 Epclusa Velpatasvir and Sofosbuvir Gilead Sciences, Inc. NDA Current 61958-2203 Epclusa Velpatasvir and Sofosbuvir Gilead Sciences, Inc. NDA Current 61958-2203 Epclusa Velpatasvir and Sofosbuvir Gilead Sciences, Inc. NDA Current 61958-2203 Epclusa Velpatasvir and Sofosbuvir Gilead Sciences, Inc. NDA Current 61958-2203 Epclusa Velpatasvir and Sofosbuvir Gilead Sciences, Inc. NDA Current 72626-2701 Sofosbuvir and Velpatasvir Velpatasvir and Sofosbuvir Asegua Therapeutics LLC NDA AUTHORIZED GENERIC Current 72626-2701 Sofosbuvir and Velpatasvir Velpatasvir and Sofosbuvir Asegua Therapeutics LLC NDA AUTHORIZED GENERIC Current 72626-2701 Sofosbuvir and Velpatasvir Velpatasvir and Sofosbuvir Asegua Therapeutics LLC NDA AUTHORIZED GENERIC Current 72626-2701 Sofosbuvir and Velpatasvir Velpatasvir and Sofosbuvir Asegua Therapeutics LLC NDA AUTHORIZED GENERIC Current 72626-2701 Sofosbuvir and Velpatasvir Velpatasvir and Sofosbuvir Asegua Therapeutics LLC NDA AUTHORIZED GENERIC Current 72626-2701 Sofosbuvir and Velpatasvir Velpatasvir and Sofosbuvir Asegua Therapeutics LLC NDA AUTHORIZED GENERIC Current 72626-2701 Sofosbuvir and Velpatasvir Velpatasvir and Sofosbuvir Asegua Therapeutics LLC NDA AUTHORIZED GENERIC Current