Home Applications 204671 Application 204671
Type NDA
Sponsor GILEAD SCIENCES INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SOVALDI SOFOSBUVIR TABLET;ORAL 400MG Yes Yes 002 SOVALDI SOFOSBUVIR TABLET;ORAL 200MG 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 N204671-001 SOVALDI SOFOSBUVIR 400MG TABLET / ORAL RLD, RS 2013-12-06 N204671-002 SOVALDI SOFOSBUVIR 200MG TABLET / ORAL RLD 2019-08-28
Orange Book patents# Current patent rows page 1 of 1 · 34 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204671-001 8334270 2028-03-21 U-1470 Drug substance, Drug product N204671-001 8580765 2028-03-21 U-1470 Drug substance, Drug product N204671-001 9085573 2028-03-21 U-1470 Drug substance, Drug product 2015-08-11 N204671-001 8334270*PED 2028-09-21 Pediatric extension N204671-001 8580765*PED 2028-09-21 Pediatric extension N204671-001 9085573*PED 2028-09-21 Pediatric extension N204671-001 7964580 2029-03-26 U-1470 Drug substance, Drug product N204671-001 8633309 2029-03-26 U-1470 Drug substance, Drug product 2014-01-29 N204671-001 8889159 2029-03-26 U-1470 Drug product 2014-12-09 N204671-001 9549941 2029-03-26 U-1958 2017-02-07 N204671-001 7964580*PED 2029-09-26 Pediatric extension N204671-001 8633309*PED 2029-09-26 Pediatric extension N204671-001 8889159*PED 2029-09-26 Pediatric extension N204671-001 9549941*PED 2029-09-26 Pediatric extension N204671-001 9284342 2030-09-13 U-1470 Drug substance, Drug product 2016-03-29 N204671-001 8618076 2030-12-11 U-1470 Drug substance, Drug product 2014-01-29 N204671-001 9284342*PED 2031-03-13 Pediatric extension N204671-001 8618076*PED 2031-06-11 Pediatric extension N204671-002 8334270 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 N204671-002 8580765 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 N204671-002 9085573 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 N204671-002 8334270*PED 2028-09-21 Pediatric extension N204671-002 8580765*PED 2028-09-21 Pediatric extension N204671-002 9085573*PED 2028-09-21 Pediatric extension N204671-002 7964580 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 N204671-002 8633309 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 N204671-002 8889159 2029-03-26 U-1470 Drug product 2019-09-23 N204671-002 7964580*PED 2029-09-26 Pediatric extension N204671-002 8633309*PED 2029-09-26 Pediatric extension N204671-002 8889159*PED 2029-09-26 Pediatric extension N204671-002 9284342 2030-09-13 U-1470 Drug substance, Drug product 2019-09-23 N204671-002 8618076 2030-12-11 U-1470 Drug substance, Drug product 2019-09-23 N204671-002 9284342*PED 2031-03-13 Pediatric extension N204671-002 8618076*PED 2031-06-11 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N204671-001 ODE* 2026-08-28 N204671-002 ODE* 2026-08-28
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 3 · 81 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 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204671-001 SOVALDI 400MG TABLET / ORAL AB RLD, RS 2013-12-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204671-001 SOVALDI 400MG TABLET / ORAL AB RLD, RS 2013-12-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204671-001 SOVALDI 400MG TABLET / ORAL AB RLD, RS 2013-12-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204671-001 SOVALDI 400MG TABLET / ORAL AB RLD, RS 2013-12-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204671-001 SOVALDI 400MG TABLET / ORAL RLD, RS 2013-12-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N204671-002 SOVALDI 200MG TABLET / ORAL RLD 2019-08-28 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 34 · 1,353 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 N204671-001 8334270 2028-03-21 U-1470 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 8580765 2028-03-21 U-1470 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 9085573 2028-03-21 U-1470 Drug substance, Drug product 2015-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 8334270*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 8580765*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 9085573*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 7964580 2029-03-26 U-1470 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 8633309 2029-03-26 U-1470 Drug substance, Drug product 2014-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 8889159 2029-03-26 U-1470 Drug product 2014-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 9549941 2029-03-26 U-1958 2017-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 7964580*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 8633309*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 8889159*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 9549941*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 9284342 2030-09-13 U-1470 Drug substance, Drug product 2016-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 8618076 2030-12-11 U-1470 Drug substance, Drug product 2014-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 9284342*PED 2031-03-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-001 8618076*PED 2031-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 8334270 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 8580765 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 9085573 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 8334270*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 8580765*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 9085573*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 7964580 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 8633309 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 8889159 2029-03-26 U-1470 Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 7964580*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 8633309*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 8889159*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 9284342 2030-09-13 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 8618076 2030-12-11 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 9284342*PED 2031-03-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204671-002 8618076*PED 2031-06-11 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204671-001 8334270 2028-03-21 U-1470 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204671-001 8580765 2028-03-21 U-1470 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204671-001 9085573 2028-03-21 U-1470 Drug substance, Drug product 2015-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204671-001 8334270*PED 2028-09-21 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204671-001 8580765*PED 2028-09-21 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204671-001 9085573*PED 2028-09-21 Pediatric extension 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 195 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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61958-1501 Sovaldi SOFOSBUVIR Gilead Sciences, Inc. NDA Current 61958-1501 Sovaldi SOFOSBUVIR Gilead Sciences, Inc. NDA Current 61958-1501 Sovaldi SOFOSBUVIR Gilead Sciences, Inc. NDA Current 61958-1501 Sovaldi SOFOSBUVIR Gilead Sciences, Inc. NDA Current 61958-1501 Sovaldi SOFOSBUVIR Gilead Sciences, Inc. NDA Current 61958-1503 Sovaldi SOFOSBUVIR Gilead Sciences, Inc. NDA Current 61958-1503 Sovaldi SOFOSBUVIR Gilead Sciences, Inc. NDA Current 61958-1503 Sovaldi SOFOSBUVIR Gilead Sciences, Inc. NDA Current 61958-1503 Sovaldi SOFOSBUVIR Gilead Sciences, Inc. NDA Current