Home Applications 209394 Application 209394
Type NDA
Sponsor ABBVIE INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MAVYRET GLECAPREVIR; PIBRENTASVIR TABLET;ORAL 100MG;40MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N209394-001 MAVYRET GLECAPREVIR; PIBRENTASVIR 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03
Orange Book patents# Current patent rows page 1 of 1 · 30 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209394-001 10028937 2030-06-10 U-2141 2018-08-24 N209394-001 10028937 2030-06-10 U-3237 2018-08-24 N209394-001 10028937 2030-06-10 U-4206 2018-08-24 N209394-001 10039754 2030-06-10 U-2141 2018-09-06 N209394-001 10039754 2030-06-10 U-3237 2018-09-06 N209394-001 10039754 2030-06-10 U-4206 2018-09-06 N209394-001 9586978 2030-11-06 U-2141 2017-08-29 N209394-001 9586978 2030-11-06 U-3237 2017-08-29 N209394-001 9586978 2030-11-06 U-4206 2017-08-29 N209394-001 10028937*PED 2030-12-10 Pediatric extension N209394-001 10039754*PED 2030-12-10 Pediatric extension N209394-001 9586978*PED 2031-05-06 Pediatric extension N209394-001 8648037 2032-01-19 U-2141 Drug substance, Drug product 2017-08-29 N209394-001 8648037 2032-01-19 U-3237 Drug substance, Drug product 2017-08-29 N209394-001 8648037 2032-01-19 U-4206 Drug substance, Drug product 2017-08-29 N209394-001 8937150 2032-05-18 Drug substance, Drug product 2017-08-29 N209394-001 8648037*PED 2032-07-19 Pediatric extension N209394-001 8937150*PED 2032-11-18 Pediatric extension N209394-001 10286029 2034-03-14 U-3237 2019-05-31 N209394-001 10286029 2034-03-14 U-4206 2019-05-31 N209394-001 11484534 2034-03-14 U-3237 2022-11-30 N209394-001 11484534 2034-03-14 U-4206 2022-11-30 N209394-001 10286029*PED 2034-09-14 Pediatric extension N209394-001 11484534*PED 2034-09-14 Pediatric extension N209394-001 RE48923 2035-05-08 Drug substance 2022-03-08 N209394-001 9321807 2035-06-05 Drug substance 2017-08-29 N209394-001 RE48923*PED 2035-11-08 Pediatric extension N209394-001 9321807*PED 2035-12-05 Pediatric extension N209394-001 11246866 2036-06-24 Drug product 2022-03-08 N209394-001 11246866*PED 2036-12-24 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 7 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 · 42 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 2026-08-18 06:07:40 2026-07 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209394-001 MAVYRET 100MG;40MG TABLET / ORAL RLD, RS 2017-08-03 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 23 · 909 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N209394-001 10028937 2030-06-10 U-4206 2018-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 10028937 2030-06-10 U-2141 2018-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 10028937 2030-06-10 U-3237 2018-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 10039754 2030-06-10 U-2141 2018-09-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 10039754 2030-06-10 U-4206 2018-09-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 10039754 2030-06-10 U-3237 2018-09-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 9586978 2030-11-06 U-4206 2017-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 9586978 2030-11-06 U-3237 2017-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 9586978 2030-11-06 U-2141 2017-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 10028937*PED 2030-12-10 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 10039754*PED 2030-12-10 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 9586978*PED 2031-05-06 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 8648037 2032-01-19 U-2141 Drug substance, Drug product 2017-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 8648037 2032-01-19 U-4206 Drug substance, Drug product 2017-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 8648037 2032-01-19 U-3237 Drug substance, Drug product 2017-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 8937150 2032-05-18 Drug substance, Drug product 2017-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 8648037*PED 2032-07-19 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 8937150*PED 2032-11-18 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 10286029 2034-03-14 U-4206 2019-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 10286029 2034-03-14 U-3237 2019-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 11484534 2034-03-14 U-4206 2022-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 11484534 2034-03-14 U-3237 2022-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 10286029*PED 2034-09-14 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 11484534*PED 2034-09-14 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 RE48923 2035-05-08 Drug substance 2022-03-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 9321807 2035-06-05 Drug substance 2017-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 RE48923*PED 2035-11-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 9321807*PED 2035-12-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 11246866 2036-06-24 Drug product 2022-03-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209394-001 11246866*PED 2036-12-24 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209394-001 10028937 2030-06-10 U-4206 2018-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209394-001 10028937 2030-06-10 U-2141 2018-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209394-001 10028937 2030-06-10 U-3237 2018-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209394-001 10039754 2030-06-10 U-2141 2018-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209394-001 10039754 2030-06-10 U-4206 2018-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209394-001 10039754 2030-06-10 U-3237 2018-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209394-001 9586978 2030-11-06 U-4206 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209394-001 9586978 2030-11-06 U-3237 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209394-001 9586978 2030-11-06 U-2141 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209394-001 10028937*PED 2030-12-10 Pediatric extension 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 10 · 362 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mavyret GLECAPREVIR AND PIBRENTASVIR AbbVie Inc. 7bf99777-0401-9095-8645-16c6e907fcc0 2025-06-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 209394 application number: NDA209394 ndc (product): 0074-2625
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0074-2625 Mavyret Glecaprevir and Pibrentasvir AbbVie Inc. NDA Current 0074-2625 Mavyret Glecaprevir and Pibrentasvir AbbVie Inc. NDA Current 0074-2625 Mavyret Glecaprevir and Pibrentasvir AbbVie Inc. NDA Current 0074-2625 Mavyret Glecaprevir and Pibrentasvir AbbVie Inc. NDA Current 0074-2625 Mavyret Glecaprevir and Pibrentasvir AbbVie Inc. NDA Current 0074-2625 Mavyret Glecaprevir and Pibrentasvir AbbVie Inc. NDA Current 0074-2625 Mavyret Glecaprevir and Pibrentasvir AbbVie Inc. NDA Current 0074-2625 Mavyret Glecaprevir and Pibrentasvir AbbVie Inc. NDA Current 0074-2625 Mavyret Glecaprevir and Pibrentasvir AbbVie Inc. NDA Current 0074-2625 Mavyret Glecaprevir and Pibrentasvir AbbVie Inc. NDA Current 0074-2625 Mavyret Glecaprevir and Pibrentasvir AbbVie Inc. NDA Current 0074-2625 Mavyret Glecaprevir and Pibrentasvir AbbVie Inc. NDA Current 0074-2625 Mavyret Glecaprevir and Pibrentasvir AbbVie Inc. NDA Current 0074-2625 Mavyret Glecaprevir and Pibrentasvir AbbVie Inc. NDA Current 0074-2625 Mavyret Glecaprevir and Pibrentasvir AbbVie Inc. NDA Current