Application 215110

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	No

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
N215110-001	MAVYRET	GLECAPREVIR; PIBRENTASVIR	50MG/PACKET;20MG/PACKET	PELLETS / ORAL		RLD, RS	2021-06-10

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215110-001	10028937	2030-06-10	U-3238		2021-07-08
N215110-001	10028937	2030-06-10	U-4206		2021-07-08
N215110-001	10039754	2030-06-10	U-3238		2021-07-08
N215110-001	10039754	2030-06-10	U-4206		2021-07-08
N215110-001	9586978	2030-11-06	U-3238		2021-07-08
N215110-001	9586978	2030-11-06	U-4206		2021-07-08
N215110-001	10028937*PED	2030-12-10		Pediatric extension
N215110-001	10039754*PED	2030-12-10		Pediatric extension
N215110-001	9586978*PED	2031-05-06		Pediatric extension
N215110-001	8648037	2032-01-19	U-3238	Drug substance, Drug product	2021-07-08
N215110-001	8648037	2032-01-19	U-4206	Drug substance, Drug product	2021-07-08
N215110-001	8937150	2032-05-18		Drug substance, Drug product	2021-07-08
N215110-001	8648037*PED	2032-07-19		Pediatric extension
N215110-001	8937150*PED	2032-11-18		Pediatric extension
N215110-001	10286029	2034-03-14	U-3238		2021-07-08
N215110-001	10286029	2034-03-14	U-4206		2021-07-08
N215110-001	10286029*PED	2034-09-14		Pediatric extension
N215110-001	RE48923	2035-05-08		Drug substance	2022-03-08
N215110-001	9321807	2035-06-05		Drug substance, Drug product	2021-07-08
N215110-001	RE48923*PED	2035-11-08		Pediatric extension
N215110-001	9321807*PED	2035-12-05		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215110-001	I-967	2028-06-10
N215110-001	ODE-372	2028-06-10
N215110-001	PED	2028-12-10

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215110-001	MAVYRET	50MG/PACKET;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215110-001	MAVYRET	50MG;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215110-001	MAVYRET	50MG/PACKET;20MG/PACKET	PELLETS / ORAL	RLD, RS	2021-06-10	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 566 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	N215110-001	10028937	2030-06-10	U-4206		2021-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	10028937	2030-06-10	U-3238		2021-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	10039754	2030-06-10	U-4206		2021-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	10039754	2030-06-10	U-3238		2021-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	9586978	2030-11-06	U-4206		2021-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	9586978	2030-11-06	U-3238		2021-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	10028937*PED	2030-12-10		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	10039754*PED	2030-12-10		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	9586978*PED	2031-05-06		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	8648037	2032-01-19	U-4206	Drug substance, Drug product	2021-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	8648037	2032-01-19	U-3238	Drug substance, Drug product	2021-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	8937150	2032-05-18		Drug substance, Drug product	2021-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	8648037*PED	2032-07-19		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	8937150*PED	2032-11-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	10286029	2034-03-14	U-4206		2021-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	10286029	2034-03-14	U-3238		2021-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	10286029*PED	2034-09-14		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	RE48923	2035-05-08		Drug substance	2022-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	9321807	2035-06-05		Drug substance, Drug product	2021-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	RE48923*PED	2035-11-08		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	9321807*PED	2035-12-05		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215110-001	10028937	2030-06-10	U-4206		2021-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	10028937	2030-06-10	U-3238		2021-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	10039754	2030-06-10	U-4206		2021-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	10039754	2030-06-10	U-3238		2021-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	9586978	2030-11-06	U-4206		2021-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	9586978	2030-11-06	U-3238		2021-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	10028937*PED	2030-12-10		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	10039754*PED	2030-12-10		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	9586978*PED	2031-05-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	8648037	2032-01-19	U-4206	Drug substance, Drug product	2021-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	8648037	2032-01-19	U-3238	Drug substance, Drug product	2021-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	8937150	2032-05-18		Drug substance, Drug product	2021-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	8648037*PED	2032-07-19		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	8937150*PED	2032-11-18		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	10286029	2034-03-14	U-4206		2021-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	10286029	2034-03-14	U-3238		2021-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	10286029*PED	2034-09-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	RE48923	2035-05-08		Drug substance	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	9321807	2035-06-05		Drug substance, Drug product	2021-07-08	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 155 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N215110-001	I-967	2028-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	ODE-372	2028-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215110-001	PED	2028-12-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215110-001	I-967	2028-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	ODE-372	2028-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215110-001	PED	2028-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215110-001	I-967	2028-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215110-001	ODE-372	2028-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215110-001	PED	2028-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215110-001	I-967	2028-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215110-001	ODE-372	2028-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215110-001	PED	2028-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215110-001	ODE-372	2028-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215110-001	PED	2028-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215110-001	ODE-372	2028-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215110-001	PED	2028-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215110-001	ODE-372	2028-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215110-001	PED	2028-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215110-001	ODE-372	2028-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215110-001	PED	2028-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215110-001	ODE-372	2028-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215110-001	PED	2028-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215110-001	ODE-372	2028-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215110-001	PED	2028-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215110-001	ODE-372	2028-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215110-001	PED	2028-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215110-001	ODE-372	2028-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215110-001	PED	2028-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215110-001	ODE-372	2028-06-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215110-001	PED	2028-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215110-001	ODE-372	2028-06-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215110-001	PED	2028-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215110-001	ODE-372	2028-06-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215110-001	PED	2028-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215110-001	NCE	2022-08-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215110-001	D-175	2022-09-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215110-001	PED	2023-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215110-001	PED	2023-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215110-001	M-259	2023-04-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215110-001	PED	2023-10-10	`5c6f7cd8ea54…`

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): 215110 application number: NDA215110 ndc (product): 0074-2600

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-2600	Mavyret	Glecaprevir and Pibrentasvir	AbbVie Inc.	NDA	Current
0074-2600	Mavyret	Glecaprevir and Pibrentasvir	AbbVie Inc.	NDA	Current
0074-2600	Mavyret	Glecaprevir and Pibrentasvir	AbbVie Inc.	NDA	Current
0074-2600	Mavyret	Glecaprevir and Pibrentasvir	AbbVie Inc.	NDA	Current
0074-2600	Mavyret	Glecaprevir and Pibrentasvir	AbbVie Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82545	SUPPL	2025-06-12
82535	SUPPL	2025-06-11
75974	SUPPL	2023-10-27
75949	SUPPL	2023-10-26
69283	ORIG	2021-11-09
68863	SUPPL	2021-10-01
68803	SUPPL	2021-09-29
67885	ORIG	2021-06-24
67779	ORIG	2021-06-14