Application 206619

Type: NDA
Sponsor: ABBVIE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIEKIRA PAK (COPACKAGED)	DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR	TABLET, TABLET;ORAL	250.0MG;12.5MG;75.0MG;EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG	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
N206619-001	VIEKIRA PAK (COPACKAGED)	DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL		RLD	2014-12-19

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206619-001	9139536	2028-11-09	U-1753		2015-10-21
N206619-001	8501238	2028-12-19	U-1636	Drug substance, Drug product	2015-01-15
N206619-001	8188104	2029-05-17	U-1636	Drug substance, Drug product	2015-01-15
N206619-001	8642538	2029-09-10	U-1638	Drug substance, Drug product	2015-01-15
N206619-001	9006387	2030-06-10	U-1687		2015-05-06
N206619-001	8420596	2031-04-10		Drug substance, Drug product	2015-01-15
N206619-001	9044480	2031-04-10	U-1638		2015-07-01
N206619-001	8686026	2031-06-09		Drug product	2015-01-15
N206619-001	8691938	2032-04-13		Drug substance, Drug product	2015-01-15
N206619-001	8466159	2032-09-04	U-1637		2015-01-15
N206619-001	8492386	2032-09-04	U-1840		2015-01-15
N206619-001	8680106	2032-09-04	U-1637		2015-01-15
N206619-001	8685984	2032-09-04	U-1840		2015-01-15
N206619-001	10201542	2033-10-18	U-1753	Drug product	2019-03-14
N206619-001	9629841	2033-10-18	U-1753	Drug product	2017-06-16

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG	TABLET, TABLET / ORAL	RLD, RS	2014-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206619-001	VIEKIRA PAK (COPACKAGED)	250.0MG;12.5MG;75.0MG;EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG	TABLET, TABLET / ORAL	RLD, RS	2014-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206619-001	VIEKIRA PAK (COPACKAGED)	250.0MG;12.5MG;75.0MG;EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG	TABLET, TABLET / ORAL	RLD, RS	2014-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206619-001	VIEKIRA PAK (COPACKAGED)	250.0MG;12.5MG;75.0MG;EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG	TABLET, TABLET / ORAL	RLD, RS	2014-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206619-001	VIEKIRA PAK (COPACKAGED)	250.0MG;12.5MG;75.0MG;EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG	TABLET, TABLET / ORAL	RLD, RS	2014-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG	TABLET, TABLET / ORAL	RLD, RS	2014-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG	TABLET, TABLET / ORAL	RLD, RS	2014-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG	TABLET, TABLET / ORAL	RLD, RS	2014-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206619-001	VIEKIRA PAK (COPACKAGED)	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET / ORAL	RLD	2014-12-19	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 695 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	N206619-001	9139536	2028-11-09	U-1753		2015-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206619-001	8501238	2028-12-19	U-1636	Drug substance, Drug product	2015-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206619-001	8188104	2029-05-17	U-1636	Drug substance, Drug product	2015-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206619-001	8642538	2029-09-10	U-1638	Drug substance, Drug product	2015-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206619-001	9006387	2030-06-10	U-1687		2015-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206619-001	8420596	2031-04-10		Drug substance, Drug product	2015-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206619-001	9044480	2031-04-10	U-1638		2015-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206619-001	8686026	2031-06-09		Drug product	2015-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206619-001	8691938	2032-04-13		Drug substance, Drug product	2015-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206619-001	8466159	2032-09-04	U-1637		2015-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206619-001	8492386	2032-09-04	U-1840		2015-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206619-001	8680106	2032-09-04	U-1637		2015-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206619-001	8685984	2032-09-04	U-1840		2015-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206619-001	10201542	2033-10-18	U-1753	Drug product	2019-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206619-001	9629841	2033-10-18	U-1753	Drug product	2017-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	9139536	2028-11-09	U-1753		2015-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	8501238	2028-12-19	U-1636	Drug substance, Drug product	2015-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	8188104	2029-05-17	U-1636	Drug substance, Drug product	2015-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	8642538	2029-09-10	U-1638	Drug substance, Drug product	2015-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	9006387	2030-06-10	U-1687		2015-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	8420596	2031-04-10		Drug substance, Drug product	2015-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	9044480	2031-04-10	U-1638		2015-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	8686026	2031-06-09		Drug product	2015-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	8691938	2032-04-13		Drug substance, Drug product	2015-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	8466159	2032-09-04	U-1637		2015-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	8492386	2032-09-04	U-1840		2015-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	8680106	2032-09-04	U-1637		2015-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	8685984	2032-09-04	U-1840		2015-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	10201542	2033-10-18	U-1753	Drug product	2019-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206619-001	9629841	2033-10-18	U-1753	Drug product	2017-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206619-001	9139536	2028-11-09	U-1753		2015-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206619-001	8501238	2028-12-19	U-1636	Drug substance, Drug product	2015-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206619-001	8188104	2029-05-17	U-1636	Drug substance, Drug product	2015-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206619-001	8642538	2029-09-10	U-1638	Drug substance, Drug product	2015-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206619-001	9006387	2030-06-10	U-1687		2015-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206619-001	8420596	2031-04-10		Drug substance, Drug product	2015-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206619-001	9044480	2031-04-10	U-1638		2015-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206619-001	8686026	2031-06-09		Drug product	2015-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206619-001	8691938	2032-04-13		Drug substance, Drug product	2015-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206619-001	8466159	2032-09-04	U-1637		2015-01-15	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N206619-001	D-163	2019-04-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206619-001	NCE	2019-12-19	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N206619-001	D-163	2019-04-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206619-001	NCE	2019-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206619-001	D-163	2019-04-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206619-001	NCE	2019-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206619-001	D-163	2019-04-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206619-001	NCE	2019-12-19	`ea99ee380514…`

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
0074-3093	Viekira Pak	Dasabuvir and Ombitasvir and Paritaprevir and Ritonavir	AbbVie Inc.	NDA	Current
0074-3093	Viekira Pak	Dasabuvir and Ombitasvir and Paritaprevir and Ritonavir	AbbVie Inc.	NDA	Current
0074-3093	Viekira Pak	Dasabuvir and Ombitasvir and Paritaprevir and Ritonavir	AbbVie Inc.	NDA	Current
0074-3093	Viekira Pak	Dasabuvir and Ombitasvir and Paritaprevir and Ritonavir	AbbVie Inc.	NDA	Current
0074-3093	Viekira Pak	Dasabuvir and Ombitasvir and Paritaprevir and Ritonavir	AbbVie Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61207	SUPPL	2019-12-10
61197	SUPPL	2019-12-09
61196	SUPPL	2019-12-09
55360	SUPPL	2018-08-29
55357	SUPPL	2018-08-29
54975	SUPPL	2018-07-25
50396	SUPPL	2017-11-13
50378	SUPPL	2017-11-13
47675	SUPPL	2017-03-24
47674	SUPPL	2017-03-24
47649	SUPPL	2017-03-23
47648	SUPPL	2017-03-23
47219	SUPPL	2017-02-15
47212	SUPPL	2017-02-15
40562	SUPPL	2016-06-23
10587	SUPPL	2016-06-23
40560	SUPPL	2016-04-27
10585	SUPPL	2016-04-26
40561	SUPPL	2016-02-01
10586	SUPPL	2016-01-29
10584	SUPPL	2015-10-26
40559	SUPPL	2015-10-23
19728	SUPPL	2015-10-15
32819	SUPPL	2015-10-14
19727	SUPPL	2015-07-22
10583	SUPPL	2015-07-22
40558	SUPPL	2015-03-26
32818	SUPPL	2015-03-26
44947	ORIG	2015-01-23
23024	ORIG	2015-01-23
40557	ORIG	2014-12-23
32817	ORIG	2014-12-23