Application 219249

Type: NDA
Sponsor: GENENTECH INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ITOVEBI	INAVOLISIB	TABLET;ORAL	3MG	Yes	No
002	ITOVEBI	INAVOLISIB	TABLET;ORAL	9MG	Yes	Yes

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
N219249-001	ITOVEBI	INAVOLISIB	3MG	TABLET / ORAL		RLD	2024-10-10
N219249-002	ITOVEBI	INAVOLISIB	9MG	TABLET / ORAL		RLD, RS	2024-10-10

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219249-001	8242104	2030-09-27		Drug substance, Drug product	2024-11-08
N219249-001	8343955	2030-09-27	U-4024		2024-11-08
N219249-001	10851091	2036-07-01		Drug substance, Drug product	2024-11-08
N219249-001	11760753	2036-07-01	U-4024		2024-11-08
N219249-001	9650393	2036-07-01	U-4024	Drug substance, Drug product	2024-11-08
N219249-001	11028100	2038-04-26		Drug substance, Drug product	2024-11-08
N219249-001	12410189	2038-06-14	U-4024		2025-10-07
N219249-002	8242104	2030-09-27		Drug substance, Drug product	2024-11-08
N219249-002	8343955	2030-09-27	U-4024		2024-11-08
N219249-002	10851091	2036-07-01		Drug substance, Drug product	2024-11-08
N219249-002	11760753	2036-07-01	U-4024		2024-11-08
N219249-002	9650393	2036-07-01	U-4024	Drug substance, Drug product	2024-11-08
N219249-002	11028100	2038-04-26		Drug substance, Drug product	2024-11-08
N219249-002	12410189	2038-06-14	U-4024		2025-10-07

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219249-001	NCE	2029-10-10
N219249-002	NCE	2029-10-10

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
2026-02-19 14:30 UTC	2026-02	N219249-001	ITOVEBI	3MG	TABLET / ORAL	RLD	2024-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219249-002	ITOVEBI	9MG	TABLET / ORAL	RLD, RS	2024-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-001	ITOVEBI	3MG	TABLET / ORAL	RLD	2024-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-002	ITOVEBI	9MG	TABLET / ORAL	RLD, RS	2024-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219249-001	ITOVEBI	3MG	TABLET / ORAL	RLD	2024-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219249-002	ITOVEBI	9MG	TABLET / ORAL	RLD, RS	2024-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219249-001	ITOVEBI	3MG	TABLET / ORAL	RLD	2024-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219249-002	ITOVEBI	9MG	TABLET / ORAL	RLD, RS	2024-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219249-001	ITOVEBI	3MG	TABLET / ORAL	RLD	2024-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219249-002	ITOVEBI	9MG	TABLET / ORAL	RLD, RS	2024-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219249-001	ITOVEBI	3MG	TABLET / ORAL	RLD	2024-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219249-002	ITOVEBI	9MG	TABLET / ORAL	RLD, RS	2024-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219249-001	ITOVEBI	3MG	TABLET / ORAL	RLD	2024-10-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219249-002	ITOVEBI	9MG	TABLET / ORAL	RLD, RS	2024-10-10	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N219249-001	ITOVEBI	3MG	TABLET / ORAL	RLD	2024-10-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N219249-002	ITOVEBI	9MG	TABLET / ORAL	RLD, RS	2024-10-10	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219249-001	ITOVEBI	3MG	TABLET / ORAL	RLD	2024-10-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219249-002	ITOVEBI	9MG	TABLET / ORAL	RLD, RS	2024-10-10	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 102 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	N219249-001	8242104	2030-09-27		Drug substance, Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219249-001	8343955	2030-09-27	U-4024		2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219249-001	10851091	2036-07-01		Drug substance, Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219249-001	11760753	2036-07-01	U-4024		2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219249-001	9650393	2036-07-01	U-4024	Drug substance, Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219249-001	11028100	2038-04-26		Drug substance, Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219249-001	12410189	2038-06-14	U-4024		2025-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219249-002	8242104	2030-09-27		Drug substance, Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219249-002	8343955	2030-09-27	U-4024		2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219249-002	10851091	2036-07-01		Drug substance, Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219249-002	11760753	2036-07-01	U-4024		2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219249-002	9650393	2036-07-01	U-4024	Drug substance, Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219249-002	11028100	2038-04-26		Drug substance, Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219249-002	12410189	2038-06-14	U-4024		2025-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-001	8242104	2030-09-27		Drug substance, Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-001	8343955	2030-09-27	U-4024		2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-001	10851091	2036-07-01		Drug substance, Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-001	11760753	2036-07-01	U-4024		2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-001	9650393	2036-07-01	U-4024	Drug substance, Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-001	11028100	2038-04-26		Drug substance, Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-001	12410189	2038-06-14	U-4024		2025-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-002	8242104	2030-09-27		Drug substance, Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-002	8343955	2030-09-27	U-4024		2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-002	10851091	2036-07-01		Drug substance, Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-002	11760753	2036-07-01	U-4024		2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-002	9650393	2036-07-01	U-4024	Drug substance, Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-002	11028100	2038-04-26		Drug substance, Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-002	12410189	2038-06-14	U-4024		2025-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219249-001	8242104	2030-09-27		Drug substance, Drug product	2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219249-001	8343955	2030-09-27	U-4024		2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219249-001	10851091	2036-07-01		Drug substance, Drug product	2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219249-001	11760753	2036-07-01	U-4024		2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219249-001	9650393	2036-07-01	U-4024	Drug substance, Drug product	2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219249-001	11028100	2038-04-26		Drug substance, Drug product	2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219249-002	8242104	2030-09-27		Drug substance, Drug product	2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219249-002	8343955	2030-09-27	U-4024		2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219249-002	10851091	2036-07-01		Drug substance, Drug product	2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219249-002	11760753	2036-07-01	U-4024		2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219249-002	9650393	2036-07-01	U-4024	Drug substance, Drug product	2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219249-002	11028100	2038-04-26		Drug substance, Drug product	2024-11-08	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219249-001	NCE	2029-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219249-002	NCE	2029-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-001	NCE	2029-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219249-002	NCE	2029-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219249-001	NCE	2029-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219249-002	NCE	2029-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219249-001	NCE	2029-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219249-002	NCE	2029-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219249-001	NCE	2029-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219249-002	NCE	2029-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219249-001	NCE	2029-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219249-002	NCE	2029-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219249-001	NCE	2029-10-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219249-002	NCE	2029-10-10	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219249-001	NCE	2029-10-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219249-002	NCE	2029-10-10	`a50c72e98297…`

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
Itovebi	INAVOLISIB	Genentech, Inc.	5de59f5b-e5db-410f-b692-658686ef4107	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219249 application number: NDA219249

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85705	SUPPL	2026-04-17
85696	SUPPL	2026-04-16
83545	SUPPL	2025-09-26
83559	SUPPL	2025-09-25
80169	ORIG	2024-11-05
79894	ORIG	2024-10-15
79857	ORIG	2024-10-11