Application 218784

Type: NDA
Sponsor: SERVIER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VORANIGO	VORASIDENIB	TABLET;ORAL	10MG	Yes	No
002	VORANIGO	VORASIDENIB	TABLET;ORAL	40MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N218784-001	VORANIGO	VORASIDENIB	10MG	TABLET / ORAL		RLD	2024-08-06
N218784-002	VORANIGO	VORASIDENIB	40MG	TABLET / ORAL		RLD, RS	2024-08-06

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218784-001	10172864	2034-07-11		Drug substance, Drug product	2024-08-27
N218784-001	12433895	2034-07-11	U-4286		2025-10-22
N218784-001	9579324	2034-07-11		Drug substance	2024-08-27
N218784-001	11844758	2035-12-04	U-3977		2024-08-27
N218784-001	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27
N218784-002	10172864	2034-07-11		Drug substance, Drug product	2024-08-27
N218784-002	12433895	2034-07-11	U-4286		2025-10-22
N218784-002	9579324	2034-07-11		Drug substance	2024-08-27
N218784-002	11844758	2035-12-04	U-3977		2024-08-27
N218784-002	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218784-001	NCE	2029-08-06
N218784-001	ODE-491	2031-08-06
N218784-002	NCE	2029-08-06
N218784-002	ODE-491	2031-08-06

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
2026-10-15 13:18:30	2026-09	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 2 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	12433895	2034-07-11	U-4286		2025-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	9579324	2034-07-11		Drug substance	2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	11844758	2035-12-04	U-3977		2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	12433895	2034-07-11	U-4286		2025-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	9579324	2034-07-11		Drug substance	2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	11844758	2035-12-04	U-3977		2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218784-001	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218784-001	9579324	2034-07-11		Drug substance	2024-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218784-001	11844758	2035-12-04	U-3977		2024-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218784-001	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218784-002	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218784-002	9579324	2034-07-11		Drug substance	2024-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218784-002	11844758	2035-12-04	U-3977		2024-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218784-002	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-001	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-001	9579324	2034-07-11		Drug substance	2024-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-001	11844758	2035-12-04	U-3977		2024-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-001	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-002	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-002	9579324	2034-07-11		Drug substance	2024-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-002	11844758	2035-12-04	U-3977		2024-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-002	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-001	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-001	9579324	2034-07-11		Drug substance	2024-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-001	11844758	2035-12-04	U-3977		2024-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-001	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-002	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-002	9579324	2034-07-11		Drug substance	2024-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-002	11844758	2035-12-04	U-3977		2024-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-002	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-001	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-001	9579324	2034-07-11		Drug substance	2024-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-001	11844758	2035-12-04	U-3977		2024-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-001	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-002	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-002	9579324	2034-07-11		Drug substance	2024-08-27	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N218784-001	NCE	2029-08-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218784-001	ODE-491	2031-08-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218784-002	NCE	2029-08-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218784-002	ODE-491	2031-08-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N218784-001	NCE	2029-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-001	ODE-491	2031-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-002	NCE	2029-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-002	ODE-491	2031-08-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218784-001	NCE	2029-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-001	ODE-491	2031-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-002	NCE	2029-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-002	ODE-491	2031-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218784-001	NCE	2029-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-001	ODE-491	2031-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-002	NCE	2029-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-002	ODE-491	2031-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	NCE	2029-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	ODE-491	2031-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	NCE	2029-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	ODE-491	2031-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218784-001	NCE	2029-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218784-001	ODE-491	2031-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218784-002	NCE	2029-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218784-002	ODE-491	2031-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-001	NCE	2029-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-001	ODE-491	2031-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-002	NCE	2029-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-002	ODE-491	2031-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-001	NCE	2029-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-001	ODE-491	2031-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-002	NCE	2029-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-002	ODE-491	2031-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-001	NCE	2029-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-001	ODE-491	2031-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-002	NCE	2029-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-002	ODE-491	2031-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218784-001	NCE	2029-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218784-001	ODE-491	2031-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218784-002	NCE	2029-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218784-002	ODE-491	2031-08-06	`2680178bc6a6…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81901	SUPPL	2025-04-09
81882	SUPPL	2025-04-08
79491	ORIG	2024-08-28
79342	ORIG	2024-08-08
79337	ORIG	2024-08-08