Application 219972

Type: NDA
Sponsor: BAYER HEALTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYRNUO	SEVABERTINIB	TABLET;ORAL	10MG	Yes	Yes

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

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
N219972-001	HYRNUO	SEVABERTINIB	10MG	TABLET / ORAL		RLD, RS	2025-11-19

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219972-001	10428063	2035-10-10		Drug substance, Drug product	2025-12-09
N219972-001	12679836	2043-11-14	U-4582	Drug substance, Drug product	2026-08-10

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219972-001	NCE	2030-11-19

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	N219972-001	HYRNUO	10MG	TABLET / ORAL	RLD, RS	2025-11-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219972-001	HYRNUO	10MG	TABLET / ORAL	RLD, RS	2025-11-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219972-001	HYRNUO	10MG	TABLET / ORAL	RLD, RS	2025-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219972-001	HYRNUO	10MG	TABLET / ORAL	RLD, RS	2025-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219972-001	HYRNUO	10MG	TABLET / ORAL	RLD, RS	2025-11-19	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219972-001	HYRNUO	10MG	TABLET / ORAL	RLD, RS	2025-11-19	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N219972-001	10428063	2035-10-10		Drug substance, Drug product	2025-12-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219972-001	12679836	2043-11-14	U-4582	Drug substance, Drug product	2026-08-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219972-001	10428063	2035-10-10		Drug substance, Drug product	2025-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219972-001	12679836	2043-11-14	U-4582	Drug substance, Drug product	2026-08-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219972-001	10428063	2035-10-10		Drug substance, Drug product	2025-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219972-001	12679836	2043-11-14	U-4582	Drug substance, Drug product	2026-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219972-001	10428063	2035-10-10		Drug substance, Drug product	2025-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219972-001	10428063	2036-01-25		Drug substance, Drug product	2025-12-09	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219972-001	10428063	2035-10-10		Drug substance, Drug product	2025-12-09	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N219972-001	NCE	2030-11-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219972-001	NCE	2030-11-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219972-001	NCE	2030-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219972-001	NCE	2030-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219972-001	NCE	2030-11-19	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219972-001	NCE	2030-11-19	`a50c72e98297…`

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
84430	ORIG	2025-12-16
84246	ORIG	2025-11-21
84233	ORIG	2025-11-20