Application 218764

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JASCAYD	NERANDOMILAST	TABLET;ORAL	9MG	Yes	No
002	JASCAYD	NERANDOMILAST	TABLET;ORAL	18MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N218764-001	JASCAYD	NERANDOMILAST	9MG	TABLET / ORAL		RLD	2025-10-07
N218764-002	JASCAYD	NERANDOMILAST	18MG	TABLET / ORAL		RLD, RS	2025-10-07

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
N218764-001	8754073	2029-11-26	U-4298	Drug substance, Drug product	2025-10-29
N218764-001	8609670	2032-08-23		Drug substance	2025-10-29
N218764-001	9802954	2034-02-19	U-4298		2025-10-29
N218764-001	11406638	2038-10-22	U-4297		2025-10-29
N218764-001	11406638	2038-10-22	U-4373		2025-10-29
N218764-001	11813266	2038-10-22	U-4292		2025-10-29
N218764-001	11813266	2038-10-22	U-4372		2025-10-29
N218764-002	8754073	2029-11-26	U-4298	Drug substance, Drug product	2025-10-29
N218764-002	8609670	2032-08-23		Drug substance	2025-10-29
N218764-002	9802954	2034-02-19	U-4298		2025-10-29
N218764-002	11406638	2038-10-22	U-4297		2025-10-29
N218764-002	11406638	2038-10-22	U-4373		2025-10-29
N218764-002	11813266	2038-10-22	U-4292		2025-10-29
N218764-002	11813266	2038-10-22	U-4372		2025-10-29

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218764-001	I-979	2028-12-19
N218764-001	NCE	2030-10-07
N218764-001	ODE-546	2032-10-07
N218764-002	I-979	2028-12-19
N218764-002	NCE	2030-10-07
N218764-002	ODE-546	2032-10-07

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
2026-09-14 22:38:34	2026-08	N218764-001	JASCAYD	9MG	TABLET / ORAL	RLD	2025-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-002	JASCAYD	18MG	TABLET / ORAL	RLD, RS	2025-10-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218764-001	JASCAYD	9MG	TABLET / ORAL	RLD	2025-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-002	JASCAYD	18MG	TABLET / ORAL	RLD, RS	2025-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218764-001	JASCAYD	9MG	TABLET / ORAL	RLD	2025-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218764-002	JASCAYD	18MG	TABLET / ORAL	RLD, RS	2025-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218764-001	JASCAYD	9MG	TABLET / ORAL	RLD	2025-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218764-002	JASCAYD	18MG	TABLET / ORAL	RLD, RS	2025-10-07	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218764-001	JASCAYD	9MG	TABLET / ORAL	RLD	2025-10-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218764-002	JASCAYD	18MG	TABLET / ORAL	RLD, RS	2025-10-07	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N218764-001	8754073	2029-11-26	U-4298	Drug substance, Drug product	2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-001	8609670	2032-08-23		Drug substance	2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-001	9802954	2034-02-19	U-4298		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-001	11406638	2038-10-22	U-4373		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-001	11406638	2038-10-22	U-4297		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-001	11813266	2038-10-22	U-4372		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-001	11813266	2038-10-22	U-4292		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-002	8754073	2029-11-26	U-4298	Drug substance, Drug product	2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-002	8609670	2032-08-23		Drug substance	2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-002	9802954	2034-02-19	U-4298		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-002	11406638	2038-10-22	U-4373		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-002	11406638	2038-10-22	U-4297		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-002	11813266	2038-10-22	U-4372		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-002	11813266	2038-10-22	U-4292		2025-10-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218764-001	8754073	2029-11-26	U-4298	Drug substance, Drug product	2025-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-001	8609670	2032-08-23		Drug substance	2025-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-001	9802954	2034-02-19	U-4298		2025-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-001	11406638	2038-10-22	U-4373		2025-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-001	11406638	2038-10-22	U-4297		2025-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-001	11813266	2038-10-22	U-4372		2025-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-001	11813266	2038-10-22	U-4292		2025-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-002	8754073	2029-11-26	U-4298	Drug substance, Drug product	2025-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-002	8609670	2032-08-23		Drug substance	2025-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-002	9802954	2034-02-19	U-4298		2025-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-002	11406638	2038-10-22	U-4373		2025-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-002	11406638	2038-10-22	U-4297		2025-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-002	11813266	2038-10-22	U-4372		2025-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-002	11813266	2038-10-22	U-4292		2025-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218764-001	8754073	2029-11-26	U-4298	Drug substance, Drug product	2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218764-001	8609670	2032-08-23		Drug substance	2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218764-001	9802954	2034-02-19	U-4298		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218764-001	11406638	2038-10-22	U-4373		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218764-001	11406638	2038-10-22	U-4297		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218764-001	11813266	2038-10-22	U-4372		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218764-001	11813266	2038-10-22	U-4292		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218764-002	8754073	2029-11-26	U-4298	Drug substance, Drug product	2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218764-002	8609670	2032-08-23		Drug substance	2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218764-002	9802954	2034-02-19	U-4298		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218764-002	11406638	2038-10-22	U-4373		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218764-002	11406638	2038-10-22	U-4297		2025-10-29	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N218764-001	I-979	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-001	NCE	2030-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-001	ODE-546	2032-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-002	I-979	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-002	NCE	2030-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218764-002	ODE-546	2032-10-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218764-001	I-979	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-001	NCE	2030-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-001	ODE-546	2032-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-002	I-979	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-002	NCE	2030-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218764-002	ODE-546	2032-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218764-001	I-979	2028-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218764-001	NCE	2030-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218764-002	I-979	2028-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218764-002	NCE	2030-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218764-001	NCE	2030-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218764-002	NCE	2030-10-07	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218764-001	I-979	2028-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218764-001	NCE	2030-10-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218764-001	ODE-546	2032-10-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218764-002	I-979	2028-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218764-002	NCE	2030-10-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218764-002	ODE-546	2032-10-07	`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
JASCAYD	NERANDOMILAST	Boehringer Ingelheim Pharmaceuticals, Inc.	fa1b14c6-957f-d326-5099-911bfe33e391	2026-08-14	Adverse reactions	Exact identifier application applno (NDA): 218764 application number: NDA218764

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
85196	SUPPL	2026-03-02
85195	SUPPL	2026-03-02
84099	ORIG	2025-11-06
83717	ORIG	2025-10-10
83688	ORIG	2025-10-07