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 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
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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N218764-001	JASCAYD	9MG	TABLET / ORAL		RLD	2025-10-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-002	JASCAYD	18MG	TABLET / ORAL		RLD, RS	2025-10-07	`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
2026-08-01 22:54:32	2026-06	N218764-001	8754073	2029-11-26	U-4298	Drug substance, Drug product	2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-001	8609670	2032-08-23		Drug substance	2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-001	9802954	2034-02-19	U-4298		2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-001	11406638	2038-10-22	U-4373		2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-001	11406638	2038-10-22	U-4297		2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-001	11813266	2038-10-22	U-4372		2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-001	11813266	2038-10-22	U-4292		2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-002	8754073	2029-11-26	U-4298	Drug substance, Drug product	2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-002	8609670	2032-08-23		Drug substance	2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-002	9802954	2034-02-19	U-4298		2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-002	11406638	2038-10-22	U-4373		2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-002	11406638	2038-10-22	U-4297		2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-002	11813266	2038-10-22	U-4372		2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-002	11813266	2038-10-22	U-4292		2025-10-29	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N218764-001	I-979	2028-12-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-001	NCE	2030-10-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-001	ODE-546	2032-10-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-002	I-979	2028-12-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-002	NCE	2030-10-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218764-002	ODE-546	2032-10-07	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	2026-02-02	Adverse reactions	Exact identifier application applno (NDA): 218764 application number: NDA218764

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