Application 217673

Type: NDA
Sponsor: INSMED INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BRINSUPRI	BRENSOCATIB	TABLET;ORAL	10MG	Yes	No
002	BRINSUPRI	BRENSOCATIB	TABLET;ORAL	25MG	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
N217673-001	BRINSUPRI	BRENSOCATIB	10MG	TABLET / ORAL		RLD	2025-08-12
N217673-002	BRINSUPRI	BRENSOCATIB	25MG	TABLET / ORAL		RLD, RS	2025-08-12

Orange Book patents#

Current patent rows page 1 of 1 · 28 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217673-001	10287258	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-001	10669245	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-001	11655221	2035-01-21	U-4257	Drug product	2025-09-05
N217673-001	11655222	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-001	11655223	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-001	11655224	2035-01-21	U-4257	Drug product	2025-09-05
N217673-001	11673871	2035-01-21	U-4257	Drug product	2025-09-05
N217673-001	11773069	2035-01-21	U-4257	Drug product	2025-09-05
N217673-001	11814359	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-001	12054465	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-001	9815805	2035-01-21	U-4257		2025-09-05
N217673-001	9522894	2035-03-12		Drug substance	2025-09-05
N217673-001	12201638	2039-03-01		Drug product	2025-09-05
N217673-001	12059424	2040-02-21		Drug product	2025-09-05
N217673-002	10287258	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-002	10669245	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-002	11655221	2035-01-21	U-4257	Drug product	2025-09-05
N217673-002	11655222	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-002	11655223	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-002	11655224	2035-01-21	U-4257	Drug product	2025-09-05
N217673-002	11673871	2035-01-21	U-4257	Drug product	2025-09-05
N217673-002	11773069	2035-01-21	U-4257	Drug product	2025-09-05
N217673-002	11814359	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-002	12054465	2035-01-21	U-4257	Drug substance	2025-09-05
N217673-002	9815805	2035-01-21	U-4257		2025-09-05
N217673-002	9522894	2035-03-12		Drug substance	2025-09-05
N217673-002	12201638	2039-03-01		Drug product	2025-09-05
N217673-002	12059424	2040-02-21		Drug product	2025-09-05

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217673-001	NCE	2030-08-12
N217673-002	NCE	2030-08-12

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	N217673-001	BRINSUPRI	10MG	TABLET / ORAL	RLD	2025-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	BRINSUPRI	25MG	TABLET / ORAL	RLD, RS	2025-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	BRINSUPRI	10MG	TABLET / ORAL	RLD	2025-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-002	BRINSUPRI	25MG	TABLET / ORAL	RLD, RS	2025-08-12	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217673-001	BRINSUPRI	10MG	TABLET / ORAL	RLD	2025-08-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217673-002	BRINSUPRI	25MG	TABLET / ORAL	RLD, RS	2025-08-12	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 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	N217673-001	10287258	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	10669245	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	11655221	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	11655222	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	11655223	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	11655224	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	11673871	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	11773069	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	11814359	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	12054465	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	9815805	2035-01-21	U-4257		2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	9522894	2035-03-12		Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	12201638	2039-03-01		Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-001	12059424	2040-02-21		Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	10287258	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	10669245	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	11655221	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	11655222	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	11655223	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	11655224	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	11673871	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	11773069	2035-01-21	U-4257	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	11814359	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	12054465	2035-01-21	U-4257	Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	9815805	2035-01-21	U-4257		2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	9522894	2035-03-12		Drug substance	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	12201638	2039-03-01		Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	12059424	2040-02-21		Drug product	2025-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	10287258	2035-01-21	U-4257	Drug substance	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	10669245	2035-01-21	U-4257	Drug substance	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	11655221	2035-01-21	U-4257	Drug product	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	11655222	2035-01-21	U-4257	Drug substance	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	11655223	2035-01-21	U-4257	Drug substance	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	11655224	2035-01-21	U-4257	Drug product	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	11673871	2035-01-21	U-4257	Drug product	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	11773069	2035-01-21	U-4257	Drug product	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	11814359	2035-01-21	U-4257	Drug substance	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	12054465	2035-01-21	U-4257	Drug substance	2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	9815805	2035-01-21	U-4257		2025-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	9522894	2035-03-12		Drug substance	2025-09-05	`31067a03dcf5…`

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	N217673-001	NCE	2030-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217673-002	NCE	2030-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-001	NCE	2030-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217673-002	NCE	2030-08-12	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217673-001	NCE	2030-08-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217673-002	NCE	2030-08-12	`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
Brinsupri	BRENSOCATIB	Insmed Incorporated	b56986ae-e7db-421e-b622-a7f41e321f3d	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217673 application number: NDA217673

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83307	ORIG	2025-09-09
83099	ORIG	2025-08-13
83096	ORIG	2025-08-12