Application 218436

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RHAPSIDO	REMIBRUTINIB	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N218436-001	RHAPSIDO	REMIBRUTINIB	25MG	TABLET / ORAL		RLD, RS	2025-09-30

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218436-001	10457647	2034-11-13	U-4280		2025-10-21
N218436-001	9512084	2034-11-13		Drug substance, Drug product	2025-10-21
N218436-001	12419889	2043-01-19	U-4281		2025-10-21

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218436-001	NCE	2030-09-30

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	N218436-001	RHAPSIDO	25MG	TABLET / ORAL	RLD, RS	2025-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218436-001	RHAPSIDO	25MG	TABLET / ORAL	RLD, RS	2025-09-30	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218436-001	RHAPSIDO	25MG	TABLET / ORAL	RLD, RS	2025-09-30	`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
2026-02-19 14:30 UTC	2026-02	N218436-001	10457647	2034-11-13	U-4280		2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218436-001	9512084	2034-11-13		Drug substance, Drug product	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218436-001	12419889	2043-01-20	U-4281		2025-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218436-001	10457647	2034-11-13	U-4280		2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218436-001	9512084	2034-11-13		Drug substance, Drug product	2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218436-001	12419889	2043-01-20	U-4281		2025-10-21	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218436-001	10457647	2034-11-13	U-4280		2025-10-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218436-001	9512084	2034-11-13		Drug substance, Drug product	2025-10-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218436-001	12419889	2043-01-19	U-4281		2025-10-21	`a50c72e98297…`

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	N218436-001	NCE	2030-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218436-001	NCE	2030-09-30	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218436-001	NCE	2030-09-30	`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
RHAPSIDO	REMIBRUTINIB	Novartis Pharmaceuticals Corporation	e5e89bff-6ced-4165-acc5-fb13136b3a3d	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 218436 application number: NDA218436

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84098	ORIG	2025-11-06
83815	ORIG	2025-10-20
83799	ORIG	2025-10-17