Application 220149

Type: NDA
Sponsor: JANSSEN BIOTECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ICOTYDE	ICOTROKINRA HYDROCHLORIDE	TABLET;ORAL	EQ 200MG BASE	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
N220149-001	ICOTYDE	ICOTROKINRA HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL		RLD, RS	2026-03-17

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
N220149-001	12552836	2039-07-12		Drug substance, Drug product	2026-04-02
N220149-001	11845808	2041-01-14	U-4447	Drug substance	2026-04-02
N220149-001	11939361	2041-11-19	U-4447	Drug product	2026-04-02

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N220149-001	NCE	2031-03-17

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
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220149-001	ICOTYDE	EQ 200MG BASE	TABLET / ORAL		RLD, RS	2026-03-17	`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
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220149-001	12552836	2039-07-12		Drug substance, Drug product	2026-04-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220149-001	11845808	2041-01-14	U-4447	Drug substance	2026-04-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220149-001	11939361	2041-11-19	U-4447	Drug product	2026-04-02	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220149-001	NCE	2031-03-17	`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
ICOTYDE	ICOTROKINRA	Janssen Biotech, Inc.	aee3c963-edc0-4252-8769-cdf6c7cdc21a	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 220149 application number: NDA220149

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85688	ORIG	2026-04-15
85511	ORIG	2026-03-24
85481	ORIG	2026-03-24
85396	ORIG	2026-03-19