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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 022059

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NDA 022059 describes TYKERB, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the TYKERB profile page.

The generic ingredient in TYKERB is lapatinib ditosylate. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the lapatinib ditosylate profile page.

Summary for 022059

Tradename:	TYKERB
Applicant:	Novartis
Ingredient:	lapatinib ditosylate
Patents:	1

Pharmacology for NDA: 022059

Mechanism of Action	Protein Kinase Inhibitors

Suppliers and Packaging for NDA: 022059

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TYKERB	lapatinib ditosylate	TABLET;ORAL	022059	NDA	Novartis Pharmaceuticals Corporation	0078-0671	0078-0671-19	150 TABLET in 1 BOTTLE (0078-0671-19)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 250MG BASE
Approval Date:	Mar 13, 2007	TE:	AB	RLD:	Yes
Patent:	8,821,927	Patent Expiration:	Sep 18, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 022059

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	7,157,466	⤷ Get Started Free
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	6,391,874	⤷ Get Started Free
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	8,513,262	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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