Details for New Drug Application (NDA): 022059

✉ Email this page to a colleague

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. Two 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:	⤷ Sign Up	Patent Expiration:	Sep 18, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 022059

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	⤷ Sign Up	⤷ Sign Up
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	⤷ Sign Up	⤷ Sign Up
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	⤷ Sign Up	⤷ Sign Up
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	⤷ Sign Up	⤷ Sign Up
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.