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Details for New Drug Application (NDA): 022059

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NDA 022059 describes TYKERB, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from two suppliers. There are seven patents 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 six 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 NDA: 022059

Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 022059

Mechanism of ActionProtein Kinase Inhibitors

Suppliers and Packaging for NDA: 022059

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
lapatinib ditosylate
TABLET;ORAL 022059 NDA Novartis Pharmaceuticals Corporation 0078-0671 0078-0671-19 150 TABLET in 1 BOTTLE (0078-0671-19)
lapatinib ditosylate
TABLET;ORAL 022059 NDA GlaxoSmithKline LLC 0173-0752 0173-0752-00 150 TABLET in 1 BOTTLE (0173-0752-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Mar 13, 2007TE:RLD:Yes
Patent:7,157,466Patent Expiration:Nov 19, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:8,513,262Patent Expiration:Jan 8, 2019Product Flag?YSubstance Flag?YDelist Request?
Patent:8,821,927Patent Expiration:Sep 18, 2029Product Flag?YSubstance Flag?YDelist Request?

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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 verifification 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.