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Last Updated: March 29, 2024

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. 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
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
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:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Mar 13, 2007TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Sep 18, 2029Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 022059

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 ⤷  Try a Trial ⤷  Try a Trial
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 ⤷  Try a Trial ⤷  Try a Trial
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 ⤷  Try a Trial ⤷  Try a Trial
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 ⤷  Try a Trial ⤷  Try a Trial
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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