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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Cantor Fitzgerald
Queensland Health
Fish and Richardson
Farmers Insurance
Citi
Fuji
Chinese Patent Office
QuintilesIMS

Generated: April 19, 2018

DrugPatentWatch Database Preview

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 one supplier. There are five 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 seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lapatinib ditosylate profile page.
Summary for 022059
Tradename:TYKERB
Applicant:Novartis Pharms Corp
Ingredient:lapatinib ditosylate
Patents:5
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
TYKERB lapatinib ditosylate TABLET;ORAL 022059 NDA Novartis Pharmaceuticals Corporation 0078-0671 N 0078-0671-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Mar 13, 2007TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Sep 29, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS WITH ADVANCED OR METASTATIC BREAST CANCER WHOSE TUMORS OVEREXPRESS HER2 AND WHO HAVE RECEIVED PRIOR THERAPY INCLUDING ANTHRACYCLINE, A TAXANE AND TRASTUZUMAB
Patent:➤ Try a Free TrialPatent Expiration:Sep 29, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS WITH BREAST CANCER WHOSE TUMORS OVEREXPRESS THE HER2 RECEPTOR
Patent:➤ Try a Free TrialPatent Expiration:Jan 8, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS WITH ADVANCED OR METASTATIC BREAST CANCER WHOSE TUMORS OVEREXPRESS HER2 AND WHO HAVE RECEIVED PRIOR THERAPY INCLUDING ANTHRACYCLINE, A TAXANE AND TRASTUZUMAB

Expired US Patents for NDA 022059

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

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Mallinckrodt
Dow
Baxter
Merck
Boehringer Ingelheim
Citi
Medtronic
Healthtrust

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