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Serving leading biopharmaceutical companies globally:

UBS
Daiichi Sankyo
Express Scripts
Dow
Cipla
Moodys
US Department of Justice
Novartis
Healthtrust
Medtronic

Generated: January 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 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. 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:7
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 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:RLD:Yes
Patent:➤ SubscribePatent Expiration:Jul 11, 2017Product 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:➤ SubscribePatent Expiration:Jul 11, 2017Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS WITH BREAST CANCER WHOSE TUMORS OVEREXPRESS THE HER2 RECEPTOR
Patent:➤ SubscribePatent 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

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

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Serving leading biopharmaceutical companies globally:

Novartis
Chubb
Julphar
McKinsey
Fish and Richardson
Boehringer Ingelheim
Federal Trade Commission
Cantor Fitzgerald
Citi

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.

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