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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Teva
Queensland Health
Baxter
Mallinckrodt
Fish and Richardson
Farmers Insurance
Citi
AstraZeneca
Federal Trade Commission

Generated: August 20, 2017

DrugPatentWatch Database Preview

TYKERB Drug Profile

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What is the patent landscape for Tykerb, and what generic Tykerb alternatives are available?

Tykerb is a drug marketed by Novartis Pharms Corp and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty patent family members in forty-nine countries.

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 Tradename: TYKERB

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list166
Clinical Trials: see list60
Patent Applications: see list5,891
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TYKERB at DailyMed

Pharmacology for Tradename: TYKERB

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
TYKERB
lapatinib ditosylate
TABLET;ORAL022059-001Mar 13, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis Pharms Corp
TYKERB
lapatinib ditosylate
TABLET;ORAL022059-001Mar 13, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis Pharms Corp
TYKERB
lapatinib ditosylate
TABLET;ORAL022059-001Mar 13, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis Pharms Corp
TYKERB
lapatinib ditosylate
TABLET;ORAL022059-001Mar 13, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis Pharms Corp
TYKERB
lapatinib ditosylate
TABLET;ORAL022059-001Mar 13, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Tradename: TYKERB

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
TYKERB
lapatinib ditosylate
TABLET;ORAL022059-001Mar 13, 2007► Subscribe► Subscribe
Novartis Pharms Corp
TYKERB
lapatinib ditosylate
TABLET;ORAL022059-001Mar 13, 2007► Subscribe► Subscribe
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Paragraph IV activity for: TYKERB

Drugname Dosage Strength RLD Submissiondate
lapatinib ditosylateTablets250 mgTykerb3/14/2011

Non-Orange Book Patents for Tradename: TYKERB

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,109,333Heterocyclic compounds► Subscribe
9,199,973Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors► Subscribe
8,912,205Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: TYKERB

Country Document Number Estimated Expiration
Spain2221354► Subscribe
Portugal1047694► Subscribe
Argentina031248► Subscribe
Turkey200002015► Subscribe
Portugal1460072► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TYKERB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2008Austria► SubscribePRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
2008000048Germany► SubscribePRODUCT NAME: LAPATINIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
C/GB08/044United Kingdom► SubscribePRODUCT NAME: LAPATINIB OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/07/440/001 20080610; UK EU/1/07/440/002 20080610
37/2008Austria► SubscribePRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON
2008012, C1047694Lithuania► SubscribePRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; FIRST REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

UBS
QuintilesIMS
Teva
Baxter
Colorcon
Medtronic
Healthtrust
Accenture
Deloitte
Daiichi Sankyo

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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