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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Novartis
Daiichi Sankyo
Moodys
Argus Health
Medtronic
Express Scripts
Julphar
Accenture
Fuji

Generated: October 23, 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 seventy patent family members in forty-nine countries and thirteen supplementary protection certificates in ten 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

US 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► Subscribe ► 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
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 (Patent) Challenges 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
Morocco29404► Subscribe
Peru14302006► Subscribe
Hong Kong1031883► Subscribe
HungaryE030982► Subscribe
Norway324637► Subscribe
Spain2262087► Subscribe
Taiwan200716204► Subscribe
Mexico2007013089► Subscribe
European Patent Office1454907► Subscribe
Spain2186908► 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
C0038France► SubscribePRODUCT NAME: LAPATINIB OU UN DE SES SELS OU PRODUITS DE SOLVATATION; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
2008012Lithuania► SubscribePRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REG. NO/DATE: EU/1/07/440/001-002 20080610
2008012, C1047694Lithuania► SubscribePRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; FIRST 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
2008012,C1047694Lithuania► SubscribePRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REGISTRATION NO/DATE: EU/1/07/440/001, 2008-06-10 EU/1/07/440/002 20080610
2008000048Germany► SubscribePRODUCT NAME: LAPATINIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
0360Netherlands► SubscribeDETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT
2008 00040Denmark► Subscribe
37/2008Austria► SubscribePRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON
C026/2008Ireland► SubscribeSPC026/2008: 20091118, EXPIRES: 20230609
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
Deloitte
Moodys
Julphar
Dow
UBS
Farmers Insurance
Baxter
Novartis
Merck

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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