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Serving leading biopharmaceutical companies globally:

Deloitte
Citi
Accenture
Daiichi Sankyo
Covington
UBS
McKesson
Johnson and Johnson
Merck
Novartis

Generated: October 23, 2017

DrugPatentWatch Database Preview

Lapatinib ditosylate - Generic Drug Details

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What are the generic sources for lapatinib ditosylate and what is the scope of lapatinib ditosylate patent protection?

Lapatinib ditosylate
is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in one NDA. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lapatinib ditosylate has one hundred and seventy patent family members in forty-nine countries and thirteen supplementary protection certificates in ten countries.

There are six drug master file entries for lapatinib ditosylate. Two suppliers are listed for this compound.

Summary for Generic Name: lapatinib ditosylate

US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list6
Suppliers / Packagers: see list2
Bulk Api Vendors: see list172
Clinical Trials: see list283
Patent Applications: see list6,912
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:lapatinib ditosylate at DailyMed

Pharmacology for Ingredient: lapatinib ditosylate

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► 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
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Expired Orange Book Patents for Generic Ingredient: lapatinib ditosylate

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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Non-Orange Book Patents for Generic Ingredient: lapatinib ditosylate

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 Ingredient: lapatinib ditosylate

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: LAPATINIB DITOSYLATE

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:

Dow
Deloitte
Argus Health
Mallinckrodt
Colorcon
Johnson and Johnson
Baxter
Cantor Fitzgerald
Chinese Patent Office
Federal Trade Commission

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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