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Serving leading biopharmaceutical companies globally:

Queensland Health
Moodys
Colorcon
QuintilesIMS
Farmers Insurance
Chinese Patent Office
Deloitte
Fuji
Novartis
Healthtrust

Generated: January 17, 2018

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-one patent family members in forty-nine countries.

There are six drug master file entries for lapatinib ditosylate. One supplier is listed for this compound.
Summary for lapatinib ditosylate
Pharmacology for lapatinib ditosylate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

US Patents and Regulatory Information for lapatinib ditosylate

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;ORAL 022059-001 Mar 13, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for lapatinib ditosylate

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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Non-Orange Book US Patents for 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
7,109,333 Heterocyclic compounds ➤ Subscribe
8,912,205 Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors ➤ Subscribe
9,199,973 Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for lapatinib ditosylate

Supplementary Protection Certificates for lapatinib ditosylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
475 Luxembourg ➤ Subscribe 91475, EXPIRES: 20230610
2008000048 Germany ➤ Subscribe PRODUCT NAME: LAPATINIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1 Finland ➤ Subscribe
C0038 France ➤ Subscribe PRODUCT NAME: LAPATINIB OU UN DE SES SELS OU PRODUITS DE SOLVATATION; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
2008012, C1047694 Lithuania ➤ Subscribe PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; FIRST REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
/2008 Austria ➤ Subscribe PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
0360 Netherlands ➤ Subscribe DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT
2008 00040 Denmark ➤ Subscribe PRODUCT NAME: LAPATINIB ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER LAPATINIBDITOSYLATMONOHYDRAT
C/GB08/044 United Kingdom ➤ Subscribe PRODUCT NAME: LAPATINIB OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/07/440/001 20080610; UK EU/1/07/440/002 20080610
2008012,C1047694 Lithuania ➤ Subscribe PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REGISTRATION NO/DATE: EU/1/07/440/001, 2008-06-10 EU/1/07/440/002 20080610
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Deloitte
Chinese Patent Office
Queensland Health
Cerilliant
Harvard Business School
Fuji
Teva
US Department of Justice

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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