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Last Updated: August 7, 2020

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Lapatinib ditosylate - Generic Drug Details

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

Lapatinib ditosylate is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are three 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 fifty-five patent family members in forty-eight countries.

There are seven drug master file entries for lapatinib ditosylate. One supplier is listed for this compound.

Summary for lapatinib ditosylate
Recent Clinical Trials for lapatinib ditosylate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Stanford UniversityPhase 2
Jonsson Comprehensive Cancer CenterPhase 1/Phase 2
Washington University School of MedicinePhase 2

See all lapatinib ditosylate clinical trials

Pharmacology for lapatinib ditosylate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for LAPATINIB DITOSYLATE
Tradename Dosage Ingredient NDA Submissiondate
TYKERB TABLET;ORAL lapatinib ditosylate 022059 2011-03-14

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

Expired US Patents for lapatinib ditosylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007   Start Trial   Start Trial
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007   Start Trial   Start Trial
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007   Start Trial   Start Trial
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for lapatinib ditosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1047694 PA2008012,C1047694 Lithuania   Start Trial PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REGISTRATION NO/DATE: EU/1/07/440/001, 2008-06-10 EU/1/07/440/002 20080610
1047694 SPC/GB08/044 United Kingdom   Start Trial PRODUCT NAME: LAPATINIB OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/07/440/001 20080610; UK EU/1/07/440/002 20080610
1047694 08C0038 France   Start Trial PRODUCT NAME: LAPATINIB OU UN DE SES SELS OU PRODUITS DE SOLVATATION; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694 PA 2008012, C1047694 Lithuania   Start Trial PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; FIRST REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694 SZ 37/2008 Austria   Start Trial PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON
1047694 331 Finland   Start Trial
1047694 122008000048 Germany   Start Trial PRODUCT NAME: LAPATINIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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