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Last Updated: March 2, 2024

Lapatinib ditosylate - Generic Drug Details


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What are the generic drug sources for lapatinib ditosylate and what is the scope of freedom to operate?

Lapatinib ditosylate is the generic ingredient in two branded drugs marketed by Natco Pharma Ltd and Novartis, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lapatinib ditosylate has twenty-eight patent family members in twenty-six countries.

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

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 Strength NDA ANDAs Submitted Submissiondate
TYKERB Tablets lapatinib ditosylate 250 mg 022059 1 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
Natco Pharma Ltd LAPATINIB DITOSYLATE lapatinib ditosylate TABLET;ORAL 203007-001 Sep 29, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 ⤷  Try a Trial ⤷  Try a Trial
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REGISTRATION NO/DATE: EU/1/07/440/001, 2008-06-10 EU/1/07/440/002 20080610
1047694 CA 2008 00040 Denmark ⤷  Try a Trial PRODUCT NAME: LAPATINIB ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER LAPATINIBDITOSYLATMONOHYDRAT
1047694 PA 2008012, C1047694 Lithuania ⤷  Try a Trial PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; FIRST 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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