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Last Updated: March 19, 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
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
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
>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
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

International Patents for lapatinib ditosylate

Country Patent Number Title Estimated Expiration
Peru 20061430 COMPOSICION FARMACEUTICA QUE COMPRENDE COMPUESTOS DE 4-QUINAZOLINAMINAS ⤷  Try a Trial
Cyprus 1118179 ⤷  Try a Trial
South Korea 101356748 ⤷  Try a Trial
China 101203211 Pharmaceutical composition ⤷  Try a Trial
Denmark 1871347 ⤷  Try a Trial
Mexico 2007013089 COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lapatinib ditosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1047694 122008000048 Germany ⤷  Try a Trial PRODUCT NAME: LAPATINIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694 SZ 37/2008 Austria ⤷  Try a Trial PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON
1047694 PA2008012 Lithuania ⤷  Try a Trial PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REG. NO/DATE: EU/1/07/440/001-002 20080610
1047694 CA 2008 00040 Denmark ⤷  Try a Trial PRODUCT NAME: LAPATINIB ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER LAPATINIBDITOSYLATMONOHYDRAT
1047694 SPC/GB08/044 United Kingdom ⤷  Try a 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 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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