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Last Updated: June 24, 2021

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TYKERB Drug Profile


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Which patents cover Tykerb, and what generic alternatives are available?

Tykerb is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-six patent family members in thirty-one countries.

The generic ingredient in TYKERB is lapatinib ditosylate. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the lapatinib ditosylate profile page.

Summary for TYKERB
Drug patent expirations by year for TYKERB
Drug Prices for TYKERB

See drug prices for TYKERB

Recent Clinical Trials for TYKERB

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

SponsorPhase
AbbVieN/A
Scariot FoundationN/A
University of Alabama at BirminghamN/A

See all TYKERB clinical trials

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

US Patents and Regulatory Information for TYKERB

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 Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 AB RX Yes Yes   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 AB RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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 TYKERB

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

Supplementary Protection Certificates for TYKERB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1047694 08C0038 France   Try Before You Buy 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   Try Before You Buy PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; FIRST REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694 122008000048 Germany   Try Before You Buy PRODUCT NAME: LAPATINIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694 37/2008 Austria   Try Before You Buy PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694 300360 Netherlands   Try Before You Buy DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT
1047694 PA2008012 Lithuania   Try Before You Buy PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REG. NO/DATE: EU/1/07/440/001-002 20080610
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
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Medtronic
Colorcon
Harvard Business School

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