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Last Updated: July 6, 2020

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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 three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-five patent family members in forty-eight countries.

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

US ANDA Litigation and Generic Entry Outlook for Tykerb

Tykerb was eligible for patent challenges on March 13, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 18, 2029. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for TYKERB
Drug Prices for TYKERB

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Generic Entry Opportunity Date for TYKERB
Generic Entry Date for TYKERB*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 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
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes   Start Trial   Start Trial   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 TYKERB

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 TYKERB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1047694 300360 Netherlands   Start Trial DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT
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 37/2008 Austria   Start Trial PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON; 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Dow
Medtronic
Colorcon
Harvard Business School

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 verification 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.