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Serving leading biopharmaceutical companies globally:

Colorcon
UBS
Moodys
Merck
Chinese Patent Office
QuintilesIMS
Dow
McKesson
Medtronic
Daiichi Sankyo

Generated: January 21, 2018

DrugPatentWatch Database Preview

TYKERB Drug Profile

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When do Tykerb patents expire, and what generic alternatives are available?

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

This drug has one hundred and seventy-one patent family members in forty-nine countries.

The generic ingredient in TYKERB is lapatinib ditosylate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lapatinib ditosylate profile page.
Drug patent expirations by year for TYKERB
Pharmacology for TYKERB
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

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

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Expired US Patents for TYKERB

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for TYKERB
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 250 mg ➤ Subscribe 3/14/2011

Non-Orange Book US Patents for TYKERB

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,109,333 Heterocyclic compounds ➤ Subscribe
8,912,205 Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors ➤ Subscribe
9,199,973 Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for TYKERB

Supplementary Protection Certificates for TYKERB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
37/2008 Austria ➤ Subscribe PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON
1 Finland ➤ Subscribe
475 Luxembourg ➤ Subscribe 91475, EXPIRES: 20230610
C0038 France ➤ Subscribe PRODUCT NAME: LAPATINIB OU UN DE SES SELS OU PRODUITS DE SOLVATATION; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
0360 Netherlands ➤ Subscribe DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT
/2008 Austria ➤ Subscribe PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
2008 00040 Denmark ➤ Subscribe PRODUCT NAME: LAPATINIB ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER LAPATINIBDITOSYLATMONOHYDRAT
C026/2008 Ireland ➤ Subscribe SPC026/2008: 20091118, EXPIRES: 20230609
2008012 Lithuania ➤ Subscribe PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REG. NO/DATE: EU/1/07/440/001-002 20080610
2008012, C1047694 Lithuania ➤ Subscribe PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; FIRST REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Chubb
McKesson
Covington
Cantor Fitzgerald
Accenture
Healthtrust
Fuji
Boehringer Ingelheim
Dow

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 verifification 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.

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