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TYKERB Drug Profile

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Which patents cover Tykerb, and what substitute generic drugs 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 forty-seven patent family members in forty-eight countries.

The generic ingredient in TYKERB is lapatinib ditosylate. There are six 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 Tradename: TYKERB

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list166
Clinical Trials: see list47
Patent Applications: see list5,704
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TYKERB at DailyMed

Pharmacology for Tradename: TYKERB

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
TYKERB
lapatinib ditosylate
TABLET;ORAL022059-001Mar 13, 2007RXYesYes6,391,874► SubscribeYY ► Subscribe
Novartis Pharms Corp
TYKERB
lapatinib ditosylate
TABLET;ORAL022059-001Mar 13, 2007RXYesYes6,828,320► Subscribe ► Subscribe
Novartis Pharms Corp
TYKERB
lapatinib ditosylate
TABLET;ORAL022059-001Mar 13, 2007RXYesYes6,713,485► SubscribeYY ► Subscribe
Novartis Pharms Corp
TYKERB
lapatinib ditosylate
TABLET;ORAL022059-001Mar 13, 2007RXYesYes6,727,256► SubscribeYY ► Subscribe
Novartis Pharms Corp
TYKERB
lapatinib ditosylate
TABLET;ORAL022059-001Mar 13, 2007RXYesYes8,513,262► SubscribeYY ► Subscribe
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Paragraph IV activity for: TYKERB

Drugname Dosage Strength RLD Submissiondate
lapatinib ditosylateTablets250 mgTykerb3/14/2011

Non-Orange Book Patents for Tradename: 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
7,109,333Heterocyclic compounds► Subscribe
8,912,205Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors► Subscribe
9,199,973Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: TYKERB

Country Document Number Estimated Expiration
Portugal1047694► Subscribe
United Kingdom9800569► Subscribe
South Korea101356748► Subscribe
Eurasian Patent Organization200702253► Subscribe
Denmark0912559► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TYKERB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0038France► SubscribePRODUCT NAME: LAPATINIB OU UN DE SES SELS OU PRODUITS DE SOLVATATION; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
0360Netherlands► SubscribeDETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT
2008012Lithuania► SubscribePRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REG. NO/DATE: EU/1/07/440/001-002 20080610
475Luxembourg► Subscribe91475, EXPIRES: 20230610
1Finland► Subscribe
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