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ZYKADIA Drug Profile

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Zykadia is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug.

This drug has two hundred and twenty patent family members in forty-nine countries.

The generic ingredient in ZYKADIA is ceritinib. One supplier is listed for this compound. Additional details are available on the ceritinib profile page.

Summary for Tradename: ZYKADIA

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
ZYKADIA
ceritinib
CAPSULE;ORAL205755-001Apr 29, 2014RXYes8,703,787► subscribe ► subscribe
Novartis Pharms Corp
ZYKADIA
ceritinib
CAPSULE;ORAL205755-001Apr 29, 2014RXYes7,964,592► subscribeYY ► subscribe
Novartis Pharms Corp
ZYKADIA
ceritinib
CAPSULE;ORAL205755-001Apr 29, 2014RXYes7,893,074► subscribeYY ► subscribe
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Non-Orange Book Patents for Tradename: ZYKADIA

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
8,263,590Pyrimidine derivatives► subscribe
8,399,450Compounds and compositions as protein kinase inhibitors► subscribe
8,957,081Compounds and compositions as protein 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: ZYKADIA

Country Document Number Estimated Expiration
China103458881► subscribe
South Korea101148261► subscribe
Russian Federation2395500► 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: ZYKADIA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90054-1Sweden► subscribePRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/15/999 20150508
90048-3Sweden► subscribePRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/999 20150508
2015 00050Denmark► subscribePRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 20150508
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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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