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Serving leading biopharmaceutical companies globally:

Express Scripts
Citi
Medtronic
Harvard Business School
US Department of Justice
Deloitte
Johnson and Johnson
Covington
Cerilliant
Fuji

Generated: November 23, 2017

DrugPatentWatch Database Preview

Ceritinib - Generic Drug Details

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What are the generic drug sources for ceritinib and what is the scope of ceritinib freedom to operate?

Ceritinib
is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ceritinib has three hundred and sixty-one patent family members in fifty-four countries and eighteen supplementary protection certificates in ten countries.

One supplier is listed for this compound.

Summary for ceritinib

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
ZYKADIA
ceritinib
CAPSULE;ORAL205755-001Apr 29, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis Pharms Corp
ZYKADIA
ceritinib
CAPSULE;ORAL205755-001Apr 29, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis Pharms Corp
ZYKADIA
ceritinib
CAPSULE;ORAL205755-001Apr 29, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
ZYKADIA
ceritinib
CAPSULE;ORAL205755-001Apr 29, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
ZYKADIA
ceritinib
CAPSULE;ORAL205755-001Apr 29, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis Pharms Corp
ZYKADIA
ceritinib
CAPSULE;ORAL205755-001Apr 29, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
ZYKADIA
ceritinib
CAPSULE;ORAL205755-001Apr 29, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis Pharms Corp
ZYKADIA
ceritinib
CAPSULE;ORAL205755-001Apr 29, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Novartis Pharms Corp
ZYKADIA
ceritinib
CAPSULE;ORAL205755-001Apr 29, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis Pharms Corp
ZYKADIA
ceritinib
CAPSULE;ORAL205755-001Apr 29, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ceritinib

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
9,540,3342,4-pyrimidinediamine compounds and their uses► Subscribe
7,557,2102,4-pyrimidinediamine compounds and their uses► Subscribe
7,498,4352,4-pyrimidinediamine compounds and their uses► Subscribe
9,162,9892,4-Pyrimidinediamine compounds and their uses► Subscribe
7,485,7242,4-pyrimidinediamine compounds and their uses► Subscribe
8,372,858Compounds and compositions as protein kinase inhibitors► Subscribe
8,148,5252,4-pyrimidinediamine compounds and their uses► Subscribe
7,803,9392,4-pyrimidinediamine compounds and their uses► Subscribe
8,748,5972,4-pyrimidinediamine compounds and their uses► Subscribe
7,655,797Intermediates for making 2,4-pyrimidinediamine compounds► 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 Ingredient: ceritinib

Country Document Number Estimated Expiration
South Korea101149295► Subscribe
Iceland2961► Subscribe
Mexico2010002336► Subscribe
Dominican RepublicP2011000074► Subscribe
Japan2007502260► Subscribe
Ukraine100846► Subscribe
Serbia20050069► Subscribe
Hong Kong1091813► Subscribe
Austria451104► Subscribe
MexicoPA04007386► 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: CERITINIB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90048-3Sweden► SubscribePRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/999 20150508
15/047Ireland► SubscribePRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION: IRELAND EU/1/15/999 (C(2015) 3218), 20150506
15/049Ireland► SubscribePRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/999 20150506
2015034Lithuania► SubscribePRODUCT NAME: CERITINIBUM; REGISTRATION NO/DATE: EU/1/15/999 20150506
2015000076Germany► SubscribePRODUCT NAME: CERITINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/999 20150506
2015 00050Denmark► SubscribePRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 20150508
C0058France► SubscribePRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/999 20150508
2015034,C2091918Lithuania► SubscribePRODUCT NAME: CERITINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/999 20150506
2015 00050Denmark► SubscribePRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 20150508
0150037 00157Estonia► SubscribePRODUCT NAME: TSERITINIIB;REG NO/DATE: EU/1/15/999 08.05.2015
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Baxter
Cerilliant
Johnson and Johnson
Fuji
AstraZeneca
Fish and Richardson
Accenture
Express Scripts
Daiichi Sankyo
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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