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Last Updated: October 26, 2021

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Ceritinib - Generic Drug Details

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What are the generic drug sources for ceritinib and what is the scope of patent protection?

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

Ceritinib has four hundred and seven patent family members in fifty-five countries.

There is one drug master file entry for ceritinib. One supplier is listed for this compound.

Summary for ceritinib
International Patents:407
US Patents:12
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 85
Clinical Trials: 30
Patent Applications: 1,847
What excipients (inactive ingredients) are in ceritinib?ceritinib excipients list
DailyMed Link:ceritinib at DailyMed
Recent Clinical Trials for ceritinib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
PfizerPhase 4
Intergroupe Francophone de Cancerologie ThoraciquePhase 2
Instituto Nacional de Cancerologia de MexicoPhase 2

See all ceritinib clinical trials

US Patents and Regulatory Information 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 ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever 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 ceritinib

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ceritinib

Country Patent Number Estimated Expiration
Chile 2007003552 ⤷  Free Forever Trial
Japan 2010512329 ⤷  Free Forever Trial
Singapore 167664 ⤷  Free Forever Trial
Slovenia 2281563 ⤷  Free Forever Trial
Singapore 10201510082X ⤷  Free Forever Trial
World Intellectual Property Organization (WIPO) 0164654 ⤷  Free Forever Trial
United Kingdom 0319227 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for ceritinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1272477 529 Finland ⤷  Free Forever Trial
1272477 132016000023559 Italy ⤷  Free Forever Trial PRODUCT NAME: CERINITIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZIKADIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/999, 20150508
1272477 15C0064 France ⤷  Free Forever Trial PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/15/999 20150508
2091918 132016000025233 Italy ⤷  Free Forever Trial PRODUCT NAME: CERITINIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYKADIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/999/001, 20150508
1272477 CR 2015 00050 Denmark ⤷  Free Forever Trial PRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 20150508
2091918 2015/047 Ireland ⤷  Free Forever Trial PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION: IRELAND EU/1/15/999 (C(2015) 3218), 20150506
2091918 C20150037 00157 Estonia ⤷  Free Forever Trial PRODUCT NAME: TSERITINIIB;REG NO/DATE: EU/1/15/999 08.05.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Baxter
McKesson
Harvard Business School
Medtronic

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.