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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

ZYKADIA Drug Patent Profile


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When do Zykadia patents expire, and when can generic versions of Zykadia launch?

Zykadia is a drug marketed by Novartis and is included in two NDAs. There are twelve patents protecting this drug.

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

The generic ingredient in ZYKADIA is ceritinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ceritinib profile page.

DrugPatentWatch® Generic Entry Outlook for Zykadia

Zykadia was eligible for patent challenges on April 29, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 18, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ZYKADIA
International Patents:407
US Patents:12
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 84
Clinical Trials: 9
Patent Applications: 815
Drug Prices: Drug price information for ZYKADIA
What excipients (inactive ingredients) are in ZYKADIA?ZYKADIA excipients list
DailyMed Link:ZYKADIA at DailyMed
Drug patent expirations by year for ZYKADIA
Drug Prices for ZYKADIA

See drug prices for ZYKADIA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ZYKADIA
Generic Entry Dates for ZYKADIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for ZYKADIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ZYKADIA

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

SponsorPhase
Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, ParisPhase 3
Commissariat A L'energie AtomiquePhase 3
Plateforme labellisée Inca – Hôpital Européen Georges Pompidou, ParisPhase 3

See all ZYKADIA clinical trials

US Patents and Regulatory Information for ZYKADIA

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 ⤷  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
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 CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No ⤷  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
>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 ZYKADIA

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

Supplementary Protection Certificates for ZYKADIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2091918 PA2015034 Lithuania ⤷  Free Forever Trial PRODUCT NAME: CERITINIBUM; REGISTRATION NO/DATE: EU/1/15/999 20150506
1272477 529 Finland ⤷  Free Forever Trial
2091918 CR 2015 00047 Denmark ⤷  Free Forever Trial PRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 (C(2015)3218) 20150508
2091918 122015000076 Germany ⤷  Free Forever Trial PRODUCT NAME: CERITINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/999 20150506
2091918 92785 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: CERITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20150508
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
2091918 1590054-1 Sweden ⤷  Free Forever Trial PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/15/999 20150508
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Colorcon
Moodys
Express Scripts
Boehringer Ingelheim

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