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Last Updated: March 27, 2023

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 eleven patents protecting this drug.

This drug has three hundred and eighty-five 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:385
US Patents:11
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 93
Clinical Trials: 11
Patent Applications: 1,267
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 – Institut Bergonié, BordeauxPhase 3
Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, ParisPhase 3
Commissariat A L'energie AtomiquePhase 3

See all ZYKADIA clinical trials

US Patents and Regulatory Information for ZYKADIA

ZYKADIA is protected by eleven US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZYKADIA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ZYKADIA

2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

2,4-di (phenylamino) pyrimidines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

2,4-pyrimidinediamine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of using ALK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)

2,4-pyrimidinediamine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

2,4-pyrimidinediamine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline forms of 5-chloro-N2-(2-isopropoxy-5-methyl-4-piperidin-4-yl-phenyl)-N4-[2-(propan- e-2-sulfonyl)-phenyl]-pyrimidine-2, 4-diamine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

2,4-pyrimidinediamine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting ZYKADIA

TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS ARE ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: See Plans and Pricing

FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: See Plans and Pricing

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 CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 TABLET;ORAL 211225-001 Mar 18, 2019 See Plans and Pricing See Plans and Pricing
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 See Plans and Pricing See Plans and Pricing
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 See Plans and Pricing See Plans and Pricing
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 See Plans and Pricing See Plans and Pricing
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 See Plans and Pricing See Plans and Pricing
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 See Plans and Pricing See Plans and Pricing
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ZYKADIA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Novartis Europharm Limited Zykadia ceritinib EMEA/H/C/003819
Zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously treated with crizotinib.
Authorised no no no 2015-05-06
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ZYKADIA

When does loss-of-exclusivity occur for ZYKADIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 4309
Estimated Expiration: See Plans and Pricing

Patent: 2395
Estimated Expiration: See Plans and Pricing

Australia

Patent: 11343775
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2013015000
Estimated Expiration: See Plans and Pricing

Canada

Patent: 21102
Estimated Expiration: See Plans and Pricing

Chile

Patent: 13001723
Estimated Expiration: See Plans and Pricing

China

Patent: 3282359
Estimated Expiration: See Plans and Pricing

Patent: 4262324
Estimated Expiration: See Plans and Pricing

Patent: 6008462
Estimated Expiration: See Plans and Pricing

Patent: 6831716
Estimated Expiration: See Plans and Pricing

Patent: 7056751
Estimated Expiration: See Plans and Pricing

Patent: 2125884
Estimated Expiration: See Plans and Pricing

Patent: 4989139
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 01792
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0171477
Estimated Expiration: See Plans and Pricing

Patent: 0181737
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 19474
Estimated Expiration: See Plans and Pricing

Patent: 21017
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 51918
Estimated Expiration: See Plans and Pricing

Patent: 21171
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 13012770
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 51918
Estimated Expiration: See Plans and Pricing

Patent: 21171
Estimated Expiration: See Plans and Pricing

Patent: 53708
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 1300153
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 41845
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6474
Estimated Expiration: See Plans and Pricing

Japan

Patent: 16752
Estimated Expiration: See Plans and Pricing

Patent: 13545812
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 51918
Estimated Expiration: See Plans and Pricing

Patent: 21171
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 4810
Estimated Expiration: See Plans and Pricing

Patent: 7742
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 8210
Estimated Expiration: See Plans and Pricing

Patent: 13006952
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 771
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0713
Estimated Expiration: See Plans and Pricing

Peru

Patent: 140698
Estimated Expiration: See Plans and Pricing

Poland

Patent: 51918
Estimated Expiration: See Plans and Pricing

Patent: 21171
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 51918
Estimated Expiration: See Plans and Pricing

Patent: 21171
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 99785
Estimated Expiration: See Plans and Pricing

Patent: 46159
Estimated Expiration: See Plans and Pricing

Patent: 13132947
Estimated Expiration: See Plans and Pricing

Patent: 16136823
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 771
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 0856
Estimated Expiration: See Plans and Pricing

Patent: 201510082X
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 51918
Estimated Expiration: See Plans and Pricing

Patent: 21171
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1303599
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2325775
Estimated Expiration: See Plans and Pricing

Patent: 130130022
Estimated Expiration: See Plans and Pricing

Patent: 180032680
Estimated Expiration: See Plans and Pricing

Patent: 190022903
Estimated Expiration: See Plans and Pricing

Patent: 200039021
Estimated Expiration: See Plans and Pricing

Spain

Patent: 43016
Estimated Expiration: See Plans and Pricing

Patent: 96526
Estimated Expiration: See Plans and Pricing

Patent: 05973
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 76343
Estimated Expiration: See Plans and Pricing

Patent: 76344
Estimated Expiration: See Plans and Pricing

Patent: 1307299
Estimated Expiration: See Plans and Pricing

Patent: 1629021
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 13000216
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZYKADIA around the world.

Country Patent Number Title Estimated Expiration
South Korea 101149295 See Plans and Pricing
Iceland 8349 2,4-pýrimídíndíamín gagnleg í meðhöndlun æxlissjúkdóma, bólgu- og ónæmiskerfissjúkdóma See Plans and Pricing
Spain 2524009 See Plans and Pricing
European Patent Office 2091918 COMPOSÉS ET COMPOSITIONS INHIBANT LA PROTÉINE KINASE (COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS) See Plans and Pricing
Cyprus 1114238 See Plans and Pricing
Poland 2091918 See Plans and Pricing
Russian Federation 2493150 СОЕДИНЕНИЯ 2,4-ПИРИМИДИНДИАМИНОВ И ИХ ПРИМЕНЕНИЕ (2,4-PYRIMIDINE DIAMINE COMPOUNDS AND USE THEREOF) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZYKADIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2091918 217 5020-2015 Slovakia See Plans and Pricing PRODUCT NAME: CERITINIB; REGISTRATION NO/DATE: EU/1/15/999 20150508
1272477 2015/049 Ireland See Plans and Pricing PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/999 20150506
2091918 PA2015034,C2091918 Lithuania See Plans and Pricing PRODUCT NAME: CERITINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/999 20150506
1272477 122015000073 Germany See Plans and Pricing PRODUCT NAME: CERITINIB ODER EINES SEINER PHARMAZEUTISCH AKZEPTABLEN SALZE; REGISTRATION NO/DATE: EU/1/15/999 20150506
1272477 CR 2015 00050 Denmark See Plans and Pricing PRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 20150508
2091918 PA2015034 Lithuania See Plans and Pricing PRODUCT NAME: CERITINIBUM; REGISTRATION NO/DATE: EU/1/15/999 20150506
2091918 C 2015 037 Romania See Plans and Pricing PRODUCT NAME: CERITINIBSAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA5-CLOR-N2-{(5-METIL-4-(PIPERIDIN-4-IL)-2-[(PROPAN-2-IL)OXI]FENIL-N4-[2-(PROPAN-2-SULFONIL)FENIL}PIRIMIDIN-2,4-DIAMINA; NATIONAL AUTHORISATION NUMBER: EU/1/15/999; DATE OF NATIONAL AUTHORISATION: 20150506; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/999; DATE OF FIRST AUTHORISATION IN EEA: 20150506
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Merck
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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 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.