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Last Updated: January 21, 2022

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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 eight 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:408
US Patents:12
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 88
Clinical Trials: 11
Patent Applications: 1,068
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
CIC-EC 1401/EUCLIDPhase 3
Institut National de la Santé Et de la Recherche Médicale, FrancePhase 3
Plateforme labellisée Inca - Institut Bergonié, BordeauxPhase 3

See all ZYKADIA clinical trials

US Patents and Regulatory Information for ZYKADIA

ZYKADIA is protected by twelve US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZYKADIA is ⤷  Try it Free.

This potential generic entry date is based on patent ⤷  Try it Free.

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

Pyrimidine compounds
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

2,4-di (phenylamino) pyrimidines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)

Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Methods of using ALK inhibitors
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)

2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

FDA Regulatory Exclusivity protecting ZYKADIA

TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB.
Exclusivity Expiration: ⤷  Try it Free

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: ⤷  Try it Free

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: ⤷  Try it Free

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: ⤷  Try it Free

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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ZYKADIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1272477 122015000073 Germany ⤷  Try it Free PRODUCT NAME: CERITINIB ODER EINES SEINER PHARMAZEUTISCH AKZEPTABLEN SALZE; REGISTRATION NO/DATE: EU/1/15/999 20150506
1272477 15C0064 France ⤷  Try it Free PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/15/999 20150508
2091918 54/2015 Austria ⤷  Try it Free PRODUCT NAME: CERITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/999 (MITTEILUNG) 20180508
2091918 15C0058 France ⤷  Try it Free PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/999 20150508
2091918 CA 2015 00047 Denmark ⤷  Try it Free PRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 (C(2015)3218) 20150506
2091918 2015/047 Ireland ⤷  Try it Free PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION: IRELAND EU/1/15/999 (C(2015) 3218), 20150506
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Johnson and Johnson
Merck
Harvard Business School

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