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Last Updated: January 27, 2023

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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ceritinib has three hundred and eighty-six 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:386
US Patents:11
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 91
Clinical Trials: 37
Patent Applications: 2,598
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
Wake Forest University Health SciencesPhase 2
Nuvalent Inc.Phase 1/Phase 2
PfizerPhase 4

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 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 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

EU/EMA Drug Approvals for ceritinib

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 ceritinib

Country Patent Number Title Estimated Expiration
South Africa 200500775 Methods of treating or preventing autoimmune diseases with 2,4-pyrimidinediamine compounds See Plans and Pricing
Japan 5837095 See Plans and Pricing
Serbia 20050069 See Plans and Pricing
European Patent Office 3453708 PROCÉDÉ POUR LA PRÉPARATION DE 5-CHLORO-N2-(2-ISOPROPOXY-5-METHYL-4-PIPERIDIN-4-YL-PHENYL)-N-2-(ISOPROPYLSULFONYL)PHENYL)-2,4-DIAMINE DI-HYDROCHLORIDE (PROCESS FOR THE PREPARATION OF 5-CHLORO-N-(2-ISOPROPOXY-5-METHYL-4-PIPERIDIN-4-YL-PHENYL)-N-2-(ISOPROPYLSULFONYL)PHENYL)-2,4-DIAMINE DI-HYDROCHLORIDE) See Plans and Pricing
South Korea 20050046714 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ceritinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1272477 15C0064 France See Plans and Pricing PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/15/999 20150508
2091918 132016000025233 Italy See Plans and Pricing PRODUCT NAME: CERITINIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYKADIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/999/001, 20150508
1272477 CA 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 C20150037 00157 Estonia See Plans and Pricing PRODUCT NAME: TSERITINIIB;REG NO/DATE: EU/1/15/999 08.05.2015
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
>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

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