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Last Updated: January 20, 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 freedom to operate?

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 four 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:404
US Patents:12
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 1
Suppliers / Packagers: 1
Bulk Api Vendors: 83
Clinical Trials: 30
Patent Applications: 939
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 CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No   Start Trial   Start Trial   Start Trial
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
>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 ceritinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2091918 1590054-1 Sweden   Start Trial PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/15/999 20150508
1272477 SPC/GB15/057 United Kingdom   Start Trial PRODUCT NAME: CERITINIB, AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/15/999 20150508
2091918 528 Finland   Start Trial
2091918 CR 2015 00047 Denmark   Start Trial PRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 (C(2015)3218) 20150508
2091918 92785 Luxembourg   Start Trial PRODUCT NAME: CERITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20150508
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Express Scripts
Baxter
Moodys
Harvard Business School

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