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Last Updated: March 29, 2024

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

Ceritinib has two hundred and eighty-six patent family members in fifty-four countries.

There is one drug master file entry for ceritinib. One supplier is listed for this compound.

Summary for CERITINIB
International Patents:286
US Patents:7
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 99
Clinical Trials: 37
Patent Applications: 2,118
What excipients (inactive ingredients) are in CERITINIB?CERITINIB excipients list
DailyMed Link:CERITINIB at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CERITINIB
Generic Entry Dates for CERITINIB*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for CERITINIB*:
Constraining patent/regulatory exclusivity:
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 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 TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 CERITINIB

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 ⤷  Try a Trial ⤷  Try a Trial
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 ⤷  Try a Trial ⤷  Try a Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 ⤷  Try a Trial ⤷  Try a Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 ⤷  Try a Trial ⤷  Try a Trial
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 ⤷  Try a Trial ⤷  Try a Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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
Ukraine 100846 СОЕДИНЕНИЯ И КОМПОЗИЦИЯ КАК ИНГИБИТОРЫ ПРОТЕИНКИНАЗЫ;СПОЛУКИ ТА КОМПОЗИЦІЯ ЯК ІНГІБІТОРИ ПРОТЕЇНКІНАЗИ (COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS) ⤷  Try a Trial
Cyprus 1117015 ⤷  Try a Trial
Tunisia 2009000225 COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE KINASE INHIBITORS ⤷  Try a Trial
Spain 2643016 ⤷  Try a Trial
European Patent Office 2537830 Composés et compositions en tant qu'inhibiteurs de protéine kinase (Compounds and compositions as protein kinase inhibitors) ⤷  Try a Trial
Peru 20140698 FORMAS CRISTALINAS DE 5-CLORO-N2-(2-ISOPROPOXI-5-METIL-4-PIPERIDIN-4-IL-FENIL)-N4-[2-(PROPAN-2-SULFONIL)-FENIL]-PIRIMIDIN-2, 4-DIAMINA ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CERITINIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2091918 300763 Netherlands ⤷  Try a Trial PRODUCT NAME: CERITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/999 20150508
1272477 122015000073 Germany ⤷  Try a Trial PRODUCT NAME: CERITINIB ODER EINES SEINER PHARMAZEUTISCH AKZEPTABLEN SALZE; REGISTRATION NO/DATE: EU/1/15/999 20150506
1272477 1590048-3 Sweden ⤷  Try a Trial PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/999 20150508
2091918 15C0058 France ⤷  Try a Trial PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/999 20150508
2091918 132016000025233 Italy ⤷  Try a Trial PRODUCT NAME: CERITINIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYKADIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/999/001, 20150508
2091918 CA 2015 00047 Denmark ⤷  Try a Trial PRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 (C(2015)3218) 20150506
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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