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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: CAPSULE;ORAL
Generic Entry Dates for ceritinib^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 2
Nuvalent Inc.	Phase 1/Phase 2
Pfizer	Phase 4

See all ceritinib clinical trials

Pharmacology for ceritinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inhibitors Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ceritinib

L01ED	Anaplastic lymphoma kinase (ALK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ceritinib

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019	⤷ Sign Up	⤷ Sign Up
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014	⤷ Sign Up	⤷ Sign Up
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for ceritinib

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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

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Country	Patent Number	Title	Estimated Expiration
Japan	5513558		⤷ Sign Up
New Zealand	585188	2,4-Pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders	⤷ Sign Up
Montenegro	00811	JEDINJENJA l KOMPOZICIJE KAO INHIBITORI PROTEIN KINAZE (COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ceritinib

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1272477	1590048-3	Sweden	⤷ Sign Up	PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/999 20150508
2091918	2015/047	Ireland	⤷ Sign Up	PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION: IRELAND EU/1/15/999 (C(2015) 3218), 20150506
1272477	2015/049	Ireland	⤷ Sign Up	PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/999 20150506
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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