Details for New Drug Application (NDA): 205755

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NDA 205755 describes ZYKADIA, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the ZYKADIA profile page.

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.

Summary for 205755

Tradename:	ZYKADIA
Applicant:	Novartis
Ingredient:	ceritinib
Patents:	7

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 205755

Generic Entry Date for 205755^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: CAPSULE;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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Apr 29, 2014	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 26, 2024
Regulatory Exclusivity Use:	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
Patent:	⤷ Sign Up	Patent Expiration:	Apr 25, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Apr 29, 2028	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 205755

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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

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Summary for 205755

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205755

Profile for product number 001

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 205755