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Last Updated: May 20, 2022

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 eleven 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:11
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 205755
Generic Entry Date for 205755*:
Constraining patent/regulatory exclusivity:
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:DISCNDosage:CAPSULE;ORALStrength150MG
Approval Date:Apr 29, 2014TE: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:See Plans and PricingPatent Expiration:Apr 25, 2026Product Flag?YSubstance Flag?YDelist Request?
Patent:See Plans and PricingPatent Expiration:Apr 29, 2028Product Flag?YSubstance Flag?YDelist Request?

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