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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.
Generic Entry Opportunity Date for 205755
*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
|Approval Date:||Apr 29, 2014||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||May 26, 2020|
|Regulatory Exclusivity Use:||INFORMATION ADDED TO LABELING REGARDING THE TREATMENT OF PATIENTS WITH ALK-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAD NOT RECEIVED PRIOR SYSTEMIC THERAPY FOR METASTATIC DISEASE.|
|Regulatory Exclusivity Expiration:||Apr 29, 2021|
|Regulatory Exclusivity Use:||TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB.|
|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|
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