DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 205755
NDA 205755 describes ZYKADIA, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are twelve 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.
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 Pharms Corp |
| Ingredient: | ceritinib |
| Patents: | 12 |
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.
Pharmacology for NDA: 205755
Suppliers and Packaging for NDA: 205755
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZYKADIA | ceritinib | CAPSULE;ORAL | 205755 | NDA | Novartis Pharmaceuticals Corporation | 0078-0640 | 0078-0640-70 | 70 CAPSULE in 1 BOTTLE (0078-0640-70) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| 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, 2019 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| 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. | ||||||||
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