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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson
Dow
Julphar
QuintilesIMS
US Department of Justice
Cantor Fitzgerald
Teva
Accenture
Johnson and Johnson

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205755

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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. 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
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 N 0078-0640-70

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Apr 29, 2014TE: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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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Covington
Daiichi Sankyo
Citi
Chinese Patent Office
Farmers Insurance
Federal Trade Commission
Express Scripts
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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