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Serving leading biopharmaceutical companies globally:

Medtronic
Covington
Boehringer Ingelheim
Fish and Richardson
Novartis
Argus Health
Johnson and Johnson
Baxter
Fuji
Colorcon

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202570

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NDA 202570 describes XALKORI, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the XALKORI profile page.

The generic ingredient in XALKORI is crizotinib. One supplier is listed for this compound. Additional details are available on the crizotinib profile page.
Summary for 202570
Tradename:XALKORI
Applicant:Pf Prism Cv
Ingredient:crizotinib
Patents:5
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 202570
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XALKORI crizotinib CAPSULE;ORAL 202570 NDA Pfizer Laboratories Div Pfizer Inc 0069-8140 N 0069-8140-20
XALKORI crizotinib CAPSULE;ORAL 202570 NDA Pfizer Laboratories Div Pfizer Inc 0069-8141 N 0069-8141-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Aug 26, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 14, 2018
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING PREVIOUSLY UNTREATED ALK-POSITIVE METASTATIC NON SMALL CELL LUNG CANCER (NSCLC)
Regulatory Exclusivity Expiration:Aug 26, 2018
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNGCANCER (NSCLC) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE AS DETECTED BY AN FDAAPPROVEDTEST
Regulatory Exclusivity Expiration:Mar 11, 2023
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS ARE ROS-1 POSITIVE.

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Queensland Health
AstraZeneca
Daiichi Sankyo
McKesson
Chubb
Citi
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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