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Last Updated: May 21, 2022

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
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 202570
Generic Entry Date for 202570*:
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.

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 0069-8140-20 60 CAPSULE in 1 BOTTLE (0069-8140-20)
XALKORI crizotinib CAPSULE;ORAL 202570 NDA Pfizer Laboratories Div Pfizer Inc 0069-8141 0069-8141-20 60 CAPSULE in 1 BOTTLE (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:Mar 11, 2023
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS ARE ROS-1 POSITIVE.
Regulatory Exclusivity Expiration:Jan 14, 2024
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ALK-POSITIVE
Regulatory Exclusivity Expiration:Jan 14, 2028
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ALK-POSITIVE

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