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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 217581


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NDA 217581 describes XALKORI, which is a drug marketed by Pf Prism Cv and is included in two NDAs. 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 217581
Tradename:XALKORI
Applicant:Pf Prism Cv
Ingredient:crizotinib
Patents:5
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217581
Generic Entry Date for 217581*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, PELLETS;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: 217581
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XALKORI crizotinib CAPSULE, PELLETS;ORAL 217581 NDA Pfizer Laboratories Div Pfizer Inc 0069-0251 0069-0251-60 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0069-0251-60)
XALKORI crizotinib CAPSULE, PELLETS;ORAL 217581 NDA Pfizer Laboratories Div Pfizer Inc 0069-0507 0069-0507-60 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0069-0507-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, PELLETS;ORALStrength20MG
Approval Date:Sep 7, 2023TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 14, 2025
Regulatory Exclusivity Use:TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH UNRESECTABLE, RECURRENT OR REFRACTORY INFLAMMATORY MYOFIBROBLASTIC TUMOR (IMT) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK) 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
Patent:⤷  Sign UpPatent Expiration:Aug 26, 2025Product Flag?Substance Flag?YDelist Request?

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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 verification 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.