Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Dow
Merck
Mallinckrodt
McKesson

Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202570

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

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
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.
Patent:  Start TrialPatent Expiration:Aug 26, 2025Product Flag?Substance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:May 12, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
Mallinckrodt
Boehringer Ingelheim
Merck
Medtronic

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.