Last Updated: November 8, 2026

Details for New Drug Application (NDA): 218592

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NDA 218592 describes PIXCLARA, which is a drug marketed by Telix and is included in one NDA. It is available from one supplier. Additional details are available on the PIXCLARA profile page.

The generic ingredient in PIXCLARA is floretyrosine f-18. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the floretyrosine f-18 profile page.
Summary for 218592
Tradename:PIXCLARA
Applicant:Telix
Ingredient:floretyrosine f-18
Patents:0
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218592
Generic Entry Date for 218592*:

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Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

SOLUTION;INTRAVENOUS

*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: 218592
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIXCLARA floretyrosine f-18 SOLUTION;INTRAVENOUS 218592 NDA Telix Pharmaceuticals (US) Inc. 74725-338 74725-338-30 30 mL in 1 VIAL, MULTI-DOSE (74725-338-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5-300mCi/ML
Approval Date:Sep 11, 2026TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 11, 2031
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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