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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 215168

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NDA 215168 describes FLYRCADO, which is a drug marketed by Ge Hlthcare and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the FLYRCADO profile page.

The generic ingredient in FLYRCADO is flurpiridaz f-18. One supplier is listed for this compound. Additional details are available on the flurpiridaz f-18 profile page.

Summary for 215168

Tradename:	FLYRCADO
Applicant:	Ge Hlthcare
Ingredient:	flurpiridaz f-18
Patents:	7

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 215168

Generic Entry Date for 215168^: ⤷ Get Started Free* 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.

Pharmacology for NDA: 215168

Mechanism of Action	Positron Emitting Activity

Suppliers and Packaging for NDA: 215168

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168	NDA	GE Healthcare Inc.	0407-8787	0407-8787-01	30 mL in 1 VIAL, GLASS (0407-8787-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	5-55mCi/ML
Approval Date:	Sep 27, 2024	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 27, 2029
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	12,527,884	Patent Expiration:	May 13, 2042	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) FOR CARDIAC DISEASES
Patent:	7,344,702	Patent Expiration:	May 26, 2026	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 215168

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024	9,161,997	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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.