Flurpiridaz f-18 - Generic Drug Details

What are the generic drug sources for flurpiridaz f-18 and what is the scope of freedom to operate?

Flurpiridaz f-18 is the generic ingredient in one branded drug marketed by Ge Hlthcare and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Flurpiridaz f-18 has one hundred and eleven patent family members in twenty-two countries.

One supplier is listed for this compound.

Summary for flurpiridaz f-18

International Patents:	111
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
Patent Applications:	92
What excipients (inactive ingredients) are in flurpiridaz f-18?	flurpiridaz f-18 excipients list
DailyMed Link:	flurpiridaz f-18 at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for flurpiridaz f-18

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.

Recent Clinical Trials for flurpiridaz f-18

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
GE Healthcare	Phase 2
Pharmaceutical Product Development, LLC	Phase 3
GE Healthcare	Phase 3

See all flurpiridaz f-18 clinical trials

Pharmacology for flurpiridaz f-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for flurpiridaz f-18

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes	9,687,571		Y
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes	9,161,997		Y	Y
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes	8,226,929
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes	7,344,702			Y
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes	9,603,951
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes	8,936,777

International Patents for flurpiridaz f-18

Country	Patent Number	Title	Estimated Expiration
Taiwan	I664169
Russian Federation	2012138262
Denmark	2534136
Lithuania	2419096
Brazil	112012019789
Japan	2018076328	造影剤およびその中間体を合成するための方法および装置 (METHODS AND APPARATUS FOR SYNTHESIZING IMAGING AGENTS AND INTERMEDIATES THEREOF)
Spain	2909318

Market Dynamics and Financial Trajectory for Flurpiridaz F-18

Last updated: October 9, 2025

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Introduction

Flurpiridaz F-18 emerges as a promising diagnostic radiopharmaceutical designed for myocardial perfusion imaging (MPI). Its distinctive mechanism, high-resolution imaging capabilities, and potential to outperform traditional agents place it at the forefront of nuclear cardiology innovation. Understanding the market dynamics and financial trajectory of Flurpiridaz F-18 involves analyzing regulatory pathways, competitive landscape, technological advancements, and clinical adoption factors.

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Regulatory and Developmental Landscape

Flurpiridaz F-18, developed by Lantheus Holdings, Inc., has shown potential for widespread clinical application, especially given its application in Positron Emission Tomography (PET) imaging. The drug's progress through regulatory channels remains a critical determinant of its market entry and financial success.

The pivotal phase III clinical trial results, demonstrating superior image quality and diagnostic accuracy over conventional SPECT agents, positioned Flurpiridaz as a candidate for FDA approval. Nonetheless, regulatory agencies emphasize safety, efficacy, and manufacturing consistency, factors that influence approval timelines and, consequently, market entry.

In recent years, Lantheus reported delays in FDA review processes due to manufacturing quality assessments. Such delays introduce uncertainties in launch timing, affecting initial revenue projections and investor confidence.

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Market Potential and Demand Drivers

The global myocardial perfusion imaging market size is projected to reach USD 2.8 billion by 2026, growing at a Compound Annual Growth Rate (CAGR) of approximately 6.2% (Market Research Future, 2022). Flurpiridaz F-18’s adoption can significantly influence this growth trajectory owing to its superior PDE (phosphodiesterase) binding properties, resulting in higher contrast images and improved lesion detectability.

Several factors underpin strong demand:

• Aging Population: The increasing prevalence of coronary artery disease (CAD) among aging demographics amplifies demand for accurate, early diagnostic tools.

• Technological Superiority: PET imaging coupled with Flurpiridaz F-18 offers enhanced spatial resolution compared to traditional SPECT agents, enabling better clinical decision-making.

• Healthcare Reforms & Reimbursement Policies: Governments and insurers are progressively adopting value-based care models, incentivizing the adoption of more precise diagnostics like Flurpiridaz F-18.

• Clinical Adoption Trends: Early clinical trials indicating positive sensitivity and specificity metrics are promising but require wider validation through post-approval studies.

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Competitive Landscape

Flurpiridaz F-18 faces competition from established MPI agents, notably Technetium-99m-based SPECT radiotracers (e.g., Tc-99m SPECT agents like Myoview, Cardiolite). While these agents have decades-long market penetration, their limitations — such as lower image resolution and longer processing times — create a market opening for newer PET agents like Flurpiridaz.

Additionally, other PET agents like Rubidium-82 and N-13 Ammonia are present, but their limitations include high costs and complex logistics, respectively. Flurpiridaz F-18 aims to overcome these issues with a longer half-life and excellent pharmacokinetics.

Market entrants, including similar novel tracers in development, will influence Flurpiridaz’s market share. The successful differentiation hinges on demonstrating clinical superiority, cost-effectiveness, and seamless integration into existing PET infrastructure.

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Financial Trajectory — Revenue Projections and Investment Outlook

Projected revenue streams depend heavily on regulatory approval, clinical adoption rates, and reimbursement policies. If Flurpiridaz F-18 gains FDA approval during 2023-2024:

• Initial Launch Phase (Year 1-2): Revenue estimates range between USD 50-150 million, primarily driven by early adopters and major hospitals equipped with PET scanners.

• Market Penetration (Year 3-5): With broader acceptance, revenues could escalate to USD 300–500 million annually, leveraging increasing procedural volumes.

• Long-term Growth: As clinical evidence solidifies and the imaging marketplace expands into emerging markets, cumulative five-year revenues could surpass USD 1 billion.

Investment in manufacturing capacity, marketing efforts, and clinching favorable reimbursement policies are crucial factors influencing this trajectory.

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Market Challenges and Risks

Several hurdles could impact the financial success of Flurpiridaz F-18:

• Regulatory Delays and Uncertainty: Further review delays or additional clinical data requirements may postpone market entry.

• High Capital Expenditures: Manufacturing of radiopharmaceuticals necessitates specialized facilities, increasing upfront investments and operational costs.

• Reimbursement Environment: Variability in payer policies could slow adoption, especially if cost-effectiveness data remain inconclusive.

• Technological Obsolescence: Rapid evolution in imaging technology and competing agents may limit long-term market dominance.

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Emerging Opportunities

Innovations in hybrid imaging modalities, AI-powered image analysis, and expanding PET infrastructure globally could accelerate Flurpiridaz’s adoption. Its diagnostic precision may also open avenues beyond cardiology, such as oncological applications, broadening its revenue base.

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Conclusion and Strategic Outlook

The financial trajectory of Flurpiridaz F-18 hinges on successful regulatory approval, clinical validation, and integration into clinical workflows. While foundational market demand is robust, success depends on overcoming developmental and reimbursement challenges. A strategic focus on demonstrating clinical superiority and cost-effectiveness can position Flurpiridaz as a significant growth driver within the nuclear imaging sector.

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Key Takeaways

• Flurpiridaz F-18 holds substantial market potential in MPI, driven by superior imaging technology and an aging population with rising CAD prevalence.

• Regulatory developments are pivotal; current delays pose risks to timely market entry and revenue realization.

• Competitive pressures from established SPECT agents and emerging PET tracers necessitate clear differentiation through clinical efficacy and cost benefits.

• Initial revenues are projected to be modest but could scale rapidly post-approval, with long-term billion-dollar sales feasible in a favorable market environment.

• Addressing manufacturing, reimbursement, and adoption barriers is critical to realizing financial growth.

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FAQs

1. What is the primary function of Flurpiridaz F-18?
   Flurpiridaz F-18 is a PET radiotracer used for myocardial perfusion imaging, enabling detailed visualization of blood flow to detect coronary artery disease.

2. When is Flurpiridaz F-18 expected to be commercially available?
   Pending FDA approval, market entry is anticipated in 2023-2024, though regulatory delays could extend this timeline.

3. How does Flurpiridaz F-18 compare to traditional SPECT agents?
   It offers higher resolution images, faster imaging times, and potentially improved diagnostic accuracy, providing significant clinical advantages.

4. What are the main barriers to Flurpiridaz F-18’s market success?
   Regulatory approval delays, high manufacturing costs, reimbursement hurdles, and competition from established imaging agents.

5. What is the long-term growth outlook for Flurpiridaz F-18?
   With successful approval and adoption, revenues could reach over USD 1 billion in five years, driven by clinical adoption, technological advancements, and expanding markets.

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Sources:

1. Market Research Future. (2022). Global Myocardial Perfusion Imaging Market Forecast.
2. FDA. (2023). Drug Approval and Regulatory Process.
3. Lantheus Holdings. (2022). Corporate and Product Pipeline Updates.
4. Global Market Insights. (2022). Nuclear Imaging Market Trends.