flurpiridaz f-18 - Profile

What are the generic sources for flurpiridaz f-18 and what is the scope of patent protection?

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

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

Summary for flurpiridaz f-18

International Patents:	121
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1

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.

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	9,603,951
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	8,936,777
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	12,527,884		Y
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes	7,344,702			Y

Expired US Patents for flurpiridaz f-18

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	7,344,702
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024	9,161,997

International Patents for flurpiridaz f-18

Country	Patent Number	Title	Estimated Expiration
Australia	2020369122	Use of cyclodextrins as a radiostabilizer
Canada	3158389	UTILISATION DE CYCLODEXTRINES EN TANT QUE RADIOSTABILISANT (USE OF CYCLODEXTRINS AS A RADIOSTABILIZER)
China	114555133	环糊精作为放射稳定剂的用途 (Use of cyclodextrins as radiation stabilizers)
European Patent Office	4048323	UTILISATION DE CYCLODEXTRINES EN TANT QUE RADIOSTABILISANT (USE OF CYCLODEXTRINS AS A RADIOSTABILIZER)
United Kingdom	201915206
Israel	292333	שימוש בציקלודקסטרין כמייצב רדיואקטיבי (Use of cyclodextrins as radiostabilisers)
Japan	2022553266	放射線安定剤としてのシクロデキストリンの使用

Flurpiridaz F-18: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

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Summary

Flurpiridaz F-18, a PET radiotracer developed for myocardial perfusion imaging, demonstrates promising clinical efficacy but remains in the pipeline for commercialization. This analysis provides a comprehensive overview of its investment potential, competitive market landscape, regulatory pathway, and projected financial outlook. Key insights include the drug’s unique positioning in cardiac imaging, the critical role of regulatory approvals, and strategic considerations for stakeholders targeting the nuclear medicine and cardiology segments.

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1. Overview of Flurpiridaz F-18

Aspect	Details
Drug Type	PET radiotracer
Primary Indication	Myocardial perfusion imaging
Development Status	Phase III clinical trials (as of 2023)
Developer	GE Healthcare, Siemens Healthineers, or other collaborators
Regulatory Status	Pending FDA NDA submission / approval
Half-life of F-18	Approximately 110 minutes
Unique Selling Point	Superior image quality, higher diagnostic accuracy than SPECT

Source: [1], [2], [3]

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2. Investment Scenario Analysis

2.1. Market Potential

Parameter	Estimate (USD)	Source/Comment
Global cardiac PET imaging market	$2.8 billion (2022)	CAGR of 11% (2022–2027) estimate [4]
Myocardial perfusion imaging segment	~$1.2 billion	Based on nuclear cardiology market shares
Target adoption rate (post-approval)	20-30% within 5 years	Early adopters in large hospitals, expanding to community centers
Peak market share (long-term)	40-50%	Considering competition and product differentiation
Revenue estimation (Year 5)	$200-400 million	Assuming steady adoption in major markets

2.2. Competitive Landscape

Competitors	Key Features	Status
Technetium-99m-based SPECT agents	Long-standing, lower cost, limited accuracy	Mature, but with declining share
Rubidium-82 PET agents	High cost, limited availability	Niche, growing segment
Other F-18 PET tracers	Varying indications	Emerging competitors

2.3. Development and Regulatory Risks

Risk Factor	Description	Impact
Clinical trial outcomes	Potential for failure or marginal benefit in larger Phase III trials	Significant delay or rejection
Regulatory approval hurdles	FDA or EMA delays, additional data requests	Extended timelines, increased costs
Market acceptance	Physician adoption, reimbursement policies	Slower revenue realization

2.4. Financial Trajectory

Timeline	Milestones	Estimated Revenue / Cost Impact
Year 1–2	Completion of Phase III trials, NDA submission	R&D expenses (~$50–$100 million), preparatory costs
Year 3	Anticipated FDA decision	Marketing and sales launch expenses
Year 4–5	Product commercialization, initial market penetration	Revenue growth to $100–200 million, breakeven or profit margins improve

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3. Market Dynamics and Key Drivers

Factor	Influence	Notes
Advancements in PET technology	Enhanced image quality, lower radiation dose	Bolsters clinical confidence, wider adoption
Reimbursement policies	Insurance coverage essential for uptake	Favorable policies accelerate market penetration
Aging population	Increased prevalence of coronary artery disease (CAD)	Expands patient base
Regulatory approvals	Critical juncture for commercial viability	Multiple agencies involved (FDA, EMA)
Competition from existing modalities	SPECT, MRI, CT; PET’s clinical superiority needed for positioning	Strategic pricing and demonstrates value proposition

4. Regulatory and Commercialization Timeline

Step	Expected Date / Period	Key Activities
IND clearance	Completed (if applicable)	Data submission before phase III trials
Phase III completion	Year 2–3	Demonstrate clinical efficacy and safety
NDA submission	Year 3–4	Engage FDA with comprehensive clinical data
Regulatory decision	Year 4–5	Approval, possible post-market study requirements
Market entry	Year 4–5	Launch phase, initial adoption

Sources: [1], [2], [3], [4].

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5. Comparative Analysis with Similar Agents

Agent	Modality	Approval Year	Market Position & Strengths	Limitations
Technetium-99m SPECT agents	SPECT imaging	1980s–2000s	Established, widespread use	Limited spatial resolution, lower accuracy
Rubidium-82	PET imaging	2004	High accuracy, rapid imaging	Costly, limited availability
Flurpiridaz F-18	PET imaging	Pending (2023)	Higher diagnostic accuracy, promising clinical data	Regulatory approval pending, market entry risk

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6. Financial Projections and Investment Recommendations

Scenario	Year 1–2	Year 3–4	Year 5–7
Conservative (base case)	R&D focus, no revenue	Minimal revenue, market access testing	$50–$100 million in revenue, breakeven possible
Optimistic (best case)	Full-scale commercialization, early market capture	Rapid growth, expanding indications	$200–$400 million, significant profit margins
Pessimistic (worst case)	Regulatory delay, clinical trial failure	Delayed approval, reduced market entry	Limited to niche markets, minimal revenue

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Key Takeaways

• High Market Potential: With a CAGR of 11% and an aging population, the myocardial perfusion imaging segment, especially PET-based agents like flurpiridaz F-18, presents attractive investment opportunities once regulatory approval is achieved.

• Regulatory Milestone Critical: The drug's success hinges on successful NDA submission and FDA approval, expected between Years 3 and 4, with pivotal trial results being decisive.

• Competitive Edge: Flurpiridaz F-18’s superior image resolution and diagnostic accuracy could position it favorably over traditional SPECT agents and niche PET tracers.

• Market Adoption Risks: Reimbursement policies, physician acceptance, and competition from established modalities may impact market penetration, requiring strategic market access planning.

• Financial Outlook: Long-term revenue projections are promising, with potential peak revenues exceeding $200 million within five years of market entry, contingent on successful commercialization.

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FAQs

Q1: What are the primary advantages of flurpiridaz F-18 over existing myocardial perfusion imaging agents?
It offers higher diagnostic accuracy and image quality than SPECT agents, with a shorter scan time compatible with routine clinical workflows.

Q2: When is flurpiridaz F-18 expected to receive regulatory approval?
Based on current data, FDA approval could occur between Years 4 and 5, following successful NDA review and satisfactory clinical trial outcomes.

Q3: What are the main competitive threats to flurpiridaz F-18?
Established SPECT agents, newer PET tracers like rubidium-82, and emerging MRI techniques pose potential competition.

Q4: How do reimbursement policies influence the market success of this drug?
Reimbursement coverage facilitates adoption; lack of coverage or low reimbursement rates can hinder uptake, especially given the higher costs associated with PET imaging.

Q5: What strategies can developers adopt to maximize market penetration?
Early engagement with payers, physician education, offering comparative effectiveness data, and establishing broad clinical protocols are essential.

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References

1. Smith, J. et al. (2022). "Development and Clinical Evaluation of Flurpiridaz F-18." Journal of Nuclear Medicine.
2. US Food and Drug Administration. (2023). "Guidance for Industry and FDA Staff."
3. GE Healthcare. (2022). "Innovations in PET Imaging."
4. MarketsandMarkets. (2022). "Cardiac PET Imaging Market by Modality."

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This comprehensive analysis aims to inform stakeholders on the strategic positioning, investment viability, and projected financial trajectory of flurpiridaz F-18, emphasizing the critical factors influencing its market success.