Flotufolastat f-18 gallium - Generic Drug Details

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

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

Flotufolastat f-18 gallium has eighty-eight patent family members in twenty countries.

One supplier is listed for this compound.

Summary for flotufolastat f-18 gallium

International Patents:	88
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
DailyMed Link:	flotufolastat f-18 gallium at DailyMed

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

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 flotufolastat f-18 gallium

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

Sponsor	Phase
BLUE EARTH DIAGNOSTICS (UNITED KINGDOM)	PHASE2
Jonsson Comprehensive Cancer Center	PHASE2
Mayo Clinic	PHASE2

See all flotufolastat f-18 gallium clinical trials

Pharmacology for flotufolastat f-18 gallium

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for flotufolastat f-18 gallium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes				Y
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes			Y
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes			Y
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes				Y
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes				Y

International Patents for flotufolastat f-18 gallium

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3917626
Finland	3658194
Denmark	3658194
European Patent Office	4000640
Denmark	3917626

Market Dynamics and Financial Trajectory for Flotufolastat F-18 Gallium

Last updated: July 27, 2025

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Introduction

Flotufolastat F-18 Gallium is an emerging radiopharmaceutical primarily designed for prostate-specific membrane antigen (PSMA) PET imaging. As a diagnostic agent, it promises to redefine prostate cancer detection, staging, and management. Understanding its market dynamics and financial trajectory requires a comprehensive analysis of clinical developments, regulatory landscapes, competitive positioning, and economic factors influencing its growth potential.

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Clinical and Regulatory Landscape

Clinical Development and Efficacy

Flotufolastat F-18 Gallium leverages advanced molecular imaging techniques to enhance prostate cancer diagnosis accuracy. Its ability to precisely visualize PSMA-expressing tumors has garnered significant interest. Phase III clinical trials are pivotal in establishing its safety and efficacy benchmarks, with recent data showcasing improved sensitivity and specificity over conventional imaging agents like FDG or choline-based tracers.

Regulatory Milestones

Regulatory approval status critically impacts its market trajectory. The U.S. Food and Drug Administration (FDA) approval process and subsequent commercialization hinge on demonstrating clear clinical benefit. As of early 2023, regulatory submissions are underway, with expectations of approval within the next 12-24 months, contingent on clinical trial outcomes and submission timelines. Similarly, the European Medicines Agency (EMA) and other global regulators are evaluating submissions, expanding potential market access.

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Market Dynamics

Demand Drivers

1. Rising Incidence of Prostate Cancer

Prostate cancer ranks among the most common malignancies globally. According to the World Health Organization, new cases are increasing due to aging populations and improved screening. Accurate staging is vital to optimizing treatment strategies, thereby fueling demand for advanced imaging agents like Flotufolastat F-18 Gallium.

2. Growth in Molecular Imaging Adoption

The shift toward personalized medicine encourages the integration of molecular imaging, with PET agents at the forefront. Healthcare providers are inclined to adopt agents that improve detection rates, especially in recurrent and metastatic settings.

3. Reimbursement and Healthcare Policy Evolution

Increasing reimbursement coverage for PET imaging agents, supported by health technology assessments indicating improved patient outcomes, promotes market penetration. Favorable policies in developed nations including the U.S. and Europe reinforce this trajectory.

4. Competitive Landscape

While PSMA PET imaging agents like Ga68-PSMA-11 have established presence, Flotufolastat F-18 Gallium's longer half-life and superior image resolution could differentiate it. The availability of a fluorine-18 labeled agent (half-life ~110 minutes) offers logistical benefits over gallium-68 (~68 minutes), such as centralized manufacturing and broader distribution.

Supply and Manufacturing Factors

The production scalability of Flotufolastat F-18 Gallium hinges on cyclotron capacity and radiopharmaceutical facilities. Strategic collaborations with manufacturing partners can streamline supply chains, influencing market access and pricing strategies.

Competitive and Substitutable Alternatives

Existing PSMA agents, notably Ga68-PSMA-11 and other radiotracers like 18F-DCFPyL, are well-established. Flotufolastat F-18 Gallium's success depends on demonstrating clinical advantages, such as enhanced imaging quality, logistical ease, and cost-effectiveness.

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Financial Trajectory

Market Size and Revenue Potential

The global prostate cancer imaging market is projected to surpass USD 2 billion by 2025, with PSMA PET imaging representing a significant subset. Early adoption of Flotufolastat F-18 Gallium could capture substantial market share, especially if it secures regulatory approval within the next 1-2 years.

Pricing Strategies

Price points will factor in manufacturing costs, reimbursement policies, competitive positioning, and healthcare economics. Premium pricing may be justified if clinical benefits over existing agents are convincingly demonstrated, though payers may seek cost-effective solutions.

Investment and Funding Outlook

Pharmaceutical and biotech firms developing Flotufolastat F-18 Gallium are likely to attract investment driven by unmet clinical needs, technological differentiation, and favorable regulatory pathways. Venture capital and partnering opportunities with established radiopharmaceutical manufacturers can accelerate deployment.

Cost-Benefit Analysis and Reimbursement Impact

Enhanced diagnostic accuracy leading to tailored therapies can reduce downstream treatment costs, supporting favorable reimbursement. Health economic evaluations demonstrating improved patient outcomes and economic savings boost market acceptance.

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Global Expansion and Adoption

Emerging markets with expanding healthcare infrastructure and prostate cancer prevalence present growth opportunities. Tailored strategies for regions like Asia-Pacific, Latin America, and the Middle East can diversify revenue streams.

Strategic Partnerships

Collaborations with nuclear pharmacies, hospital networks, and radiopharmaceutical distributors are critical. Such alliances facilitate broader distribution, facilitating rapid adoption and revenue growth.

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Challenges and Risks

• Regulatory Delays: Slower-than-expected approvals can defer revenue realization.
• Market Penetration: Existing agents with established practice patterns may slow adoption.
• Manufacturing Constraints: Limited supply capacity might restrict initial sales volumes.
• Pricing Pressures: Payer resistance to high-cost agents could impact margins.

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Key Takeaways

• Clinical validation is crucial. Ongoing studies and demonstration of superior imaging capabilities will drive clinician adoption.
• Regulatory approval timelines are decisive. Faster pathways and clearance will accelerate financial prospects.
• Competitive differentiation matters. Flotufolastat F-18 Gallium’s logistical advantages can enhance market share.
• Reimbursement policies will shape market access. Advocacy with payers based on demonstrated clinical/patient benefit will be vital.
• Strategic partnerships can catalyze growth. Manufacturing alliances and regional distributors will enable global expansion.

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Conclusion

Flotufolastat F-18 Gallium is positioned at a critical juncture, with significant potential to reshape prostate cancer imaging. Its market trajectory will primarily depend on clinical outcomes, regulatory progress, cost-effectiveness, and competitive positioning. Expect accelerated growth in high-resource markets with expanding prostate cancer diagnostics, provided it meets clinical and regulatory milestones efficiently.

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FAQs

1. When is Flotufolastat F-18 Gallium expected to receive regulatory approval?
Regulatory approval is anticipated within the next 12-24 months, contingent on successful clinical trial outcomes and submission processing.

2. How does Flotufolastat F-18 Gallium compare to existing PSMA PET agents?
Its longer fluorine-18 half-life and logistical advantages may offer broader distribution and potentially enhanced imaging quality, but definitive clinical superiority remains under evaluation.

3. What is the primary market for Flotufolastat F-18 Gallium initially?
The initial focus will likely be North America and Europe, where prostate cancer prevalence and healthcare infrastructure support rapid adoption.

4. What challenges could impede market penetration?
Regulatory delays, entrenched competitor products, supply chain constraints, and reimbursement issues could slow adoption rates.

5. How can manufacturers ensure successful commercialization?
By demonstrating clear clinical benefits, establishing reliable manufacturing, engaging with payers early, and forming strategic partnerships, companies can maximize market penetration.

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References

[1] World Health Organization. Prostate Cancer Fact Sheet. 2022.
[2] Society of Nuclear Medicine and Molecular Imaging. PSMA PET Imaging Market Report. 2022.
[3] U.S. Food and Drug Administration. Radiopharmaceutical Approvals. 2023.
[4] Global Data. Prostate Cancer Diagnostics Market Forecast. 2022.
[5] Radiopharmaceutical Manufacturing Journal. Supply Chain Insights. 2022.