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-nine patent family members in twenty countries.

One supplier is listed for this compound.

Summary for flotufolastat f-18 gallium

International Patents:	89
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	12,377,176			Y
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes	12,036,290		Y
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes	12,357,711			Y
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes	12,390,540			Y
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes	12,427,207		Y

International Patents for flotufolastat f-18 gallium

Country	Patent Number	Title	Estimated Expiration
Japan	7771080
Israel	303420	חומרי דימות אבחוניים לסרטן (Cancer diagnostic imaging agents)
Denmark	3917626
Eurasian Patent Organization	202192045	СРЕДСТВА ДЛЯ ДИАГНОСТИЧЕСКОЙ ВИЗУАЛИЗАЦИИ РАКОВОГО ЗАБОЛЕВАНИЯ
South Korea	20210153036	암 진단 영상화제들
World Intellectual Property Organization (WIPO)	2021205185

Market Dynamics and Financial Trajectory for Flotufolastat F-18 Gallium

Last updated: February 13, 2026

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What is Flotufolastat F-18 Gallium?

Flotufolastat F-18 Gallium is a diagnostic radiopharmaceutical used in positron emission tomography (PET) imaging. It targets prostate-specific membrane antigen (PSMA) to detect prostate cancer. The drug combines F-18, a fluorine isotope, with a gallium-based chelator. Its design aims for high specificity and early detection of prostate cancer recurrence and metastasis.

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What is the Current Market Landscape?

Market Size and Growth

• The global prostate cancer imaging market was valued at approximately $420 million in 2022 and is projected to reach $680 million by 2030, with a compound annual growth rate (CAGR) of about 6.2% (source: MarketsandMarkets).

• The segment for PSMA-targeted PET imaging is expanding rapidly, driven by improvements in imaging technology and increasing prostate cancer incidence.

Key Players

• First-in-class agents like Gallium-68 PSMA-11 are validated and commercially available, primarily in Europe and the U.S.

• Flotufolastat F-18 Gallium is in late-stage clinical development or regulatory review, aiming to provide alternative imaging options with possible advantages in half-life and image resolution.

Regulatory Status

• As of 2023, Flotufolastat F-18 Gallium is undergoing FDA review, with full approval anticipated within the next 12 to 24 months.

• Similar agents have received approvals in Europe and other territories, boosting the global market openness.

What Are the Drivers of Market Growth?

• Rising prostate cancer incidence worldwide, expected to exceed 2 million new cases annually by 2025 (source: WHO).

• Increased adoption of PET imaging for prostate cancer staging, driven by its specificity over conventional imaging.

• Demand for more precise, earlier detection tools to guide treatment plans.

• Technological advancements enabling higher resolution imaging and improved radiotracer stability.

What Are the Barriers and Challenges?

• Regulatory delays or rejections could hinder market entry.

• The high cost of PET imaging procedures limits access in some regions.

• Competition from established agents like Gallium-68 PSMA-11, which has broad commercialization, could impact market penetration.

• Production complexity and logistics for radiotracers pose operational challenges.

What Is the Financial Trajectory?

• Pricing assumptions: A typical PET radiotracer is priced between $2,500 and $6,000 per dose.

• Market penetration: On approval, Flotufolastat F-18 Gallium could target about 10-15% of the prostate cancer PET imaging market initially, growing to 25-30% within five years.

• Revenue estimates:

  Year	Estimated Doses (000s)	Potential Revenue (USD millions)
  2024	50	$125-$300
  2025	150	$375-$900
  2026	300	$750-$1,800

• The revenue growth depends on factors like licensing agreements, reimbursement policies, and physician adoption.

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How Do Technological and Competitive Trends Affect Financial Outlook?

• Improved imaging techniques, like ultra-high-resolution PET scanners, extend tracer utility.

• The entry of biosimilar or alternative agents could intensify competition, potentially lowering prices.

• Strategic partnerships with imaging centers and hospitals enhance adoption and revenue streams.

What Are the Key Markets?

• North America: Largest market due to high prostate cancer prevalence, advanced healthcare infrastructure.

• Europe: Growing adoption, supported by favorable regulatory environment.

• Asia-Pacific: Rising market potential with expanding healthcare access and screening programs.

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Key Takeaways

• Flotufolastat F-18 Gallium is positioned to benefit from rising prostate cancer diagnosis and advances in PET imaging.

• Market entry is closely linked to regulatory approval timelines, reimbursement pathways, and physician adoption.

• The total addressable market could reach over $600 million globally within five years after launch, assuming moderate market penetration.

• Competition with existing agents and logistical challenges still pose risks to revenue growth.

• Strategic partnerships and cost management are critical for financial success.

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FAQs

1. When is Flotufolastat F-18 Gallium expected to receive FDA approval?
Indicative timelines suggest approval within 12 to 24 months from 2023, contingent on successful clinical trial outcomes and review processes.

2. How does Flotufolastat F-18 Gallium differ from existing PSMA PET agents?
It offers F-18 labeling, which provides a longer half-life (about 110 minutes versus 68 minutes for Gallium-68), allowing broader distribution and potentially improved image clarity.

3. What are reimbursement prospects for this agent?
Reimbursement depends on payer acceptance, cost-effectiveness analyses, and coverage determinations. Existing positive reimbursement pathways for PSMA PET tracers in the U.S. and Europe favor market access.

4. What logistical considerations affect market penetration?
The short half-life of radiotracers requires proximity to production facilities. F-18’s longer half-life compared to Gallium-68 affords wider distribution options.

5. Which regions hold the most growth potential?
North America and Europe are primary, but Asia-Pacific offers significant long-term expansion due to increasing prevalence and infrastructure investments.

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References

[1] MarketsandMarkets. "Prostate Cancer Diagnostics Market." 2022.
[2] WHO. "Cancer Fact Sheet." 2022.
[3] FDA. "Regulatory Review Status for PSMA PET Agents." 2023.