Fluciclovine f-18 - Generic Drug Details

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

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

Fluciclovine f-18 has thirty patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for fluciclovine f-18

International Patents:	30
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	44
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluciclovine f-18
What excipients (inactive ingredients) are in fluciclovine f-18?	fluciclovine f-18 excipients list
DailyMed Link:	fluciclovine f-18 at DailyMed

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

Constraining patent/regulatory exclusivity:

10,010,632

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 fluciclovine f-18

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

Sponsor	Phase
Abramson Cancer Center at Penn Medicine	EARLY_PHASE1
VA Greater Los Angeles Healthcare System	PHASE4
National Cancer Institute (NCI)	PHASE2

See all fluciclovine f-18 clinical trials

Pharmacology for fluciclovine f-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for fluciclovine f-18

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	10,010,632		Y
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	10,124,079
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	10,933,147
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	11,980,674
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	10,967,077

Expired US Patents for fluciclovine f-18

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016	5,808,146

International Patents for fluciclovine f-18

Country	Patent Number	Title	Estimated Expiration
Japan	5635225
Israel	191184	ציקלובוטיל מותמר כתרכובת אב לתרכובות אורגנית המתויגת עם הלוגן רדיואקטיבי (Substituted cyclobutyl precursor compound for radioactive halogen-labeled organic compounds)
South Korea	20130101158	PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND
Norway	20082877
China	101316812	Precursor compound of radioactive halogen labeled organic compound

Market Dynamics and Financial Trajectory for Fluciclovine F-18

Last updated: July 30, 2025

Introduction

Fluciclovine F-18, commercially known as Axumin, is a positron emission tomography (PET) imaging agent primarily approved for detecting recurrent prostate cancer. Its unique mechanism targets amino acid transporters, providing detailed imaging for clinicians. As an integral component of precision oncology, fluciclovine F-18’s market environment reflects evolving diagnostic paradigms, regulatory pathways, and industry competition.

This report offers a comprehensive analysis of the current market dynamics and projected financial trajectory of fluciclovine F-18, framing it within broader healthcare trends, regulatory influences, commercialization strategies, and competitive pressures.

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Regulatory Landscape and Market Adoption

FDA Approval and Clinical Acceptance

In 2016, the U.S. Food and Drug Administration (FDA) approved fluciclovine F-18 for re-staging prostate cancer recurrence based on evidence demonstrating enhanced detection over conventional imaging modalities like MRI or bone scans. The approval marked a significant milestone, positioning fluciclovine F-18 as a complementary tool for precise management of prostate cancer.

However, regulatory acceptance remains pivotal. Although FDA approval confers credibility, widespread clinical adoption hinges on reimbursement policies, evolving guidelines, and clinician familiarity. Market penetration has been steady but cautious, as nuclear medicine centers integrate the tracer into routine protocols.

Reimbursement and Healthcare Policy

Medicare reimbursement decisions significantly influence market expansion. The Current Procedural Terminology (CPT) code 78814 facilitates reimbursement, but coverage varies by region and specific provider contracts. Pending approval and clearer coverage in international markets further modulate adoption rates.

Clinical Evidence and Competitive Positioning

Fluciclovine F-18’s primary competitors include choline-based PET tracers, PSMA-targeted agents, and conventional imaging. While PSMA PET imaging has gained prominence due to higher sensitivity, especially for low PSA levels, fluciclovine retains a niche where amino acid transport imaging provides added value.

Manufacturing and Distribution

The production of fluciclovine F-18 relies on a cyclotron for radiolabeling with a short half-life (~110 minutes). This technical constraint necessitates centralized manufacturing with efficient distribution networks, impacting supply reliability and market access, especially outside the U.S.

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Market Size and Growth Drivers

Base Market Assessment

The global prostate cancer diagnostic market was valued at approximately $1.4 billion in 2022, with nuclear imaging agents constituting a significant subset. Fluciclovine F-18’s current revenues are estimated to be in the range of $100–150 million in the U.S., according to industry reports, representing a niche but growing segment.

Incidence and Prevalence Trends

Prostate cancer remains the most diagnosed male malignancy worldwide, with approximately 1.4 million new cases annually. The increasing prevalence of prostate cancer, particularly in aging populations, fuels demand for sensitive diagnostic tools like fluciclovine F-18.

Market Drivers

• Advancement in Imaging Techniques: Precision medicine demands improved imaging sensitivity, positioning fluciclovine F-18 as a valuable diagnostic adjunct.
• Clinical Practice Guidelines: Growing inclusion of fluciclovine F-18 in NCCN and other guidelines accelerates clinical adoption.
• Reimbursement Expansion: Positive coverage decisions facilitate broader access, especially in community settings.
• Industry Collaborations: Strategic partnerships enhance distribution and clinician education.

Market Constraints

• Competitive Imaging Agents: PSMA PET tracers like ^68Ga-PSMA-11 and ^18F-DCFPyL demonstrate superior sensitivity, challenging fluciclovine F-18’s market share.
• Technical Limitations: Short radioisotope half-life complicates logistics.
• Limited International Approvals: Outside the U.S., regulatory hurdles slow expansion.

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Financial Trajectory and Future Outlook

Revenue Projections

Industry analysts project a compound annual growth rate (CAGR) of approximately 8–12% for fluciclovine F-18 over the next five years, driven by increasing adoption and expanding indications, including post-treatment surveillance in prostate cancer.

• Short-Term (1–3 years): Growth remains moderate, focusing on increasing utilization within existing indications and expanding into additional clinical centers.
• Medium to Long-Term (4–10 years): Potential for revenue doubling contingent on broader acceptance, international approval, and emerging indications like treatment response assessment.

Factors Influencing Financial Performance

• Regulatory Approvals: New indications and expanded labeling could unlock additional revenue streams.
• Market Penetration: Penetration in emerging markets, driven by partnerships with regional distributors.
• Competitive Landscape: Loss of share to superior PSMA tracers may temper growth unless strategic positioning occurs.
• Cost Dynamics: Manufacturing efficiencies and supply chain optimization influence pricing strategies and margins.

Strategic Considerations

Pharmaceutical companies like Blue Earth Diagnostics (a member of GE Healthcare) are investing in clinician education and market expansion strategies. Investment in R&D to develop next-generation amino acid-based tracers or combination imaging approaches could shape future financial trajectories.

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Emerging Trends and Future Opportunities

Clinical Trials and New Indications

Ongoing clinical trials evaluating fluciclovine F-18 for other cancers, such as gliomas or breast cancer, may diversify its application portfolio, positively impacting revenues.

Technological Innovations

Advancements in PET imaging, radiochemistry, and hybrid modalities (PET/MRI) can improve diagnostic accuracy, making fluciclovine F-18 more attractive within comprehensive cancer management frameworks.

Market Expansion Strategies

• International Regulatory Approvals: Securing approvals in Europe, Asia, and Latin America is imperative for substantial revenue growth.
• Reimbursement Policies: Proactively engaging with payers can facilitate coverage and adoption.
• Educational Campaigns: Increasing awareness among clinicians enhances utilization.

Impact of Competitive Dynamics

With PSMA-based tracers gaining favor, fluciclovine F-18 faces challenges in maintaining market share. However, its unique amino acid transport mechanism offers complementary value, especially in cases where PSMA expression is low.

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Key Takeaways

• Regulatory and reimbursement pathways significantly influence fluciclovine F-18’s market growth, with U.S. pathways well-established but international expansion still underway.
• Industry competition, notably from PSMA PET tracers, constrains market share but also presents opportunities for combined or complementary diagnostic approaches.
• Incidence trends in prostate cancer are strong drivers, supported by aging populations and expanded screening.
• Manufacturing logistics and distribution strategies impact supply reliability and market accessibility.
• Future revenue growth hinges on regulatory approvals, clinical guideline integration, and technological advancements, with projections supporting moderate to high CAGR over the next decade.

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FAQs

1. What are the primary advantages of fluciclovine F-18 over other prostate cancer imaging agents?
Fluciclovine F-18 offers high specificity for amino acid transporters overexpressed in prostate cancer cells, enabling detection of recurrent disease even at low PSA levels. Its favorable pharmacokinetics allow clear imaging with reduced background noise compared to older agents.

2. How does regulatory acceptance affect fluciclovine F-18’s market trajectory?
Regulatory approval, such as FDA clearance, builds clinical trust and facilitates reimbursement. Lack of approvals in key markets hampers international growth, while further regulatory endorsements can expand access and revenue.

3. Who are the main competitors to fluciclovine F-18 in prostate cancer imaging?
PSMA PET tracers like ^68Ga-PSMA-11 and ^18F-DCFPyL dominate in sensitivity, especially at early recurrence stages, challenging fluciclovine F-18’s market share.

4. What factors could accelerate the international adoption of fluciclovine F-18?
Securing approvals from agencies like the EMA and PMDA, establishing robust distribution networks, and demonstrating cost-effectiveness can promote global adoption.

5. What is the outlook for fluciclovine F-18’s role in prostate cancer management?
While competing modalities emerge, fluciclovine F-18 retains a niche for specific patient populations. Its future depends on clinical trial outcomes, guideline endorsements, and integration into multimodal imaging workflows.

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References

1. FDA. (2016). FDA approves Axumin to detect recurrent prostate cancer.
2. Industry Reports. (2022). Global prostate cancer diagnostic market.
3. NCCN Guidelines. (2023). Prostate cancer detection and management.
4. GE Healthcare. (2022). Fluciclovine (Axumin) product overview.
5. ClinicalTrials.gov. (2023). Ongoing trials involving fluciclovine F-18.