AXUMIN Drug Patent Profile

Which patents cover Axumin, and what generic alternatives are available?

Axumin is a drug marketed by Blue Earth and is included in one NDA. There are eight patents protecting this drug.

This drug has thirty patent family members in sixteen countries.

The generic ingredient in AXUMIN is fluciclovine f-18. One supplier is listed for this compound. Additional details are available on the fluciclovine f-18 profile page.

DrugPatentWatch^® Generic Entry Outlook for Axumin

Axumin was eligible for patent challenges on May 27, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 28, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for AXUMIN

International Patents:	30
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	26
Patent Applications:	137
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AXUMIN
What excipients (inactive ingredients) are in AXUMIN?	AXUMIN excipients list
DailyMed Link:	AXUMIN at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AXUMIN

NDA:

208054

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 AXUMIN

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

Sponsor	Phase
VA Greater Los Angeles Healthcare System	PHASE4
Dana-Farber Cancer Institute	Phase 1
Oregon Health and Science University	Phase 4

See all AXUMIN clinical trials

Pharmacology for AXUMIN

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for AXUMIN

AXUMIN is protected by eight US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes			Y
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes

Expired US Patents for AXUMIN

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

International Patents for AXUMIN

When does loss-of-exclusivity occur for AXUMIN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

European Patent Office

Poland

Russian Federation

South Korea

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AXUMIN around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0619213	composto precursor de composto orgánico marcado com haloênio radioativo
Poland	1978015
Japan	2011207901	AMINO ACID ANALOG FOR TUMOR IMAGING
South Korea	101643991
Japan	2013177468	METHOD FOR PRODUCING RADIOACTIVE HALOGEN-LABELED ORGANIC COMPOUND

Market Dynamics and Financial Trajectory for Axumin (Fluciclovine)

Last updated: July 27, 2025

Introduction

Axumin (generic name: fluciclovine) is a diagnostic radiopharmaceutical developed for detecting recurrent prostate cancer through positron emission tomography (PET). Approved by the U.S. Food and Drug Administration (FDA) in May 2016, Axumin addresses a significant clinical need in prostate cancer management, particularly in patients with rising prostate-specific antigen (PSA) levels post-primary therapy. The drug’s market trajectory is shaped by evolving clinical practices, technological advancements, regulatory dynamics, and competitive landscape.

Market Overview

Prostate cancer remains one of the most prevalent cancers among men globally, with increasing incidence correlating with aging populations. Accurate detection of recurrent disease significantly influences treatment plans and patient outcomes, with traditional imaging modalities such as bone scans and CT scans exhibiting limitations in sensitivity and specificity. The advent of PET agents like Axumin has transformed diagnostic paradigms, enabling precise localization of disease recurrence at lower PSA levels.

The global prostate cancer imaging market was valued at approximately USD 600 million in 2021 and is projected to grow at a compound annual growth rate (CAGR) of about 8-10% over the next five years. Axumin’s share constitutes a notable segment within this niche, driven by its unique mechanism as an amino acid analog facilitating superior detection capabilities.

Market Drivers

1. Clinical Unmet Need for Precise Recurrent Disease Detection
   Axumin fills a critical gap for clinicians seeking accurate detection of prostate cancer recurrence at low PSA levels (>0.2 ng/mL). This specificity enhances clinical decision-making, influencing therapy adjustments, such as salvage radiotherapy.

2. Regulatory Approval and Reimbursement Pathways
   Regulatory approvals in key markets, including the U.S. and Europe, have catalyzed adoption. Medicare and private payers in the U.S. have established reimbursement pathways, providing financial viability to imaging centers and providers.

3. Growing Adoption of PET Imaging
   PET imaging’s superior sensitivity compared to conventional modalities propels its adoption. Regulatory clearances for Axumin reinforce its legitimacy relative to emerging competitors.

4. Advancements in Prostate Cancer Management
   Advances toward personalized medicine and targeted interventions drive demand for precise diagnostics like Axumin.

Market Challenges

• Limited Awareness and Access
  The penetration of Axumin remains limited, partly due to the availability constraints of PET facilities and lack of awareness among clinicians.

• Competition from Alternative Agents
  Emerging agents, especially those based on versatile isotopes like Gallium-68 and Fluorine-18, pose a threat via improved imaging attributes and broader production logistics.

• Pricing and Reimbursement Constraints
  Cost considerations and variations in reimbursement policies affect the profitability and market penetration in different regions.

• Regulatory Variability
  Different regulatory landscapes and approval processes influence the speed and extent of Axumin’s adoption in non-U.S. markets.

Competitive Landscape

While Axumin pioneered the amino acid PET agent for prostate cancer detection, its competition includes:

• Pylarify (Gallium-68 PSMA): Approved by the FDA in 2021, Pylarify targets prostate-specific membrane antigen (PSMA), offering potentially higher sensitivity at lower PSA levels (starting as low as 0.2 ng/mL).

• Prostascint (Capromab Pendetide): An earlier monoclonal antibody-based imaging agent, with limited current use.

• Other emerging radiotracers and imaging modalities: Ongoing research into PSMA-targeted agents and theranostics may shift market dynamics further.

Financial Trajectory and Revenue Forecast

The commercial success of Axumin hinges on several factors:

• Market Penetration and Volume Growth
  In the U.S., Axumin’s adoption has historically been incremental. The number of PET centers equipped to administer Axumin expanded from approximately 100 centers in 2016 to over 250 as of 2022, reflecting healthy growth in installed capacity.

• Reimbursement Expansion
  Coverage by Medicare and Medicaid, along with private insurers, facilitates increased utilization. Reports suggest reimbursement rates of approximately USD 4,000–5,500 per scan, depending on the region and facility.

• Sales Trajectory
  Estimates project that Axumin’s sales could reach USD 50–70 million annually in the U.S. within the next 3-5 years, assuming stable growth and expanding provider networks. International markets are nascent but expected to follow similar trends as regulatory approvals increase.

• Impact of Competition
  The introduction of PSMA-based agents like Pylarify may influence Axumin’s market share, although Axumin’s advantage lies in its early mover status and established regulatory status.

• Partnerships and Licensing Deals
  Brand owner Blue Earth Diagnostics (a division of General Electric Healthcare) actively promotes Axumin, with potential licensing agreements aimed at expanding geographic footprint.

Financial Outlook

Current forecasts indicate moderate revenue growth driven by clinical demand, infrastructure expansion, and reimbursement facilitation. Peak revenues for Axumin could approximate USD 100–150 million globally, primarily within North America, with steady but slower growth expected elsewhere due to market penetration barriers.

Regulatory and Market Expansion Opportunities

• Regulatory Advances: Approvals in the European Union, Canada, and other regions would unlock new revenue streams.

• Technological Innovations: Integration with hybrid PET/CT systems and development of automated synthesis methods could reduce costs and increase accessibility.

• Clinical Trials and Companion Diagnostics: Further validation in prospective studies, and potential label expansion for broader indications, can enhance market applicability.

Conclusion

Axumin’s market dynamics are influenced by its pivotal role in prostate cancer diagnostics, competitive innovations, reimbursement landscape, and clinical adoption rates. The drug stands at a strategic inflection point, with growth potential driven by technological advances and expanded regulatory approvals. Financially, it is positioned to sustain modest but steady revenue increases in the near term, with prospects for substantial growth contingent upon addressing access barriers and competing agents.

---

Key Takeaways

• Axumin holds a critical niche in prostate cancer recurrence detection, leveraging PET imaging for elevated clinical precision.

• The market is expanding, fueled by rising prostate cancer incidence, advocacy for advanced diagnostics, and regulatory acceptance.

• Competitive innovations, notably PSMA-targeted agents like Pylarify, could influence Axumin’s market share but also affirm the growth trajectory of prostate cancer imaging.

• Reimbursement policies and infrastructure development remain pivotal in scaling adoption and revenue generation.

• Strategic collaborations and international regulatory approvals are essential for expanding Axumin’s footprint and maximizing its financial potential.

---

FAQs

1. How does Axumin compare with newer agents like PSMA-based radiotracers?
While Axumin targets amino acid transport, PSMA-based tracers such as Pylarify offer higher sensitivity at lower PSA levels, possibly leading to superior detection rates. However, Axumin's earlier market entry provides established clinical validation and reimbursement pathways, maintaining its relevance.

2. What are the primary cost considerations for deploying Axumin in clinical settings?
Costs include radiotracer synthesis, infrastructure for PET imaging, personnel, and reimbursement coverage. The per-scan reimbursement (~USD 4,000–5,500) influences adoption, with higher reimbursement encouraging utilization.

3. What regulatory challenges could impact Axumin’s international expansion?
Different markets have varying approval timelines and requirements; delays or rejections can hinder widespread adoption. Addressing regulatory hurdles involves localized clinical data and compliance.

4. How significant is the role of reimbursement policies in Axumin’s market success?
Reimbursement is critical; favorable policies encourage clinics to adopt Axumin. Limited or lack of coverage can substantially suppress utilization regardless of clinical value.

5. What future developments could enhance Axumin's market trajectory?
Advancements include broader regulatory approvals, integration with hybrid imaging technology, increased awareness among clinicians, and competitive positioning through clinical validation.

---

Sources:
[1] FDA Approves Axumin for Recurrent Prostate Cancer Detection, FDA.gov, 2016.
[2] MarketResearch.com, Prostate Cancer Imaging Market Analysis, 2022.
[3] Blue Earth Diagnostics, Axumin Clinical Data and Commercial Strategy Reports, 2022.
[4] Centers for Medicare & Medicaid Services, Reimbursement Policies for PET Imaging, 2022.