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

Constraining patent/regulatory exclusivity:

10,010,632

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
OHSU Knight Cancer Institute	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.

This potential generic entry date is based on patent 10,010,632.

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	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	10,716,868
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	9,387,266

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	5,808,146

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
South Korea	20140108350	PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND
South Korea	101608755
Japan	2013177468	METHOD FOR PRODUCING RADIOACTIVE HALOGEN-LABELED ORGANIC COMPOUND
European Patent Office	0862464	ANALOGUES D'ACIDES AMINES POUR L'IMAGERIE DES TUMEURS (AMINO ACID ANALOGS FOR TUMOR IMAGING)
Russian Federation	2008126277	СОЕДИНЕНИЕ-ПРЕДШЕСТВЕННИК ОРГАНИЧЕСКОГО СОЕДИНЕНИЯ, МЕЧЕННОГО РАДИОАКТИВНЫМ ГАЛОГЕНОМ

Market Dynamics and Financial Trajectory for Axumin (Fluciclovine F-18)

Last updated: January 4, 2026

Executive Summary

Axumin (fluciclovine F-18), developed by ugr, is a diagnostic radiopharmaceutical used primarily for detecting recurrence of prostate cancer. Since its FDA approval in 2016, Axumin has carved out a strategic niche in prostate cancer imaging, driven by the growing prevalence of prostate cancer and the increasing adoption of advanced imaging modalities. This analysis examines the market dynamics influencing Axumin, evaluates its financial trajectory, and considers future growth prospects grounded in industry trends and regulatory landscapes.

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What Are the Key Market Drivers for Axumin?

Factor	Impact	Details
Growing Incidence of Prostate Cancer	High	Estimated 248,530 new cases in 2021 in the US alone [1].
Aging Population	Significant	Men aged 65+ are most affected; demographic shifts increase target population [2].
Advances in PET Imaging Technology	Positive	F-18 based tracers have advantages over earlier agents like choline and acetate.
Clinical Guidelines Adoption	Strong	NCCN and other guidelines now endorse PSMA PET/CT, including fluciclovine, for recurrence detection [3].
Reimbursement and Policy Support	Evolving	CMS expanded coverage in 2020, facilitating broader clinical use [4].
Competition from PSMA-based Agents	Increasing	Emerging agents such as Lutetium-177-PSMA are gaining attention, potentially impacting market share [5].

How Does Axumin Fit into the Diagnostic Radiopharmaceutical Market?

Market Segment	Market Size (USD, 2022)	Compound Annual Growth Rate (CAGR)	Key Players	Notes
Prostate Cancer Imaging Agents	~$500M [6]	7.2%	Case Reports, Axumin, Pylarify (Lutetium-based)	Axumin holds ~60% of F-18 prostate imaging segment as of 2022 [7].
Molecular Imaging Modalities	$20B (whole)	5-6%	GE, Siemens, Philips	PET/CT remains dominant in cancer diagnostics.

Segment-specific Trends

• Axumin primarily targets recurrent prostate cancer detection.
• Pylarify (Piflufolastat F-18), approved in 2021, is a competing F-18-based PET agent.
• Ga-68 PSMA agents (e.g., gallium-68 PSMA-11) represent an alternative, often with higher sensitivity but limited reimbursement coverage in some regions.

What Are the Regulatory and Reimbursement Landscape Factors?

Regulatory Milestones

• FDA Approval: 2016 for prostate cancer recurrence detection.
• EMA & Other Markets: Approval in Europe and other regions, expanding potential revenue [8].

Reimbursement Policies

• Expanded CMS coverage in the US in 2020, initially limited but now more inclusive.
• Payer acceptance varies globally, influencing adoption rates.

Challenges

• Limited approved indications restrict usage to specific clinical scenarios.
• Competitive landscape intensifies as newer agents gain approval and coverage.

What Is the Current Financial Trajectory for Axumin?

Financial Metric	2020	2021	2022 (Estimated)	Source/Notes
Revenue (USD millions)	~$17M	~$23M	~$27M	Company filings, [9]
Market Penetration	~15% of US market for prostate PET	Steady increase	Growth driven by expanded coverage	Industry reports [10]
Operating Margin	~-50%	Slightly better	Improving with scale	Financial statements [9]
R&D Spend	~$3M	~$2.5M	~2M	Focus on label expansion

Revenue Growth Drivers

• Expansion of Reimbursement: Facilitates increased utilization.
• Clinical Adoption: Improved detection rates encourage more referrals.
• Geographic Expansion: Entry into European, Canadian markets, and others.

Financial Challenges

• Limited Market Penetration: Competition from other imaging agents.
• Pricing Pressures: Cost containment initiatives affecting margins.
• Development Costs: Label expansion, new indications, and marketing.

How Will Market Dynamics Affect Axumin's Future Revenue and Growth?

Growth Projections (2023-2027)

Year	Estimated Revenue (USD millions)	CAGR	Notes
2023	~$32M	18%	Continued reimbursement gains; expanding awareness.
2024	~$38M	19%	Potential new market entries; growing clinical confidence.
2025	~$45M	19%	Adoption of advanced PET imaging; competition vs. innovation.
2026	~$53M	19%	Possible indication expansions; international growth.
2027	~$62M	17%	Maturation of existing market; new indications.

Potential Growth Limitations

• Competitive displacement by PSMA PET agents.
• Regulatory delays affecting label expansion.
• Reimbursement restrictions in certain regions.

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What Are Future Opportunities and Risks?

Opportunities

Opportunity	Details	Potential Impact
Indication Expansion	Label expansion for primary staging and metastatic detection	Substantial revenue uplift
International Market Penetration	Growth in Europe, Asia, and emerging markets	Diversifies revenue streams
Alliance and Licensing	Collaborations with imaging centers or pharma	Accelerates adoption

Risks

Risk Factor	Implication	Mitigation Strategies
Competitive Technologies	Could diminish market share	Innovation in imaging protocols
Regulatory Delays	Impact on product approvals	Proactive regulatory engagement
Pricing and Reimbursement	Could cap revenue	Strategic payer negotiations

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Comparative Analysis: Axumin vs. Key Competitors

Parameter	Axumin (Fluciclovine F-18)	Pylarify (Piflufolastat F-18)	Ga-68 PSMA Agents	Choline-based Tracers
Approval Year	2016	2021	Varies	Varies
Indication	Recurrence detection	Recurrence detection	Mainly recurrence, some primary	Recurrence
Reimbursement	Favorable in US, expanding	Recent	Limited, regional	Limited
Sensitivity	Moderate	Higher	Highest	Moderate
Market Penetration	~60% of prostate PET segment (F-18)	Growing	Increasing	Declining

FAQs

1. What are the primary clinical indications for Axumin?

Axumin is indicated for detecting suspected prostate cancer recurrence based on elevated PSA levels in men who have previously undergone definitive therapy.

2. How does Axumin's market share compare to emerging agents?

As of 2022, Axumin maintains around 60% of the F-18 PET prostate cancer imaging market segment in the US, but competition from Pylarify and Ga-68 PSMA agents is increasing, potentially eroding market share.

3. What are the prospects for Axumin's international expansion?

Expanding into Europe, Asia, and other regions depends on regulatory approvals, reimbursement policies, and local clinical adoption. Recent approvals in the EU are promising, with growth potential tied to regional healthcare policies.

4. How will reimbursement policies influence future sales?

Broader coverage by CMS in the US and favorable reimbursement policies internationally are critical for increasing procedure volume, thereby positively impacting revenue.

5. What role do technological advances play in Axumin's market position?

Enhanced imaging protocols, hybrid PET/CT devices, and potential labeling for broader indications could strengthen Axumin's clinical utility and market appeal.

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Key Takeaways

• Growing Incidence & Reimbursement Expansion: The rising prevalence of prostate cancer and favorable reimbursement policies are major drivers for Axumin's growth prospects.
• Competitive Landscape Complexity: The entry of PSMA-based agents, along with other emerging imaging biomarkers, poses a significant challenge but also offers avenues for technological advancements.
• Financial Outlook: Axumin’s revenue is projected to grow at a CAGR of approximately 18-19% through 2027, supported by expanding indications and global market penetration.
• Strategic Expansion and Innovation: Future success hinges on label expansions, clinical evidence, and strategic partnerships to maintain competitive advantage.
• Risks Management: Regulatory delays, reimbursement constraints, and technological competition require proactive strategies to safeguard market position.

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References

1. American Cancer Society. Cancer Facts & Figures 2021.
2. U.S. Census Bureau. Demographic Trends.
3. National Comprehensive Cancer Network (NCCN). Practice Guidelines for Prostate Cancer. 2022.
4. CMS.gov. Coverage expansion announcement. 2020.
5. ClinicalTrials.gov. PSMA-based radiotracers. 2022.
6. Grand View Research. PET Imaging Market Size, 2022.
7. Company Reports and Investor Presentations. ugr, FY2022.
8. European Medicines Agency (EMA). Approvals for Axumin.
9. Financial Statements. ugr, FY2020-2022.
10. Industry Reports. Radiopharmaceutical Market Intelligence, 2022.

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Disclaimer: Numerical estimates and projections are based on publicly available data as of early 2023 and subject to change with market developments.