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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.

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:	17
Clinical Trials:	25
Patent Applications:	75
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
Dana-Farber Cancer Institute	Phase 1
Oregon Health and Science University	Phase 4
Blue Earth Diagnostics, Inc	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

Brazil

Canada

China

European Patent Office

Israel

Japan

New Zealand

Norway

Poland

Portugal

Russian Federation

South Korea

Spain

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
Japan	5341136
Canada	2629227	COMPOSE PRECURSEUR DE COMPOSE ORGANIQUE MARQUE A L'HALOGENE RADIOACTIF (PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND)
Japan	5684333
Portugal	1978015
Spain	2663496

AXUMIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Axumin

Introduction

Axumin (fluciclovine F 18) is a positron emission tomography (PET) imaging agent specifically designed for detecting and locating suspected prostate cancer recurrence in men with elevated prostate-specific antigen (PSA) levels after prior treatment. Here, we delve into the market dynamics and financial trajectory of Axumin, highlighting its development, regulatory approvals, market performance, and future prospects.

Development and Regulatory Approval

Axumin was initially developed by researchers at Emory University, with the patent obtained in the United States in the mid-1990s. However, its journey to market was fraught with challenges. GE Healthcare, which initially held the rights to Axumin, put the project on the backburner to focus on a PET imaging agent for Alzheimer's disease, a market perceived as more lucrative[1].

The breakthrough came when two former GE Healthcare employees left to form Blue Earth Diagnostics, a company dedicated to bringing Axumin to market. With significant investment from Syncona, the venture capital arm of the Wellcome Trust, Blue Earth Diagnostics successfully navigated the regulatory approval process. Axumin received FDA approval in 2016 for PET imaging of prostate cancer recurrence[1][2].

Market Indications and Target Audience

Axumin is indicated for use in men with suspected prostate cancer recurrence based on elevated PSA levels following prior treatment. This specific indication positions Axumin as a critical diagnostic tool in the management of recurrent prostate cancer, a condition that affects thousands of men annually[2].

Market Performance

Since its approval, Axumin has shown promising market performance. The drug's sales have been driven by its unique positioning as a diagnostic tool for a specific and significant medical need. Blue Earth Diagnostics has worked closely with healthcare professionals and patients to ensure widespread availability of Axumin across the U.S., with the drug available exclusively through Siemens’ PETNET Solutions[2].

Sales and Revenue

While specific quarterly sales figures for Axumin are not publicly detailed, the overall trend in the oncology sector suggests that diagnostic imaging agents like Axumin can achieve significant revenue. For instance, oncology drugs and diagnostic agents often see increasing sales in the first few years after approval, with some reaching peak sales several years later[3].

Competitive Landscape

Axumin operates in a competitive landscape where other PET imaging agents are in various stages of clinical trials. However, its FDA approval and established market presence give it a significant advantage. Goodman, one of the researchers involved in Axumin's development, remains unfazed by potential competition, noting that any new agents would need to demonstrate significant improvements over Axumin to gain market share[1].

Financial Trajectory

Initial Investment and Funding

The financial trajectory of Axumin was significantly influenced by the investment from Syncona. This funding was crucial in completing the regulatory approval process and launching the product in the market. The investment reflected Syncona's commitment to supporting innovative healthcare solutions, particularly in areas with high unmet medical needs[1][5].

Revenue Growth

Since its commercial launch in 2016, Axumin has contributed to the growth of Blue Earth Diagnostics. While exact revenue figures are not provided, the company's commitment to expanding indications for Axumin, including potential use in primary prostate cancer diagnoses and other types of cancer, suggests a positive revenue growth trajectory[1][2].

Future Prospects

As the patent for Axumin is set to expire, Blue Earth Diagnostics will face the possibility of generic alternatives entering the market. However, the company is proactive in seeking additional indications for Axumin, which could help maintain its market position. The expansion into new indications, such as primary prostate cancer and potentially other cancers like bladder and breast cancer, could further bolster Axumin's financial performance[1].

Regulatory and Approval Processes

The regulatory approval process for Axumin was complex and lengthy, particularly in regions outside the U.S. The Japanese regulatory approval process, for example, has been ongoing, highlighting the challenges faced by diagnostic imaging agents in gaining international approvals[1].

Clinical Trials and Efficacy

Axumin's approval was based on evidence from two clinical trials conducted in the USA, Italy, and Norway. These trials involved male patients with suspected prostate cancer recurrence due to rising PSA levels. The data from these trials demonstrated the efficacy of Axumin in detecting and locating recurrent prostate cancer, which was pivotal in securing FDA approval[4].

Conclusion

Axumin's market dynamics and financial trajectory are characterized by a challenging development phase, successful regulatory approval, and a strong market presence. The drug's unique indication and the commitment of Blue Earth Diagnostics to expanding its use have positioned it as a valuable diagnostic tool in the management of recurrent prostate cancer.

Key Takeaways

• Development and Approval: Axumin was developed by Emory University researchers and brought to market by Blue Earth Diagnostics after overcoming significant challenges.
• Market Indications: Axumin is specifically indicated for PET imaging in men with suspected prostate cancer recurrence.
• Market Performance: The drug has shown promising sales and revenue growth since its FDA approval in 2016.
• Financial Trajectory: Supported by significant investment from Syncona, Axumin's financial performance is expected to continue positively as Blue Earth Diagnostics seeks additional indications.
• Regulatory and Approval Processes: The approval process was lengthy, especially in international markets.
• Clinical Trials and Efficacy: Axumin's approval was based on robust clinical trial data demonstrating its efficacy in detecting recurrent prostate cancer.

FAQs

Q: What is Axumin used for?

A: Axumin (fluciclovine F 18) is used for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate-specific antigen (PSA) levels following prior treatment.

Q: Who developed Axumin?

A: Axumin was developed by researchers at Emory University.

Q: When did Axumin receive FDA approval?

A: Axumin received FDA approval in June 2016.

Q: What company is responsible for marketing Axumin?

A: Blue Earth Diagnostics is responsible for marketing Axumin.

Q: What are the future prospects for Axumin?

A: Blue Earth Diagnostics is seeking to expand the indications for Axumin, including potential use in primary prostate cancer diagnoses and other types of cancer, which could further bolster its market position and financial performance.

Sources

1. Atlanta GA - Axumin | Emory University
2. Axumin® (fluciclovine F 18) injection | For Healthcare Professionals
3. MARKET PERFORMANCE ANALYSIS - Antimicrobial Drugs ... - NCBI
4. Drug Trials Snapshots: Axumin - FDA
5. Interim Results - Syncona