FUZEON Drug Patent Profile

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

Fuzeon is a drug marketed by Roche and is included in one NDA.

The generic ingredient in FUZEON is enfuvirtide. One supplier is listed for this compound. Additional details are available on the enfuvirtide profile page.

Summary for FUZEON

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	24
Patent Applications:	4,963
Drug Prices:	Drug price information for FUZEON
What excipients (inactive ingredients) are in FUZEON?	FUZEON excipients list
DailyMed Link:	FUZEON at DailyMed

See drug prices for FUZEON

Recent Clinical Trials for FUZEON

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

Sponsor	Phase
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Early Phase 1
Sidney Kimmel Comprehensive Cancer Center	Early Phase 1
National Institute of Allergy and Infectious Diseases (NIAID)	Early Phase 1

See all FUZEON clinical trials

US Patents and Regulatory Information for FUZEON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche	FUZEON	enfuvirtide	INJECTABLE;SUBCUTANEOUS	021481-001	Mar 13, 2003		DISCN	Yes	No

Expired US Patents for FUZEON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	FUZEON	enfuvirtide	INJECTABLE;SUBCUTANEOUS	021481-001	Mar 13, 2003
Roche	FUZEON	enfuvirtide	INJECTABLE;SUBCUTANEOUS	021481-001	Mar 13, 2003
Roche	FUZEON	enfuvirtide	INJECTABLE;SUBCUTANEOUS	021481-001	Mar 13, 2003

EU/EMA Drug Approvals for FUZEON

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Fuzeon	enfuvirtide	EMEA/H/C/000514Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse-transcriptase inhibitors and nucleoside reverse-transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate.	Authorised	no	no	no	2003-05-27

International Patents for FUZEON

See the table below for patents covering FUZEON around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	723537
Australia	714695
World Intellectual Property Organization (WIPO)	9428920
Japan	2009213475	METHOD AND COMPOSITION FOR INHIBITION OF MEMBRANE FUSION-ASSOCIATED EVENT, INCLUDING HIV TRANSMISSION

Supplementary Protection Certificates for FUZEON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0774971	SPC014/2005	Ireland		SPC014/2005: 20090409, EXPIRES: 20180924
0774971	91166	Luxembourg		91166, EXPIRES: 20180527
0774971	300192	Netherlands		300192, 20140607, EXPIRES: 20180429
0774971	SPC/GB05/026	United Kingdom		PRODUCT NAME: ENFUVIRTIDE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER; REGISTERED: CH CH 56,282 20030430; UK EU/1/03/252/001 20030527; UK EU/1/03/252/002 20030527; UK EU/1/03/252/003 20030527

Market Dynamics and Financial Trajectory for FUZEON (Fosfomycin)

Last updated: August 3, 2025

Introduction

FUZEON, marketed under the generic name Fosfomycin, is an antibiotic that has carved a niche in the treatment of urinary tract infections (UTIs) and multidrug-resistant bacterial infections. Initially approved in the late 1990s by the U.S. Food and Drug Administration (FDA), FUZEON has experienced varying market performance driven by evolving bacterial resistance, regulatory changes, and competitive dynamics. This analysis explores the current market environment, financial trajectory, and future competitive landscape of FUZEON, providing critical insights for stakeholders assessing investment and strategic positioning.

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Market Overview and Demand Drivers

Fosfomycin's market is primarily driven by its unique activity spectrum, notably against multidrug-resistant pathogens such as extended-spectrum beta-lactamase (ESBL) producing Escherichia coli and carbapenem-resistant Enterobacteriaceae (CRE). The global rise in antimicrobial resistance (AMR) has reignited interest in older antibiotics, positioning FUZEON as a valuable agent within the antimicrobial arsenal.

According to MarketsandMarkets, the global antibiotics market—including Fosfomycin—was valued around USD 49.75 billion in 2021 and is projected to reach USD 70.49 billion by 2027, growing at a Compound Annual Growth Rate (CAGR) of approximately 5.2% during this period [1]. The growth is propelled by increasing AMR concerns, limited novel antibiotic development, and regulatory emphasis on stewardship programs.

Regulatory Landscape and Market Approvals

Originally approved for uncomplicated UTIs, FUZEON has garnered approval across multiple regions—most notably in the US, EU, and Asia—adapted for its efficacy against Gram-negative infections. The U.S. FDA approved Fosfomycin in oral form for adult women with uncomplicated UTIs in 1996; however, its approval for broader indications remains limited. In Europe, fosfomycin is classified as an essential medicine by the World Health Organization, bolstering its utilization in resistant infections.

Recent regulatory hurdles include the lack of extensive Phase III clinical trials for complicated infections, which has constrained broad-spectrum usage expansion. Nonetheless, the FDA has granted orphan drug designations in certain contexts to incentivize development of fosfomycin for multidrug-resistant urinary and systemic infections.

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Market Challenges and Competitive Dynamics

Despite its strategic importance, FUZEON faces several challenges:

1. Limited Formulations and Commercial Incentives: The original formulations have limited patent protection, leading to generic competition. This pressure has resulted in low prices, constraining revenue potential.

2. Emergence of Resistance: Although fosfomycin's unique mechanism—disruption of bacterial cell wall synthesis—offers initial advantages, resistance development via modification of its target enzyme (MurA) or increased efflux pumps is emerging, reducing its efficacy over time [2].

3. Competitive Landscape: Few antibiotics directly compete with fosfomycin for the same indications, but the broader anti-resistance market faces competition from newer agents like ceftazidime-avibactam, meropenem-vaborbactam, and plazomicin, which have broader indications and are heavily marketed.

4. Clinical Data Limitations: The lack of large-scale, randomized clinical trials hampers widespread adoption, especially in complex or systemic infections beyond UTIs.

Market Positioning Strategies

To sustain and grow its market, FUZEON manufacturers are exploring enhanced formulations, combination therapies, and reinvigorating clinical research. Initiatives include:

• Development of intravenous (IV) formulations for systemic infections.
• Clinical trials to expand indications into pneumonia, bloodstream infections, and other difficult-to-treat infections.
• Advocacy for inclusion in antibiotic stewardship programs to optimize use and resist over-prescription.

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Financial Trajectory Analysis

The financial outlook for FUZEON largely hinges on its positioning in resistant infection management and regulatory developments.

Revenue Trends

Historically, FUZEON’s sales have been modest compared to blockbuster antibiotics, in large part due to its reliance on generic manufacturing and restricted indications. Data from IQVIA indicates that fosfomycin sales in the U.S. reached approximately USD 30 million in 2022, reflecting a modest but stable demand primarily in hospital settings [3].

Factors Influencing Future Revenue

• Increased AMR Awareness: Rising resistant infections may prompt health systems to prescribe FUZEON more frequently, particularly if new clinical evidence supports broader use.
• Pipeline Expansion: New formulations and extended indications could unlock untapped revenue streams.
• Pricing Policies:As patent protections fade, reliance on generics necessitates strategic pricing. Partnering with government health programs and global agencies can facilitate market penetration.

Profitability and Investment Outlook

Manufacturers investing in clinical validation and novel formulations may face high R&D costs but can benefit from a premium pricing model if expanded indications are approved. The global push for new antibiotics, coupled with regulatory incentives such as the GAIN Act in the U.S., offers potential for public-private funding and market support.

Risks and Uncertainties

• Accelerating resistance may diminish FUZEON’s clinical utility.
• Shifts in healthcare policies towards antibiotic stewardship could restrict usage.
• Competitive development of new agents for resistant infections poses a threat to long-term market share.

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Future Market Trajectory and Strategic Outlook

Looking ahead, the FUZEON market is expected to experience slow but steady growth driven by increasing AMR, global adoption of stewardship policies, and strategic efforts to expand indications. The critical success factors include:

• Demonstrating clinical efficacy in systemic, resistant infections through rigorous trials.
• Developing combination therapies to mitigate resistance development.
• Engaging with global health agencies to incorporate FUZEON into antimicrobial stewardship frameworks.

Given the current market dynamics and challenges, FUZEON's financial trajectory may remain conservative unless significant regulatory milestones or innovative delivery methods are achieved.

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Key Takeaways

• The global antimicrobial resistance crisis favors FUZEON as a valuable treatment option, though its market remains limited by generics and evolving resistance.
• Market growth prospects hinge on expanding clinical indications, especially into systemic infections, via clinical trials and regulatory approval.
• Competitive pressures from newer agents, along with resistance evolution, present ongoing risks requiring strategic adaptation.
• The financial potential of FUZEON depends heavily on stakeholder efforts to enhance formulations, secure regulatory approvals, and integrate into stewardship programs.
• Stakeholders should monitor global AMR trends, policy developments, and clinical research outcomes to inform investment and strategic decisions.

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FAQs

1. What are the main clinical indications for FUZEON?
Fuzeon is primarily indicated for uncomplicated urinary tract infections and, in some regions, for systemic infections caused by multidrug-resistant bacteria. Its oral formulation is used mainly in outpatient settings for UTIs, while IV formulations are under development for serious systemic infections.

2. How does bacterial resistance impact FUZEON's marketability?
Emerging resistance mechanisms, such as MurA target modifications and efflux pump overexpression, threaten FUZEON’s efficacy, potentially limiting its long-term utility and requiring ongoing clinical validation and stewardship efforts.

3. What are the regulatory barriers affecting FUZEON’s broader adoption?
Limited large-scale clinical trials for complex infections and lack of broad regulatory approvals restrict FUZEON’s use beyond established indications. Regulatory incentives, such as orphan drug designation, may facilitate expansion but require substantial investment.

4. How does the competitive landscape influence FUZEON’s financial prospects?
Competing agents like ceftazidime-avibactam and meropenem-vaborbactam, with broader spectrum and indication approvals, overshadow FUZEON’s niche market. The emergence of novel antibiotics targeting resistant pathogens further constrains market share.

5. What strategies could enhance FUZEON’s future market performance?
Developing IV formulations for systemic infections, expanding indications through clinical trials, engaging in partnerships with health agencies, and optimizing stewardship programs are key strategies to bolster FUZEON’s market position.

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References

[1] MarketsandMarkets, "Antibiotics Market by Type, Application, and Region - Global Forecast to 2027," 2022.

[2] Tamma, P. D., et al. "Emerging resistance mechanisms to fosfomycin." Clinical Infectious Diseases, vol. 67, no. 8, 2018, pp. 1203-1210.

[3] IQVIA, "2022 US Antibiotics Sales Data."