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Last Updated: December 12, 2025

PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Phoxillum Bk 4/2.5 In Plastic Container, and what generic alternatives are available?

Phoxillum Bk 4/2.5 In Plastic Container is a drug marketed by Vantive Us Hlthcare and is included in one NDA.

The generic ingredient in PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER is calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate. There are two hundred and eighty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate profile page.

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  • What is the 5 year forecast for PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER?
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Summary for PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER
Drug patent expirations by year for PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER

US Patents and Regulatory Information for PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vantive Us Hlthcare PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate INJECTABLE;INJECTION 207026-001 Jan 13, 2015 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for PHOXILLUM BK 4/2.5 in Plastic Container

Last updated: August 3, 2025

Introduction

The pharmaceutical landscape for antimicrobial solutions is evolving rapidly, shaped by regulatory changes, technological advancements, and shifting healthcare demands. PHOXILLUM BK 4/2.5, a brand of chlorhexidine-based antiseptic solution in a plastic container, exemplifies this progression. Its market dynamics and financial trajectory are influenced by factors spanning regulatory environments, competitive landscape, clinical efficacy perceptions, and healthcare industry trends. This analysis dissects these elements, offering a comprehensive outlook for stakeholders.

Product Overview and Market Positioning

PHOXILLUM BK 4/2.5, comprising chlorhexidine gluconate at a 4% concentration, combined with 2.5% alcohol, is primarily used as a surgical scrub and skin antiseptic. Packaged in a plastic container, it caters to both hospital and outpatient settings. Its formulation offers rapid antimicrobial action, broad-spectrum efficacy, and relatively favorable safety profiles, making it a preferred choice in operating rooms, intensive care units, and general health facilities.

The product's positioning hinges on its efficacy, safety, ease of use, and compliance with regulatory standards. Its plastic container facilitates safe, portable, and user-friendly handling, aligning with hygiene and infection control protocols.

Market Dynamics Influencing PHOXILLUM BK 4/2.5

Regulatory Environment and Approvals

Stringent regulatory frameworks globally, such as the FDA in the U.S. and the EMA in Europe, govern antiseptic products. Regulatory approval processes influence market entry and product lifecycle. Recent updates emphasizing sterile manufacturing, stability, and safety data have heighted compliance costs, potentially affecting profitability and market access timelines.

In jurisdictions with robust regulatory oversight, product approval can delay market entry but ensures higher trust among healthcare providers. Conversely, in emerging markets, regulatory pathways are less onerous but may raise questions about product quality and safety, influencing adoption rates.

Competitive Landscape

The antimicrobial market is crowded with numerous established brands like Hibiclens, Betadine, and locally manufactured antiseptics. PHOXILLUM BK 4/2.5 competes primarily on efficacy, safety, pricing, and supply reliability. Its market share is contingent upon physician preferences, hospital procurement policies, and price competitiveness.

Generic and local manufacturers, often offering lower-cost alternatives, pose significant threats, especially in price-sensitive regions. Patent expirations and dosage innovations also influence competitive dynamics, with emerging formulations or delivery systems potentially eroding traditional market shares.

Healthcare Industry Trends and Adoption Patterns

Growing emphasis on infection control, especially post-COVID-19, has increased demand for effective antiseptics. Hospitals are prioritizing products with proven efficacy, safety, and supply stability. Moreover, initiatives promoting antimicrobial stewardship and antimicrobial resistance mitigation have led to reevaluations of antiseptic usage patterns.

In addition, increasing awareness about healthcare-associated infections (HAIs) enhances demand for reliable preoperative skin preparation solutions like PHOXILLUM BK 4/2.5. Institutions are favoring products aligning with infection control guidelines, favoring reputable brands with regulatory approvals and clinical backing.

Supply Chain and Manufacturing Considerations

Supply chain robustness significantly impacts the financial trajectory. In recent years, disruptions caused by global events such as the COVID-19 pandemic highlighted vulnerabilities in raw material sourcing and distribution channels. Manufacturers with diversified supply sources and flexible logistics have a competitive advantage.

Production costs, especially for active ingredients and packaging materials, influence pricing strategies. Investments in manufacturing quality and scalability determine the ability to meet rising demand and maintain profit margins.

Pricing Strategies and Reimbursement Policies

Pricing remains pivotal. Hospitals and healthcare providers often negotiate procurement contracts emphasizing cost-effectiveness. Reimbursement policies, especially in publicly funded health systems, influence product adoption.

Premium pricing for products with superior efficacy or safety profiles can be justified, but aggressive price competition from generics constrains margins. Volume-driven sales are typically essential for sustaining profitability in this segment.

Regulatory and Market Risks

Risks include regulatory delays, non-compliance penalties, and shifts in clinical guidelines favoring alternative antiseptic agents, such as alcohol-based wipes or chlorhexidine patches. Patent challenges, intellectual property issues, and counterfeit risks also pose threats.

Environmental regulations pertaining to plastic packaging waste may influence future packaging standards, affecting manufacturing costs and product design.

Financial Trajectory and Growth Projections

Historical Performance

While specific financial data on PHOXILLUM BK 4/2.5 are typically proprietary, the broader antiseptic market has demonstrated moderate growth, averaging around 4-6% annually in value terms over recent years [1]. This growth is driven by increased infection prevention initiatives, an aging population, and expansion into emerging markets.

Projected Market Growth

Projections indicate the antiseptic and disinfectant market could reach USD 12.5 billion by 2026, growing at a CAGR of approximately 5% [2]. PHOXILLUM BK 4/2.5 is positioned to benefit from this upward trend, provided it can secure regulatory approvals, maintain supply chains, and differentiate via product efficacy and safety.

Revenue Opportunities and Market Penetration

Expansion into emerging economies with rising healthcare infrastructure investments presents opportunities. Strategic partnerships and local manufacturing can facilitate market entry and cost competitiveness.

Premium positioning, driven by clinical evidence of efficacy, allows for higher margins in mature markets. Innovations, such as concentrated formulations or eco-friendly packaging, further enhance growth prospects.

Challenges to Financial Growth

Competition from lower-cost generics and alternative antiseptic agents constrains margins. Regulatory hurdles and supply chain disruptions pose risks to consistent revenue streams. Additionally, shifting clinical preferences toward alcohol-based sanitizers could impact demand.

Investment Considerations

Investing in manufacturing capacity, R&D for formulation improvements, and regulatory compliance enhances long-term profitability. Cost control measures and effective sales strategies tailored to regional needs substantially influence financial outcomes.

Strategic Recommendations for Stakeholders

  • Manufacturers should prioritize regulatory compliance, supply chain resilience, and innovation to differentiate PHOXILLUM BK 4/2.5.
  • Investors ought to monitor regional market growth, regulatory changes, and competitive landscape shifts to align investment strategies.
  • Healthcare providers benefit from understanding product efficacy, safety profiles, and regulatory approvals to optimize procurement decisions.
  • Regulatory bodies can facilitate equitable access by streamlining approval processes while maintaining standards.

Conclusion

The financial trajectory of PHOXILLUM BK 4/2.5 in plastic containers is intrinsically tied to the evolving dynamics of the antimicrobial and antiseptic markets. Capitalizing on increasing infection control needs, expanding global healthcare infrastructure, and maintaining regulatory and supply chain agility will position this product favorably. It remains essential for stakeholders to adapt to regulatory shifts, competitive pressures, and clinical practice evolutions to sustain growth and profitability.


Key Takeaways

  • Regulatory Compliance: Navigating stringent approval processes enhances market access and product credibility.

  • Market Expansion: Growth opportunities lie in emerging markets and hospital procurement channels prioritizing safety and efficacy.

  • Competitive Differentiation: Emphasizing clinical efficacy, safety, and packaging advantages is crucial against generics and alternative antiseptics.

  • Supply Chain Resilience: Robust, diversified manufacturing and logistics are vital to ensure steady revenue streams amid disruptions.

  • Innovation and Sustainability: Eco-friendly packaging and formulation innovations can open new market segments and meet evolving regulatory standards.


FAQs

1. How does regulatory approval affect the market trajectory of PHOXILLUM BK 4/2.5?
Regulatory approval determines legal market entry, influences trust among healthcare providers, and impacts over time when renewing or expanding indications. Stringent standards can delay entry but elevate product credibility.

2. What factors influence the competitive positioning of PHOXILLUM BK 4/2.5?
Key factors include clinical efficacy, safety profile, price competitiveness, supply chain reliability, and alignment with clinical guidelines.

3. How do global healthcare trends influence demand for antiseptic solutions like PHOXILLUM BK 4/2.5?
Rising awareness of infection control, aging populations, and the COVID-19 pandemic have heightened demand for reliable antiseptics, favoring products endorsed by guidelines and proven in clinical settings.

4. What risks could impact the financial growth of PHOXILLUM BK 4/2.5?
Risks include regulatory delays, competition from generics, supply chain disruptions, shifts in clinical preferences, and environmental packaging regulations.

5. What strategic actions can maximize the product's market potential?
Investing in innovation, ensuring regulatory compliance, strengthening supply chains, expanding into emerging markets, and enhancing clinical evidence will optimize financial outcomes and market share.


Sources:

[1] MarketsandMarkets. Disinfectants and Sanitizers Market by Type, Application, and Region — Global Forecast to 2026.
[2] Grand View Research. Antiseptics and Disinfectants Market Size, Share & Trends Analysis Report.

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