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Last Updated: December 12, 2025

MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Mefoxin In Sodium Chloride 0.9% In Plastic Container, and what generic alternatives are available?

Mefoxin In Sodium Chloride 0.9% In Plastic Container is a drug marketed by Merck and is included in one NDA.

The generic ingredient in MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is cefoxitin sodium. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cefoxitin sodium profile page.

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Summary for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Drug patent expirations by year for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
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US Patents and Regulatory Information for MEFOXIN IN SODIUM CHLORIDE 0.9% 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
Merck MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER cefoxitin sodium INJECTABLE;INJECTION 050581-002 Sep 20, 1984 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Merck MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER cefoxitin sodium INJECTABLE;INJECTION 050581-001 Sep 20, 1984 DISCN Yes No ⤷  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 MEFOXIN in Sodium Chloride 0.9% in Plastic Container

Last updated: July 29, 2025

Introduction

MEFOXIN, a pharmaceutical antibiotic primarily comprised of cefoxitin, combined with sodium chloride 0.9% in a plastic container, occupies a niche within the broad pharmaceutical landscape. This injectable antibiotic is designed to treat various bacterial infections, predominantly in hospital settings. Understanding its market dynamics and financial trajectory involves dissecting its manufacturing, regulatory landscape, competitive positioning, and evolving healthcare trends impacting its demand.

Product Overview and Clinical Utility

MEFOXIN’s formulation as cefoxitin in sodium chloride 0.9% solution offers the advantage of intravenous administration, making it suitable for inpatient care. Cefoxitin, a second-generation cephalosporin, exhibits broad-spectrum activity against anaerobic bacteria and certain Gram-negative organisms [1]. Its stability in solution within a plastic container simplifies storage and administration, key for hospital procurement routines.

The product’s clinical utility lies in treating abdominal infections, urinary tract infections, genital infections, and perioperative prophylaxis [2]. The rising incidence of complex infections, coupled with increased hospital admissions, sustains demand for such formulations. Moreover, its compatibility with modern infusion systems enhances administrative convenience.

Market Dynamics

Demand Drivers

  • Rising Antibiotic Use in Hospitals: As antimicrobial resistance (AMR) escalates globally, the demand for effective broad-spectrum antibiotics such as cefoxitin increases, particularly in hospital settings. The robust global prevalence of bacterial infections necessitates reliable IV antibiotics [3].

  • Aging Population: The demographic shift toward an aging population globally correlates with higher hospitalization rates and infection susceptibility, pushing up the utilization of injectable antibiotics like MEFOXIN [4].

  • Surgical and Critical Care Procedures: Surgery-related prophylaxis accounts for a steady infusion of such antibiotics, especially in orthopedic, abdominal, and gynecological procedures, reinforcing demand stability.

Supply Chain and Manufacturing Factors

Manufacturers of MEFOXIN benefit from centralized production in established pharmaceutical hubs—mainly India, China, and Western markets with mature pharmaceutical industries. The key to maintaining competitive pricing and supply chain resilience includes:

  • Ensuring compliance with Good Manufacturing Practices (GMP)
  • Maintaining stable raw material supplies, particularly cefoxitin and suitable plastic containers
  • Navigating potential disruptions caused by geopolitical issues, pandemics, or raw material shortages [5].

Regulatory Climate

The regulatory environment influences market access and dynamics:

  • Approval Status: MEFOXIN’s approval in multiple countries hinges on regional regulatory agencies' evaluations, such as the FDA, EMA, or WHO prequalification schemes.
  • Antibiotic Stewardship and Regulation: Stricter guidelines for antibiotic use aim to curb AMR but may also restrict overuse, influencing demand volume.
  • Intellectual Property (IP): Generic manufacturers can introduce bioequivalent products upon patent expiry, intensifying price competition.

Competitive Landscape

The market for cefoxitin in intravenous formulations is populated predominantly by generic pharmaceutical companies. Key competing products include brands like Mefoxin (Johnson & Johnson), generic cefoxitin solutions from Indian and Chinese manufacturers, and other second-generation cephalosporins such as cefotetan or cefmetazole.

Market entry barriers for new entrants include regulatory hurdles and the need for manufacturing scale. Nonetheless, price competition among generics exerts downward pressure on profit margins.

Pricing Trends

Due to high generic competition, prices for MEFOXIN are predominantly driven by cost efficiencies, supply reliability, and regulatory approvals. In many regions, especially in developing markets, aggressive price competitiveness constrains margins but sustains access.

Emerging Trends Impacting the Market

  • Increased Use of Biosimilars and Alternatives: While biosimilars are not applicable to small-molecule antibiotics like cefoxitin, the rise of alternative antibiotics—particularly newer carbapenems or combination therapies—may influence MEFOXIN’s market share.

  • Focus on Stewardship Programs: Countries implementing antimicrobial stewardship programs tend to restrict broad-spectrum antibiotic use, potentially decreasing usage or shifting preference toward narrower-spectrum agents.

  • Novel Formulations and Delivery Methods: Innovations such as sustained-release formulations or pre-mixed infusion bags could influence demand patterns.

Financial Trajectory

Revenue Projections

Projection of revenues for MEFOXIN hinges on factors like:

  • Market Penetration: Given its established clinical indications, revenue growth will mostly derive from increased adoption within existing hospital accounts, expansion into new geographies, and hospital procurement budgets.
  • Price Dynamics: Intense generic competition limits pricing power, so profit margins rely heavily on manufacturing efficiencies.

Profitability Outlook

Gross margins for generic injectable antibiotics like MEFOXIN tend to be tight, often constrained to single digits percentage-wise due to intense price competition. Investment in quality manufacturing practices and supply chain resilience forms the core profitability strategy.

Growth Opportunities

  • Expanding into Emerging Markets: As healthcare infrastructure expands, particularly in Asia, Latin America, and Africa, unmet demand for affordable IV antibiotics creates significant growth potential.
  • Strategic Partnerships: Collaboration with regional distributors and hospitals can bolster market penetration.
  • Regulatory Approvals: Achieving approvals in underrepresented markets enhances revenue streams.

Challenges to Financial Growth

  • Antimicrobial Stewardship: Heightened regulation and stewardship initiatives may limit volume growth.
  • Pricing Pressures: Competition and regulatory price controls in public healthcare systems depress profitability.
  • Patent and Regulatory Barriers: Even in the absence of patent protections, regulatory hurdles can delay market entry or expansion plans.

Conclusion

The market for MEFOXIN in sodium chloride 0.9% in plastic containers remains steady but must navigate a complex matrix of demand drivers, competitive pressures, regulatory frameworks, and healthcare trends. While current revenues benefit from established clinical utility, future growth depends on strategic positioning within emerging markets, regulatory acceptance, and proactive engagement with antimicrobial stewardship policies. The financial trajectory is characterized by modest but consistent revenue expansion aligned with hospital demand and cost efficiencies, tempered by market competition.


Key Takeaways

  • The demand for MEFOXIN sustains due to its clinical utility in hospital settings, especially amid rising bacterial infections and surgical procedures.
  • Price competition among generics constrains margins but promotes widespread accessibility.
  • Expansion into emerging markets provides significant growth prospects but requires strategic regulatory and distribution collaborations.
  • Evolving antimicrobial stewardship policies and the development of alternative therapies pose ongoing challenges.
  • Profitability hinges on manufacturing efficiencies, regulatory approvals, and market penetration strategies.

FAQs

  1. What factors influence the pricing of MEFOXIN in various markets?
    Pricing is primarily influenced by the level of generic competition, regulatory environments, procurement policies in healthcare institutions, and local economic conditions.

  2. How does antimicrobial resistance impact the demand for MEFOXIN?
    While increasing resistance may reduce the efficacy of cefoxitin against certain bacteria, the continued prevalence of susceptible infections sustains its demand, especially in settings lacking newer alternatives.

  3. Are there upcoming regulatory changes that could affect MEFOXIN?
    Regulations focusing on antimicrobial use and stricter approval standards in key markets could affect supply and market access, particularly for new or reformulated versions.

  4. What opportunities exist for expanding MEFOXIN's market share?
    Leveraging emerging markets, securing regulatory approvals, optimizing supply chain efficiencies, and engaging in hospital procurement programs offer avenues for growth.

  5. What are the principal challenges facing manufacturers of MEFOXIN?
    Market saturation by generics, regulatory hurdles, antimicrobial stewardship restrictions, and price sensitivity in healthcare procurement are key challenges.


Sources:

[1] Food and Drug Administration (FDA). "Cefoxitin Injection, USP." 2020.
[2] World Health Organization (WHO). "Antimicrobial Medicines Use and Resistance." 2015.
[3] European Centre for Disease Prevention and Control (ECDC). "Antimicrobial Resistance Surveillance in Europe." 2021.
[4] United Nations Department of Economic and Social Affairs. "World Population Ageing." 2019.
[5] McKinsey & Company. "Global Supply Chain Disruptions and Strategic Responses." 2022.

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