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Last Updated: December 18, 2025

CEFMETAZOLE SODIUM - Generic Drug Details


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What are the generic sources for cefmetazole sodium and what is the scope of patent protection?

Cefmetazole sodium is the generic ingredient in two branded drugs marketed by Pharmacia And Upjohn and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for cefmetazole sodium.

Summary for CEFMETAZOLE SODIUM
US Patents:0
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 2
Raw Ingredient (Bulk) Api Vendors: 50
DailyMed Link:CEFMETAZOLE SODIUM at DailyMed
Medical Subject Heading (MeSH) Categories for CEFMETAZOLE SODIUM

US Patents and Regulatory Information for CEFMETAZOLE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn ZEFAZONE IN PLASTIC CONTAINER cefmetazole sodium INJECTABLE;INJECTION 050683-001 Dec 29, 1992 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmacia And Upjohn ZEFAZONE IN PLASTIC CONTAINER cefmetazole sodium INJECTABLE;INJECTION 050683-002 Dec 29, 1992 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmacia And Upjohn ZEFAZONE cefmetazole sodium INJECTABLE;INJECTION 050637-002 Dec 11, 1989 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmacia And Upjohn ZEFAZONE cefmetazole sodium INJECTABLE;INJECTION 050637-001 Dec 11, 1989 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 Cefmetazole Sodium

Last updated: August 6, 2025

Introduction

Cefmetazole sodium is a second-generation cephalosporin antibiotic recognized for its broad-spectrum activity and efficacy against various bacterial infections. Historically utilized in Asia and parts of Europe, cefmetazole’s role in antimicrobial therapy remains significant amid evolving bacterial resistance patterns. This analysis explores the market forces, regulatory landscape, competitive environment, and financial outlook influencing cefmetazole sodium’s trajectory.

Market Overview and Demand Drivers

The global demand for cefmetazole sodium stems primarily from its application in treating complicated urinary tract infections, intra-abdominal infections, and certain respiratory tract infections. Its efficacy against multidrug-resistant bacteria makes it a strategic choice within hospital settings, especially where antimicrobial stewardship initiatives are increasingly emphasized.

The rise in bacterial resistance to first-line antibiotics has bolstered the use of second-generation cephalosporins like cefmetazole. Additionally, the increased prevalence of healthcare-associated infections (HAIs) propels demand, particularly in regions with advancing healthcare infrastructure.

Regional Market Dynamics

  • Asia-Pacific: Dominates the cefmetazole market, propelled by high infection rates and widespread antibiotic usage. Countries like Japan, China, and South Korea are key consumers due to their advanced healthcare setups and regulatory acceptance.
  • Europe: Limited but steady growth, with regional initiatives to combat antimicrobial resistance influencing the antibiotic’s clinical use.
  • North America: Minimal current usage, primarily because of regulatory approvals being limited or absent. However, potential future demand exists if approvals expand.

Regulatory and Patent Landscape

Cefmetazole sodium’s market landscape is shaped substantially by regulatory approvals and patent statuses. In some markets, it remains off-patent, allowing generic manufacturers to produce and distribute the drug at lower costs, impacting pricing strategies and profit margins.

Regulatory approval remains consistent with national healthcare authorities’ assessments of safety and efficacy. The absence of recent patent protections in major markets like the US and Europe favors generic proliferation, exerting downward pressure on prices but broadening access.

Competitive Environment

The market comprises several key players, including multinational pharmaceuticals and regional generic manufacturers. Companies such as Tahoma, Zhejiang Mastour Pharmaceuticals, and others primarily dominate production, offering cefmetazole sodium at competitive prices.

The competitive advantage hinges on manufacturing capacity, regulatory approvals, distribution networks, and pricing strategies. Despite the presence of generics, innovative formulations or combination therapies could serve as differentiation strategies.

Pricing and Revenue Potential

Pricing varies significantly across regions, primarily driven by regulatory status, manufacturing costs, and market competition. In Asia, cefmetazole often commands higher prices due to its established clinical efficacy and approvals. Conversely, in markets with multiple generics, price erosion continues.

Revenue projections are contingent upon regional demand, the extent of generic competition, and healthcare policies promoting or restricting cephalosporin use. The global cefmetazole market was valued at approximately USD 300 million in 2022, with an expected compound annual growth rate (CAGR) of 4-6% over the next five years, driven by increased bacterial resistance and hospital procurement.

Emerging Trends and Innovation Potential

The key trends influencing cefmetazole’s market include:

  • Emergence of Resistance: Antimicrobial resistance (AMR) heightens demand but also prompts stricter usage policies, balancing growth with stewardship efforts.
  • Test-and-Treat Strategies: Improved diagnostics can optimize cefmetazole use, supporting market stability.
  • Combination Therapies: Developing formulations to enhance efficacy or reduce resistance emergence may create new revenue streams.
  • Regulatory Expansions: Approval in new geographies, particularly North America, could markedly increase demand.

Financial Trajectory and Investment Outlook

Forecasting cefmetazole sodium’s financial future involves considering current growth drivers alongside challenges such as market saturation and regulatory restrictions. Investment perspectives suggest:

  • Positive Outlook: In regions with high infection burdens and limited alternatives, cefmetazole remains a profitable option for manufacturers, especially generics.
  • Risks: Price competition, patent expirations, and antimicrobial stewardship policies pose headwinds.
  • Profit Margins: Margins are attractive in emerging markets where manufacturing costs are lower and regulatory barriers manageable. In developed regions, margins depend on negotiated procurement prices and hospital contracts.

Investors should monitor regulatory updates, resistance trends, and new formulation developments, which directly influence revenue streams.

Market Entry and Expansion Strategies

For current and prospective players, success hinges on strategic considerations:

  • Establishing local manufacturing facilities to reduce costs.
  • Securing regulatory approvals in high-demand markets.
  • Developing unique formulations or combination therapies.
  • Partnering with healthcare providers to promote rational antibiotic use.

Key Challenges and Opportunities

Challenges

  • Increasing antimicrobial resistance complicates clinical application.
  • Price erosion due to generic competition.
  • Regulatory variability across regions.
  • Limited pipeline innovation for cefmetazole-specific derivatives.

Opportunities

  • Expanding into untapped markets with rising infection rates.
  • Developing novel delivery systems to improve patient compliance.
  • Integrating diagnostics to optimize deployment.
  • Policy-driven incentives for antimicrobial development.

Conclusion

Cefmetazole sodium remains a vital part of the antibacterial arsenal, especially within Asia-Pacific markets. Its financial trajectory will continue to be influenced by bacterial resistance patterns, regulatory landscapes, and competitive pressures. Overall, while challenges persist, strategic investments in formulation innovation, regional expansion, and collaborative antimicrobial stewardship can sustain and enhance its market performance.

Key Takeaways

  • Cefmetazole sodium's market is buoyed by increasing bacterial resistance and hospital demand but faces price competition and regulatory constraints.
  • The Asia-Pacific region dominates the market, but opportunities exist for expansion into North American and European territories pending regulatory approvals.
  • Generic manufacturing lowers prices but constrains profit margins; innovation and strategic partnerships offer growth avenues.
  • The global market is projected to grow modestly at 4-6% CAGR through 2027, driven by rising infection rates.
  • Stakeholders should prioritize antimicrobial stewardship and innovative formulations to navigate evolving regulatory and resistance landscapes.

FAQs

1. What are the primary medical indications for cefmetazole sodium?
Cefmetazole sodium is mainly prescribed for complicated urinary tract infections, intra-abdominal infections, gynecological infections, and respiratory tract infections caused by susceptible bacteria.

2. How does antimicrobial resistance impact the cefmetazole market?
Rising antimicrobial resistance increases demand for second-generation cephalosporins like cefmetazole but also prompts stricter usage regulations, influencing market access and pricing.

3. In which regions is cefmetazole sodium most widely used?
Usage is most prominent in Asia-Pacific due to high infection rates and established clinical protocols; its clinical adoption remains limited in North America and parts of Europe.

4. What are the key factors affecting the pricing of cefmetazole sodium?
Pricing is influenced by regional regulatory approvals, competition from generics, manufacturing costs, and hospital procurement policies.

5. What future developments could influence cefmetazole sodium’s market growth?
Emerging formulations, combination therapies, expanding approvals into new geographies, and advancements in rapid diagnostics are vital to future growth.


Sources:
[1] Market Research Future, "Global Cephalosporin Market," 2022.
[2] GlobalData Healthcare, "Antibiotic Market Outlook," 2023.
[3] CDC, "Antimicrobial Resistance Threats Report," 2022.

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