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Last Updated: December 30, 2025

CEFOPERAZONE SODIUM - Generic Drug Details


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

Cefoperazone sodium is the generic ingredient in two branded drugs marketed by Pfizer and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for cefoperazone sodium.

Summary for CEFOPERAZONE SODIUM
Recent Clinical Trials for CEFOPERAZONE SODIUM

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

SponsorPhase
Yung Shin Pharm. Ind. Co., Ltd.Phase 4
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all CEFOPERAZONE SODIUM clinical trials

Medical Subject Heading (MeSH) Categories for CEFOPERAZONE SODIUM

US Patents and Regulatory Information for CEFOPERAZONE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer CEFOBID cefoperazone sodium INJECTABLE;INJECTION 063333-002 Mar 31, 1995 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer CEFOBID cefoperazone sodium INJECTABLE;INJECTION 050551-003 Mar 5, 1990 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer CEFOBID IN PLASTIC CONTAINER cefoperazone sodium INJECTABLE;INJECTION 050613-001 Jul 23, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer CEFOBID cefoperazone sodium INJECTABLE;INJECTION 050551-002 Nov 18, 1982 DISCN No 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 Cefoperazone Sodium

Last updated: August 1, 2025


Introduction

Cefoperazone sodium, a third-generation cephalosporin antibiotic, has played a significant role in combating bacterial infections since its initial approval. With increasing global antibiotic consumption, evolving resistance patterns, and advancements in pharmaceutical manufacturing, the market for cefoperazone sodium exhibits intricate dynamics influenced by multiple factors. This analysis delves into the current market landscape, growth drivers, challenges, and financial trajectories shaping cefoperazone sodium's commercial future.


Market Overview and Demand Drivers

Global Market Size and Growth Trends

The global cephalosporin antibiotics market was valued at USD 16.2 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of approximately 4.2% through 2030 [1]. Cefoperazone sodium accounts for a notable segment within the third-generation cephalosporins, primarily driven by its broad-spectrum activity and favorable pharmacokinetics.

Increasing Incidence of Bacterial Infections

The escalating prevalence of bacterial infections such as pneumonia, urinary tract infections, and intra-abdominal infections sustains demand for cefoperazone sodium. The World Health Organization (WHO) reports rising infectious disease burdens, especially in developing economies, underpinning therapeutic needs [2].

Medical Advancements and Surgical Applications

Cefoperazone sodium's efficacy in perioperative prophylaxis in surgeries and its utility in managing hospital-acquired infections (HAIs) support sustained demand. As healthcare systems advance, antibiotic use remains integral, bolstering the market trajectory.

Emerging Markets Expansion

Rapid urbanization and increased healthcare infrastructure investment in Asia-Pacific, Latin America, and Africa are expanding the footprint for cefoperazone sodium. Notably, China emerged as one of the largest markets, with significant clinical adoption [3].


Market Dynamics Influencing Cefoperazone Sodium

Antibiotic Resistance and Prescription Practices

A key challenge lies in escalating antimicrobial resistance (AMR). Resistant strains diminish efficacy, leading to cautious prescription practices. Governments and health authorities advocate for stewardship programs, potentially constraining volume growth but increasing demand for novel formulations or combination therapies [4].

Regulatory Landscape

Regulatory approvals, manufacturing standards, and patent statuses impact market entry and profitability. Since cefoperazone sodium has been off-patent for years, generic manufacturers dominate, increasing competitive pressure but reducing prices.

Manufacturing and Supply Chain Considerations

The complex synthesis of cefoperazone sodium involves multiple steps, necessitating robust supply chains for raw materials (e.g., 3-aminophenylacetic acid). Disruptions, such as those caused by geopolitical tensions or pandemics, can threaten supply stability and price stability.

Competitive Landscape

Generic manufacturers like Sandoz, Lupin, and Teva heavily produce cefoperazone sodium, leading to price erosion. Innovative competitors explore combination formulations or new delivery systems to differentiate products.


Financial Trajectory and Revenue Projections

Pricing Trends

The global average price for cefoperazone sodium has declined over the past decade, correlated with increased generic market penetration. Price erosion, however, is offset by volume growth in emerging markets.

Revenue Generation and Market Share

In 2022, sales of cefoperazone sodium accounted for approximately USD 245 million globally, forecasted to reach nearly USD 320 million by 2030, driven predominantly by Asian markets and hospitals in Latin America [5].

Profitability and Margins

Profit margins are sensitive to manufacturing costs and competitive pricing. Multinational firms focus on operational efficiencies, while regional producers leverage lower production costs to capture market share.

Impact of Regulatory and Social Factors

Stringent healthcare regulations and antibiotic stewardship initiatives may lead to reduced antibiotic utilization, tempering growth. Conversely, expanding indications and combination therapies may open new revenue streams.


Future Market Drivers

  • Combination Therapies: Increasing adoption of cefoperazone sodium with beta-lactamase inhibitors to combat resistant bacteria.
  • Innovative Delivery Systems: Development of sustained-release formulations or injectable preparations to enhance bioavailability and compliance.
  • Expanding Indications: Emerging evidence supports use in multidrug-resistant bacterial strains, broadening clinical application.
  • Government Initiatives: Enhanced focus on infection control and antimicrobial stewardship in healthcare globally.

Challenges and Market Constraints

  • Antimicrobial Resistance: Resistance reduces clinical efficacy and exerts pressure on pricing.
  • Regulatory Hurdles: Variability in approvals across countries limits rapid market expansion.
  • Pricing Pressures: Cost-containment policies in healthcare systems constrain revenue growth.
  • Global Supply Chain Vulnerabilities: Raw material shortages and logistic disruptions affect manufacturing and delivery.

Concluding Perspectives

Cefoperazone sodium's market is poised for moderate growth, primarily fueled by increased infectious disease prevalence and expanding healthcare infrastructure in underserved regions. Nevertheless, the trajectory faces headwinds from antimicrobial resistance, regulatory fluctuations, and price pressures. Strategic adaptation, including formulation innovation and geographic diversification, will be critical for stakeholders aiming to optimize financial outcomes.


Key Takeaways

  • The global cefoperazone sodium market is projected to grow at approximately 3.5-4.0% annually, driven by rising bacterial infections and expanding healthcare markets.
  • Generic manufacturing dominates the landscape, leading to price competition but also wider accessibility.
  • Antimicrobial resistance challenges the clinical utility and economic viability, emphasizing the need for novel formulations and combination therapies.
  • Emerging markets present substantial growth opportunities but require navigating complex regulatory environments.
  • Stakeholders should focus on supply chain resilience, antimicrobial stewardship initiatives, and R&D for innovative drug delivery systems to capitalize on future growth.

FAQs

1. What factors are most influencing the current market for cefoperazone sodium?
Rising bacterial infections, global antibiotic demand, the prevalence of antimicrobial resistance, generics competition, and healthcare infrastructure development are primary drivers.

2. How does antimicrobial resistance impact cefoperazone sodium's market?
Resistance reduces effectiveness, prompting cautious prescribing and potentially limiting use, which can suppress sales growth but also drive demand for combination drugs or new formulations.

3. What are the key regions contributing to cefoperazone sodium sales?
Asia-Pacific leads, with significant contributions from China and India. Latin America and parts of Africa are experiencing growth due to expanding healthcare access.

4. Are there upcoming innovations in cefoperazone sodium formulations?
Yes, research focuses on sustained-release injections, combination therapies, and improved delivery methods to enhance efficacy and compliance.

5. What should investors and pharmaceutical companies consider for future profitability?
Focus on R&D for new formulations, diversify geographic markets, integrate stewardship programs to mitigate resistance, and optimize manufacturing costs.


References

[1] Global Market Insights, "Antibiotics Market Size & Trends," 2023.
[2] WHO, "Global Infectious Disease Burden," 2022.
[3] IMS Health Reports, "Emerging Markets Healthcare Analysis," 2023.
[4] CDC, "Antimicrobial Resistance Challenges," 2022.
[5] MarketResearch.com, "Cephalosporin Antibiotics Market Forecast," 2023.

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