You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 15, 2025

CEFOTAXIME SODIUM - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for cefotaxime sodium and what is the scope of freedom to operate?

Cefotaxime sodium is the generic ingredient in seven branded drugs marketed by Fresenius Kabi Usa, Hikma, Wockhardt, B Braun, Aurobindo Pharma, Aurobindo Pharma Ltd, Cephazone Pharma, Hospira, Hospira Inc, Lupin, Sanofi Aventis Us, and Sterimax, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for cefotaxime sodium. One supplier is listed for this compound.

Recent Clinical Trials for CEFOTAXIME SODIUM

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

SponsorPhase
Fayoum University HospitalPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4

See all CEFOTAXIME SODIUM clinical trials

Pharmacology for CEFOTAXIME SODIUM
Medical Subject Heading (MeSH) Categories for CEFOTAXIME SODIUM

US Patents and Regulatory Information for CEFOTAXIME SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma CEFOTAXIME SODIUM cefotaxime sodium INJECTABLE;INJECTION 065517-002 Nov 6, 2009 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Aurobindo Pharma CEFOTAXIME SODIUM cefotaxime sodium INJECTABLE;INJECTION 065517-001 Nov 6, 2009 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira Inc CEFOTAXIME SODIUM cefotaxime sodium INJECTABLE;INJECTION 065292-001 Aug 10, 2006 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER cefotaxime sodium INJECTABLE;INJECTION 050792-001 Jul 29, 2004 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Lupin CEFOTAXIME SODIUM cefotaxime sodium INJECTABLE;INJECTION 065124-002 Sep 24, 2003 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hikma CEFOTAXIME cefotaxime sodium INJECTABLE;INJECTION 065071-001 Nov 20, 2002 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa CEFOTAXIME cefotaxime sodium INJECTABLE;INJECTION 064200-002 Mar 24, 2000 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 Cefotaxime Sodium

Last updated: July 28, 2025

Introduction

Cefotaxime sodium is a third-generation cephalosporin antibiotic widely used to treat a broad spectrum of bacterial infections. Its efficacy in combating serious infections like pneumonia, septicemia, and meningitis has established it as a critical component of hospital formularies worldwide. Understanding the market dynamics and financial trajectory of cefotaxime sodium involves examining manufacturing trends, regulatory pathways, competitive landscape, demand drivers, and pricing strategies. As antibiotic resistance escalates and healthcare settings evolve, these factors influence the drug’s commercial potential and investment viability.


Market Overview and Industry Background

The global cephalosporin antibiotics market, valued at approximately USD 18 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of around 3.5% over the next five years [1]. Cefotaxime sodium represents a significant segment within this domain, primarily employed in hospital settings for severe bacterial infections.

The increasing prevalence of multidrug-resistant bacteria, such as extended-spectrum beta-lactamase (ESBL) producers, underscores the importance of third-generation cephalosporins. Yet, this same antimicrobial resistance (AMR) challenge threatens to limit cefotaxime’s efficacy, potentially impacting sales and driving demand for newer agents or combination therapies.


Market Dynamics

Supply and Manufacturing Landscape

Cefotaxime sodium is manufactured predominantly by multinational pharmaceutical giants and select generic producers. The synthesis involves complex chemical processes requiring high-purity reagents, stringent quality controls, and compliance with regulatory standards such as the FDA and EMA.

Most manufacturers operate in India, China, and Europe, leveraging cost advantages and established supply chains. The market has witnessed increased investments in process optimization and biosynthesis innovations to reduce costs and improve yields, thereby affecting the overall supply chain stability.

Regulatory Environment

Regulatory agencies scrutinize manufacturing practices, especially amid global concerns over antibiotic stewardship. Generic manufacturers often face patent expirations, enabling market entry and price competition. Conversely, new formulations or drug delivery systems incorporating cefotaxime sodium may require extensive clinical trials, impacting time-to-market and profit margins.

In recent years, regulatory agencies have emphasized antimicrobial stewardship programs, which can influence prescribing practices, potentially disrupting demand patterns for cefotaxime sodium.

Market Demand Drivers

  • Infectious Disease Burden: Rising incidents of hospital-acquired infections (HAIs) and community-onset bacterial infections sustain demand for broad-spectrum antibiotics.
  • Hospitalization Trends: Growth in inpatient care, especially in aging populations, drives consumption.
  • Antimicrobial Resistance: While AMR limits some antibiotics' utility, cefotaxime remains a frontline agent in many regions, especially where resistance patterns are still manageable.
  • Global Health Initiatives: Efforts to combat infectious diseases continue to incentivize antibiotic availability and access.
  • Emergence of Resistance: Increasing resistance could necessitate shifts toward combination therapies or alternative drugs, constraining future demand for cefotaxime.

Competitive Landscape

The market is highly competitive, with generic manufacturers dominating due to patent expirations and cost-effective manufacturing. Innovative formulations and conjugates aim to improve activity and pharmacokinetics, offering potential market differentiation. However, competition from other third-generation cephalosporins like ceftriaxone and cefepime, and newer agents addressing resistant pathogens, could limit cefotaxime’s growth.


Financial Trajectory and Market Forecast

Pricing Trends and Revenue Estimates

Pricing strategies for cefotaxime sodium vary regionally, influenced by manufacturers' cost structures, regulatory requirements, and market competition. Generic entry typically precipitates price erosion, with wholesale prices declining by an average of 10-15% annually in mature markets [2].

Global sales are projected to reach approximately USD 1.2 billion by 2025, reflecting a CAGR of around 4%, driven mainly by emerging markets such as India, Brazil, and Southeast Asia, where infection rates are high, and healthcare infrastructure expands [3].

Profitability Considerations

Margins for cefotaxime sodium are influenced by raw material costs, manufacturing efficiencies, and regulatory compliance investments. In developed markets, price negotiations and reimbursement pressures reduce profitability, while in developing regions, volume-based sales maintain competitiveness.

Risks Impacting Financial Trajectory

  • Antimicrobial Stewardship: Policies promoting judicious use may constrain volume sales.
  • AMR: Rising resistance diminishes clinical efficacy, pushing for alternative therapies, or combination regimens involving cefotaxime.
  • Regulatory Changes: Stricter approval requirements or import restrictions can impact supply chains and margins.
  • Patent Expirations: Though cefotaxime sodium is off-patent, new formulations or combinations could face patent protections, creating revenue opportunities.

Future Outlook and Strategic Considerations

The financial trajectory will hinge on balancing generic price erosion with volume growth in emerging markets. Companies investing in process innovations or novel delivery systems can generate premium pricing, enhancing profitability. Furthermore, partnerships with healthcare providers and investments in antimicrobial stewardship stewardship programs can help sustain demand.

The ongoing need for effective antibiotics amid rising resistance underscores cefotaxime sodium's continuing relevance, but the market will likely evolve toward combination therapies and improved formulations. Companies must monitor resistance patterns, regulatory shifts, and regional epidemiology to optimize their go-to-market strategies.


Key Takeaways

  • The global cefotaxime sodium market is poised for steady growth, primarily driven by demand in developing regions and hospital settings.
  • Price competition and patent expirations exert downward pressure on margins, emphasizing the importance of manufacturing efficiencies and value-added formulations.
  • Antimicrobial resistance poses both a challenge and a catalyst; while resistance limits efficacy, it also incentivizes innovation and strategic positioning.
  • Regulatory policies emphasizing antimicrobial stewardship influence prescribing patterns and market size.
  • Diversified portfolio strategies, including novel delivery systems and combination therapies, can mitigate market saturation risks and amplify long-term profitability.

FAQs

Q1: What factors are likely to influence cefotaxime sodium’s market growth over the next five years?
Demand remains robust in regions with high infectious disease burdens, but antimicrobial resistance and antimicrobial stewardship policies could temper growth. Cost-effective manufacturing and product innovation will be crucial for capturing market share.

Q2: How does antimicrobial resistance impact cefotaxime sodium’s profitability?
Rising resistance diminishes clinical utility, potentially reducing sales volume. However, in regions where resistance remains manageable, cefotaxime continues to generate reliable revenue, especially through generic options.

Q3: What are the main competitive threats facing cefotaxime sodium?
Emerging therapies, such as new-generation cephalosporins, beta-lactamase inhibitors, and combination agents, threaten to erode market share. Patent expirations further intensify price competition.

Q4: How are regulatory policies shaping the future of cefotaxime sodium?
Regulatory emphasis on antimicrobial stewardship and drug safety can restrict prescribing practices. Additionally, approvals for innovative formulations may create new commercialization opportunities while complicating regulatory pathways for generics.

Q5: What strategic moves can manufacturers adopt to maintain profitability?
Investing in process innovation, developing combination therapies, exploring new delivery systems, and forming strategic alliances with healthcare systems can enhance market positioning and revenue streams.


References

  1. Global Antibiotics Market Report, 2022-2027. [Industry Research, 2022].
  2. Pharmaceutical Pricing Trends, 2022. Pharma Price Index.
  3. Emerging Markets Outlook for Antibiotics, 2022. WHO Global Antimicrobial Resistance Surveillance System (GLASS).

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.