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Last Updated: November 6, 2025

CEFAZOLIN AND DEXTROSE Drug Patent Profile


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When do Cefazolin And Dextrose patents expire, and what generic alternatives are available?

Cefazolin And Dextrose is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in CEFAZOLIN AND DEXTROSE is cefazolin sodium. There are twenty-seven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cefazolin And Dextrose

A generic version of CEFAZOLIN AND DEXTROSE was approved as cefazolin sodium by SANDOZ on December 9th, 1988.

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Drug patent expirations by year for CEFAZOLIN AND DEXTROSE
Recent Clinical Trials for CEFAZOLIN AND DEXTROSE

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SponsorPhase
Hamilton Health Sciences CorporationPHASE4
Asan Medical CenterNA
Canadian Institutes of Health Research (CIHR)PHASE4

See all CEFAZOLIN AND DEXTROSE clinical trials

Pharmacology for CEFAZOLIN AND DEXTROSE

US Patents and Regulatory Information for CEFAZOLIN AND DEXTROSE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun CEFAZOLIN AND DEXTROSE cefazolin sodium INJECTABLE;INJECTION 050779-002 Jul 27, 2000 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun CEFAZOLIN AND DEXTROSE cefazolin sodium INJECTABLE;INJECTION 050779-001 Jul 27, 2000 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun CEFAZOLIN AND DEXTROSE cefazolin sodium INJECTABLE;INJECTION 050779-003 Jan 13, 2012 RX Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun CEFAZOLIN AND DEXTROSE cefazolin sodium INJECTABLE;INJECTION 050779-004 Aug 26, 2024 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 Cefazolin and Dextrose

Last updated: August 3, 2025

Introduction

Cefazolin combined with dextrose remains an essential component of antimicrobial therapy, particularly in surgical prophylaxis and infection management. The pharmaceutical landscape surrounding this combination involves multiple facets influencing its market growth, including clinical demand, regulatory pathways, manufacturing trends, and competitive pressures. Analyzing these dynamics provides insights into its financial trajectory and strategic positioning within the global pharmaceutical market.


Market Overview

Cefazolin, a first-generation cephalosporin antibiotic, exhibits broad-spectrum activity against many gram-positive and some gram-negative bacteria. It is predominantly used for surgical prophylaxis, skin infections, and respiratory tract infections. Dextrose, a form of glucose, is commonly used as an excipient or carrier in injectable formulations, facilitating reconstitution and enhancing stability.

The combination of cefazolin and dextrose is typically administered as an injectable solution, often as a part of preoperative care or for treating specific infections where intravenous therapy is indicated.


Market Drivers

Rising Surgical Procedures and Infection Control Needs

Global increases in surgeries—particularly orthopedics, cardiovascular, and gastrointestinal operations—drive demand for effective antibiotic prophylaxis like cefazolin. The World Health Organization (WHO) reports a consistent rise in surgical interventions, necessitating dependable antimicrobial agents to prevent postoperative infections [1].

Antibiotic Stewardship and Resistance Patterns

The shift towards targeted antibiotic use spurs growth in cephalosporin prescriptions. Cefazolin’s favorable safety profile and efficacy against common pathogens such as Staphylococcus aureus make it a preferred option in many clinical settings. However, the emergence of resistant strains (e.g., MRSA) exerts pressure to develop newer agents, impacting long-term market growth.

Regulatory Approvals and Manufacturing Trends

Generic manufacturing of cefazolin solutions combined with dextrose is widespread, leading to price competition yet ensuring broad accessibility. Regulatory approvals in emerging markets expand the geographic footprint, further stimulating sales, especially where healthcare infrastructure is growing rapidly.

Pharmaceutical Innovation and Formulation Optimization

Efforts to enhance stability, shelf life, and ease of administration through novel formulations (e.g., preservative-free solutions, lyophilized powders reconstituted with dextrose) bolster market appeal. These innovations improve patient compliance, paving the way for sustained demand.


Market Challenges

Antimicrobial Resistance and Therapeutic Limitations

Rising resistance diminishes cefazolin's clinical utility, prompting clinicians to deploy alternative agents. This trend poses a threat to long-term sales stability and mandates ongoing investment in surveillance and stewardship programs.

Regulatory Hurdles and Patent Lifecycles

While many cefazolin products are off-patent, regulatory delays or stringent approval processes in certain jurisdictions can hinder market expansion. Additionally, patent protections on formulations or delivery devices may temporarily restrict commercialization of innovative versions.

Pricing Pressures and Competitive Landscape

High manufacturing costs, coupled with intense price competition among generics, pressure profit margins. Governments’ procurement policies favor low-cost antibiotics, especially in low- and middle-income countries (LMICs), constraining revenue potential.


Financial Trajectory and Market Forecast

Current Market Valuation

The global injectable antibiotics market, including cefazolin and dextrose formulations, was valued at approximately USD 7.2 billion in 2022, with cephalosporins representing the largest segment within antibiotics—driven by their broad-spectrum activity and historical efficacy [2].

Projected Growth

Analysts forecast a compounded annual growth rate (CAGR) of about 3.2% over the next five years for cefazolin-based formulations, reaching an estimated USD 8.8 billion by 2027. The growth trajectory is supported by increasing surgical cases, expanding access in LMICs, and ongoing formulation innovations.

Regional Market Dynamics

North America dominates the market, propelled by high surgical volumes, stringent clinical guidelines, and advanced healthcare infrastructure. The Asia-Pacific region exhibits the fastest growth potential, attributed to rising healthcare investments, expanding hospital networks, and increased antibiotic prescriptions.

Impact of Biosimilars and Generics

The proliferation of generic manufacturers ensures competitive pricing but limits profit margins. The entry of biosimilars or advanced formulations could alter the dynamics further, although the complex manufacturing process for biologics contrasts with small molecule antibiotics like cefazolin.


Regulatory and Economic Factors

FDA and EMA Approvals

Regulatory bodies prioritize approvals for cefazolin formulations with proven safety and efficacy, with some jurisdictions embracing new delivery mechanisms or stability profiles. Streamlined approval pathways support faster market entry for innovative formulations.

Market Entry Barriers

Barriers include maintaining manufacturing quality, achieving regulatory compliance across different regions, and competing in an environment saturated with generic options. Strategic partnerships and local manufacturing can mitigate these challenges.

Pricing and Reimbursement Policies

Price sensitivity varies globally. In high-income markets, reimbursement schemes support more consistent revenue streams. Conversely, price caps and procurement tenders in LMICs necessitate cost-effective production strategies to sustain margins.


Strategic Outlook

Innovation and Differentiation

Manufacturers focusing on patenting novel formulations, such as extended-release variants or combination products with enhanced stability in dextrose solutions, can differentiate offerings and command premium pricing.

Market Expansion Strategies

Targeting emerging markets through partnerships with local distributors and tailored pricing models will improve market penetration. Education campaigns emphasizing cefazolin's efficacy can also stimulate demand.

Monitoring Resistance Trends

Investing in antimicrobial stewardship programs and developing rapid diagnostic tools are vital for maintaining clinical relevance, especially as resistance evolves. companies should anticipate shifts toward alternative therapies and adapt their portfolios accordingly.


Key Takeaways

  • The cefazolin and dextrose combination maintains a significant role in infection control, especially in surgical prophylaxis.
  • Market growth is driven by increasing surgical procedures, rising demand in emerging markets, and formulation innovations.
  • Resistance patterns and regulatory landscapes pose challenges, requiring ongoing R&D and compliance strategies.
  • Competitive dynamics favor generic manufacturers, with a preference for cost-effective production and strategic regional expansion.
  • The financial outlook remains positive with projected CAGR of over 3%, yet long-term sustainability depends on innovation and adaptation to resistance trends.

Frequently Asked Questions

  1. What are the primary clinical uses of cefazolin combined with dextrose?
    Cefazolin with dextrose is mainly used for surgical prophylaxis, treatment of bacterial infections, and in settings requiring intravenous antibiotics. The dextrose acts as a solvent and carrier, facilitating reconstitution of the medication for injection.

  2. How does antimicrobial resistance impact the market for cefazolin formulations?
    Resistance diminishes cefazolin's efficacy against certain pathogens, leading clinicians to select alternative antibiotics. This trend can limit market growth unless new formulations or delivery methods address resistance challenges.

  3. Are there significant regulatory hurdles in expanding the cefazolin and dextrose market globally?
    Yes, especially in regions with stringent approval processes or limited regulatory infrastructure. Achieving regulatory approval for new formulations or combinations may require comprehensive clinical data and compliance with diverse standards.

  4. What technological innovations are influencing the future market of cefazolin formulations?
    Innovations include developing extended-release formulations, preservative-free solutions, and formulations optimized for stability with dextrose. These enhance patient compliance and product shelf-life, offering market differentiation.

  5. Which regions are expected to exhibit the fastest growth in the cefazolin and dextrose market?
    The Asia-Pacific region is projected to experience rapid growth driven by expanding healthcare infrastructure, increasing surgeries, and rising adoption of injectable antibiotics in emerging markets.


References

  1. WHO Surgical Site Infection Prevention. World Health Organization, 2020.
  2. Global Injectable Antibiotics Market Report, 2022. MarketResearch.com.

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