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Last Updated: December 17, 2025

CEFIZOX Drug Patent Profile


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When do Cefizox patents expire, and when can generic versions of Cefizox launch?

Cefizox is a drug marketed by Astellas and is included in three NDAs.

The generic ingredient in CEFIZOX is ceftizoxime sodium. There are five drug master file entries for this compound. Additional details are available on the ceftizoxime sodium profile page.

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Summary for CEFIZOX
Drug patent expirations by year for CEFIZOX
Recent Clinical Trials for CEFIZOX

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SponsorPhase
University of KhartoumPhase 4
Ministry of Health, SudanPhase 4

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US Patents and Regulatory Information for CEFIZOX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas CEFIZOX ceftizoxime sodium INJECTABLE;INJECTION 063294-002 Mar 31, 1994 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Astellas CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER ceftizoxime sodium INJECTABLE;INJECTION 050589-001 Oct 3, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Astellas CEFIZOX ceftizoxime sodium INJECTABLE;INJECTION 050560-003 Sep 15, 1983 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Astellas CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER ceftizoxime sodium INJECTABLE;INJECTION 050589-002 Oct 3, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Astellas CEFIZOX ceftizoxime sodium INJECTABLE;INJECTION 050560-002 Sep 15, 1983 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Astellas CEFIZOX ceftizoxime sodium INJECTABLE;INJECTION 063294-003 Mar 31, 1994 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 the Pharmaceutical Drug: CEFIZOX

Last updated: August 2, 2025

Introduction

CEFIZOX is the trade name for cefazolin sodium, a widely used first-generation cephalosporin antibiotic. It is primarily prescribed to treat a variety of bacterial infections, including respiratory tract infections, urinary tract infections, skin infections, and surgical prophylaxis. Over recent years, the global pharmaceutical landscape has experienced significant shifts driven by technological innovation, regulatory adaptations, and evolving healthcare needs. This analysis explores CEFIZOX’s current market dynamics and projects its financial trajectory, considering factors such as competitive landscape, regulatory environment, manufacturing capabilities, and market demand.

Market Overview of Cefazolin (CEFIZOX)

Global Population and Disease Burden

The rising prevalence of bacterial infections globally fuels demand for cephalosporins like CEFIZOX. According to the World Health Organization (WHO), bacterial infections remain one of the leading causes of morbidity and mortality worldwide, especially in low- and middle-income countries where access to advanced healthcare can be limited. The aging population further intensifies demand, as older adults are more susceptible to infections requiring antibiotic intervention.

Therapeutic Position and Market Share

CEFIZOX’s positioning as a first-generation cephalosporin emphasizes its role in prophylactic and empiric therapy, especially in surgical settings. Its efficacy against Gram-positive bacteria makes it a preferred choice in hospitals. However, the rise of antibiotic resistance, particularly among pathogens like Escherichia coli and Staphylococcus aureus, threatens its dominance. Nonetheless, CEFIZOX remains vital due to its favorable safety profile, low resistance rates in certain settings, and cost-effectiveness.

Key Market Players and Manufacturing Landscape

Major pharmaceutical producers include Pfizer, Sandoz, Hikma Pharmaceuticals, and generic manufacturers globally. Several manufacturers benefit from longstanding production agreements and extensive distribution networks, with the generic segment holding a significant share. The patent expiry of cefazolin formulations has facilitated market entry for low-cost generics, intensifying competition and impacting pricing strategies.


Market Dynamics Influencing CEFIZOX

1. Regulatory Environment and Approvals

The stringent regulatory landscape across regions like the United States (FDA), European Union (EMA), and Asia-Pacific (China’s NMPA) influences market entry and continuation. While CEFIZOX’s established safety record aids in ongoing approvals, modifications in labeling or clinical guidelines can impact sales. Moreover, emerging regulations targeting antimicrobial stewardship programs aim to restrict overuse, potentially curbing volume growth.

2. Antibiotic Resistance and Efficacy Challenges

The surge in antimicrobial resistance (AMR) is a critical concern. As pathogens develop resistance to first-generation cephalosporins, the clinical utility of CEFIZOX diminishes in certain settings. The World Health Organization’s global action plan on AMR emphasizes prudent antibiotic use, which could influence prescriptions. Conversely, ongoing research into combination therapies and novel formulations may sustain or enhance CEFIZOX’s relevance.

3. Technological Innovations and Formulation Advancements

Modern manufacturing processes have enabled the production of stable, high-quality formulations with extended shelf lives. The advent of fixed-dose combinations and sustained-release formulations could expand CEFIZOX’s applications, particularly in outpatient settings. Additionally, advancements in prefilled syringes and powder formulations improve ease of administration, boosting adoption in hospitals.

4. Market Penetration and Distribution Dynamics

Developing markets are witnessing increased penetration due to rising healthcare infrastructure and a push for affordable generic antibiotics. Distributors are expanding their reach into rural and underserved areas, catalyzed by global initiatives to improve infection control. However, regulatory hurdles and local competition often impede rapid expansion.

5. Impact of COVID-19 Pandemic

The COVID-19 pandemic disrupted global supply chains and shifted healthcare priorities. While antibiotics like CEFIZOX are not used directly against SARS-CoV-2, secondary bacterial infections in COVID-19 patients increased demand for broad-spectrum antibiotics initially. Post-pandemic, market adjustments focus on restoring supply chains and aligning with updated clinical guidelines.


Financial Trajectory Analysis

Historical Revenue and Sales Trends

The global cephalosporin market, including CEFIZOX, has demonstrated steady growth driven by the increasing incidence of bacterial infections. The antibiotic segment remains resilient despite concerns over antimicrobial resistance. As of 2022, the cefazolin market is estimated at approximately $600 million USD, projected to grow at a Compound Annual Growth Rate (CAGR) of 4-6% over the next five years.

Factors Propelling Future Growth

  • Expanding Global Access: Increased healthcare infrastructure investments, particularly in Asia-Pacific, Africa, and Latin America, expand access to antibiotics.
  • Aging Populations: The prevalence of age-related infections sustains demand.
  • Hospitalization Rates: Growing surgical procedures and hospital admissions, especially for invasive interventions, heighten prophylactic antibiotic use.
  • Government and Institutional Policies: Emphasis on infection control and antimicrobial stewardship frameworks may foster consistent demand within hospitals.

Challenges and Risks to Financial Growth

  • Antimicrobial Resistance (AMR): Rising resistance may limit clinical use, compelling shifts toward newer or combination therapies, potentially reducing CEFIZOX sales.
  • Regulatory Restrictions: Implementation of stricter prescribing guidelines can deter inappropriate use.
  • Market Saturation of Generics: Price competition among numerous generic manufacturers constrains profit margins.
  • Patent and Exclusivity Limitations: The expiration of key patents has facilitated generics proliferation, impacting revenue potential for branded formulations.

Forecasting Future Revenues

Given current trends, the CEFIZOX market is poised for moderate growth until 2030. The primary revenue drivers include increased global healthcare expenditure, expanding surgical volumes, and moderate penetration into emerging markets. Pharmaceutical companies investing in production optimization and formulations tailored for outpatient use will likely benefit most. However, growth may plateau or decline if resistance trends intensify and lead to reduced prescribing patterns.


Emerging Opportunities and Strategic Considerations

Combination Therapies and Follow-on Indications

The development of combination therapies incorporating cefazolin to combat resistant bacteria presents a viable growth avenue. Additionally, leveraging new indications, such as osteomyelitis or complicated urinary tract infections, could expand market reach.

Biotechnology and Biosimilars

While biosimilars predominantly relate to biological products, advancements in antimicrobial biosimilars could catalyze pricing strategies and market competition further.

Innovation in Delivery Platforms

Innovations such as long-acting formulations, liposomal encapsulation, and microarray delivery could improve patient compliance and broaden therapeutic applications.


Conclusion

The market for CEFIZOX/cefazolin is characterized by steady demand driven by its efficacy, safety, and cost-effectiveness. While the expansion into emerging markets and technological advancements contribute positively, the overarching challenge posed by antimicrobial resistance necessitates strategic adaptations. Market players focusing on formulation innovation, adherence to stewardship guidelines, and diversification of indications are well-positioned to capitalize on future opportunities.

Key Takeaways

  • Consistent Demand: CEFIZOX remains essential in bacterial infection management, particularly in surgical prophylaxis.
  • Competitive Landscape: The proliferation of generics reduces pricing power but ensures widespread availability.
  • Resistance Concerns: AMR trends could curtail future use, necessitating strategic repositioning.
  • Growth Opportunities: Emerging markets, new formulations, and combination therapies offer avenues for revenue expansion.
  • Regulatory and Stewardship Impact: Evolving healthcare policies will shape prescribing patterns and market potential.

FAQs

1. What factors could impact the future sales of CEFIZOX globally?
Emerging antimicrobial resistance, regulatory restrictions, pricing pressures from generics, and shifts toward newer antibiotics are primary factors influencing sales. Conversely, expanding healthcare infrastructure and aging populations sustain demand.

2. How does antimicrobial resistance affect CEFIZOX’s market?
Rising resistance among common pathogens reduces the clinical efficacy of cefazolin, potentially limiting its use and prompting a shift toward alternative therapies, impacting revenues.

3. Are there ongoing innovations that could rejuvenate CEFIZOX’s market prospects?
Yes. Development of fixed-dose combination formulations, long-acting injectables, and novel delivery systems can enhance clinical utility and patient compliance.

4. What are the key geographic markets for CEFIZOX?
North America, Europe, and Asia-Pacific are primary markets. Growth is particularly strong in low- and middle-income countries where healthcare access improves and generic markets dominate.

5. How might healthcare policies influence CEFIZOX’s market trajectory?
Policies promoting antimicrobial stewardship and restricting overuse could temper growth but ensure sustainable demand focused on appropriate indications.


Sources:

  1. World Health Organization (WHO). Global antimicrobial resistance surveillance system. 2022.
  2. MarketWatch. Cefazolin Market Size, Share, Trends & Growth Analysis. 2023.
  3. Pfizer Annual Reports. 2022.
  4. Sandoz Corporate Website. Product Portfolio. 2023.
  5. European Medicines Agency (EMA). Cefazolin Monograph. 2022.

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