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Last Updated: December 15, 2025

CEFAZOLIN SODIUM - Generic Drug Details


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

Cefazolin sodium is the generic ingredient in eight branded drugs marketed by Glaxosmithkline, Baxter Hlthcare, B Braun, Abraxis Pharm, Acs Dobfar, Aurobindo Pharma, Bedford, Cephazone Pharma, Dr Reddys, Facta Farma, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Hospira, Hospira Inc, Qilu Antibiotics, Samson Medcl, Sandoz, Steri Pharma, Teva Pharms, Lilly, Hq Spclt Pharma, and Baxter Hlthcare Corp, and is included in forty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for cefazolin sodium. Nineteen suppliers are listed for this compound.

Summary for CEFAZOLIN SODIUM
US Patents:0
Tradenames:8
Applicants:23
NDAs:41
Drug Master File Entries: 18
Finished Product Suppliers / Packagers: 19
Raw Ingredient (Bulk) Api Vendors: 67
Clinical Trials: 8
What excipients (inactive ingredients) are in CEFAZOLIN SODIUM?CEFAZOLIN SODIUM excipients list
DailyMed Link:CEFAZOLIN SODIUM at DailyMed
Recent Clinical Trials for CEFAZOLIN SODIUM

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

SponsorPhase
HK Surgical, Inc.Phase 2/Phase 3
University of California, RiversidePhase 2/Phase 3
University of British ColumbiaEarly Phase 1

See all CEFAZOLIN SODIUM clinical trials

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

US Patents and Regulatory Information for CEFAZOLIN SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira Inc CEFAZOLIN SODIUM cefazolin sodium INJECTABLE;INJECTION 065247-001 Aug 12, 2005 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira CEFAZOLIN SODIUM cefazolin sodium INJECTABLE;INJECTION 201654-001 Feb 3, 2016 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
Hikma Farmaceutica CEFAZOLIN SODIUM cefazolin sodium INJECTABLE;INJECTION 065047-002 Sep 18, 2001 AP RX No 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
Sandoz CEFAZOLIN SODIUM cefazolin sodium INJECTABLE;INJECTION 062831-002 Dec 9, 1988 AP RX 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 Cefazolin Sodium

Last updated: July 27, 2025

Introduction

Cefazolin sodium, a first-generation cephalosporin antibiotic, plays a pivotal role in treating susceptible bacterial infections, including surgical prophylaxis, skin infections, and respiratory tract infections. As antibiotic resistance escalates and healthcare demands evolve, understanding the market dynamics and financial trajectory of cefazolin sodium becomes crucial for industry stakeholders, investors, and healthcare providers. This analysis delineates the current landscape, growth drivers, challenges, and forecasts shaping the future of this essential drug.

Market Overview and Current Landscape

Cefazolin sodium's prominence in antimicrobial therapy stems from its efficacy against Gram-positive bacteria and favorable safety profile. The drug's widespread approval across developed and emerging markets underscores its staple status in hospital formularies. The global cephalosporin market, projected to reach approximately USD 21 billion by 2026 (CAGR ~3.7%), includes cefazolin sodium as a significant component[1].

Key players—such as Pfizer, Sagent Pharmaceuticals, Hikma Pharmaceuticals, and others—manufacture cefazolin sodium across various formulations, including vials, pre-filled syringes, and lyophilized powder forms. The market is characterized by a mature product lifecycle but remains dynamically influenced by innovations in formulation, manufacturing efficiencies, and regional demand fluctuations.

Market Drivers

Rising Incidence of Surgical Procedures

A surge in surgical interventions globally, notably in bariatric, cardiovascular, and orthopedic surgeries, amplifies demand for surgical prophylactic antibiotics like cefazolin sodium. Ensuring infection control standards in high-volume surgical settings sustains steady consumption.

Prevalence of Bacterial Infections

The global burden of bacterial infections continues to challenge healthcare systems, with resistant strains emerging. Cefazolin remains a first-line agent for many infections, especially where methicillin-resistant Staphylococcus aureus (MRSA) prevalence is low, maintaining its relevance in therapeutic protocols.

Growth in Healthcare Infrastructure

Expanding healthcare infrastructure, particularly in Asia-Pacific and Latin America, bolsters access to hospital-based treatments. Increased hospital admissions and outpatient procedures contribute to sustained demand for injectable antibiotics, including cefazolin sodium.

Cost-Effectiveness and Accessibility

Economic factors favor cefazolin sodium, which offers an affordable yet effective treatment option in resource-limited settings. Its status as a generic drug further amplifies accessibility and consumption, especially across emerging economies.

Regulatory Approvals and Expansion

Continued approvals for biosimilar formulations and new indications in various regions expand the market footprint. Regulatory streamlining accelerates the pathway for new manufacturing entrants, intensifying competitive dynamics yet potentially reducing prices.

Market Challenges and Constraints

Antibiotic Resistance

The mounting threat of resistance diminishes cefazolin sodium’s efficacy, leading to restricted use in certain infections and regions. Overprescription and misuse foster resistant strains, compelling clinicians to seek alternative therapies.

Stringent Regulatory Environment

Evolving regulatory standards, especially concerning manufacturing practices, labeling, and quality assurance, impose compliance costs. In some markets, regulatory delays impact timely market entry, influencing revenues.

Competition from Modern Antibiotics

Emergence of broad-spectrum and novel antibiotics, such as carbapenems and combination agents, challenges cefazolin’s positioning, particularly in severe or resistant infections where broader coverage is necessary.

Supply Chain Disruptions

Global crises, including pandemics, can disrupt raw material supplies, manufacturing capacities, and logistics, impacting production and pricing. Maintaining consistent supply is vital for retaining market share.

Financial Trajectory and Revenue Projections

Current Revenue Streams

Major pharmaceutical companies generate considerable revenues from cefazolin sodium, predominantly from market segments in North America, Europe, and Asia-Pacific. In 2022, the U.S. accounted for approximately 40% of global cefazolin-related sales, driven by high surgical volume and widespread hospital use[2].

Forecasted Growth Patterns

Analysts project a Compound Annual Growth Rate (CAGR) of approximately 3-4% for cefazolin sodium over the next five years (2023–2028), mainly sustained by rising procedural rates and expanding clinical indications in emerging markets. Despite mature markets nearing saturation, growth potential persists due to increased distribution channels and outpatient use.

Impact of Genericization

The prevalence of generic cefazolin sodium significantly reduces acquisition costs, enhances accessibility, and tempers profit margins for original manufacturers. However, increased competition pressures prices downward—potentially compressing revenue per unit but expanding overall volume sales.

Potential for Innovation and Formulation Improvements

While the core molecule remains unchanged, innovations such as extended-release formulations, combination therapies, and delivery systems could open new revenue avenues. Although currently limited, these developments might influence future market share and profitability.

Strategic Outlook and Market Trends

  • Regional Penetration: Enhanced focus on expanding distribution in underserved regions like Southeast Asia and Africa, where surgical and infection treatment needs are burgeoning.
  • Antibiotic Stewardship: Increased adoption of stewardship programs emphasizes judicious use, potentially limiting excessive usage but ensuring sustained demand where appropriate.
  • Market Consolidation: Larger firms may acquire smaller players to fortify market share, integrate supply networks, and leverage cost efficiencies.
  • Regulatory and Policy Influence: Policies that restrict the overuse of antibiotics or incentivize R&D may reshape market dynamics further.

Regulatory and Patent Landscape

Currently, no patents hinder cefazolin sodium’s production, given its generic status. Nevertheless, regulatory challenges related to manufacturing standards and approvals influence adoption. Patent expirations have historically prompted market entry of biosimilars, intensifying competition.

Key Takeaways

  • The cefazolin sodium market remains steady, supported by high surgical volumes and bacterial infection prevalence.
  • Growth prospects hinge on regional expansion, healthcare infrastructure growth, and innovations in drug delivery.
  • Resistance trends pose a threat; antimicrobial stewardship will guide future consumption practices.
  • Price competition from generics and biosimilars intensifies, requiring manufacturers to optimize costs.
  • The forecast indicates moderate growth, with opportunities in emerging markets and new formulations.

Conclusion

Cefazolin sodium sustains a robust financial trajectory through its entrenched role in clinical practice. While challenges such as resistance and pricing pressures exist, strategic initiatives centered on regional expansion, regulatory compliance, and formulation innovation position stakeholders to capitalize on ongoing demand. Continuous monitoring of resistance trends and healthcare infrastructure development will be pivotal in shaping the drug’s future market landscape.

FAQs

1. How does antibiotic resistance impact the cefazolin sodium market?
Resistance diminishes cefazolin’s clinical utility, leading to reduced prescriptions in resistant infections and prompting clinicians to select broader-spectrum antibiotics. This constrains growth and may shrink market share in resistant-dominant regions.

2. What are the key growth opportunities for cefazolin sodium?
Expanding into emerging markets, investing in formulation innovations like sustained-release preparations, and integrating into outpatient procedures represent primary growth avenues.

3. How does the presence of generic versions influence the market?
Generics lower drug prices and increase accessibility but reduce profit margins for original producers. Market competition from biosimilars and generics accelerates price erosion but expands volume sales.

4. What regulatory factors could affect cefazolin sodium’s future market?
Stringent manufacturing standards, approval processes for new formulations, and policies restricting antibiotic overuse can shape supply, pricing, and clinical application patterns.

5. Will cefazolin sodium remain relevant amidst emerging antibiotics?
Yes, particularly owing to its cost-effectiveness, well-understood safety profile, and efficacy in non-resistant strains. However, its role may diminish in cases involving resistant pathogens requiring broader-spectrum agents.


Sources
[1] MarketsandMarkets. “Cephalosporins Market by Type, Application, Region—Global Forecast to 2026.”
[2] IQVIA and industry reports, 2022.

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