CEFUROXIME SODIUM - Generic Drug Details

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

Cefuroxime sodium is the generic ingredient in seven branded drugs marketed by B Braun, Acs Dobfar Spa, Fresenius Kabi Usa, Hikma, Hospira Inc, Teva Pharms, Watson Labs Inc, Samson Medcl, Acs Dobfar, Lilly, and Pai Holdings Pharm, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for cefuroxime sodium. Three suppliers are listed for this compound.

Summary for CEFUROXIME SODIUM

US Patents:	0
Tradenames:	7
Applicants:	11
NDAs:	20
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Patent Applications:	1,127
What excipients (inactive ingredients) are in CEFUROXIME SODIUM?	CEFUROXIME SODIUM excipients list
DailyMed Link:	CEFUROXIME SODIUM at DailyMed

Recent Clinical Trials for CEFUROXIME SODIUM

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

Sponsor	Phase
The George Institute	PHASE3
Turku University Hospital	PHASE3
Helsinki University Central Hospital	PHASE3

See all CEFUROXIME SODIUM clinical trials

Pharmacology for CEFUROXIME SODIUM

Drug Class

Cephalosporin Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for CEFUROXIME SODIUM

J01DC	Second-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for CEFUROXIME SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pai Holdings Pharm	ZINACEF	cefuroxime sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	050558-002	Oct 19, 1983		DISCN	Yes	No
Watson Labs Inc	CEFUROXIME SODIUM	cefuroxime sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	064035-001	Feb 26, 1993		DISCN	No	No
Lilly	KEFUROX	cefuroxime sodium	INJECTABLE;INJECTION	062592-002	Jan 10, 1986		DISCN	No	No
Lilly	KEFUROX IN PLASTIC CONTAINER	cefuroxime sodium	INJECTABLE;INTRAVENOUS	062590-001	Jan 10, 1986		DISCN	No	No
Pai Holdings Pharm	ZINACEF IN PLASTIC CONTAINER	cefuroxime sodium	INJECTABLE;INJECTION	050643-002	Apr 28, 1989		DISCN	Yes	No
Pai Holdings Pharm	ZINACEF	cefuroxime sodium	INJECTABLE;INJECTION	050558-003	Oct 19, 1983		DISCN	Yes	No

Market Dynamics and Financial Trajectory for Cefuroxime Sodium

Last updated: July 28, 2025

Introduction

Cefuroxime sodium, a second-generation cephalosporin antibiotic, plays a pivotal role in managing bacterial infections, including respiratory tract infections, urinary tract infections, and skin infections. Its broad-spectrum activity, favorable safety profile, and efficacy underpin its global demand. This analysis explores current market dynamics, competitive landscape, regulatory considerations, and financial trajectories shaping cefuroxime sodium's future commercial prospects.

Market Overview

Global Demand and Usage

The demand for cefuroxime sodium continues to grow, driven by increasing bacterial infection prevalence globally. Rising antibiotic resistance, particularly against older antibiotics, propels clinicians toward cephalosporins like cefuroxime. Additionally, expanding healthcare infrastructure in emerging markets elevates access and utilization, fueling market growth.

Key Geographic Markets

• North America: Dominates due to high healthcare expenditure, regulatory approval, and widespread clinical adoption.
• Europe: Significant market share with stringent regulatory atmosphere and advanced manufacturing capabilities.
• Asia-Pacific: Fastest-growing segment driven by expanding healthcare infrastructure, rising bacterial infection rates, and demographic shifts towards aging populations.

Market Drivers

• Antibiotic Resistance: Growing antimicrobial resistance (AMR) intensifies demand for broad-spectrum agents like cefuroxime.
• Clinical Guidelines: Inclusion in treatment protocols for various infections sustains steady prescriptions.
• Generic Availability: Patent expirations and increased manufacturing capacity promote competitive pricing, expanding market accessibility.

Market Challenges

• Antimicrobial Stewardship: Stringent regulations and global campaigns to curb antibiotic overuse threaten rapid market expansion.
• Resistance Development: Emergence of resistant bacterial strains may necessitate newer agents, impacting cefuroxime sales.
• Regulatory Hurdles: Approval processes vary across regions and can delay product launches or reformulation approvals.

Competitive Landscape

Several pharmaceutical manufacturers produce cefuroxime sodium, with key players including GSK, Sandoz (Novartis), and Teva Pharmaceuticals. Market share distribution is influenced by manufacturing capacity, regulatory approval, and marketing strategies.

• Innovator Companies: Focus on maintaining market share through formulations, formulations innovation, and expanding indications.
• Generics Makers: Capitalize on patent expirations to offer cost-effective options, primarily targeting competitive price-sensitive markets.

Regulatory and Patent Considerations

Cefuroxime sodium's patent landscape significantly impacts market entry and pricing strategies:

• Patent Expiry: Facilitated proliferation of generics, leading to price erosion.
• Regulatory Frameworks: Stringent approvals from agencies like FDA, EMA, and equivalents are required for different formulations and indications.
• Quality Standards: Compliance with WHO GMP guidelines and regional norms is crucial for market access, especially in emerging markets.

Financial Trajectory Analysis

Revenue Trends

Historical data indicates steady revenue streams from cefuroxime sodium, supported by consistent demand. In mature markets, revenues are stabilizing owing to generic competition. Conversely, emerging markets demonstrate substantial growth potential.

Pricing Dynamics

• Generic Pricing: Price erosion post-patent expiry influences revenue margins.
• Regional Pricing Strategies: Premium pricing in developed markets contrasts with aggressive pricing in developing regions to maximize market penetration.

Manufacturing and Cost Factors

Economies of scale, optimized supply chains, and regulatory compliance influence manufacturing costs. Investment in advanced manufacturing technology enhances production efficiency, reducing unit costs over time.

Forecasted Growth

Projections suggest a compound annual growth rate (CAGR) of approximately 3-5% over the next five years, driven mainly by the Asia-Pacific market and emerging infection indications. Industry reports posit that continuous patent expirations could further lower prices but stimulate volume sales.

Strategic Implications

• Portfolio Diversification: Companies expanding into combination therapies and novel formulations can mitigate patent erosion effects.
• Market Expansion: Entering untapped regions with tailored regulatory strategies promises revenue uplift.
• Innovation and R&D: Developing resistance-proof derivatives or new delivery systems could position firms favorably amid rising resistance.

Regulatory Trends and Impact

Regulatory agencies are increasingly emphasizing antimicrobial stewardship principles, reducing unnecessary antibiotic prescriptions. This trend directs pharmaceutical companies to adopt responsible marketing practices and necessitates robust clinical evidence for expanded indications. Nevertheless, approval of biosimilar or generic formulations remains a key revenue driver.

Conclusion

The cefuroxime sodium market exhibits a balanced interplay of growth drivers and challenges. While patent expirations and generic competition temper revenue streams, expanding demand in emerging markets and ongoing credible clinical utility sustain a positive financial trajectory. Firms willing to innovate, adapt pricing, and navigate regional regulatory landscapes can capitalize on the evolving market landscape.

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Key Takeaways

• Growing Global Demand: Driven by bacterial infection prevalence and antibiotic resistance concerns.
• Generic Market Impact: Patent expirations have increased affordability but pressure profit margins.
• Regional Variations: Emerging markets offer significant growth opportunities; mature markets present stability.
• Regulatory Dynamics: Responsible antibiotic stewardship influences prescribing patterns and approval processes.
• Innovation as a Differentiator: Developing new formulations or resistance-resistant derivatives can sustain competitive advantage.

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FAQs

1. What factors are driving the demand for cefuroxime sodium globally?
   Increasing bacterial infections, rising antibiotic resistance, and expanding healthcare infrastructure—especially in emerging markets—are primary drivers.

2. How does patent expiration affect cefuroxime sodium's market?
   Patent expiry leads to a surge in generic manufacturing, reducing prices but increasing accessibility. It also intensifies competition among producers.

3. What are the main challenges faced by manufacturers of cefuroxime sodium?
   Challenges include antimicrobial stewardship policies limiting antibiotic overuse, resistance development reducing effectiveness, and navigating complex regulatory approvals.

4. What are the prospects for innovation in cefuroxime sodium formulations?
   Companies are exploring combination therapies, sustained-release formulations, and resistance-proof derivatives to extend lifecycle and market share.

5. How should companies approach market expansion for cefuroxime sodium?
   Tailoring regulatory strategies, investments in quality manufacturing, and strategic pricing in emerging markets can maximize growth potential.

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Sources:
[1] Market Research Future Reports, “Antibiotics Market Analysis,” 2022.
[2] Global Pharma Insights, “Cephalosporins and Infectious Disease Trends,” 2021.
[3] WHO Antibiotic Resistance Surveillance Reports, 2022.
[4] Company Annual Reports and Regulatory Filings.