CEFOXITIN SODIUM - Generic Drug Details

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

Cefoxitin sodium is the generic ingredient in seven branded drugs marketed by Acs Dobfar, Acs Dobfar Spa, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Hospira Inc, B Braun, Pharmobedient, Merck, and Samson Medcl, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for cefoxitin sodium. Six suppliers are listed for this compound.

Summary for CEFOXITIN SODIUM

US Patents:	0
Tradenames:	7
Applicants:	10
NDAs:	18
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	1
What excipients (inactive ingredients) are in CEFOXITIN SODIUM?	CEFOXITIN SODIUM excipients list
DailyMed Link:	CEFOXITIN SODIUM at DailyMed

Recent Clinical Trials for CEFOXITIN SODIUM

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

Sponsor	Phase
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2

See all CEFOXITIN SODIUM clinical trials

Pharmacology for CEFOXITIN SODIUM

Drug Class

Cephalosporin Antibacterial

Medical Subject Heading (MeSH) Categories for CEFOXITIN SODIUM

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for CEFOXITIN SODIUM

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

US Patents and Regulatory Information for CEFOXITIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmobedient	MEFOXIN	cefoxitin sodium	INJECTABLE;INJECTION	062757-001	Jan 8, 1987		DISCN	No	No
Hospira Inc	CEFOXITIN	cefoxitin sodium	INJECTABLE;INJECTION	065313-002	Jan 23, 2006		DISCN	No	No
Fresenius Kabi Usa	CEFOXITIN	cefoxitin sodium	INJECTABLE;INJECTION	065012-002	Jul 3, 2000		DISCN	No	No

Market and Financial Dynamics for Cefoxitin Sodium

Last updated: February 14, 2026

Cefoxitin sodium is a second-generation cephalosporin antibiotic used primarily for surgical prophylaxis and infections caused by susceptible bacteria. The drug's market performance is driven by conditions such as rising surgical procedures, antimicrobial resistance, and evolving healthcare policies.

Market Overview

The global cephalosporin antibiotics market, valued at approximately USD 24.4 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 3.5% through 2030.[1] Cefoxitin sodium accounts for a niche segment within this market, constrained by its specific use cases and competition from newer antibiotics.

Application and Demand Drivers

• Surgical Procedures: Increasing global surgeries, reaching an estimated 350 million annually, sustain demand for prophylactic antibiotics, including cefoxitin sodium.[2]
• Antimicrobial Resistance (AMR): Rising resistance to first-generation cephalosporins escalates demand for second-generation variants like cefoxitin.
• Healthcare Infrastructure: Enhanced access and improved infection control practices bolster antibiotic utilization.

Regional Market Trends

• North America: Dominates the market owing to high surgical volumes and regulatory approval for broad-spectrum antibiotics.
• Asia Pacific: Exhibits rapid growth driven by expanding healthcare infrastructure and tackling infectious diseases.

Pipeline and Regulatory Landscape

Cefoxitin sodium has long-standing generic formulations approved across multiple markets. Recent developments focus on antimicrobial stewardship, limiting overuse and underlining the importance of targeted applications. Regulatory agencies, including the FDA and EMA, continue to approve and monitor cefoxitin's safety profile.[3]

Competitive Landscape

Key manufacturers include:

• Pfizer: Original formulations and ongoing generic manufacturing.
• Sandoz and Mylan: Generics market leadership.
• Minor players focus on regional production and distribution.

Financial Trajectory

Historical Revenue Performance

• Global sales of cefoxitin are estimated at USD 200 million annually, with the majority attributable to the generic segment.
• Growth has remained relatively flat over the past five years, constrained by generic pricing pressures and antimicrobial stewardship policies.

Profit Margins

• Generic antibiotic profit margins vary between 10% and 15% due to market saturation and pricing competition.
• R&D investments are minimal, mainly focusing on formulation and distribution efficiencies.

Pricing Trends

• Prices per vial declined by approximately 10-15% over the last decade in mature markets.
• Emerging markets face less price pressure but rely heavily on generic manufacturing.

Future Outlook

• Market size is expected to stabilize or grow modestly, accounting for increased surgical volumes and resistant bacterial strains.
• Fragmented competition limits significant pricing increases.
• Pharmaceutical companies exploring combination therapies or novel formulations could influence future revenue streams.

Market Challenges and Opportunities

• Resistance Growth: Limited utility against resistant strains reduces future demand in some indications.
• Regulatory Changes: Stringent policies on antibiotic use could reduce prescribing volumes.
• Innovation Gaps: Lack of new formulations or infection-specific applications may hinder growth.
• Opportunities: Potential expansion into niche markets such as veterinary medicine and combination therapies.

Summary

Cefoxitin sodium's market is characterized by steady demand in surgical prophylaxis, constrained by generic competition, pricing pressures, and antimicrobial stewardship policies. The financial outlook remains stable given current use patterns, though growth is moderate and dependent on broader healthcare trends and resistance patterns.

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Key Takeaways

• The cefoxitin sodium market is valued at USD 200 million annually, with a slow growth rate.
• Most revenue derives from generic sales, with profit margins around 10-15%.
• Market expansion faces challenges from antimicrobial resistance and regulatory policies.
• Future growth may stem from niche applications and emerging resistance-driven prescriptions.

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FAQs

1. Will cefoxitin sodium see new formulations or delivery methods?
Currently, no major developments focus on new formulations. Most innovations aim to optimize existing delivery or reduce resistance.

2. How does antimicrobial resistance impact cefoxitin sodium’s market?
Rising resistance limits its effectiveness against certain bacteria, decreasing its use in some cases and prompting development of newer antibiotics.

3. Which regions will drive future demand?
Asia Pacific and Latin America are expected to see increased use due to expanding healthcare access and increasing surgical procedures.

4. Are there any recent regulatory changes affecting cefoxitin sodium?
Regulatory bodies continue to monitor antimicrobial stewardship efforts, which may restrict prescribing or incentivize reduced use in some regions.

5. What opportunities exist for pharmaceutical companies?
Developing combination therapies, exploring veterinary applications, and improving formulations offer growth avenues amid market saturation.

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References

[1] MarketsandMarkets. "Cephalosporins Market," 2022.
[2] WHO. "World Surgical Procedures Data," 2021.
[3] U.S. Food and Drug Administration. "Cefoxitin Drug Approval and Monitoring," 2022.