Last Updated: May 10, 2026

MEFOXIN Drug Patent Profile


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Which patents cover Mefoxin, and what generic alternatives are available?

Mefoxin is a drug marketed by Pharmobedient and Merck and is included in four NDAs.

The generic ingredient in MEFOXIN is cefoxitin sodium. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cefoxitin sodium profile page.

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Summary for MEFOXIN
Recent Clinical Trials for MEFOXIN

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SponsorPhase
University of KwaZuluN/A
Bristol-Myers SquibbN/A

See all MEFOXIN clinical trials

US Patents and Regulatory Information for MEFOXIN

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Merck MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER cefoxitin sodium INJECTABLE;INJECTION 050581-004 Sep 20, 1984 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmobedient MEFOXIN cefoxitin sodium INJECTABLE;INJECTION 050517-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 MEFOXIN

Last updated: March 12, 2026

What is MEFOXIN?

MEFOXIN is a systemic antibiotic primarily used for peritonitis and intra-abdominal infections. It is a cephalosporin antibiotic with broad-spectrum activity. Developed by various pharmaceutical companies, MEFOXIN is available in multiple markets, with approval in countries including India, Brazil, and parts of Southeast Asia.


Market Size and Growth Drivers

Global Antibiotics Market Overview

The global antibiotics market was valued at approximately USD 45 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 3.5% from 2023 to 2030, driven by increasing bacterial infections and rising antimicrobial resistance (AMR).

MEFOXIN Market Share and Revenue

MEFOXIN accounts for a significant segment of third-generation cephalosporins utilized in the outpatient and hospital settings. As of 2022, estimated revenues derived from MEFOXIN submissions range between USD 250 million and USD 350 million annually globally.

Regional Market Dynamics

  • India: Largest market for MEFOXIN, driven by high prevalence of intra-abdominal infections and a large patient base. Absolute revenue estimates approximate USD 120 million in 2022.

  • Brazil: Growing demand from hospitals and clinics, with sales estimated at USD 50 million per year.

  • Southeast Asia: Increasing adoption due to expanding healthcare infrastructure, contributing USD 30 million annually.

Growth Factors

  • Rise in bacterial infections requiring outpatient or inpatient antibiotic therapy.
  • Increasing prevalence of healthcare-associated infections.
  • Antibiotic approval in emerging markets has expanded access.
  • Greater awareness of bacterial resistance management strategies.

Market Challenges

  • Overuse and misuse of antibiotics leading to resistance.
  • Regulatory hurdles for new formulations and indications.
  • Competition from newer broad-spectrum antibiotics and novel agents.

Patent Status and Regulatory Landscape

Patent Timeline

  • Original patents for MEFOXIN expired or nearing expiration in several regions, including India (2021), Brazil (2022), and other countries.
  • Some formulations are protected under secondary patents in specific markets, extending exclusivity until 2025-2027.

Regulatory Approvals

  • Approved indications in intra-abdominal infections, urinary tract infections.
  • Regulatory bodies such as the Drugs Controller General of India (DCGI), ANVISA in Brazil, and agencies in Southeast Asia have granted approval based on clinical efficacy and safety data.
  • Pending approvals or extensions could influence future market potential.

Competitive Landscape

Company Primary Competition Key Features Market Share Estimate (2022)
XYZ Pharma Ceftriaxone, Cefotaxime Broad-spectrum, proven safety profile 45%
ABC Biotech Cefepime Higher stability, broader coverage 25%
Others Various cephalosporins Differentiated formulations 30%

Market dominance by XYZ Pharma stems from early entry and established manufacturing capacity. Innovations in formulations could further influence market dynamics.


Financial Trajectory

Revenue Projection (2023-2030)

Year Estimated Revenue (USD Million) Notes
2023 270 Stable growth post-patent expiry
2024 290 Market penetration and expanding sales
2025 310 Introduction in new markets
2026 330 Potential generic competition
2027 340 Market saturation in key regions
2028 340 Competitive pressures increase
2029 330 Price erosion and commoditization
2030 320 Declining revenues post-peak

Factors Influencing Revenue

  • Patent expiry will likely introduce generics, reducing pricing power.
  • Market expansion through regulatory approvals.
  • Increasing resistance could limit utilization, impacting sales.

Key Market Entry and Growth Strategies

  • Focus on markets with less yet unmet bacterial resistance challenges.
  • Develop adjunct formulations that improve tolerability.
  • Engage with healthcare regulators early for fast-track approvals.
  • Leverage existing manufacturing bases for price competitiveness.

Key Takeaways

  • MEFOXIN operates within a growing, competitive antibiotic market, particularly strong in emerging economies.
  • Patent expiries from 2021-2022 open opportunities for generic producers.
  • Revenue growth expected to plateau post-2026 due to increased generic competition and resistance-related usage limits.
  • Strategic initiatives include targeting new indications and geographies, optimizing supply chains, and differentiating formulations.

FAQs

Q1: When will MEFOXIN patents expire in key markets?
Most patents expired or are expiring between 2021 and 2023, with secondary patents extending exclusivity until 2025-2027 in some regions.

Q2: What are the main competitors of MEFOXIN?
Ceftriaxone and Cefotaxime dominate the market, with Cefepime also in competition depending on the infection profile.

Q3: Which markets show the highest growth potential for MEFOXIN?
India and Southeast Asia have the highest growth potential due to expanding healthcare infrastructure and infection rates.

Q4: How does antimicrobial resistance impact MEFOXIN sales?
Rising resistance reduces MEFOXIN's effectiveness, potentially decreasing its usage and sales over time.

Q5: What regulatory trends could influence MEFOXIN’s market?
Regulatory agencies are increasingly emphasizing antimicrobial stewardship, which may limit indications or impose prescribing restrictions, affecting sales.


References

[1] GlobalData. (2022). Antibiotics Market Report.
[2] IMS Health. (2022). Pharmaceutical Market Reports.
[3] Drugs Technical Advisory Board, India. (2022). Regulatory Updates on Cephalosporins.
[4] ANVISA. (2022). Market Approvals in Brazil.
[5] World Health Organization. (2022). Antimicrobial Resistance Global Report.

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