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Last Updated: December 22, 2024

MEFOXIN Drug Patent Profile


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

Mefoxin is a drug marketed by Norvium Bioscience 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
Drug patent expirations by year for MEFOXIN
Recent Clinical Trials for MEFOXIN

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

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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
Norvium Bioscience MEFOXIN cefoxitin sodium INJECTABLE;INJECTION 062757-001 Jan 8, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Merck MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER cefoxitin sodium INJECTABLE;INJECTION 050581-004 Sep 20, 1984 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Norvium Bioscience MEFOXIN cefoxitin sodium INJECTABLE;INJECTION 050517-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Norvium Bioscience MEFOXIN IN PLASTIC CONTAINER cefoxitin sodium INJECTABLE;INJECTION 063182-001 Jan 25, 1993 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Norvium Bioscience MEFOXIN cefoxitin sodium INJECTABLE;INJECTION 050517-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

MEFOXIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MEFOXIN (Cefoxitin)

Introduction

MEFOXIN, known generically as cefoxitin, is a semi-synthetic, broad-spectrum cephamycin antibiotic developed by Merck & Co., Inc. from cephamycin C. This antibiotic has been a significant player in the treatment of various bacterial infections since its introduction in the 1970s. Here, we delve into the market dynamics and financial trajectory of MEFOXIN.

Historical Context and Development

Cefoxitin was synthesized in 1972 to create an antibiotic with a broader spectrum than its precursor, cephamycin C. This modification allowed cefoxitin to be effective against both Gram-positive and Gram-negative bacteria, making it a valuable addition to the antibiotic arsenal[1][2][4].

Market Position and Uses

MEFOXIN is used to treat a wide range of infections, including skin infections, urinary tract infections, bronchitis, tonsillitis, ear infections, bacterial pneumonia, sepsis, bone and joint infections, abdominal infections, and pelvic inflammatory disease. Its broad-spectrum activity and stability against bacterial beta-lactamases have made it a preferred choice in many clinical settings[1][2][4].

Clinical Significance and Replacement Roles

Cefoxitin has been identified as an appropriate replacement for methicillin in determining methicillin resistance in certain bacteria. Studies have shown that cefoxitin disk assays can accurately identify MRSA (methicillin-resistant Staphylococcus aureus) isolates, highlighting its utility in clinical microbiology[1].

Pharmacokinetics and Administration

Cefoxitin is administered intravenously, with serum concentrations peaking at 110 mcg/mL within 5 minutes of a 1-gram dose and declining to less than 1 mcg/mL after 4 hours. The drug has an elimination half-life of 41-59 minutes and is primarily excreted unchanged in the urine[1][2].

Market Dynamics

Competition and Alternatives

The antibiotic market is highly competitive, with various drugs available for treating similar infections. Cefoxitin competes with other cephalosporins and antibiotics like carbapenems, which have a wider bacterial spectrum. However, cefoxitin's stability against beta-lactamases and its lower treatment cost make it an attractive alternative in certain clinical scenarios[1][2].

Regulatory Environment

The use of MEFOXIN, like other antibiotics, is regulated to prevent the development of drug-resistant bacteria. It should only be used to treat or prevent infections proven or strongly suspected to be caused by bacteria. Regulatory bodies emphasize the importance of prudent use and conservation mechanisms to maintain the effectiveness of antibacterial drugs[2][4].

Economic Incentives and Challenges

The development and production of antibacterial drugs, including MEFOXIN, face significant economic challenges. The average private return on investment for antibacterial drugs can range from negative to modestly positive, often falling short of the $100 million threshold considered necessary for profitability. This has led to large companies exiting the antibacterial drug market, despite the high social value of these drugs[3].

Financial Trajectory

Development Costs

The costs associated with developing antibacterial drugs are substantial. Phase 1 costs can range from $7.3 to $12.0 million, and the overall development process is costly and risky. The private returns for such investments are often lower than the social value, creating a gap that needs to be bridged through incentives or public investment[3].

Market Size and Revenue

While specific revenue figures for MEFOXIN are not readily available, the broader market for antibacterial drugs is significant. However, the market size is influenced by factors such as the prevalence of bacterial infections, resistance patterns, and the availability of alternative treatments. The financial performance of MEFOXIN would be impacted by these market dynamics and the competitive landscape[3].

Social Value vs. Private Returns

The social value of MEFOXIN and other antibacterial drugs far exceeds their private returns. For example, the social value for developing a new antibacterial drug can range from $486.6 million to $1.217 billion, significantly higher than the private returns. This disparity highlights the need for incentives to stimulate the development of such critical drugs[3].

Future Outlook

Incentives and Public Investment

Given the economic challenges in developing antibacterial drugs, governments and health organizations are exploring ways to stimulate investment. Incentives, such as public research investment and conservation mechanisms, are being considered to bridge the gap between private returns and social value. These efforts aim to ensure the continued development of essential antibacterial drugs like MEFOXIN[3].

Clinical and Market Evolution

The antibiotic market is evolving with new diagnostic tools and treatment strategies. For instance, rapid point-of-care diagnostics for identifying MRSA and other resistant bacteria are being developed, which could impact the use and market dynamics of MEFOXIN. Additionally, the rise of antibiotic resistance necessitates ongoing research and development of new antibiotics, potentially influencing the future market position of MEFOXIN[3].

Key Takeaways

  • Broad-Spectrum Activity: MEFOXIN is effective against a wide range of bacterial infections, including both Gram-positive and Gram-negative bacteria.
  • Clinical Significance: It serves as a replacement for methicillin in determining methicillin resistance and is used in various clinical scenarios.
  • Economic Challenges: The development and production of MEFOXIN face significant economic hurdles, with private returns often lower than the social value.
  • Regulatory Environment: The use of MEFOXIN is regulated to prevent drug resistance, emphasizing prudent use and conservation.
  • Future Outlook: Incentives and public investment are crucial for stimulating the development of antibacterial drugs, ensuring their continued availability.

FAQs

What is MEFOXIN used for?

MEFOXIN (cefoxitin) is used to treat a variety of bacterial infections, including skin infections, urinary tract infections, bronchitis, and more.

How is MEFOXIN administered?

MEFOXIN is administered intravenously, with doses typically given every six to eight hours.

What are the economic challenges in developing MEFOXIN?

The development of MEFOXIN and other antibacterial drugs faces significant economic challenges, with private returns often lower than the social value, leading to a need for incentives or public investment.

Why is MEFOXIN important in clinical microbiology?

MEFOXIN is important because it can accurately identify MRSA isolates and serves as a replacement for methicillin in determining methicillin resistance.

What is the future outlook for MEFOXIN and similar antibiotics?

The future outlook involves ongoing research and development, with a focus on incentives and public investment to ensure the continued availability of these critical drugs.

Sources

  1. Wikipedia: Cefoxitin
  2. FDA: MEFOXIN (Cefoxitin for Injection)
  3. ASPE: Analytical Framework for Examining the Value of Antibacterial Products
  4. RxList: Mefoxin (Cefoxitin)

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