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Last Updated: December 25, 2024

MOXALACTAM DISODIUM - Generic Drug Details


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What are the generic sources for moxalactam disodium and what is the scope of freedom to operate?

Moxalactam disodium is the generic ingredient in one branded drug marketed by Lilly and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for MOXALACTAM DISODIUM
Recent Clinical Trials for MOXALACTAM DISODIUM

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SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4

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Medical Subject Heading (MeSH) Categories for MOXALACTAM DISODIUM

US Patents and Regulatory Information for MOXALACTAM DISODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly MOXAM moxalactam disodium INJECTABLE;INJECTION 050550-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lilly MOXAM moxalactam disodium INJECTABLE;INJECTION 050550-008 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lilly MOXAM moxalactam disodium INJECTABLE;INJECTION 050550-001 Approved Prior to Jan 1, 1982 DISCN No 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

MOXALACTAM DISODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Moxalactam Disodium

Introduction

Moxalactam disodium, also known as latamoxef, is a synthetically derived, structurally unique beta-lactam antibiotic. This drug has been in use for several decades, treating a wide range of bacterial infections. Here, we will delve into the market dynamics and financial trajectory of moxalactam disodium, exploring its historical performance, current market status, and future prospects.

Historical Context and Development

Moxalactam disodium was first introduced in the early 1980s as a third-generation cephalosporin antibiotic. Its development was part of the broader effort to create antibiotics with a wider spectrum of activity and improved pharmacokinetic profiles compared to earlier generations of cephalosporins[5].

Mechanism of Action and Therapeutic Uses

Moxalactam disodium works by inhibiting bacterial cell wall synthesis, which is a common mechanism among beta-lactam antibiotics. It is effective against a broad range of Gram-negative and some Gram-positive bacteria, including strains of pseudomonal species. The drug is used to treat various infections such as lower respiratory, urinary-tract, intra-abdominal, central nervous system, skin and skin-structure, and bone and joint infections, as well as bacterial septicemia[5].

Market Performance

Early Adoption and Peak Sales

In the initial years following its introduction, moxalactam disodium saw significant adoption due to its broad-spectrum activity and longer elimination half-life compared to first- and second-generation cephalosporins. This led to substantial sales, particularly in the 1980s and early 1990s.

Competition and Market Saturation

As the antibiotic market evolved, moxalactam disodium faced increasing competition from newer antibiotics and alternative treatments. The rise of fourth-generation cephalosporins and other classes of antibiotics, such as carbapenems and fluoroquinolones, eroded its market share. Additionally, concerns about antibiotic resistance and the need for more targeted therapies further impacted its sales.

Financial Trajectory

Revenue Trends

The revenue generated by moxalactam disodium peaked in the late 1980s and early 1990s. However, as competition increased and newer antibiotics entered the market, the revenue began to decline. By the early 2000s, the drug's sales had significantly diminished, reflecting a common pattern seen with many older antibiotics.

Cost and Pricing

The cost of moxalactam disodium has been a factor in its market dynamics. Initially priced competitively with other cephalosporins, the drug's cost has decreased over time due to generic competition and the availability of cheaper alternatives. This has made it more accessible in some markets but has also reduced its profitability.

Regulatory and Patent Landscape

Patent Expiration

The patents for moxalactam disodium have long since expired, allowing for generic versions to enter the market. This has further reduced the drug's revenue potential for the original developers.

Regulatory Approvals and Compliance

Moxalactam disodium has maintained regulatory approvals in various countries, but the regulatory environment has become more stringent over the years. Compliance with newer regulations and guidelines on antibiotic use has also impacted its market position.

Market Dynamics: Supply and Demand

Supply Chain

The supply chain for moxalactam disodium has been affected by the availability of raw materials and the manufacturing capabilities of generic producers. The drug's production is no longer a priority for major pharmaceutical companies, leading to occasional shortages.

Demand Factors

Demand for moxalactam disodium is influenced by several factors, including the prevalence of bacterial infections, the availability of alternative treatments, and healthcare policies. In regions where access to newer antibiotics is limited, moxalactam disodium may still see significant use.

Future Prospects

Niche Markets

Despite the decline in its overall market share, moxalactam disodium may still find niche markets where its specific properties are advantageous. For example, in areas with limited access to newer antibiotics or in cases where resistance patterns favor its use.

Repurposing and Combination Therapies

There is ongoing research into repurposing older antibiotics, including moxalactam disodium, in combination with other drugs to combat antibiotic resistance. This could potentially revitalize interest in the drug.

Adverse Reactions and Safety Profile

The safety profile of moxalactam disodium is generally favorable, with adverse reactions similar to those of other beta-lactam antibiotics. However, the risk of colonization by resistant organisms and superinfection remains a concern[5].

Conclusion

Moxalactam disodium has had a significant impact on the treatment of bacterial infections since its introduction. However, its market dynamics and financial trajectory have been influenced by the emergence of newer antibiotics, generic competition, and changing regulatory landscapes. While its peak sales are behind it, the drug still holds value in certain niche markets and may see renewed interest through repurposing and combination therapies.

Key Takeaways

  • Historical Significance: Moxalactam disodium was a groundbreaking antibiotic in the 1980s.
  • Market Competition: Faced significant competition from newer antibiotics.
  • Financial Decline: Revenue peaked in the late 1980s and early 1990s, then declined.
  • Regulatory and Patent Landscape: Patents have expired, allowing for generic competition.
  • Supply and Demand: Demand influenced by availability of alternatives and healthcare policies.
  • Future Prospects: Potential in niche markets and through repurposing.

FAQs

What is moxalactam disodium used for?

Moxalactam disodium is used to treat a variety of bacterial infections, including lower respiratory, urinary-tract, intra-abdominal, central nervous system, skin and skin-structure, and bone and joint infections, as well as bacterial septicemia[5].

How does moxalactam disodium work?

Moxalactam disodium works by inhibiting bacterial cell wall synthesis, a common mechanism among beta-lactam antibiotics[5].

What are the common adverse reactions associated with moxalactam disodium?

Adverse reactions associated with moxalactam disodium are similar to those of other beta-lactam antibiotics and include risks such as colonization by resistant organisms and superinfection[5].

Is moxalactam disodium still widely used?

While moxalactam disodium is not as widely used as it once was, it still finds use in certain niche markets and regions where access to newer antibiotics is limited.

Are there any ongoing research or development efforts involving moxalactam disodium?

There is ongoing research into repurposing older antibiotics, including moxalactam disodium, in combination with other drugs to combat antibiotic resistance.

Sources

  1. MedChemExpress: Moxalactam sodium salt (Latamoxef sodium) | Antibacterial Agent
  2. ACS Publications: Natural Products as Sources of New Drugs over the Nearly Four Decades from 1981 to 2019
  3. ACS Publications: Natural Products as Sources of New Drugs from 1981 to 2014
  4. NCI Drug Dictionary: Definition of moxalactam
  5. PubMed: Evaluation of moxalactam

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