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Last Updated: December 22, 2024

Cinoxacin - Generic Drug Details


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

Cinoxacin is the generic ingredient in two branded drugs marketed by Lilly and Teva, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for cinoxacin.

Summary for cinoxacin
Recent Clinical Trials for cinoxacin

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SponsorPhase
University of LouisvilleEarly Phase 1
James Graham Brown Cancer CenterEarly Phase 1
Julio RamirezEarly Phase 1

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Medical Subject Heading (MeSH) Categories for cinoxacin

US Patents and Regulatory Information for cinoxacin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva CINOXACIN cinoxacin CAPSULE;ORAL 073006-001 Feb 28, 1992 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lilly CINOBAC cinoxacin CAPSULE;ORAL 018067-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva CINOXACIN cinoxacin CAPSULE;ORAL 073005-001 Feb 28, 1992 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lilly CINOBAC cinoxacin CAPSULE;ORAL 018067-002 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

Cinoxacin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cinoxacin

Introduction

Cinoxacin, a synthetic antibacterial agent, has been in use since its approval in the late 20th century. This article delves into the market dynamics and financial trajectory of cinoxacin, exploring its mechanism of action, market performance, and the broader context of antibiotic development and resistance.

Mechanism of Action

Cinoxacin inhibits bacterial DNA synthesis by binding to DNA gyrase, an enzyme crucial for DNA replication and cell division. This mechanism is similar to other quinolone antibiotics, such as nalidixic acid, with which it shows cross-resistance[4].

Market Approval and Early Adoption

Cinoxacin was approved for use in the late 20th century, primarily for treating urinary tract infections caused by gram-negative bacteria. Its initial adoption was driven by its effectiveness against strains of the Enterobacteriaceae family and its bactericidal properties over a wide pH range[4].

Market Performance

The market performance of cinoxacin has been influenced by several factors, including competition from newer antibiotics, resistance development, and regulatory environments.

Competition and Resistance

The rise of newer, more potent quinolones and other antibiotic classes has reduced the market share of cinoxacin. Bacterial resistance to quinolones, including cinoxacin, has also become a significant issue, limiting its long-term efficacy and market viability[4].

Regulatory Environment

Regulatory changes and guidelines on antibiotic use have impacted the market for cinoxacin. For instance, stricter regulations on antibiotic prescriptions and the push for more targeted and less broad-spectrum antibiotics have affected sales. Additionally, the approval and withdrawal of antibiotics are closely monitored, with a focus on safety and efficacy, which can influence the financial trajectory of drugs like cinoxacin[5].

Financial Trajectory

Initial Revenue and Peak Sales

Upon its introduction, cinoxacin generated significant revenue due to its effectiveness and the lack of alternative treatments for certain bacterial infections. However, as resistance grew and newer antibiotics were developed, its sales began to decline.

Decline and Current Status

The decline in sales of cinoxacin is attributed to several factors:

  • Resistance Development: The emergence of resistant bacterial strains has reduced the drug's efficacy.
  • Competition: Newer antibiotics with broader spectra of activity and lower resistance rates have captured market share.
  • Regulatory Pressures: Stricter antibiotic stewardship programs and guidelines have limited the prescription of older antibiotics like cinoxacin[3][4].

Economic Impact of AMR

The broader economic impact of antibiotic resistance (AMR) also affects the financial trajectory of cinoxacin. According to the AMR Review, the global economic cost of AMR could reach $100 trillion by 2050 if not addressed. This has significant implications for the pharmaceutical industry, including reduced revenue from antibiotics and increased costs for developing new drugs[3].

Market Entry Rewards and Incentives

To combat the issue of declining antibiotic efficacy and to encourage the development of new antibiotics, market entry rewards have been proposed. These rewards, potentially up to $1 billion per successful new drug, aim to incentivize pharmaceutical companies to invest in antibiotic research and development. However, cinoxacin, being an older drug, does not benefit from these incentives[3].

Global Market and Brand Variations

Cinoxacin is marketed under various brand names globally, such as Cinobac, Mecicon, Tatsulexin, and Urocinox. The international market presence helps in maintaining some level of revenue, although it is significantly lower than during its peak[4].

Pharmacogenomic and Safety Considerations

The safety profile of cinoxacin, including its pharmacogenomic effects, has been a factor in its market dynamics. Side effects such as gastrointestinal issues, headache, and dizziness have been reported, which can affect patient compliance and overall market performance[4].

Future Outlook

Given the current landscape of antibiotic resistance and the push for new, innovative antibiotics, the future outlook for cinoxacin is limited. The focus is shifting towards developing drugs that can overcome resistance mechanisms, such as the newer quinolones and other classes of antibiotics discussed in recent research[1].

Key Takeaways

  • Mechanism of Action: Cinoxacin inhibits DNA gyrase, affecting bacterial DNA synthesis.
  • Market Performance: Affected by competition, resistance, and regulatory changes.
  • Financial Trajectory: Initial success followed by decline due to resistance and competition.
  • Economic Impact of AMR: Significant global economic costs associated with antibiotic resistance.
  • Market Entry Rewards: Incentives for new antibiotic development do not apply to older drugs like cinoxacin.
  • Global Market: Available under various brand names but with reduced revenue.

FAQs

What is the primary mechanism of action of cinoxacin?

Cinoxacin inhibits bacterial DNA synthesis by binding to DNA gyrase, an enzyme essential for DNA replication and cell division[4].

How has antibiotic resistance affected the market for cinoxacin?

The emergence of resistant bacterial strains has significantly reduced the efficacy and market viability of cinoxacin, leading to a decline in sales[3][4].

What are the proposed market entry rewards for new antibiotics?

Market entry rewards of up to $1 billion per successful new drug are proposed to incentivize the development of new antibiotics, though these do not apply to older drugs like cinoxacin[3].

What are some of the side effects associated with cinoxacin?

Common side effects include gastrointestinal issues, headache, dizziness, and other symptoms that can affect patient compliance[4].

How does the global economic impact of AMR affect the pharmaceutical industry?

The global economic cost of AMR could reach $100 trillion by 2050, significantly impacting the pharmaceutical industry's revenue and investment in new antibiotic development[3].

What is the current market status of cinoxacin?

Cinoxacin is still available under various brand names globally but with significantly reduced revenue compared to its peak due to competition and resistance issues[4].

Sources

  1. DNA Gyrase as a Target for Quinolones - MDPI
  2. Common recognition topology of mex transporters of Pseudomonas - Frontiers in Pharmacology
  3. Tackling Drug-Resistant Infections Globally - AMR Review
  4. Cinoxacin: Uses, Interactions, Mechanism of Action - DrugBank Online
  5. Approval and Withdrawal of New Antibiotics and Other Antiinfectives - Boston University Scholarship

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