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Last Updated: December 22, 2024

ENOXACIN - Generic Drug Details


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What are the generic drug sources for enoxacin and what is the scope of patent protection?

Enoxacin is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for enoxacin.

Summary for ENOXACIN
Recent Clinical Trials for ENOXACIN

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SponsorPhase
University of UtahPhase 2
Ohio State UniversityPhase 2
McGill UniversityPhase 1/Phase 2

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Medical Subject Heading (MeSH) Categories for ENOXACIN

US Patents and Regulatory Information for ENOXACIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us PENETREX enoxacin TABLET;ORAL 019616-004 Dec 31, 1991 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us PENETREX enoxacin TABLET;ORAL 019616-005 Dec 31, 1991 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

Expired US Patents for ENOXACIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us PENETREX enoxacin TABLET;ORAL 019616-005 Dec 31, 1991 4,359,578 ⤷  Subscribe
Sanofi Aventis Us PENETREX enoxacin TABLET;ORAL 019616-004 Dec 31, 1991 4,352,803 ⤷  Subscribe
Sanofi Aventis Us PENETREX enoxacin TABLET;ORAL 019616-005 Dec 31, 1991 4,442,101 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

ENOXACIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Enoxacin

Introduction

Enoxacin, an antibiotic belonging to the fluoroquinolone class, has been a significant player in the pharmaceutical market, particularly in the treatment of bacterial infections. This article delves into the market dynamics and financial trajectory of enoxacin, highlighting its current status, future projections, and the factors influencing its market performance.

Global Market Size and Growth

The global enoxacin market has shown a robust growth trajectory. As of 2023, the global enoxacin gluconate market size was valued at approximately USD 1.5 billion. This market is projected to grow significantly, reaching USD 2.7 billion by 2032[1].

Market Drivers

Several factors are driving the growth of the enoxacin market:

Increasing Demand for Antibiotics

The rising incidence of bacterial infections and the need for effective antibiotics are key drivers. Enoxacin's broad-spectrum activity against both Gram-positive and Gram-negative bacteria makes it a preferred choice in many clinical settings.

Expanding Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in developing countries, have increased access to antibiotics like enoxacin. This expansion is expected to continue, driving market growth.

Resistance to Other Antibiotics

The growing resistance to other antibiotics has led to an increased reliance on fluoroquinolones like enoxacin. This shift is likely to sustain the demand for enoxacin in the foreseeable future.

Market Challenges

Despite the growth, the enoxacin market faces several challenges:

Regulatory Scrutiny

Fluoroquinolones, including enoxacin, have come under regulatory scrutiny due to potential side effects such as tendonitis and neurological issues. Strict regulations and safety monitoring can impact market growth.

Generic Competition

The expiration of patents for enoxacin has led to the entry of generic versions, which can reduce the market share of branded products. However, the complexity of manufacturing fluoroquinolones can limit the number of generic entrants[3].

Financial Trajectory

The financial performance of enoxacin is closely tied to its market dynamics:

Revenue Projections

The projected growth from USD 1.5 billion in 2023 to USD 2.7 billion by 2032 indicates a robust financial trajectory. This growth is driven by increasing demand and the lack of effective alternatives in some regions[1].

Pricing Strategies

The pricing of enoxacin is influenced by its status as a prescription drug and the presence of generic competitors. While branded versions may command higher prices, generic versions can offer more affordable alternatives, affecting overall revenue.

Geographic Market Analysis

The market for enoxacin varies significantly across different regions:

Developed Markets

In developed countries, the market is more saturated, and the presence of generic competitors is higher. This leads to lower prices and reduced revenue for branded products.

Developing Markets

In developing countries, the demand for antibiotics is higher due to limited access to healthcare. Here, enoxacin can command a premium price due to its effectiveness and limited competition from generics.

Competitive Landscape

The competitive landscape for enoxacin includes both branded and generic manufacturers:

Branded Products

Companies that hold the original patents for enoxacin continue to play a significant role in the market. However, their market share is decreasing as generic versions become more prevalent.

Generic Products

Generic manufacturers are increasingly entering the market, offering cheaper alternatives. This competition is expected to intensify, affecting the pricing and revenue of branded products.

Research and Development

Continuous research and development are crucial for maintaining the market position of enoxacin:

New Formulations

Efforts to develop new formulations, such as injectable forms, can expand the market reach and improve patient compliance[4].

Combination Therapies

Research into combination therapies involving enoxacin and other antibiotics can enhance its efficacy and extend its market life.

Regulatory Environment

The regulatory environment significantly impacts the market dynamics of enoxacin:

Safety Monitoring

Regulatory bodies closely monitor the safety profile of fluoroquinolones, including enoxacin. Any adverse findings can lead to restrictions or warnings, affecting market performance.

Patent Expirations

The expiration of patents allows generic entry, which can reduce the market share of branded products. However, the complexity of manufacturing fluoroquinolones can limit the number of generic entrants[3].

Economic Implications

The economic implications of the enoxacin market are multifaceted:

Pricing and Profitability

The high development costs and the need for significant investment in research and development justify the higher prices of branded enoxacin products. However, generic competition can reduce profitability over time[3].

Access and Innovation

The balance between access to current treatments and innovation for future treatments is a critical economic consideration. High prices for branded products can fund further research, but they also limit access to essential medications[3].

Conclusion

The market for enoxacin is characterized by robust growth driven by increasing demand and limited alternatives. However, it faces challenges such as regulatory scrutiny, generic competition, and the need for continuous innovation. Understanding these dynamics is crucial for stakeholders to navigate the market effectively.

Key Takeaways

  • The global enoxacin gluconate market is projected to grow from USD 1.5 billion in 2023 to USD 2.7 billion by 2032.
  • Increasing demand for antibiotics and expanding healthcare infrastructure are key drivers.
  • Regulatory scrutiny and generic competition are significant challenges.
  • The market is influenced by geographic variations, with different dynamics in developed and developing countries.
  • Continuous research and development are essential for maintaining market position.

FAQs

1. What is the current market size of the global enoxacin gluconate market? The global enoxacin gluconate market size was valued at approximately USD 1.5 billion in 2023[1].

2. What are the primary drivers of the enoxacin market growth? The primary drivers include increasing demand for antibiotics, expanding healthcare infrastructure, and the growing resistance to other antibiotics[1].

3. What are the major challenges facing the enoxacin market? The major challenges include regulatory scrutiny, generic competition, and the need for continuous innovation[1][3].

4. How does the regulatory environment impact the enoxacin market? The regulatory environment significantly impacts the market through safety monitoring and patent expirations, which can affect pricing and market share[3].

5. What are the economic implications of the enoxacin market? The economic implications include the balance between access to current treatments and innovation for future treatments, as well as the justification of high prices for branded products to fund further research[3].

Sources

  1. Dataintelo, Global Enoxacin Gluconate Market Research Report 2032, https://dataintelo.com/report/global-enoxacin-gluconate-market
  2. MDPI, Huntington's Disease Drug Development: A Phase 3 Pipeline Analysis, https://www.mdpi.com/1424-8247/16/11/1513
  3. NBER, The Economics of Drug Development: Pricing and Innovation in a Changing Market, https://www.nber.org/reporter/2018number3/economics-drug-development-pricing-and-innovation-changing-market
  4. Market Research Intellect, Global Enoxacin Injection Market Size, Scope And Forecast Report, https://www.marketresearchintellect.com/product/global-enoxacin-injection-market/

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