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Last Updated: December 22, 2024

Erythromycin ethylsuccinate; sulfisoxazole acetyl - Generic Drug Details


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What are the generic sources for erythromycin ethylsuccinate; sulfisoxazole acetyl and what is the scope of patent protection?

Erythromycin ethylsuccinate; sulfisoxazole acetyl is the generic ingredient in three branded drugs marketed by Barr, Alra, and Ross Labs, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Summary for erythromycin ethylsuccinate; sulfisoxazole acetyl
US Patents:0
Tradenames:3
Applicants:3
NDAs:3
DailyMed Link:erythromycin ethylsuccinate; sulfisoxazole acetyl at DailyMed

US Patents and Regulatory Information for erythromycin ethylsuccinate; sulfisoxazole acetyl

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL erythromycin ethylsuccinate; sulfisoxazole acetyl GRANULE;ORAL 062759-001 May 20, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ross Labs PEDIAZOLE erythromycin ethylsuccinate; sulfisoxazole acetyl GRANULE;ORAL 050529-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alra ERYZOLE erythromycin ethylsuccinate; sulfisoxazole acetyl GRANULE;ORAL 062758-001 Jun 15, 1988 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

Erythromycin ethylsuccinate; sulfisoxazole acetyl Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl

Introduction

Erythromycin ethylsuccinate and sulfisoxazole acetyl is a combination antibiotic used primarily to treat bacterial infections, such as acute otitis media caused by bacteria like Haemophilus influenzae. This article delves into the market dynamics and financial trajectory of this drug, exploring its current status, future projections, and the factors influencing its market.

Market Overview

The market for erythromycin ethylsuccinate and sulfisoxazole acetyl is part of the broader antibiotic market, which is driven by the increasing prevalence of bacterial infections and the need for effective antibiotic therapies.

Current Market Size

While specific market size data for erythromycin ethylsuccinate and sulfisoxazole acetyl is not readily available, the overall market for erythromycin and its derivatives is substantial. For instance, the erythromycin thiocyanate market, which is closely related, was valued at USD 26.08 million in 2023 and is expected to grow to USD 38.95 million by 2031, at a CAGR of 5% from 2024 to 2031[3].

Segmentation

The market for erythromycin ethylsuccinate and sulfisoxazole acetyl can be segmented based on several factors:

By Type

  • Erythromycin ethylsuccinate
  • Sulfisoxazole acetyl
  • Combination products

By Application

  • Human Medicine (Antibiotics)
    • Acute otitis media
    • Other bacterial infections
  • Veterinary Medicine (though less common for this specific combination)

By Geography

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle East and Africa

Market Drivers

Several factors are driving the growth of the market for erythromycin ethylsuccinate and sulfisoxazole acetyl:

Increasing Prevalence of Bacterial Infections

The rising incidence of bacterial infections globally is a significant driver. As bacterial diseases become more prevalent, the demand for effective antibiotics like erythromycin ethylsuccinate and sulfisoxazole acetyl increases[3].

Technological Advancements

Advancements in drug manufacturing and formulation technologies enhance the quality and efficiency of antibiotic production. This leads to better products and higher demand[3].

Regulatory Support

Initiatives by regulatory authorities to encourage the development of new and potent antibiotics also drive market growth. The FDA's guidance on bioequivalence studies and other regulatory frameworks support the approval and marketing of these drugs[1][5].

Healthcare Infrastructure and Research

Investments in healthcare infrastructure and research initiatives are crucial. These investments lead to better healthcare outcomes and an increased need for antibiotics, including erythromycin ethylsuccinate and sulfisoxazole acetyl[3].

Market Challenges

Despite the growth drivers, there are several challenges facing the market:

Resistance to Antibiotics

The increasing resistance to antibiotics is a significant challenge. As bacteria develop resistance, the effectiveness of antibiotics like erythromycin ethylsuccinate and sulfisoxazole acetyl may decrease, impacting market demand[4].

Side Effects and Contraindications

Erythromycin ethylsuccinate and sulfisoxazole acetyl have several side effects and contraindications, such as hepatic dysfunction, respiratory hypersensitivity reactions, and pseudomembranous colitis. These can limit their use and impact market growth[4].

Competition from Other Antibiotics

The antibiotic market is highly competitive, with many other effective antibiotics available. This competition can affect the market share of erythromycin ethylsuccinate and sulfisoxazole acetyl[4].

Financial Trajectory

Revenue Projections

Given the broader market trends for erythromycin derivatives, the revenue for erythromycin ethylsuccinate and sulfisoxazole acetyl is expected to grow steadily. The CAGR of 5% for the related erythromycin thiocyanate market from 2024 to 2031 suggests a positive financial trajectory for this combination antibiotic as well[3].

Key Players

Several pharmaceutical companies are involved in the production and marketing of erythromycin ethylsuccinate and sulfisoxazole acetyl, including Teva, Physicians Total Care, Inc., and Amdipharm Ltd. These companies play a crucial role in driving market growth through their manufacturing and distribution capabilities[2][4].

Competitive Landscape

The competitive landscape for erythromycin ethylsuccinate and sulfisoxazole acetyl involves various players in the pharmaceutical industry. Here are some key aspects:

Porter’s Five Forces Analysis

  • Buyer Bargaining Power: Moderate to high due to the availability of alternative antibiotics.
  • Supplier Bargaining Power: Moderate, influenced by the availability of raw materials and manufacturing technologies.
  • Threat of New Entrants: Low to moderate due to regulatory barriers and the need for significant investment in research and development.
  • Threat of Substitutes: High due to the presence of other effective antibiotics.
  • Degree of Competition: High, given the competitive nature of the antibiotic market[3].

Regulatory Environment

The FDA plays a crucial role in regulating the market for erythromycin ethylsuccinate and sulfisoxazole acetyl through guidance documents and bioequivalence studies. These regulations ensure that generic versions of the drug meet the same standards as the reference listed drug (RLD)[1][5].

Conclusion

The market for erythromycin ethylsuccinate and sulfisoxazole acetyl is driven by the increasing need for effective antibiotic therapies, technological advancements, and regulatory support. However, it faces challenges such as antibiotic resistance, side effects, and competition from other antibiotics. The financial trajectory is expected to be positive, with steady growth projected over the coming years.

Key Takeaways

  • The market is driven by the increasing prevalence of bacterial infections and technological advancements.
  • Regulatory support and investments in healthcare infrastructure are crucial.
  • Challenges include antibiotic resistance, side effects, and competition.
  • The financial trajectory is expected to be positive with a steady growth rate.
  • Key players include Teva, Physicians Total Care, Inc., and Amdipharm Ltd.

FAQs

What is the primary use of erythromycin ethylsuccinate and sulfisoxazole acetyl?

Erythromycin ethylsuccinate and sulfisoxazole acetyl is primarily used to treat bacterial infections, such as acute otitis media caused by bacteria like Haemophilus influenzae[2].

What are the common side effects of erythromycin ethylsuccinate and sulfisoxazole acetyl?

Common side effects include hepatic dysfunction, respiratory hypersensitivity reactions, and pseudomembranous colitis[4].

How does the FDA regulate this drug?

The FDA regulates this drug through guidance documents and bioequivalence studies to ensure that generic versions meet the same standards as the reference listed drug (RLD)[1][5].

What is the expected market growth for erythromycin ethylsuccinate and sulfisoxazole acetyl?

The market is expected to grow steadily, with a CAGR similar to that of related erythromycin derivatives, such as erythromycin thiocyanate[3].

Who are the key players in the market for erythromycin ethylsuccinate and sulfisoxazole acetyl?

Key players include Teva, Physicians Total Care, Inc., and Amdipharm Ltd[2][4].

What are the main challenges facing the market for this drug?

The main challenges include antibiotic resistance, side effects, and competition from other antibiotics[4].

Sources

  1. FDA Guidance on Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl - FDA.
  2. Acetyl sulfisoxazole: Uses, Interactions, Mechanism of Action - DrugBank.
  3. Erythromycin Thiocyanate Market Size and Projections - Market Research Intellect.
  4. ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL granule, for suspension - DailyMed.
  5. Draft Guidance on Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl - FDA.

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