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Last Updated: December 22, 2024

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL Drug Patent Profile


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When do Erythromycin Ethylsuccinate And Sulfisoxazole Acetyl patents expire, and when can generic versions of Erythromycin Ethylsuccinate And Sulfisoxazole Acetyl launch?

Erythromycin Ethylsuccinate And Sulfisoxazole Acetyl is a drug marketed by Barr and is included in one NDA.

The generic ingredient in ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL is erythromycin ethylsuccinate; sulfisoxazole acetyl. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin ethylsuccinate; sulfisoxazole acetyl profile page.

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Summary for ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL at DailyMed
Drug patent expirations by year for ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL

US Patents and Regulatory Information for ERYTHROMYCIN ETHYLSUCCINATE AND 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl

Overview of Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl

Erythromycin ethylsuccinate and sulfisoxazole acetyl, commonly known as Pediazole, is a combination antibiotic used primarily for the treatment of acute otitis media (AOM) in children. This combination drug targets a range of bacterial infections, including those caused by Haemophilus influenzae and Streptococcus pneumoniae[2][4].

Therapeutic Areas and Efficacy

The drug is effective against various bacterial pathogens, including beta-lactamase-producing strains of Haemophilus influenzae and macrolide-resistant strains of Streptococcus pneumoniae. Clinical studies have shown that erythromycin ethylsuccinate and sulfisoxazole acetyl have high cure rates for AOM, with cure rates of 89% for all organisms and 98% for Streptococcus pneumoniae infections[1][2].

Market Size and Growth

While the specific market size for erythromycin ethylsuccinate and sulfisoxazole acetyl is not isolated, it is part of the broader erythromycin market. The global erythromycin thiocyanate market, which is closely related due to its role in erythromycin synthesis, was valued at USD 26.08 million in 2023 and is expected to reach USD 38.95 million by 2031, growing at a 5% CAGR from 2024 to 2031[3].

Drivers of Market Growth

Several factors are driving the growth of the market for erythromycin and its derivatives:

Increasing Demand for Antibiotics

The rising prevalence of bacterial diseases globally is increasing the demand for effective antibiotic therapies. This demand is a significant driver for the market growth of erythromycin ethylsuccinate and sulfisoxazole acetyl[3].

Expansion of the Pharmaceutical Industry

The growth of the pharmaceutical industry, particularly in emerging markets, is another key factor. Initiatives by regulatory authorities to encourage the development of new, potent antibiotics also contribute to market demand[3].

Technological Advancements

Advancements in drug manufacturing that enhance product quality and production efficiency are further driving the market. Growing investments in healthcare infrastructure and research initiatives also support the market's growth trajectory[3].

Competitive Landscape

The market for antibiotics, including erythromycin ethylsuccinate and sulfisoxazole acetyl, is competitive and involves several major pharmaceutical companies. Key players in the broader erythromycin market include Pfizer Inc., Abbott Laboratories, GlaxoSmithKline plc, Bayer AG, and others[3].

Regulatory Environment

The FDA plays a crucial role in regulating the use and approval of erythromycin ethylsuccinate and sulfisoxazole acetyl. Draft guidance from the FDA outlines the requirements for studies and approvals, ensuring that any generic or new formulations meet stringent standards[5].

Financial Performance

While specific financial data for erythromycin ethylsuccinate and sulfisoxazole acetyl is not readily available, the overall market for erythromycin derivatives is expected to grow steadily. The increasing demand and expanding pharmaceutical industry suggest a positive financial outlook for this segment.

Challenges and Risks

Resistance and Side Effects

One of the challenges facing the market is the development of antibiotic resistance. Additionally, side effects such as pseudomembranous colitis and other adverse reactions can impact the drug's usage and market perception[4].

Regulatory Changes

Changes in regulatory requirements or guidelines can also affect the market dynamics. Ensuring compliance with FDA regulations and maintaining high standards of safety and efficacy is crucial for market stability.

Key Takeaways

  • Efficacy: Erythromycin ethylsuccinate and sulfisoxazole acetyl are highly effective against various bacterial infections, including AOM.
  • Market Growth: The market is driven by increasing demand for antibiotics, expansion of the pharmaceutical industry, and technological advancements.
  • Regulatory Environment: FDA regulations play a critical role in ensuring the safety and efficacy of the drug.
  • Challenges: Antibiotic resistance and side effects are significant challenges that need to be addressed.

FAQs

Q1: What is the primary use of erythromycin ethylsuccinate and sulfisoxazole acetyl? The primary use of erythromycin ethylsuccinate and sulfisoxazole acetyl is for the treatment of acute otitis media (AOM) in children.

Q2: How effective is erythromycin ethylsuccinate and sulfisoxazole acetyl against bacterial infections? Erythromycin ethylsuccinate and sulfisoxazole acetyl have high cure rates, with 89% efficacy against all organisms and 98% against Streptococcus pneumoniae infections[1][2].

Q3: What are the key drivers of the market growth for erythromycin ethylsuccinate and sulfisoxazole acetyl? The key drivers include increasing demand for antibiotics, expansion of the pharmaceutical industry, and technological advancements in drug manufacturing[3].

Q4: Which companies are major players in the erythromycin market? Major players include Pfizer Inc., Abbott Laboratories, GlaxoSmithKline plc, Bayer AG, and others[3].

Q5: What are the potential risks associated with erythromycin ethylsuccinate and sulfisoxazole acetyl? Potential risks include the development of antibiotic resistance and side effects such as pseudomembranous colitis[4].

Sources

  1. JAMA Pediatrics: Erythromycin-Sulfisoxazole vs Amoxicillin in the Treatment of Acute Otitis Media in Children.
  2. Patsnap Synapse: Erythromycin Ethylsuccinate/Sulfisoxazole Acetyl.
  3. Market Research Intellect: Global Erythromycin Thiocyanate Market Size and Projections.
  4. DailyMed: Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl.
  5. FDA: Draft Guidance on Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl.

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