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Last Updated: December 22, 2024

PEDIAMYCIN 400 Drug Patent Profile


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When do Pediamycin 400 patents expire, and what generic alternatives are available?

Pediamycin 400 is a drug marketed by Arbor Pharms Llc and is included in one NDA.

The generic ingredient in PEDIAMYCIN 400 is erythromycin ethylsuccinate. There are one hundred and three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the erythromycin ethylsuccinate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Pediamycin 400

A generic version of PEDIAMYCIN 400 was approved as erythromycin ethylsuccinate by AZURITY on December 31st, 1969.

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Summary for PEDIAMYCIN 400
Drug patent expirations by year for PEDIAMYCIN 400

US Patents and Regulatory Information for PEDIAMYCIN 400

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc PEDIAMYCIN 400 erythromycin ethylsuccinate SUSPENSION;ORAL 062304-002 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

PEDIAMYCIN 400 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pediatric Antibiotics: A Case Study on Erythromycin (PEDIAMYCIN 400)

Introduction

Pediatric antibiotics, such as erythromycin, play a crucial role in treating bacterial infections in children. Understanding the market dynamics and financial trajectory of these medications is essential for pharmaceutical companies, healthcare providers, and patients alike.

Market Overview of Pediatric Antibiotics

The market for pediatric antibiotics is driven by the need to treat a wide range of bacterial infections in children. Erythromycin, marketed under various names including PEDIAMYCIN 400, is a macrolide antibiotic commonly used for this purpose.

Demand and Usage

Erythromycin is prescribed for various infections, including respiratory tract infections, skin infections, and diphtheria. The demand for this antibiotic is consistent due to its effectiveness and the ongoing need for bacterial infection treatment in pediatric populations[3].

Competitive Landscape

The pediatric antibiotic market is competitive, with several other antibiotics available, such as amoxicillin and azithromycin. However, erythromycin remains a preferred option due to its broad-spectrum activity and safety profile, especially in children who are allergic to penicillin.

Pricing Strategies

Pricing strategies for pediatric antibiotics like erythromycin are complex and influenced by several factors.

Local Health System Dynamics

Pharmaceutical companies consider the unique health system dynamics of different regions when setting prices. For instance, AbbVie's approach to pricing involves accounting for the additional value the medicine brings to society and the local healthcare environment[1].

Regulatory and Government Influence

Government policies and regulatory frameworks significantly impact the pricing of antibiotics. In many countries, there are price controls and reimbursement schemes that affect how much patients pay for these medications.

Patient Access Programs

To ensure broad and rapid access to their medicines, pharmaceutical companies often implement patient access programs, including discounts, co-pay assistance, and Medicaid rebates. For example, programs like those offered for KEYTRUDA help reduce out-of-pocket costs for patients[4].

Financial Performance

The financial performance of pediatric antibiotics is influenced by several key factors.

Revenue Generation

Companies generating revenue from pediatric antibiotics like erythromycin typically see stable income due to the consistent demand for these medications. For instance, Recordati's annual reports show significant revenue from their pharmaceutical products, including those in the pediatric segment[2].

Research and Development (R&D) Expenses

Continuous investment in R&D is crucial for maintaining market position and developing new or improved antibiotics. Companies allocate a substantial portion of their budget to R&D, which can impact their net income but is essential for long-term growth[2].

Geographical Presence

The geographical distribution of sales can significantly affect the financial trajectory. Companies with a strong presence in multiple regions, such as Recordati with its products sold in over 150 countries, tend to have more stable and diverse revenue streams[2].

Key Financial Metrics

Revenue Growth

Revenue from pediatric antibiotics can grow steadily, driven by increasing demand and expanding market reach. Recordati's annual reports show a consistent increase in revenue over the years, reflecting the growth in the pharmaceutical market[2].

Operating Income and Net Income

Operating income and net income are critical metrics that reflect the profitability of selling pediatric antibiotics. Companies like Recordati have seen improvements in these metrics, indicating efficient operations and effective pricing strategies[2].

Debt and Equity

The financial health of a company is also reflected in its debt and equity positions. A balanced financial position, such as Recordati's net financial position and shareholders' equity, is essential for sustaining long-term growth[2].

Challenges and Opportunities

Resistance and Side Effects

One of the significant challenges facing pediatric antibiotics is the rise of antibiotic resistance. This necessitates ongoing R&D to develop new antibiotics and alternative treatments. Additionally, side effects, such as those seen with erythromycin (e.g., diarrhea, loss of appetite), can impact patient compliance and market dynamics[3].

Regulatory Changes

Changes in regulatory policies can both challenge and opportunity for pharmaceutical companies. For example, stricter regulations on antibiotic use can reduce sales, but they can also drive innovation in developing more targeted and effective treatments.

Emerging Markets

Expanding into emerging markets can provide significant growth opportunities. Companies that establish strong distribution networks and pricing strategies tailored to these markets can capitalize on the growing demand for pediatric antibiotics.

Key Takeaways

  • Consistent Demand: Pediatric antibiotics like erythromycin have a consistent demand due to their effectiveness in treating bacterial infections.
  • Pricing Strategies: Pricing is influenced by local health system dynamics, regulatory policies, and patient access programs.
  • Financial Performance: Revenue growth, operating income, and net income are key metrics that reflect the financial health of companies selling pediatric antibiotics.
  • Challenges and Opportunities: Antibiotic resistance, side effects, regulatory changes, and emerging markets are critical factors that shape the market dynamics and financial trajectory.

FAQs

What are the common uses of erythromycin in pediatric patients?

Erythromycin is used to treat various bacterial infections in children, including respiratory tract infections, skin infections, and diphtheria[3].

How does the pricing of pediatric antibiotics vary across different regions?

Pricing varies based on local health system dynamics, regulatory frameworks, and the additional value the medicine brings to society[1].

What are the financial implications of antibiotic resistance on pharmaceutical companies?

Antibiotic resistance can lead to reduced sales and increased R&D expenses as companies seek to develop new, effective antibiotics.

How do patient access programs impact the financial trajectory of pediatric antibiotics?

Patient access programs can reduce out-of-pocket costs for patients, increasing access and potentially stabilizing revenue for pharmaceutical companies[4].

What role does R&D play in the financial performance of companies selling pediatric antibiotics?

R&D is crucial for maintaining market position and developing new treatments, impacting net income but essential for long-term growth[2].

Sources

  1. Pricing and Access of Our Innovative Medicines 2023 - AbbVie
  2. Annual Report 2018 - Recordati
  3. Erythromycin (oral route) - Mayo Clinic
  4. Cost, Insurance, & Financial Help With KEYTRUDA® (pembrolizumab) - Merck Sharp & Dohme LLC
  5. An update on the available medications and drugs under investigation - The Lancet

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