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Last Updated: December 22, 2024

AUGMENTIN ES-600 Drug Patent Profile


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When do Augmentin Es-600 patents expire, and what generic alternatives are available?

Augmentin Es-600 is a drug marketed by Us Antibiotics and is included in one NDA.

The generic ingredient in AUGMENTIN ES-600 is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

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Summary for AUGMENTIN ES-600
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 15
Clinical Trials: 75
Patent Applications: 720
What excipients (inactive ingredients) are in AUGMENTIN ES-600?AUGMENTIN ES-600 excipients list
DailyMed Link:AUGMENTIN ES-600 at DailyMed
Drug patent expirations by year for AUGMENTIN ES-600
Recent Clinical Trials for AUGMENTIN ES-600

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Wisconsin, MadisonPhase 4
Patient-Centered Outcomes Research InstitutePhase 4
Daniel MerensteinPhase 4

See all AUGMENTIN ES-600 clinical trials

Pharmacology for AUGMENTIN ES-600

US Patents and Regulatory Information for AUGMENTIN ES-600

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Us Antibiotics AUGMENTIN ES-600 amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 050755-001 Jun 22, 2001 AB RX Yes 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

AUGMENTIN ES-600 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Augmentin ES-600

Introduction

Augmentin ES-600, a combination antibiotic consisting of amoxicillin and clavulanate potassium, has been a significant player in the pediatric antibiotic market. Here, we will delve into the market dynamics and financial trajectory of this drug.

Approval and Manufacturing

Augmentin ES-600 was approved by the FDA on June 22, 2001, and is manufactured by several companies, including US Antibiotics and Teva[1][4].

Indications and Usage

This antibiotic is specifically indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media caused by certain bacteria, including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis[4].

Market Position

Augmentin ES-600 holds a niche position in the market due to its specific formulation and indication for pediatric use. It is designed to combat bacterial infections that are resistant to other antibiotics, making it a valuable option for pediatric care.

Generic Availability

The brand name Augmentin ES-600 has been discontinued in the U.S., but generic versions are available and approved by the FDA. This has opened up the market to more affordable alternatives, which can impact the financial trajectory of the original brand[1][4].

Pricing and Cost

The cost of Augmentin ES-600 can be significant, with a supply of 200 milliliters costing around $973 for cash-paying customers. However, generic versions are substantially cheaper, starting from around $22.68 for 75 milliliters[5].

Financial Performance of Manufacturers

GlaxoSmithKline (GSK), one of the original developers of Augmentin, has seen strong financial performance driven by key pharmaceutical products, including Augmentin in its broader portfolio. In 2005, GSK reported a turnover of £21.7 billion, with an 18% growth in earnings per share. Although Augmentin ES-600 is not specifically highlighted in these reports, it contributes to the overall success of GSK's antibiotic segment[3].

Competitive Landscape

The antibiotic market is highly competitive, with numerous brands and generics available. Augmentin ES-600 competes with other amoxicillin/clavulanate formulations as well as other antibiotics. The availability of generic versions has increased competition, potentially reducing the market share of the original brand[1][4].

Clinical Trials and Safety

Clinical trials have shown that Augmentin ES-600 is generally safe and effective for pediatric patients. However, common adverse events include vomiting, fever, and diarrhea. These safety profiles are crucial for maintaining market trust and compliance[4].

Regulatory Considerations

Regulatory factors play a significant role in the market dynamics of Augmentin ES-600. The FDA approval and subsequent generic approvals have shaped the drug's availability and pricing. Additionally, warnings about fraudulent online pharmacies selling counterfeit versions of the drug highlight the need for regulatory vigilance[1].

Patient Assistance and Discounts

To make the drug more accessible, various discount programs and patient assistance cards are available. For example, the Drugs.com Discount Card can save patients up to 80% on prescription medicines, including Augmentin ES-600[5].

Impact of Generic Versions

The availability of generic versions has significantly impacted the financial trajectory of Augmentin ES-600. Generic drugs are often cheaper, which can lead to a reduction in sales for the brand name product. However, this also makes the treatment more affordable for a wider population, potentially increasing overall usage[1][5].

Future Outlook

Given the discontinuation of the brand name and the prevalence of generic versions, the future financial trajectory of Augmentin ES-600 is likely to be driven by the generic market. The drug will continue to be an important treatment option for pediatric infections, but its financial performance will be influenced by the competitive generic landscape.

Key Takeaways

  • Augmentin ES-600 is a specific formulation of amoxicillin/clavulanate indicated for pediatric use.
  • The brand name has been discontinued, but generic versions are available.
  • The drug faces competition from other antibiotics and generic formulations.
  • Pricing is a significant factor, with generics offering more affordable options.
  • Regulatory and safety considerations continue to shape the market dynamics.
  • Patient assistance programs help make the drug more accessible.

FAQs

Q: What is Augmentin ES-600 used for?

A: Augmentin ES-600 is used for the treatment of pediatric patients with recurrent or persistent acute otitis media caused by specific bacteria.

Q: Is Augmentin ES-600 still available under its brand name?

A: No, the brand name Augmentin ES-600 has been discontinued in the U.S., but generic versions are available.

Q: How much does Augmentin ES-600 cost?

A: The cost of Augmentin ES-600 can be around $973 for a 200 milliliter supply, but generic versions are significantly cheaper.

Q: What are the common side effects of Augmentin ES-600?

A: Common side effects include vomiting, fever, contact dermatitis, upper respiratory tract infection, and diarrhea.

Q: Can I purchase Augmentin ES-600 online safely?

A: It is crucial to purchase medications from reputable and valid online pharmacies to avoid counterfeit drugs.

Sources

  1. Generic Augmentin ES-600 Availability - Drugs.com
  2. AUGMENTIN ES-600 - FDA
  3. FORM 20-F GlaxoSmithKline plc - GSK
  4. Augmentin ES-600: Package Insert / Prescribing Information - Drugs.com
  5. Augmentin ES-600 Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com

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