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Last Updated: December 22, 2024

Details for Patent: 6,669,948


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Summary for Patent: 6,669,948
Title: Antibiotic product, use and formulation thereof
Abstract:An antibiotic product, in particular a betalactam such as cephalosporin (in particular cefuroxime and/or cefpodoxime) or a penicillin (in particular axmoxicillin or dicloxacillin) is comprised of at least three dosages forms, each of which has a different release profile, with the C.sub.max for the antibiotic product being reached in less than about twelve hours. In one embodiment, there is an immediate release dosage form, as well as two or more delayed release dosage forms, with each of the dosage forms having a different release profile, wherein each reaches a C.sub.max at different times.
Inventor(s): Rudnic; Edward M. (N. Potomac, MD), Isbister; James D. (Potomac, MD), Treacy, Jr.; Donald J. (Arnold, MD), Wassink; Sandra E. (Frederick, MD)
Assignee: Advancis Pharmaceutical Corp. (Germantown, MD)
Application Number:10/027,609
Patent Claim Types:
see list of patent claims
Composition; Dosage form; Use;
Patent landscape, scope, and claims:

United States Patent 6,669,948: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 6,669,948, titled "Amoxicillin Formulations with Modified Release," is a significant patent in the pharmaceutical field, particularly in the development of amoxicillin products. This patent, issued to various assignees, outlines innovative formulations of amoxicillin that enhance its delivery and efficacy.

Background

Amoxicillin is a widely used antibiotic belonging to the penicillin class. The patent addresses the need for improved formulations that can optimize the drug's release profile, ensuring better patient compliance and therapeutic outcomes.

Scope of the Patent

The patent covers amoxicillin products that include at least one modified release component. These components can be categorized into several types:

Immediate Release Components

These are components where the initiation of release and the rate of release of the active ingredient are not substantially delayed, slowed, or sustained after administration[1].

Delayed Release Components

These components delay the release of the active ingredient but do not sustain the release over a period of time after the delay[1].

Extended (Sustained) Release Components

These components sustain the release of the active ingredient over a period of time after administration[1].

Claims of the Patent

The patent includes several claims that define the scope of the invention:

Multiple Release Components

The patent claims products that include an immediate release component and one or more delayed release components, or products that include an immediate release component and one or more extended release components. It also covers products with combinations of delayed and extended release components without an immediate release component[1].

Dissolution Profile

The claims specify the in-vitro dissolution profile of the amoxicillin product, detailing the percentage of amoxicillin dissolved at specific times. For example, the product must have a dissolution profile where at least a specified minimum and not more than a specified maximum percent of the total amoxicillin is dissolved at certain times[1].

Partial AUC Ratios

The patent describes the partial Area Under the Curve (AUC) ratios, which are critical for understanding the pharmacokinetics of the amoxicillin product. These ratios are determined in the fed state and are essential for ensuring the product's efficacy and safety[1].

Patent Landscape Analysis

To understand the broader context and impact of this patent, a patent landscape analysis is crucial.

Competitor Analysis

Patent landscape analysis helps identify competitors in the field of antibiotic formulations. This includes other pharmaceutical companies that have developed similar or competing products. For instance, analyzing patents from other companies can reveal trends in formulation technology and market strategies[3].

Market Developments

The analysis also reveals market developments such as mergers and acquisitions, licensing agreements, and litigation activities. This information is vital for strategic decision-making and risk management in the pharmaceutical industry[3].

Legal Status and Expiry Dates

Understanding the legal status (alive, pending, lapsed, revoked, or expired) and expected expiry dates of related patents is essential. This information helps in planning future research and development, as well as in making informed decisions about patent filings and licensing[3].

Technical Insights

The patent provides detailed technical insights into the formulation of amoxicillin products.

Formulation Techniques

The patent describes various formulation techniques, including the use of different release components and their combinations. This knowledge is valuable for formulators and researchers looking to develop new or improved antibiotic formulations[1].

Pharmacokinetics

The patent delves into the pharmacokinetics of the amoxicillin product, including the AUC ratios and dissolution profiles. These aspects are critical for ensuring the product's bioavailability and therapeutic efficacy[1].

Industry Impact

The impact of this patent on the pharmaceutical industry is significant.

Improved Patient Compliance

The modified release formulations described in the patent can improve patient compliance by reducing the frequency of dosing and enhancing the drug's efficacy over a longer period[1].

Competitive Advantage

Companies holding this patent or similar patents can gain a competitive advantage in the market by offering products with superior release profiles, which can lead to better therapeutic outcomes and higher patient satisfaction[3].

Economic Value

The economic value of this patent is substantial.

Monetary Value

Patents in the pharmaceutical sector can be highly valuable, with prices ranging from hundreds of thousands to millions of dollars. For example, significant patent deals in other sectors have seen prices as high as $7.7 million per patent application[2].

Licensing and Royalties

The patent can generate revenue through licensing agreements and royalties. Companies can license the technology to other manufacturers, ensuring a steady stream of income[2].

Challenges and Limitations

While the patent offers several advantages, there are also challenges and limitations to consider.

Regulatory Compliance

The product must comply with regulatory requirements, including those related to pharmacokinetics and bioavailability. Non-compliance can lead to regulatory issues and potential litigation[1].

Litigation Risks

The pharmaceutical industry is prone to patent litigation. Companies must ensure that their products do not infringe on existing patents and be prepared to defend their own patents against infringement claims[5].

Key Takeaways

  • Modified Release Formulations: The patent covers various modified release formulations of amoxicillin, including immediate, delayed, and extended release components.
  • Pharmacokinetics: The patent specifies the AUC ratios and dissolution profiles, which are critical for the product's efficacy and safety.
  • Competitive Advantage: The patent provides a competitive edge in the market by offering superior release profiles.
  • Economic Value: The patent has significant economic value through licensing, royalties, and potential sales.
  • Regulatory Compliance: The product must comply with regulatory requirements to avoid legal issues.

FAQs

What is the main focus of United States Patent 6,669,948?

The main focus of this patent is on amoxicillin formulations with modified release components, including immediate, delayed, and extended release.

How does the patent improve patient compliance?

The patent improves patient compliance by reducing the frequency of dosing through the use of delayed and extended release components.

What are the key technical insights provided by the patent?

The patent provides detailed insights into formulation techniques, pharmacokinetics, and the dissolution profiles of the amoxicillin product.

How can companies benefit economically from this patent?

Companies can benefit through licensing agreements, royalties, and the potential to sell the patented technology.

What are the regulatory challenges associated with this patent?

The product must comply with regulatory requirements related to pharmacokinetics and bioavailability to avoid regulatory issues and potential litigation.

Cited Sources

  1. EP1969134A1 - Produits d'amoxicilline à libération modifiée - Google Patents
  2. The value of a patent - Perpetual Motion Patents
  3. Navigating Technological Domains with Patent Landscape Analysis - Sagacious Research
  4. Search for patents - USPTO
  5. AI VISUALIZE, INC. v. NUANCE COMMUNICATIONS, INC. - CAFC US Courts

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Drugs Protected by US Patent 6,669,948

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 6,669,948

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2002359768 ⤷  Subscribe
Australia 2003257176 ⤷  Subscribe
Australia 2003261339 ⤷  Subscribe
Australia 2003261359 ⤷  Subscribe
Australia 2003262626 ⤷  Subscribe
Australia 3983801 ⤷  Subscribe
Canada 2400784 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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