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Last Updated: December 22, 2024

Details for Patent: 5,653,972


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Summary for Patent: 5,653,972
Title: Preserved ophthalmic drug compositions containing polymeric quaternary ammonium compounds
Abstract:Disclosed are storage-stable preserved ophthalmic compositions containing acidic drugs in combination with polymeric quaternary ammonium compounds and boric acid.
Inventor(s): Desai; Suketu Dipakbhai (Fort Worth, TX), Nelms; Diane S. (Fort Worth, TX)
Assignee: Alcon Laboratories, Inc. (Fort Worth, TX)
Application Number:08/700,960
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

United States Patent 5,653,972: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 5,653,972, titled "Aqueous Liquid Preparation Containing 2-Amino-3-(4-Bromobenzoyl)Phenylacetic Acid," is a significant patent in the field of pharmaceuticals, particularly in ophthalmic and other medical formulations. This patent, assigned to Senju Pharmaceutical Co., Ltd., was granted on August 5, 1997. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Inventors and Assignee

The patent was invented by Shirou Sawa and Shuhei Fujita, both from Japan, and assigned to Senju Pharmaceutical Co., Ltd., based in Osaka, Japan[1][2][5].

Background of the Invention

The patent addresses the stabilization of 2-amino-3-(4-bromobenzoyl)phenylacetic acid, a compound used in various pharmaceutical preparations, particularly in eye drops. This compound is known for its therapeutic properties, such as anti-inflammatory and analgesic effects, but it is challenging to stabilize in aqueous solutions.

Summary of the Invention

The invention involves an aqueous liquid preparation that stabilizes 2-amino-3-(4-bromobenzoyl)phenylacetic acid through the addition of specific polymers and other stabilizing agents. The key components include:

  • Water-soluble polymers: Such as tyloxapol or polyethylene glycol fatty acid esters, which help maintain the stability of the aqueous solution within a non-irritating pH range[1][5].
  • Preservatives: The invention also ensures that the preservative effect, typically provided by agents like benzalkonium chloride, is maintained over time without deterioration[1][5].

Claims of the Patent

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

  • Claim 1: An aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid or a pharmacologically acceptable salt or hydrate thereof, and a water-soluble polymer such as tyloxapol or polyethylene glycol monostearate[1][5].
  • Claim 2: The preparation of Claim 1, further comprising a preservative, where the addition of the polymer inhibits the decrease in preservative effect[1][5].
  • Subsequent Claims: These claims detail various aspects of the preparation, including the concentration of the active ingredient, the type of polymers used, and the pH range of the solution[1][5].

Scope of the Invention

The scope of this patent is broad, covering various aspects of the aqueous liquid preparation:

  • Stability: The invention ensures the stability of the active ingredient in aqueous solutions, which is crucial for maintaining the efficacy of the pharmaceutical preparation[1][5].
  • Non-Irritating pH Range: The preparation is designed to be within a pH range that does not irritate the eyes, making it suitable for ophthalmic use[1][5].
  • Preservative Effect: The inclusion of stabilizing agents prevents the deterioration of the preservative effect, ensuring the long-term stability of the preparation[1][5].

Patent Landscape

The patent landscape surrounding this invention is complex and involves several related patents and technologies:

  • Related Patents: Other patents by the same inventors and assignee, such as US 9,561,277 B2 and US 8,129,431 B2, also deal with similar aqueous liquid preparations and stabilization techniques[1][2].
  • Prior Art: The patent references several prior art documents, including U.S. patents and foreign patent documents, which indicate the evolution of stabilization techniques in pharmaceutical preparations[1][2].
  • Competitive Landscape: The pharmaceutical industry is highly competitive, with numerous companies holding patents related to ophthalmic and other medical formulations. This patent positions Senju Pharmaceutical Co., Ltd. as a key player in this field[3].

Impact on the Industry

This patent has significant implications for the pharmaceutical industry:

  • Innovation in Stabilization: The invention provides a novel method for stabilizing a critical active ingredient, enhancing the shelf life and efficacy of ophthalmic preparations[1][5].
  • Compliance with Regulatory Standards: The non-irritating pH range and maintained preservative effect ensure compliance with regulatory standards, making the product safer for use[1][5].
  • Market Dominance: By securing this patent, Senju Pharmaceutical Co., Ltd. gains a competitive edge in the market, protecting its intellectual property and preventing others from using similar stabilization techniques without permission[3].

Claim Coverage and Patent Analytics

To fully understand the protection offered by this patent, it is essential to analyze the claim coverage using tools like Claim Coverage Matrix and Claim Charts. These tools help in categorizing patents by claims and scope concepts, identifying gaps or opportunities in the patent landscape, and determining the value of the patent claims to the company[3].

Future Directions and Opportunities

The patent opens up several future directions and opportunities:

  • New Formulations: The stabilization technique can be applied to other pharmaceutical preparations, expanding the product portfolio of Senju Pharmaceutical Co., Ltd.[1][5].
  • Collaborations and Licensing: The company can explore collaborations or licensing agreements with other pharmaceutical companies to leverage the technology and expand its market reach[3].

Key Takeaways

  • The patent 5,653,972 provides a novel method for stabilizing 2-amino-3-(4-bromobenzoyl)phenylacetic acid in aqueous solutions.
  • The invention involves the use of water-soluble polymers and preservatives to maintain stability and efficacy.
  • The patent has significant implications for the pharmaceutical industry, particularly in ophthalmic preparations.
  • It positions Senju Pharmaceutical Co., Ltd. as a leader in stabilization technology and provides a competitive edge in the market.

Frequently Asked Questions (FAQs)

What is the main purpose of the United States Patent 5,653,972?

The main purpose of this patent is to provide a method for stabilizing 2-amino-3-(4-bromobenzoyl)phenylacetic acid in aqueous solutions, ensuring the efficacy and safety of ophthalmic preparations.

Who are the inventors of this patent?

The inventors of this patent are Shirou Sawa and Shuhei Fujita from Japan.

What company holds this patent?

This patent is held by Senju Pharmaceutical Co., Ltd., based in Osaka, Japan.

What are the key components of the aqueous liquid preparation described in this patent?

The key components include 2-amino-3-(4-bromobenzoyl)phenylacetic acid, water-soluble polymers like tyloxapol or polyethylene glycol monostearate, and preservatives such as benzalkonium chloride.

How does this patent impact the pharmaceutical industry?

This patent provides a novel stabilization technique, enhancing the shelf life and efficacy of ophthalmic preparations, and gives Senju Pharmaceutical Co., Ltd. a competitive edge in the market.

Cited Sources:

  1. Sawa et al., US9561277B2 - Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid, Google Patents.
  2. Sawa et al., US8129431B2 - Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid, Google Patents.
  3. Schwegman, Patent Analytics, SLWIP.
  4. Halyard Health, Patent Information, Halyard Health.
  5. Google Patents, US9561277B2 - Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid.

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Drugs Protected by US Patent 5,653,972

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

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