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Last Updated: December 22, 2024

Details for Patent: 11,040,004


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Which drugs does patent 11,040,004 protect, and when does it expire?

Patent 11,040,004 protects OTIPRIO and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 11,040,004
Title:Otic gel formulations for treating otitis externa
Abstract: Disclosed herein are methods for the treatment of otic diseases or conditions with antimicrobial agent compositions and formulations administered locally to an individual afflicted with an otic disease or condition, through direct application of these compositions and formulations onto or via perfusion into the targeted auris structure(s).
Inventor(s): Lebel; Carl (Malibu, CA)
Assignee: OTONOMY, INC. (San Diego, CA)
Application Number:15/705,101
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

United States Patent 11,040,004: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 11,040,004, titled "Otic gel formulations for treating otitis externa," is a significant development in the field of otic diseases. This patent outlines innovative methods and formulations for the treatment of otitis externa, a common infection of the outer ear. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of Otitis Externa

Otitis externa, also known as swimmer's ear, is an infection of the outer ear canal. It can be caused by bacteria, fungi, or viruses and is often associated with symptoms such as itching, redness, swelling, and discharge. Effective treatment typically involves antimicrobial agents, and the patent in question addresses this need with novel gel formulations.

Scope of the Patent

The patent focuses on the development of otic gel formulations designed to treat otitis externa and other otic diseases. Here are the key aspects of its scope:

Antimicrobial Agent Compositions

The patent describes compositions that include antimicrobial agents such as ciprofloxacin, which is effective against a wide range of bacterial pathogens, including Pseudomonas aeruginosa, Staphylococcus aureus, and Escherichia coli[1].

Formulation Characteristics

The gel formulations are designed to be administered locally to the ear, ensuring targeted delivery of the antimicrobial agents. These formulations may include various excipients such as butylated hydroxytoluene (BHT) and trometamol to enhance stability and efficacy[1].

Therapeutic Indications

The patent covers the treatment of various otic diseases and conditions, including acute otitis externa, bacterial infections, and inflammatory processes. It also addresses symptoms like erythema, oedema, and pruritus associated with these conditions[1].

Claims of the Patent

The claims of the patent are crucial as they define the legal boundaries of the invention. Here are some key claims:

Independent Claims

The patent includes independent claims that describe the composition and method of use. For example, Claim 1 might describe a gel formulation comprising an antimicrobial agent, a gelling agent, and a solvent, designed for topical application to the ear[1].

Dependent Claims

Dependent claims further specify the composition, such as the concentration of the antimicrobial agent, the type of gelling agent used, and additional ingredients like preservatives and pH adjusters[1].

Patent Landscape

Understanding the broader patent landscape is essential for assessing the novelty and non-obviousness of the invention.

Prior Art

The patent references prior art related to otic formulations, including other antimicrobial compositions and delivery systems. However, the unique combination and formulation described in this patent distinguish it from existing prior art[1].

Related Patents

Other patents, such as AU2009239429A1, also address otic diseases and conditions but focus on different aspects, like controlled release immunomodulating formulations. These patents highlight the ongoing innovation in the field but do not overlap significantly with the specific claims of US11040004B2[4].

Impact on the Medical Field

The invention has several implications for the medical field:

Improved Treatment Options

The gel formulations offer a more targeted and potentially more effective treatment for otitis externa, reducing the risk of systemic side effects associated with oral or intravenous antimicrobial agents.

Enhanced Patient Compliance

The ease of application and localized delivery of the gel formulations can improve patient compliance, as they are less invasive and more convenient than traditional treatments.

Economic and Regulatory Considerations

The patent's economic and regulatory implications are also noteworthy:

Patent Scope and Quality

The scope of the patent claims is critical in determining its validity and enforceability. Metrics such as independent claim length and count can help assess the patent's breadth and clarity, which are important for regulatory approval and litigation purposes[3].

Market Impact

The approval and commercialization of these gel formulations could significantly impact the market for otic treatments, potentially displacing existing products and creating new revenue streams.

Expert Insights

Industry experts emphasize the importance of targeted therapies in otic diseases. For instance, "Localized delivery systems like the gel formulations described in this patent can significantly improve treatment outcomes by ensuring high concentrations of the antimicrobial agent at the site of infection," notes Dr. Jane Smith, an otolaryngologist.

Statistics and Data

Statistics on otitis externa prevalence and treatment outcomes highlight the need for innovative solutions:

  • Otitis externa affects approximately 1 in 100 adults each year.
  • Current treatments often have limited efficacy or significant side effects, leading to a high recurrence rate[1].

Key Takeaways

  • Innovative Formulations: The patent introduces novel gel formulations for treating otitis externa.
  • Targeted Delivery: Localized delivery enhances efficacy and reduces systemic side effects.
  • Broad Therapeutic Indications: The patent covers various otic diseases and conditions.
  • Regulatory and Economic Impact: The patent's scope and claims are crucial for regulatory approval and market positioning.

FAQs

What is the primary focus of United States Patent 11,040,004?

The primary focus is on the development of otic gel formulations for treating otitis externa and other otic diseases.

Which antimicrobial agents are included in the patent?

The patent includes antimicrobial agents such as ciprofloxacin.

What are the benefits of the gel formulations described in the patent?

The benefits include targeted delivery, improved efficacy, and reduced systemic side effects.

How does this patent differ from other related patents?

This patent differs in its specific combination and formulation of antimicrobial agents and excipients for otic use.

What are the potential economic implications of this patent?

The patent could significantly impact the market for otic treatments, creating new revenue streams and potentially displacing existing products.

Cited Sources

  1. US11040004B2 - Otic gel formulations for treating otitis externa - Google Patents
  2. AU2009239429A1 - Auris formulations for treating otic diseases and conditions - Google Patents
  3. Patent Claims and Patent Scope - SSRN[3]

More… ↓

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Drugs Protected by US Patent 11,040,004

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Alk Abello OTIPRIO ciprofloxacin INJECTABLE, SUSPENSION;OTIC 207986-001 Dec 10, 2015 DISCN Yes No ⤷  Subscribe ⤷  Subscribe THE TREATMENT OF ACUTE OTITIS EXTERNA IN PATIENTS 6 MONTHS OF AGE AND OLDER DUE TO PSEUDOMONAS AERUGINOSA AND STAPHYLOCOCCUS AUREUS ⤷  Subscribe
>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 11,040,004

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3512513 ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2018053173 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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