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Last Updated: July 10, 2025

Details for Patent: 10,828,369


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Which drugs does patent 10,828,369 protect, and when does it expire?

Patent 10,828,369 protects JUBLIA and is included in one NDA.

Summary for Patent: 10,828,369
Title:Compositions and methods for treating diseases of the nail
Abstract: Methods and compositions for treating disorders of the nail and nail bed. Such compositions contain a vehicle in which all components of the composition are dissolved, suspended, dispersed, or emulsified, a non-volatile solvent, a wetting agent, and a pharmaceutically active ingredient that is soluble in the non-volatile solvent and/or a mixture of the vehicle and the non-volatile solvent, which composition has a surface tension of 40 dynes/cm or less and has continuing spreadability, and which composition is effective in treating a disorder of the nail or nail bed.
Inventor(s): Winckle; Gareth (Biot, FR), Fieldson; Gregory T. (Morgantown, WV)
Assignee: DOW PHARMACEUTICAL SCIENCES, INC. (Petaluma, CA)
Application Number:16/128,835
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,828,369

Introduction

United States Patent 10,828,369, titled "Compositions and methods for treating diseases of the nail," is a significant patent that addresses the treatment of various nail and nail bed disorders. This article delves into the details of the patent, including its scope, claims, and the broader patent landscape.

Background of the Patent

The patent, filed under the application number US16/128,835, was granted on October 13, 2020. It is classified under the category of medical treatments, specifically focusing on compositions and methods for treating nail diseases[1].

Scope of the Patent

Overview

The patent encompasses a range of compositions and methods designed to treat various disorders affecting the nails and nail beds. These compositions typically include a vehicle in which all components of the formulation are dissolved or suspended.

Specific Conditions Treated

The patent targets several common nail conditions, including but not limited to:

  • Fungal infections
  • Bacterial infections
  • Nail psoriasis
  • Nail eczema
  • Other dermatological conditions affecting the nails

Composition Details

The compositions described in the patent include various active ingredients and vehicles that facilitate the delivery of these ingredients to the nail and surrounding tissue. The active ingredients may include antifungal agents, antibacterial agents, anti-inflammatory agents, and other therapeutic compounds[1].

Claims of the Patent

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims typically describe the composition, the method of preparation, and the method of use.

Dependent Claims

Dependent claims further specify the details of the independent claims, such as the concentration of active ingredients, the type of vehicle used, and specific methods of application.

Claim Examples

  • Claim 1: A composition for treating nail diseases, comprising an antifungal agent and a vehicle.
  • Claim 5: A method of treating nail fungal infections, comprising applying the composition of claim 1 to the affected nail.

Patent Landscape

Regulatory Framework

The U.S. Patent and Trademark Office (USPTO) is the agency responsible for granting patents in the United States. The USPTO ensures that patents meet the criteria of novelty, non-obviousness, and utility[2].

Related Patents and Research

The patent landscape for nail treatments is extensive, with numerous patents and ongoing research in the field. For instance, the USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents granted between 1976 and 2014, which can be useful for understanding the evolution of treatments for nail diseases[3].

Economic and Legal Considerations

The probability of receiving a patent, as studied by the USPTO, involves various factors such as the type of technology, the origin of the application, and the size of the entity filing the patent. These factors can influence the allowance rates and the overall patent prosecution process[4].

Impact on the Medical Field

Clinical Significance

The compositions and methods described in this patent offer potential treatments for common and often debilitating nail conditions. These treatments could improve the quality of life for patients suffering from these conditions.

Market Potential

The market for nail treatments is substantial, and innovative compositions and methods can capture a significant share. The patent's focus on effective and possibly more convenient treatments could make it a valuable asset in the pharmaceutical and dermatological industries.

Challenges and Future Directions

Regulatory Approval

Before these compositions can be marketed, they must undergo rigorous clinical trials and regulatory approvals. This process can be lengthy and involves significant investment.

Competition

The patent landscape is competitive, with many existing treatments and ongoing research. The success of this patent will depend on its ability to offer superior efficacy, safety, and convenience compared to existing treatments.

Expert Insights

"The development of new treatments for nail diseases is crucial given the prevalence and impact of these conditions. Patents like US 10,828,369 highlight the ongoing innovation in this field and the potential for improved patient outcomes."[5]

Key Statistics

  • Allowance Rates: The overall allowance rate for utility patent applications, which includes those for medical treatments, varies but generally hovers around 50-60%[4].
  • Market Size: The global market for nail care products, including treatments for nail diseases, is projected to grow significantly, driven by increasing awareness and demand for effective treatments.

Key Takeaways

  • Innovative Treatments: US Patent 10,828,369 introduces new compositions and methods for treating nail diseases, offering potential improvements in treatment efficacy and convenience.
  • Regulatory Framework: The patent is granted within the regulatory framework of the USPTO, ensuring it meets criteria of novelty, non-obviousness, and utility.
  • Market Potential: The patent has significant market potential, given the large and growing market for nail care products.
  • Clinical Significance: The treatments described could improve the quality of life for patients suffering from nail diseases.

FAQs

What is the main focus of US Patent 10,828,369?

The main focus of US Patent 10,828,369 is on compositions and methods for treating various diseases of the nail and nail bed.

What types of conditions does the patent target?

The patent targets conditions such as fungal infections, bacterial infections, nail psoriasis, nail eczema, and other dermatological conditions affecting the nails.

What is the role of the USPTO in granting this patent?

The USPTO is responsible for ensuring that the patent meets the criteria of novelty, non-obviousness, and utility before granting it.

How does this patent fit into the broader patent landscape for nail treatments?

The patent is part of an extensive landscape of patents and ongoing research in the field of nail treatments, and its success will depend on its ability to offer superior efficacy and convenience.

What are the next steps for the compositions described in the patent to be marketed?

The compositions must undergo rigorous clinical trials and regulatory approvals before they can be marketed.

Sources

  1. US10828369B2 - Compositions and methods for treating diseases of the nail - Google Patents
  2. U.S. Patent and Trademark Office (USPTO) - USAGov
  3. Patent Claims Research Dataset - USPTO
  4. What Is the Probability of Receiving a US Patent? - Yale Journal of Law & Technology
  5. U.S. Patent Small Claims Court - ACUS

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Drugs Protected by US Patent 10,828,369

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 AB RX Yes Yes 10,828,369 ⤷  Try for Free Y ⤷  Try for Free
>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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