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Last Updated: December 22, 2024

Details for Patent: 10,751,325


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Which drugs does patent 10,751,325 protect, and when does it expire?

Patent 10,751,325 protects RHOFADE and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 10,751,325
Title:Stabilized oxymetazoline formulations and their uses
Abstract: The present invention provides stabilized cream formulations of oxymetazoline and uses thereof. The present invention also provides a method of treating facial erythema associated with rosacea in a patient in need of such treatment, comprising topically administering once or twice daily to the site of erythema on the face of the patient a pharmaceutical composition comprising 0.5%, 1.0% or 1.5% oxymetazoline or a pharmaceutically acceptable salt thereof as the sole active ingredient.
Inventor(s): Sarpotdar; Pramod (Rohnert Park, CA), Warner; Kevin (Anaheim, CA), Zhang; Steven (Newton, MA), Ahluwalia; Gurpreet (Tustin, CA), Kuang; Amy (Irvine, CA)
Assignee: EPI HEALTH, LLC (Charleston, SC)
Application Number:16/380,538
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

United States Patent 10,751,325: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,751,325, titled "Stabilized oxymetazoline formulations and their uses," is a significant patent in the pharmaceutical industry, particularly in the treatment of rosacea and other skin conditions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Invention Description

The patent describes stabilized cream formulations of oxymetazoline, a vasoconstrictor commonly used to treat rosacea and other dermatological conditions. The invention includes methods for preparing these formulations and their therapeutic applications[4].

Key Components

  • Active Ingredient: Oxymetazoline, known for its vasoconstrictive properties.
  • Formulation: The patent details various cream formulations that stabilize oxymetazoline, enhancing its efficacy and shelf life.
  • Therapeutic Uses: The formulations are designed to treat conditions such as rosacea, erythema, and other skin-related issues.

Scope of the Patent

Claims

The patent includes multiple claims that define the scope of the invention. These claims can be broadly categorized into:

  • Composition Claims: These claims describe the specific formulations of oxymetazoline, including the types and amounts of ingredients used.
  • Method Claims: These claims outline the processes for preparing the stabilized formulations.
  • Use Claims: These claims specify the therapeutic applications of the formulations, such as treating rosacea and other skin conditions[4].

Claim Examples

  • Claim 1: A stabilized cream formulation comprising oxymetazoline, a polyethylene glycol, and an octadecan-1-ol.
  • Claim 10: A method of treating rosacea comprising applying the stabilized cream formulation to the affected skin area.

Patent Landscape

Related Patents

The patent 10,751,325 is part of a larger family of patents related to oxymetazoline formulations and their therapeutic uses. Other patents in this family include:

  • United States Patent Nos. 7,812,049; 8,420,688; 8,815,929; 8,883,838; 9,974,773; and 10,335,391, which are also associated with the treatment of rosacea and are owned by EPI Health and Allergan[5].

Global Dossier

Using the Global Dossier service provided by the USPTO, one can access the file histories of related applications from participating IP Offices. This service helps in understanding the global patent family and the dossier, classification, and citation data for these applications[1].

Common Citation Document (CCD)

The CCD application consolidates prior art cited by all participating offices for the family members of a patent application. This tool is useful for visualizing the search results for the same invention produced by several offices on a single page[1].

Litigation and Enforcement

Infringement Claims

The patent 10,751,325 has been involved in litigation, particularly in a case where EPI Health and Allergan alleged that Perrigo UK FINCO Ltd. Partnership's generic version of oxymetazoline cream infringed on their patents. Perrigo had submitted an Abbreviated New Drug Application (ANDA) seeking FDA approval for their generic product, which the plaintiffs claimed would infringe on their patents[5].

Legal Implications

The litigation highlights the importance of patent protection in the pharmaceutical industry. The plaintiffs' assertion that Perrigo's ANDA product would infringe on their patents underscores the need for thorough patent searches and analysis to avoid potential legal disputes.

Economic and Market Impact

Market Dominance

Patents like 10,751,325 play a crucial role in maintaining market dominance for pharmaceutical companies. By protecting their formulations and therapeutic uses, companies like EPI Health and Allergan can ensure exclusivity in the market, which is vital for recouping investment in research and development.

Research and Development

The detailed information on claims from patents like 10,751,325, as provided in the Patent Claims Research Dataset by the USPTO, can be invaluable for researchers and developers. This dataset helps in understanding patent scope and trends, which can guide future research and innovation[3].

Conclusion

United States Patent 10,751,325 is a significant patent in the pharmaceutical sector, particularly for the treatment of rosacea. Understanding its scope, claims, and the broader patent landscape is crucial for both legal and business strategies.

Key Takeaways

  • Stabilized Formulations: The patent describes stabilized cream formulations of oxymetazoline.
  • Therapeutic Uses: The formulations are used to treat rosacea and other skin conditions.
  • Litigation: The patent has been involved in infringement claims against generic manufacturers.
  • Market Impact: The patent helps in maintaining market dominance and guides future research and development.
  • Global Patent Family: The patent is part of a larger family of related patents.

FAQs

1. What is the main invention described in United States Patent 10,751,325?

The main invention is stabilized cream formulations of oxymetazoline and their therapeutic uses.

2. What are the key components of the stabilized formulations?

The key components include oxymetazoline, polyethylene glycol, and octadecan-1-ol.

3. What are the therapeutic applications of the formulations?

The formulations are used to treat conditions such as rosacea, erythema, and other skin-related issues.

4. Has this patent been involved in any litigation?

Yes, it has been involved in litigation where EPI Health and Allergan alleged infringement by Perrigo UK FINCO Ltd. Partnership.

5. How does this patent impact the market?

The patent helps in maintaining market dominance for the pharmaceutical companies and guides future research and development in the field.

Sources

  1. USPTO - Search for patents https://www.uspto.gov/patents/search
  2. ACUS - U.S. Patent Small Claims Court https://www.acus.gov/research-projects/us-patent-small-claims-court
  3. USPTO - Patent Claims Research Dataset https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  4. Google Patents - Stabilized oxymetazoline formulations and their uses https://patents.google.com/patent/US10751325B2/en
  5. Law Street Media - EPI Health, Allergan Claim Perrigo Infringing on Rosacea Treatment Patents https://lawstreetmedia.com/news/health/epi-health-allergan-claim-perrigo-infringing-on-rosacea-treatment-patents/

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Drugs Protected by US Patent 10,751,325

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mayne Pharma RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS ⤷  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 10,751,325

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015274532 ⤷  Subscribe
Canada 2951725 ⤷  Subscribe
European Patent Office 3154517 ⤷  Subscribe
Spain 2796871 ⤷  Subscribe
Mexico 2016016400 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.