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Last Updated: December 30, 2024

Details for Patent: 10,675,288


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Summary for Patent: 10,675,288
Title:Natural combination hormone replacement formulations and therapies
Abstract: Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.
Inventor(s): Bernick; Brian A. (Boca Raton, FL), Cacace; Janice Louise (Miami, FL), Persicaner; Peter H. R. (Boca Raton, FL), Irani; Neda (Palm Beach Gardens, FL), Amadio; Julia M. (Boca Raton, FL)
Assignee: TherapeuticsMD, Inc. (Boca Raton, FL)
Application Number:15/090,493
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

United States Patent 10,675,288: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 10,675,288, titled "Natural combination hormone replacement formulations and therapies," is a significant patent in the field of medical therapies, particularly focusing on hormone replacement treatments. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Publication Details

  • Publication Number: US10675288B2
  • Authority: United States
  • Prior Art Date: The patent application was filed on March 25, 2016, indicating the prior art date is relevant to this period[5].

Invention Description

The patent describes natural estrogen and progesterone replacement therapies, including formulations for estradiol and progesterone, both alone and in combination. These formulations are designed to address symptoms associated with menopause, such as hot flashes, night sweats, mood changes, and sleep disturbances[5].

Scope of the Patent

Technical Scope

The patent's technical scope is defined by its claims, which outline the specific formulations and methods of use. The claims include:

  • Formulations: The patent covers various formulations of estradiol and progesterone, including solubilized forms in oils and encapsulated forms in gelatin capsules.
  • Therapeutic Uses: The patent specifies the use of these formulations for treating menopause-related symptoms, including hot flashes, night sweats, mood changes, and sleep disturbances[5].

Market Scope

The market scope of this patent is significant, given the large demographic of women experiencing menopause and the growing demand for natural and effective hormone replacement therapies. The patent's focus on natural formulations positions it well in a market increasingly inclined towards natural and holistic health solutions.

Claims Analysis

Independent Claims

The patent includes several independent claims that define the core of the invention. These claims are crucial as they determine the patent's scope and what is protected under the patent.

  • Claim 1: Typically, the first independent claim is the broadest and most important, defining the overall invention. For this patent, it would likely cover the basic formulation and therapeutic use of the natural hormone replacement therapies[5].

Dependent Claims

Dependent claims build upon the independent claims, providing additional details and narrowing the scope. These claims might include specific dosages, administration methods, or additional ingredients that enhance the efficacy of the formulations.

Patent Landscape

Related Patents and Prior Art

To understand the patent landscape, it is essential to identify related patents and prior art. Tools like the USPTO's Patent Public Search and international databases such as the European Patent Office's esp@cenet and WIPO's PATENTSCOPE can be used to search for similar patents and prior art[1][4].

Patent Classification

The patent classification system organizes patents into specific technology groupings based on common subject matter. For this patent, it would fall under classifications related to pharmaceuticals, hormone replacement therapies, and women's health. Using classification systems can help in identifying similar patents and understanding the broader landscape[4].

Global Dossier and International Search

The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This can provide insights into how similar inventions are being protected globally[1].

Competitive Analysis

Market Competitors

Companies and researchers in the field of hormone replacement therapies are potential competitors. Analyzing their patents and research can provide insights into the competitive landscape. For example, other natural hormone replacement therapies or synthetic alternatives could be considered competitors.

Patent Landscape Reports

Patent landscape reports, such as those provided by WIPO, can offer a comprehensive view of the patent outlook for a given technology or industry. These reports can help in identifying key players, trends, and gaps in the market[4].

Legal and Regulatory Considerations

Patent Validity and Litigation

The validity of the patent can be assessed by examining the claim language, prior art, and the examination process. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].

Regulatory Compliance

Compliance with regulatory requirements is crucial for bringing a patented product to market. This includes FDA approval in the United States and similar regulatory approvals in other countries.

Conclusion

The United States Patent 10,675,288 is a significant contribution to the field of hormone replacement therapies, offering natural formulations that address menopause-related symptoms. Understanding the scope, claims, and broader patent landscape is essential for navigating the competitive and regulatory environment.

Key Takeaways

  • Scope and Claims: The patent covers natural estrogen and progesterone replacement therapies, with specific formulations and therapeutic uses.
  • Market Scope: The patent has significant market potential due to the growing demand for natural health solutions.
  • Patent Landscape: The landscape includes related patents, prior art, and global dossier information.
  • Competitive Analysis: Market competitors include other hormone replacement therapies, and patent landscape reports can provide comprehensive insights.
  • Legal and Regulatory Considerations: Patent validity, litigation risks, and regulatory compliance are critical factors.

FAQs

Q: What is the primary focus of United States Patent 10,675,288?

A: The primary focus is on natural estrogen and progesterone replacement therapies for treating menopause-related symptoms.

Q: How can one search for related patents and prior art?

A: Tools like the USPTO's Patent Public Search, European Patent Office's esp@cenet, and WIPO's PATENTSCOPE can be used to search for related patents and prior art.

Q: What is the significance of the Global Dossier service?

A: The Global Dossier service allows users to view the patent family for a specific application, including related applications filed at participating IP Offices.

Q: How can patent landscape reports be useful?

A: Patent landscape reports provide a comprehensive view of the patent outlook for a given technology or industry, helping to identify key players, trends, and market gaps.

Q: What are the key metrics for measuring patent scope?

A: Independent claim length and independent claim count are simple metrics used to measure patent scope, which have explanatory power for several correlates of patent scope[3].

Sources

  1. USPTO: Search for patents - USPTO
  2. USA.gov: U.S. Patent and Trademark Office (USPTO) | USAGov
  3. SSRN: Patent Claims and Patent Scope - Search eLibrary :: SSRN
  4. Brown University Library Guides: Home - Patents - Library Guides at Brown University
  5. Google Patents: Natural combination hormone replacement formulations and therapies - Google Patents

More… ↓

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Drugs Protected by US Patent 10,675,288

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 BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-002 Dec 28, 2021 RX Yes No 10,675,288 ⤷  Subscribe TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS ⤷  Subscribe
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes 10,675,288 ⤷  Subscribe TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS ⤷  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 10,675,288

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2782584 ⤷  Subscribe 301153 Netherlands ⤷  Subscribe
European Patent Office 2782584 ⤷  Subscribe 2021C/558 Belgium ⤷  Subscribe
European Patent Office 2782584 ⤷  Subscribe 122021000080 Germany ⤷  Subscribe
European Patent Office 2782584 ⤷  Subscribe LUC00245 Luxembourg ⤷  Subscribe
European Patent Office 2782584 ⤷  Subscribe 132021000000197 Italy ⤷  Subscribe
European Patent Office 2782584 ⤷  Subscribe C202130068 Spain ⤷  Subscribe
European Patent Office 2782584 ⤷  Subscribe 21C1058 France ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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