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Last Updated: December 22, 2024

Details for Patent: 11,123,283


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Summary for Patent: 11,123,283
Title:Soluble estradiol capsule for vaginal insertion
Abstract: According to various embodiments of this disclosure, pharmaceutical formulations comprising solubilized estradiol are provided. In various embodiments, such formulations are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.
Inventor(s): Bernick; Brian A. (Boca Raton, FL), Amadio; Julia M. (Boca Raton, FL), Persicaner; Peter H. R. (Boca Raton, FL), Thorsteinsson; Thorsteinn (Boynton Beach, FL), Cacace; Janice Louise (St. Petersburg, FL), Sancilio; Frederick D. (Stuart, FL), Irani; Neda (Palm Beach Gardens, FL)
Assignee: TherapeuticsMD, Inc. (Boca Raton, FL)
Application Number:16/837,937
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

United States Patent 11,123,283: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 11,123,283 is a significant patent in the pharmaceutical sector, particularly related to the products of TherapeuticsMD. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

Patent Number and Title

The patent in question is U.S. Patent 11,123,283. While the specific title of the patent is not provided in the sources, it is associated with TherapeuticsMD's products, such as IMVEXXY® and BIJUVA®[2].

Scope of the Patent

Product Association

This patent is linked to IMVEXXY®, a vaginal insert used for the treatment of moderate to severe dyspareunia (painful sex) due to menopause. It may also be related to other TherapeuticsMD products, given the overlap in patent numbers[2].

Technological Field

The patent falls under the broader category of pharmaceuticals, specifically within the realm of women's health and hormonal treatments. This field is highly competitive and regulated, with stringent requirements for patentability and regulatory approval.

Claims of the Patent

Claim Structure

Patent claims define the scope of protection and are crucial for understanding what the patent covers. For U.S. Patent 11,123,283, the claims would typically include:

  • Independent Claims: These define the broadest scope of the invention.
  • Dependent Claims: These narrow down the invention and often provide additional details or specific embodiments.
  • Method Claims: If applicable, these would describe the process or method related to the invention.

While the exact claims are not detailed here, they would likely cover the composition, method of use, and any unique aspects of the vaginal insert or related formulations[3].

Patent Landscape

Related Patents

TherapeuticsMD holds a portfolio of patents related to their products. For example, IMVEXXY® is protected by multiple patents, including U.S. Patents 9180091, 9289382, and others[2]. These patents collectively create a robust intellectual property barrier around the product.

Continuation Applications

The USPTO allows for continuation applications, which can extend the life of a patent or cover additional aspects of the invention. For instance, serialized continuations can result in multiple patents from a single progenitor application, complicating the calculation of allowance rates but providing broader protection[1].

Global Patent Family

To ensure comprehensive protection, TherapeuticsMD likely has a global patent family for U.S. Patent 11,123,283, with corresponding patents in other jurisdictions. Tools like the Global Dossier and Common Citation Document (CCD) can help track these related applications across different intellectual property offices[4].

Examination and Allowance Rates

USPTO Data

The USPTO's internal databases provide insights into patent allowance rates. For utility patents, the allowance rates can vary significantly based on factors such as the technology field, application origin, and entity size. For example, the family allowance rate, which includes the outcomes of continuation applications, can be a key metric in understanding the overall success rate of patent applications in the same field[1].

Economic and Strategic Impact

Market Protection

Patents like U.S. Patent 11,123,283 are crucial for protecting market share and preventing generic competition. The expiration dates of these patents are closely monitored by competitors and generic drug manufacturers, who await the opportunity to enter the market with similar products[5].

Innovation and R&D

The presence of strong patent protection encourages innovation and research and development (R&D) in the pharmaceutical sector. Companies like TherapeuticsMD invest heavily in R&D, and patents ensure a return on this investment by providing exclusive rights to market their inventions.

Search and Analysis Tools

USPTO Resources

The USPTO offers several tools for searching and analyzing patents, including the Patent Public Search tool, Global Dossier, and the Patent Examination Data System (PEDS). These resources help in understanding the patent landscape, tracking related applications, and analyzing the claims and scope of patents like U.S. Patent 11,123,283[4].

Key Takeaways

  • Patent Scope and Claims: U.S. Patent 11,123,283 covers specific aspects of TherapeuticsMD's pharmaceutical products, such as IMVEXXY®, with claims that define the composition, method of use, and unique features.
  • Patent Landscape: The patent is part of a broader portfolio of related patents and continuation applications, ensuring comprehensive protection.
  • Global Protection: The patent likely has corresponding global filings, managed through tools like the Global Dossier.
  • Economic Impact: The patent protects market share and encourages innovation and R&D in the pharmaceutical sector.
  • Search and Analysis: Utilizing USPTO resources is essential for understanding the patent landscape and analyzing the claims and scope of such patents.

FAQs

What is the significance of U.S. Patent 11,123,283?

U.S. Patent 11,123,283 is significant because it protects TherapeuticsMD's products, such as IMVEXXY®, from generic competition and ensures market exclusivity.

How do continuation applications affect patent protection?

Continuation applications can extend the life of a patent or cover additional aspects of the invention, providing broader and longer protection for the patent holder.

What tools are available for searching and analyzing patents?

The USPTO offers tools like the Patent Public Search, Global Dossier, and PEDS for searching and analyzing patents, including tracking related applications and analyzing claims and scope.

Why is patent protection important in the pharmaceutical sector?

Patent protection is crucial in the pharmaceutical sector as it encourages innovation and R&D by ensuring a return on investment through exclusive market rights.

How can one determine the expiration date of a patent?

The expiration date of a patent can be determined by checking the patent details on the USPTO website or through databases that track patent expiration dates, such as DrugPatentWatch[5].

Sources

  1. Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent?. The Yale Journal of Law & Technology.
  2. TherapeuticsMD. (n.d.). Patents. Retrieved from https://www.therapeuticsmd.com/patents.php
  3. USPTO. (2017, August 28). Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  4. USPTO. (2018, October 18). Search for patents. Retrieved from https://www.uspto.gov/patents/search
  5. DrugPatentWatch. (n.d.). Patent 11,123,283. Retrieved from https://www.drugpatentwatch.com/p/patent/11123283

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Drugs Protected by US Patent 11,123,283

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 IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 RX Yes No 11,123,283 ⤷  Subscribe Y ⤷  Subscribe
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes 11,123,283 ⤷  Subscribe Y ⤷  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 11,123,283

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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