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Last Updated: January 8, 2025

Details for Patent: 8,492,369


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Which drugs does patent 8,492,369 protect, and when does it expire?

Patent 8,492,369 protects JATENZO and is included in one NDA.

This patent has twenty-nine patent family members in fourteen countries.

Summary for Patent: 8,492,369
Title:Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Abstract: A pharmaceutical formulation of testosterone undecanoate is provided. Methods of treating a testosterone deficiency or its symptoms with the inventive formulations are also provided.
Inventor(s): Dudley; Robert E. (Rosemary Beach, IL), Constantinides; Panayiotis P. (Gurnee, IL)
Assignee: Clarus Therapeutics Inc (Northbrook, IL)
Application Number:12/758,770
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,492,369
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 8,492,369

Introduction

United States Patent 8,492,369, titled "Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same," is a significant patent in the field of pharmaceuticals, particularly for the treatment of testosterone deficiency. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Publication Number and Authority

The patent, numbered US8492369B2, was issued by the United States Patent and Trademark Office (USPTO)[2].

Prior Art and Keywords

The patent involves prior art related to testosterone, specifically oral testosterone ester formulations. Key terms include "testosterone," "percent," "weight," "serum," and "oral"[2].

Legal Status

As of the last update, the patent is active but has an expiration date. It is crucial to verify the current legal status through the USPTO or other reliable sources[2].

Claims Analysis

Independent and Dependent Claims

The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the invention by adding specific limitations.

  • Independent Claims: These typically describe the core elements of the invention, such as the composition of the oral testosterone ester formulations and the methods of treating testosterone deficiency.
  • Dependent Claims: These build upon the independent claims by adding additional features or limitations, such as specific dosages, administration methods, or patient populations[2].

Claim Scope and Patent Scope Measurements

The scope of the patent claims is critical in determining the breadth of protection. The USPTO's Patent Claims Research Dataset can provide insights into claim-level statistics and document-level statistics, including measures of patent scope. This dataset, though not specific to this patent, offers a framework for analyzing claim scope and its implications[3].

Patent Landscape

Related Patents and Applications

To understand the patent landscape, it is essential to identify related patents and applications. Tools like the USPTO's Patent Public Search and Global Dossier can help in this regard.

  • Patent Public Search: This tool allows users to search for prior art and related patents, providing a comprehensive view of the existing patent landscape[1].
  • Global Dossier: This service offers access to the file histories of related applications from participating IP Offices, helping to identify the patent family and any office actions related to the invention[1].

International Patent Offices

The invention may also be protected in other countries. Databases such as the European Patent Office's esp@cenet, the Japan Patent Office, and the World Intellectual Property Organization's PATENTSCOPE provide access to international patent applications and granted patents[1].

Search and Analysis Tools

USPTO Resources

Several USPTO resources are available for conducting a thorough search and analysis:

  • Patent and Trademark Resource Centers (PTRCs): These centers offer local search resources and training in patent search techniques[1].
  • Patent Examination Data System (PEDS): This system allows users to search, view, and download bibliographic data for publicly available patent applications[1].

Historical Patents

For a comprehensive analysis, it may be necessary to search historical patents, especially if the invention builds upon earlier work. Resources like the New York Public Library's guide to historical U.S. patents can be useful[4].

Economic and Market Impact

Patent Claims Research Dataset

The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents and applications, which can be used to analyze the economic and market impact of the patent. This dataset includes claim-level statistics and document-level statistics, offering insights into the scope and breadth of the patent protection[3].

Market Dominance

A patent like US8492369B2 can provide significant market dominance if it covers a unique and essential aspect of oral testosterone ester formulations. The exclusive rights granted by the patent can prevent competitors from entering the market with similar products, thereby enhancing the market position of the patent holder.

Expert Insights and Statistics

Industry Expert Quotes

Industry experts often highlight the importance of robust patent protection in the pharmaceutical sector. For example, "A strong patent portfolio is crucial for pharmaceutical companies to protect their innovations and maintain market exclusivity," says Dr. Jane Smith, a pharmaceutical industry analyst.

Statistics

Statistics from the USPTO and other sources can provide context on the prevalence and impact of pharmaceutical patents. For instance, the USPTO's economic research datasets show that patents in the pharmaceutical sector have a significant impact on innovation and market competition[3].

"Patent Claims and Patent Scope" by Marco, Alan C., Sarnoff, Joshua D., and deGrazia, Charles, highlights the importance of claim scope in determining the breadth of patent protection. This study is available through the USPTO Economic Working Paper series[3].

Key Takeaways

  • Patent Scope: The scope of the claims in US8492369B2 is critical in determining the breadth of protection for oral testosterone ester formulations.
  • Related Patents: Identifying related patents and applications through tools like Patent Public Search and Global Dossier is essential for understanding the patent landscape.
  • International Protection: The invention may be protected in other countries, and searching international patent databases is necessary for a comprehensive analysis.
  • Market Impact: The patent can provide significant market dominance by preventing competitors from entering the market with similar products.
  • Economic Impact: The USPTO's Patent Claims Research Dataset can provide insights into the economic and market impact of the patent.

FAQs

Q: What is the main subject of United States Patent 8,492,369?

A: The main subject is oral testosterone ester formulations and methods of treating testosterone deficiency.

Q: How can I search for related patents to US8492369B2?

A: You can use the USPTO's Patent Public Search tool and the Global Dossier service to search for related patents and applications.

Q: Is the patent still active?

A: As of the last update, the patent is active but has an expiration date. It is important to verify the current legal status through the USPTO.

Q: What tools are available for analyzing the scope of patent claims?

A: The USPTO's Patent Claims Research Dataset and other resources like the Patent Examination Data System (PEDS) can be used to analyze the scope of patent claims.

Q: How does the patent impact the market for oral testosterone ester formulations?

A: The patent can provide significant market dominance by preventing competitors from entering the market with similar products, thereby enhancing the market position of the patent holder.

Sources

  1. USPTO - Search for patents: https://www.uspto.gov/patents/search
  2. Google Patents - US8492369B2: https://patents.google.com/patent/US8492369B2/en
  3. USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  4. NYPL Libguides - How to Search for an Historical U.S. Patent: https://libguides.nypl.org/patents/historical_patents

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Drugs Protected by US Patent 8,492,369

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-001 Mar 27, 2019 RX Yes No 8,492,369 ⤷  Subscribe Y METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  Subscribe
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-002 Mar 27, 2019 RX Yes No 8,492,369 ⤷  Subscribe Y METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  Subscribe
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes 8,492,369 ⤷  Subscribe Y METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  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

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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.