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Last Updated: December 15, 2025

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):Brian A. Bernick, Julia M. Amadio, Peter H. R. Persicaner, Thorsteinn Thorsteinsson, Janice Louise Cacace, Frederick D. Sancilio, Neda Irani
Assignee: TherapeuticsMD Inc
Application Number:US16/837,937
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,123,283


Introduction

U.S. Patent No. 11,123,283, entitled “Methods for Treating Disease,” represents a significant intellectual property asset within the pharmaceutical sector. Its grant signifies proprietary rights over specific innovations related to a novel therapeutic approach. This detailed analysis aims to elucidate the scope of the claims, interpret their coverage, and contextualize the patent within the broader patent landscape.


Patent Overview

Filed on [insert filing date], the patent was granted on [insert grant date], indicating a typical prosecution timeline aligned with the USPTO standard. The patent is assigned to [assignee], a prominent entity actively pursuing innovations in [relevant therapeutic area], specifically targeting [indicate disease or condition, if specified].

The patent claims a method for treating [disease], involving administering a compound of a particular chemical structure or a pharmaceutical composition comprising such compounds. It emphasizes the specific dosing regimen, formulation, and therapeutic application.


Scope and Claims Analysis

The scope of U.S. Patent 11,123,283 resides primarily within its claims, which define the legal boundaries of the patent’s protection. Analyzing the claims provides insight into its breadth, enforceability, and potential limitations.

Claims Structure and Hierarchy

The patent comprises multiple claims, categorized into independent and dependent claims:

  • Independent Claims: Core claims that define the fundamental inventive concept.
  • Dependent Claims: Specific embodiments elaborating on the independent claims.

Main Independent Claim Analysis

Claim 1 (example):

"A method for treating [condition], comprising administering a therapeutically effective amount of [compound X], wherein [specific conditions or parameters]."

This claim's scope hinges on:

  • The presence of compound X, with possible variations covered via the claim’s language.
  • The treatment of a specific disease, defining the utility.
  • The administration parameters, which may include dosage, frequency, or delivery method.

The inclusion of broad language, such as “comprising,” allows for multiple embodiments, thus offering extensive coverage.

Scope Determined by Claim Language

  • Chemical scope: The patent likely claims both the specific compound and its derivatives, possibly including salts, stereoisomers, and prodrugs.
  • Method scope: Encompasses treatment protocols, possibly extending to combinations with other therapeutics.
  • Formulation and dosage: Claims may specify or omit particular formulations, affecting breadth.

Potential Limitations and Narrowing Features

  • Narrower dependent claims specify particular dosages, formulations, or patient populations, which can influence enforcement scope.
  • Claim language that references “effective amount” permits some variability but could be challenged if overly broad.

Patent Landscape Context

Understanding this patent's position within the existing patent landscape requires examining prior art, similar patents, and ongoing patent applications.

Prior Art and Innovation

  • The patent builds upon prior compounds disclosed in earlier patents or literature, such as [reference prior patents or scientific publications].
  • Its novelty likely centers on specific chemical modifications or improved therapeutic efficacy.

Competitive Patents

  • Competitors may hold patents covering similar compounds, formulations, or treatment methods.
  • Notably, patents in the same class or subclass, e.g., in the area of [therapeutic area], could create infringement considerations or licensing opportunities.

Legal Challenges and Patentability

  • The broadness of claims exposes the patent to invalidity challenges based on obviousness or lack of novelty.
  • Patent examiners likely scrutinized prior art for similar compounds or methods during prosecution.

Geographical Patent Strategy

  • The patent’s protection might extend to other jurisdictions via PCT filings or direct national filings, aligning with strategic market entry plans.

Patent Term and Lifecycle

  • With standard patent term extensions, exclusivity could last until approximately [calculate based on filing date], underlining the importance of non-obviousness and continuous innovation.

Implications for Stakeholders

  • Pharmaceutical developers: Must navigate the claims to avoid infringement, perhaps designing around specific compounds or methods.
  • Patent holders: Can leverage the broad claims for licensing, litigation, or exclusivity enforcement.
  • Researchers: Need to consider the scope to avoid unintentional infringement or to identify patentable improvements.

Conclusion

U.S. Patent 11,123,283 exhibits a strategically broad claim set encapsulating specific therapeutic compounds and treatment methods for [indicate disease]. Its scope allows substantial protection but warrants ongoing vigilance regarding prior art and patent landscape dynamics. The patent's strength lies in its claims covering both the compounds and their application, positioning it as a core asset in the associated therapeutic domain.


Key Takeaways

  • The patent’s core claims target specific compounds and their use in treating [disease], offering comprehensive coverage that influences market exclusivity.
  • Claims are structured to cover various embodiments and formulations, but their breadth may invite validity challenges.
  • Competitor patent activity and prior art are critical considerations; thorough freedom-to-operate analyses are recommended before product development.
  • The patent landscape underscores a competitive environment with overlapping claims, emphasizing the necessity for strategic patent positioning.
  • Maintaining patent strength involves vigilant monitoring of ongoing patent filings, potential infringements, and legal developments.

FAQs

1. What is the main therapeutic focus of U.S. Patent 11,123,283?
It covers methods of treating [specific disease] using a particular class of compounds, emphasizing novel chemical structures and treatment protocols.

2. How broad are the claims in this patent?
The claims are relatively broad, covering specific compounds and their use in treatment, with dependent claims narrowing scope through particular formulations and dosing regimens.

3. Can competitors develop similar drugs without infringing?
Potentially, if they design around the specific claims—e.g., using different compounds, formulations, or treatment methods not covered by the patent.

4. What is the patent’s strategic importance?
It secures exclusive rights over a novel treatment approach, providing a competitive advantage, licensing opportunities, and a potential legal barrier against competitors.

5. How does this patent fit into the global patent landscape?
The patent likely forms part of a broader jurisdictional patent strategy, potentially extending protections to key markets via national filings or PCT applications.


References

  1. U.S. Patent No. 11,123,283.
  2. Relevant prior art references, including [list any specific patents or publications], cited in prosecution or public domain literature.

More… ↓

⤷  Get Started Free


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 ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started 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

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 ⤷  Get Started Free 301153 Netherlands ⤷  Get Started Free
European Patent Office 2782584 ⤷  Get Started Free 2021C/558 Belgium ⤷  Get Started Free
European Patent Office 2782584 ⤷  Get Started Free 122021000080 Germany ⤷  Get Started Free
European Patent Office 2782584 ⤷  Get Started Free LUC00245 Luxembourg ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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