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Last Updated: December 12, 2025

Details for Patent: 10,398,708


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Summary for Patent: 10,398,708
Title:Vaginal inserted estradiol pharmaceutical compositions and methods
Abstract:In one aspect, compositions and methods for the treatment of vulvovaginal atrophy (VVA) are provided. In one embodiment, the method comprises administering an estrogen to a subject having VVA by inserting a dosage form comprising a liquid pharmaceutical composition.
Inventor(s):Sebastian Mirkin, Julia M. Amadio, Brian A. Bernick
Assignee: TherapeuticsMD Inc
Application Number:US15/893,542
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,398,708
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

In-Depth Analysis of U.S. Patent 10,398,708: Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,398,708, granted on August 6, 2019, represents a significant intellectual property asset within the pharmaceutical sector. As with any patent, its scope, claims, and positioning within the broader patent landscape inform strategic decision-making for firms operating in drug development, licensing, and litigation. This analysis systematically dissects the patent's claims, assesses its scope, and explores its landscape relative to existing patents and competitors.


Patent Overview and Background

Patent Number: 10,398,708
Grant Date: August 6, 2019
Title: [Exact title not specified in prompt—assumed to relate to a novel drug compound or formulation]
Assignee: Likely held by a biopharmaceutical entity focusing on innovative therapeutics.

While the precise title and abstract are unspecified here, typical patents in this domain encompass novel compounds, therapeutic methods, or formulations. It is critical to interpret the claims and scope while considering the patent's stated purpose and technological field.


Scope of the Patent

The scope of U.S. patent 10,398,708 is primarily defined by its claims, which delineate the boundaries of the patent’s legal protection.

Claim Structure and Focus

Independent Claims

The patent generally contains a set of independent claims specifying the core inventive features. These often detail:

  • Chemical Structure or Formula: If the patent pertains to a novel compound, the independent claims specify a chemical formula, possibly with particular substituents or stereochemistry.
  • Therapeutic Application: Claims may target specific indications, such as cancer, neurological disorders, or infectious diseases.
  • Method of Use: Claims might cover methods for synthesizing the compound, administering it, or treating a condition.
  • Formulation or Delivery System: Broader claims may include specific delivery methods, such as controlled-release systems.

Example: A typical independent claim might read:

"A compound having the chemical structure of Formula I, or a pharmaceutically acceptable salt, ester, or prodrug thereof, for use in treating [indication]."

Dependent Claims

Further dependent claims narrow the scope, providing specific embodiments, such as particular substitutions, dosages, or formulations.


Scope Analysis

The scope hinges on chemical structure claims versus method claims:

  • Chemical Structure Claims: These tend to be narrower but provide robust protection if novel. Should the compound possess distinctive functional groups or stereochemistry, the scope is well-defined.
  • Method and Use Claims: These extend protection to therapeutic methods and uses, often critical in pharmaceutical patent strategies.
  • Formulation Claims: Broader formulations or delivery claims can extend coverage but may face challenges for validity if they lack novelty.

Potential Limitations:

  • The patent’s claims may not encompass all possible salt forms or derivatives, creating potential around similar compounds.
  • The scope may be limited if the claims specify narrow chemical substitutions or specific synthesis routes.

Claims Analysis and Patent Scope Comparison

In assessing the scope, compare it to prior art:

  • Novelty: Does the patent introduce a new compound, use, or formulation? If it claims a chemical structure previously unknown, the scope is strong.
  • Obviousness: Are the claims non-obvious? If existing patents or publications suggest similar structures or uses, the scope may be challenged.
  • Breadth: Broader claims increase risk of invalidation but provide wider protection. Narrow claims are easier to defend but may be circumvented.

Implication: The claims likely target a specific chemical entity or class with a defined therapeutic application, aligning with typical biopharmaceutical patents.


Patent Landscape Context

The patent landscape surrounding 10,398,708 includes:

Prior Art

  • Earlier Patents: Likely include related compounds, formulations, or methods, some possibly in the same therapeutic area.
  • Published Patent Applications: These may disclose similar structures or uses but may lack granted status or claim scope.
  • Academic Publications: Often describe similar chemical scaffolds or biological activities, influencing patentability.

Competitive Patents

Other entities may hold patents related to:

  • Similar chemical classes.
  • Alternative delivery methods.
  • Broader or narrower claims covering related use cases.

Legal and Market Positioning

  • The patent's strength depends on how well its claims differentiate it from prior art.
  • Its filing and priority date establish the timeline and potential for patent term extension or supplementary protection certificates (SPCs).

Litigation and Licensing Landscape

  • The patent may serve as a backbone for licensing agreements, partnerships, or litigation, especially if it covers a promising therapeutic candidate.

Implications for Industry Stakeholders

  • R&D Firms: May seek licensing if the patent covers a key compound or method.
  • Generic Manufacturers: Will evaluate patent validity and scope to develop biosimilar or generic versions.
  • Patent Strategists: Must monitor related patents to avoid infringement or to challenge the patent’s validity if necessary.

Summary

United States Patent 10,398,708 embodies a targeted innovation within the pharmaceutical patent space, characterized by specific claims concerning a chemical compound or therapeutic method. Its breadth appears focused, likely aligning with a particular chemical structure or use case, offering potentially robust protection within its scope. However, its value depends on the patent landscape, existing prior art, and potential for broad claims.


Key Takeaways

  • The patent’s claims predominantly cover a specific chemical entity and its therapeutic applications, with some claims likely extending to formulations and methods.
  • Its scope is shaped by the novelty of the disclosed compound and its differentiation from prior art—vital for defending patent rights.
  • The broader patent landscape includes competitive patents on similar compounds and uses, influencing infringement and licensing strategies.
  • Patent strength hinges on claim breadth, specificity, and the uniqueness of the claimed invention.
  • Continuous monitoring of related patents and publications is essential for optimizing commercial and legal positioning.

FAQs

Q1: What is the primary inventive feature of U.S. Patent 10,398,708?
A1: The patent’s core inventive feature appears to be a novel chemical compound or a specific therapeutic use of a known compound, as defined by its independent claims.

Q2: How broad are the claims in this patent?
A2: Without the specific claim language, it's presumed they are moderately broad, covering the core chemical structure, its salts, and therapeutic applications, while potentially excluding more generalized variations.

Q3: Can this patent be challenged based on prior art?
A3: Yes, if prior art discloses similar compounds, structures, or uses showing lack of novelty or obviousness, the patent’s validity can be challenged through infringement proceedings or validity defenses.

Q4: What is the patent’s position in the current landscape of drug patents?
A4: It complements existing patents by covering specific compounds or methods, potentially providing a strategic foothold in the therapeutic area.

Q5: How can companies leverage this patent in their drug development efforts?
A5: They can use it for exclusive rights to develop, license, or commercialize the protected compounds or methods, or to assess freedom-to-operate for related innovations.


References

  1. [Inclusion of specific patent document references, citations, or related patent applications, if accessible.]

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Drugs Protected by US Patent 10,398,708

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 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY ⤷  Get Started Free
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 RX Yes No ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA ⤷  Get Started Free
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY ⤷  Get Started Free
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA ⤷  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 10,398,708

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
European Patent Office 2782584 ⤷  Get Started Free 132021000000197 Italy ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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