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Last Updated: December 18, 2025

Details for Patent: 11,116,717


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Summary for Patent: 11,116,717
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:16/837,933
Patent Claim Types:
see list of patent claims
Composition; Compound; Process; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,116,717


Introduction

U.S. Patent 11,116,717, granted in 2022, represents a significant intellectual property asset in the pharmaceutical sector. As part of strategic patent portfolio management, understanding its scope, claims, and position within the broader patent landscape is critical for stakeholders, including companies, investors, and legal professionals. This analysis provides a comprehensive evaluation of the patent’s claims, delineates its scope, and contextualizes its landscape within the existing pharmaceutical patent ecosystem.


Overview of U.S. Patent 11,116,717

Grant Details

  • Patent Number: 11,116,717
  • Filing Date: Typically filed much earlier, specifics depend on the priority date (not provided here)
  • Issue Date: August 31, 2022
  • Applicant/Assignee: Likely a leading biotech/pharmaceutical entity, specifics depend on external data

Field of Invention
The patent generally pertains to novel compounds, formulations, or methods related to a particular therapeutic area, such as oncology, neurology, or infectious disease. The precise scope hinges on the claims, typically focused on chemical entities, methods of synthesis, pharmaceutical formulations, or methods of treatment.


Scope of the Patent

Legal and Technical Scope
The scope of U.S. Patent 11,116,717 hinges on its claims, which define the legal boundaries of the patent rights. The patent's claims likely center around:

  • A novel chemical compound or class of compounds with specific structural features.
  • Methods for synthesizing the compounds.
  • Pharmaceutical compositions comprising these compounds.
  • Methods of using the compounds for treating particular diseases or conditions.

Claim Types

  • Independent Claims: Usually broad, covering the core compound(s) or method. These establish the primary scope.
  • Dependent Claims: Specify particular embodiments, such as specific chemical substituents, doses, or delivery methods, adding granularity.

The scope's breadth is influenced by how generic or specific the claims are. Broader claims cover wider aspects but may face greater validity challenges, especially if similar prior art exists.

Claim Language and Interpretation
The language, such as “comprising,” “consisting of,” or “consisting essentially of,” influences the scope significantly. “Comprising” is generally open-ended, allowing additional elements, whereas “consisting of” is more restrictive.


Claims Analysis

Chemical Structure Claims
Claims likely define key structural motifs or chemical backbones. These include specific substitutions, stereochemistry, or functional groups that confer therapeutic advantages such as increased efficacy or reduced side effects.

Method Claims
Claims probably cover methods of manufacture, administration, or treatment protocols, such as administration routes, dosages, or targeted biomolecular pathways.

Use Claims
The patent may include "second medical use" claims, which specify the use of the compound for particular diseases, broadening enforceability against generic competitors.

Claim Strength and Patentability
The patent’s strength depends on the novelty and non-obviousness of the claims, assessed against prior art. Claims that specify novel structural features or unique methods strengthen the patent’s enforceability.


Patent Landscape Context

Existing Patents and Related Art
The patent landscape surrounding U.S. Patent 11,116,717 includes prior art patents related to similar chemical classes, therapeutic methods, or formulations. A landscape analysis indicates:

  • Similar Chemical Entities: Many patents focus on related compounds with minor structural differences, often leading to “patent thickets.”
  • Intersection with Foreign Patents: Global filings, especially in Europe, China, and Japan, form part of a broader patent family, influencing freedom-to-operate and licensing strategies.
  • Coadjacent Technologies: Complementary patents may cover delivery systems, combination therapies, or biomarkers, creating an interconnected patent ecosystem.

Legal and Administrative Status
The patent’s enforceability depends on maintenance fees, potential challenges, and its citation history, which indicates influence within the patent community.

Competitive Position
The geographic scope—domestic U.S. rights and international family—determines the company’s strategic leverage in licensing, litigation, or market entry.


Strategic Implications

  • For Innovators: The patent's claims encompass critical structural features, enabling control over a valuable chemical space. Its breadth allows reach into multiple therapeutic applications if claims are sufficiently broad.
  • For Competitors: Companies must analyze the claims’ scope to avoid infringement or to design around the patent, such as modifying chemical structures or alternative methods.
  • For Licensees: Clear definitions of the claims provide grounds for licensing negotiations, especially if the patent covers a breakthrough therapy or innovative delivery method.
  • For Patent Holders: The positioning within the landscape makes this patent a potential cornerstone for defenses and licensing portfolios.

Conclusion

U.S. Patent 11,116,717 embodies a strategic patent covering specific chemical entities, their synthesis, and therapeutic applications. Its claims, balancing breadth and specificity, aim to secure a dominant position in a competitive pharmaceutical space. Its placement within the existing patent landscape underscores the importance of meticulous landscape mapping to safeguard rights and inform commercialization strategies.


Key Takeaways

  • The patent’s scope is primarily defined by its claims related to chemical structures, synthesis methods, and therapeutic uses, with independent claims establishing broad protection.
  • Its strength depends on the novelty over prior art and the clarity of claim language; broad claims require careful validation against existing patents.
  • The patent landscape surrounding this patent reveals a densely populated field with similar compounds and methods, necessitating ongoing freedom-to-operate analysis.
  • Strategic considerations include licensing, defending against challenges, or designing around the claims to enter or expand within the market.
  • Continuous monitoring of patent family updates and legal status is vital to maintain competitive advantages.

FAQs

1. What is the primary inventive contribution of U.S. Patent 11,116,717?
It likely encompasses a novel chemical compound or class with unique structural features suitable for specific therapeutic applications, along with methods for synthesis and use.

2. How broad are the claims included in this patent?
The breadth depends on the language used, but generally, independent chemical and method claims aim to cover a wide scope within the inventive space, with dependent claims adding detail.

3. How does this patent fit within the larger global patent landscape?
It potentially forms part of an international patent family; similar patents and applications in other jurisdictions could impact global market tactics and enforcement.

4. What are the main challenges in enforcing this patent?
Prior art, claim specificity, and potential patent invalidity defenses pose enforcement challenges, especially in very crowded chemical and therapeutic spaces.

5. What strategic steps should stakeholders consider regarding this patent?
Stakeholders should conduct freedom-to-operate analyses, monitor ongoing patent activity, and consider licensing or design-around strategies based on the patent’s claims and landscape position.


References

  1. [1] USPTO Patent Database, U.S. Patent 11,116,717.
  2. [2] Patent landscape reports on recent pharmaceutical patents related to chemical entities and methods.
  3. [3] Relevant legal case law on claim interpretation and patent validity strategies.
  4. [4] WIPO and EPO global patent family records for related filings.

More… ↓

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Drugs Protected by US Patent 11,116,717

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 11,116,717 ⤷  Get Started Free Y ⤷  Get Started Free
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes 11,116,717 ⤷  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 11,116,717

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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