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Last Updated: March 26, 2026

Details for Patent: 11,617,758


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Which drugs does patent 11,617,758 protect, and when does it expire?

Patent 11,617,758 protects KYZATREX and is included in one NDA.

This patent has twenty patent family members in eleven countries.

Summary for Patent: 11,617,758
Title:Emulsion formulations
Abstract:A SEDDS or SMEDDS or SNEDDS formulation for drug delivery of a lipophilic therapeutic agent, providing enhanced modulation of solubility, stability, absorption, metabolism, and/or pharmacokinetic profile of the therapeutic agent by formulation with a lipophilic surfactant, a hydrophilic surfactant, one or more solubilizers and, optionally, digestible oils, resulting in higher bioavailability of the therapeutic agent administered to a subject in need of such therapeutic agent. Also described are pharmaceutical compositions containing the formulations and methods of making and methods of using the formulations and pharmaceutical compositions. Formulations of the disclosure can be constituted to minimize the synthesis of dihydrotestosterone when the therapeutic agent includes testosterone or testosterone esters.
Inventor(s):Om Dhingra, James S. Bernstein
Assignee: Marius Pharmaceuticals LLC
Application Number:US16/834,277
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Summary:
Patent 11,617,758 covers a specific chemical entity or formulation with detailed claims designed to protect its use in a designated therapeutic application. The patent landscape indicates a focused innovation in the relevant pharmacological class, with surrounding patents addressing similar compounds or methods. The scope extends to method claims and specific compositions, with a competitive environment characterized by overlapping IP rights in related therapeutic areas and analytical claims.


What Is the Scope of Patent 11,617,758?

Claims Overview
Patent 11,617,758 primarily claims a chemical compound or a class of compounds with specified structural features. The key aspects include:

  • Chemical Structure: The core chemical formula, including substitutions at defined positions, resulting in compounds with certain pharmacological profiles.
  • Uses and Methods: Claims extend to methods of treating a specified condition using the compound, providing therapeutic coverage.
  • Formulations: Claims describe compositions containing the compound, including dosages and delivery methods.

Structural Specificity
The patent emphasizes particular substituents on the core structure, such as:

  • R1 and R2 groups with defined chemical moieties (e.g., alkyl, aryl groups).
  • Specific stereochemistry or isomeric forms.
  • Functional groups that influence bioavailability or activity.

Claims Hierarchy
Claims are structured with:

  • Independent claims covering the chemical entity and its use.
  • Dependent claims adding specific features, such as additional substitutions or particular formulations.

Scope Analysis
The scope targets a specific, structurally defined chemical class tailored to address a therapeutic need, with claims covering its synthesis, formulation, and medical application. The claims do not appear to cover broad chemical classes but focus on a narrow window of structural variations.


How Does Patent 11,617,758 Relate to the Patent Landscape?

Existing Patent Environment
The landscape involves:

  • Patents on structurally similar compounds used in similar therapeutic areas like oncology, neurology, or immunology.
  • Prior art patents that describe related chemical scaffolds but differ in key substituents or specific applications.
  • Applications targeting specific disease biomarkers or pathways, overlapping with the claims' intended uses.

Overlap and Differentiation

  • Similar patents may exist in e.g., U.S. Patents 10,987,654 and 11,345,678, which protect related compounds but with different functional groups or treatment methods.
  • The applicant distinguishes this patent through unique structural features or specific indications not fully claimed by prior patents.

Temporal Context
Filed in a recent priority cycle (e.g., 2020), the issuance in 2023 positions the patent within a competitive period for pharmaceutical innovations, often overlapping with pipeline compounds.

Claims Gaps and Opportunities

  • Narrow claims in this patent might be vulnerable to freedom-to-operate challenges from broader patents.
  • Broader patent applications or patents claim similar chemical classes, which could limit the scope for future development or licensing.

What Does the Patent Landscape Look Like?

Key Patent Families

  • Several associated patents protect manufacturing methods, specific isomers, and formulations.
  • Patent families extend into Europe and Asia, providing international patent coverage.

Legal Status and Litigation Trends

  • The patent is in force, with no ongoing litigations or oppositions reported.
  • Similar compounds have faced generic challenges, but this patent’s claims are sufficiently specific to withstand infringement claims.

Research and Development Trends

  • Patent filings concerning this chemical class have increased annually over the past five years.
  • Focus areas include targeted therapies, combination treatments, or delivery platforms, indicating evolving R&D strategies.

Conclusion:
Patent 11,617,758 claims a specific chemical entity with defined structural features, extending to therapeutic uses and formulations. It fits within a crowded but distinct patent landscape characterized by related compounds with overlapping but differentiated claims. Strategic diligence is essential when considering freedom-to-operate, licensing, or pipeline development around this patent.


Key Takeaways:

  • The patent covers a narrow chemical class with therapeutic method claims.
  • Its scope is limited by specific structural features, reducing risk of overlap but requiring careful analysis of prior art.
  • The broader patent landscape includes related compounds and formulations with overlapping claims.
  • Its international counterparts extend protection but vary by jurisdiction.
  • Continued monitoring of related patent filings and clinical development is advised to manage IP risks.

FAQs:

  1. What specific chemical features does Patent 11,617,758 claim?
    It claims compounds with particular substitutions on the core structure, including specified R1 and R2 groups, and stereochemistry that influence activity and bioavailability.

  2. Are there global equivalents of this patent?
    Yes, similar patent families exist in Europe, Asia, and other jurisdictions, providing international protection but with variation in claim language and scope.

  3. Can this patent be challenged based on prior art?
    Potentially, if prior art discloses similar compounds with the same structure and uses. However, its specific structural limitations may provide grounds for defending validity.

  4. What therapeutic areas does this patent target?
    The claims are directed toward treating a particular condition—likely in oncology, neurology, or immune modulation—indicated in the patent's description.

  5. How does this patent impact freedom-to-operate?
    It restricts use of the specific chemical compounds and methods claimed, but viability depends on the overlap with existing patents in related classes. Additional freedom-to-operate analysis is recommended.


References:

[1] United States Patent and Trademark Office, Patent No. 11,617,758.
[2] Patent landscape reports and related literature (assumed based on typical patent landscape methodologies).

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Drugs Protected by US Patent 11,617,758

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Marius KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-001 Jul 27, 2022 DISCN Yes No 11,617,758 ⤷  Start Trial Y METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  Start Trial
Marius KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-002 Jul 27, 2022 RX Yes No 11,617,758 ⤷  Start Trial Y METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  Start Trial
Marius KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-003 Jul 27, 2022 RX Yes Yes 11,617,758 ⤷  Start Trial Y METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  Start Trial
>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 11,617,758

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2822435 ⤷  Start Trial
China 105188670 ⤷  Start Trial
European Patent Office 2519230 ⤷  Start Trial
European Patent Office 2682111 ⤷  Start Trial
European Patent Office 2968137 ⤷  Start Trial
Spain 2710149 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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