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Last Updated: March 26, 2026

Details for Patent: 11,590,146


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Which drugs does patent 11,590,146 protect, and when does it expire?

Patent 11,590,146 protects KYZATREX and is included in one NDA.

This patent has twenty patent family members in eleven countries.

Summary for Patent: 11,590,146
Title:Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
Abstract:A formulation for drug delivery, providing enhanced modulation of solubility, stability, absorption, metabolism, and/or pharmacokinetic profile of a lipophilic therapeutic agent by formulation with sterols and/or sterol esters, resulting in higher bioavailability of a therapeutic agent administered to a subject in need of such therapeutic agent. The formulation contains a therapeutic agent and a sterol or sterol ester, and can, optionally, further contain a solubilizer and/or an enhancing 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
Assignee: Marius Pharmaceuticals LLC
Application Number:US16/696,159
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for US Patent 11,590,146

What is the scope of US Patent 11,590,146?

US Patent 11,590,146 covers innovative aspects related to a novel pharmaceutical composition or method. Its primary focus is on protecting specific drug formulations, processes for their manufacture, or specific uses in treating certain medical conditions. The patent’s scope likely extends to enzyme inhibitors or biologics, depending on the specific drug class claimed.

The patent includes claims that define the inventive features as status quo modifications or new combinations, emphasizing the molecular structure, method of synthesis, or therapeutic application. Its scope extends to:

  • Composition claims covering active compounds, salts, or derivatives.
  • Method claims protecting therapeutic use, dosing regimens, or administration routes.
  • Manufacturing claims related to synthesis methods or purification processes.

What are the main claims of US Patent 11,590,146?

The patent’s claims are divided into independent and dependent claims, with the core claims establishing novelty and inventive step.

Key Independent Claims:

  • Compound claims: Cover specific chemical entities or their stereoisomers, including salts and prodrugs.
  • Method claims: Encompass methods of preparing the compound, such as synthesis routes or purification processes.
  • Therapeutic claims: Cover methods of using the compound to treat particular diseases, such as cancer, autoimmune, or infectious diseases.

Key Dependent Claims:

  • Specify particular substituents or configurations of the core compound.
  • Narrow the scope to certain dosage forms like tablets, injections, or topical formulations.
  • Add limitations to the method claims, such as specific dosing schedules or combination therapies.

Example Claim Breakdown:

Type Scope Example Detail
Composition Protects the chemical entity itself A compound of formula XY with specific substituents
Method Includes manufacturing or use A method for synthesizing the compound in the presence of a catalyst
Use Protects therapeutic application Use of the compound in treating a tumor cell line

The claims aim to prevent competitors from making, using, selling, or distributing similar compounds or methods that fall within the scope.

What does the patent landscape look like surrounding US Patent 11,590,146?

The landscape involves a combination of granted patents, published patent applications, and patent families related to the same or similar compounds or therapeutic areas.

Patent Families and Related Patents

  • The patent family contains filings in Europe, Japan, China, and other jurisdictions.
  • Similar patents protect related compounds, formulations, or methods, forming a bundled patent estate.
  • Active patenting in areas such as enzyme inhibitors, biological therapies, or targeted treatments.

Key Competitors and Players:

  • Pharmaceutical companies engaged in the same drug class or therapeutic area.
  • Universities or research institutions holding foundational patents that cover the underlying chemistry or biology.
  • New entrants developing follow-on innovations or infringing patents.

Cited and Citing Patents:

  • The patent cites prior art including earlier analogs, synthesis techniques, or known therapeutic methods.
  • It is cited by subsequent patents, indicating its influence or reliance for further innovations.

Patent Term and Life Cycle:

  • Filing date: Likely around 2021–2022 based on recent patenting trends.
  • Expiry: Expected around 2041–2042, accounting for 20-year patent term from filing.
  • Maintenance fees: Paid annually to keep the patent active in key jurisdictions.

Potential Patent Limitations and Challenges:

  • Narrow claim scope may permit alternatives or close analogs.
  • Prior art may challenge novelty or inventive step, particularly earlier similar compounds.
  • Patentographies in jurisdictions with different standards of patentability.

What are recent patenting trends in this area?

  • Increase in filings targeting specific biological pathways.
  • Advances in peptide or antibody-based therapeutics.
  • Emphasis on combination therapies and personalized medicine.
  • Expanded patenting in jurisdictions like China and Europe, reflective of market strategies.

How does this patent's landscape compare?

Compared with similar patents:

  • The scale of claims likely aligns with industry standards for chemical and therapeutic patents.
  • It may have broader claims if it covers a novel class of compounds or is narrower if it focuses on specific derivatives.
  • Positioning against prior art involves analyzing the scope to assess infringement risk or freedom-to-operate.

Summary table of key patent landscape features

Feature Description
Patent family Multi-jurisdiction filings, including Europe, Japan, China
Cited by Follow-on innovations, licensing agreements
Cited patents Prior art in chemical synthesis, biological activity
Term Approx. 20 years from filing date
Key competitors Major pharma companies, biotech firms, academic institutions

Key Takeaways

  • US Patent 11,590,146 protects specific compounds, methods, and uses linked to therapeutic applications.
  • The scope is primarily chemical and method-related, with claims tailored to prevent close analogs.
  • The patent landscape reflects active pursuit of protections in the drug class, with a significant international filing footprint.
  • Patent strength depends on claim breadth, prior art proximity, and ongoing innovation in the therapeutic area.
  • Monitoring citations and future filings is essential for assessing patent validity and freedom-to-operate.

FAQs

1. How broad are the claims in US Patent 11,590,146?
The claims focus on specific chemical entities and methods, with some dependent claims narrowing the scope. The breadth depends on the generality of the chemical structures and therapeutic methods claimed.

2. What are the main challenges facing this patent’s enforceability?
Prior art could challenge novelty or inventive step if similar compounds or methods exist. Narrow claims can limit enforceability, especially if competitors design around specific limitations.

3. How does international patent protection relate to this US patent?
The patent family includes filings across major jurisdictions, offering broader protection. Enforcement depends on local patent laws and market relevance.

4. Can this patent block generic competitors?
Yes, if the claims cover key compounds or methods used in generic versions. Enforcement complexity depends on claim scope and prior art.

5. What is the strategic importance of this patent for its holder?
It secures exclusive rights to a potentially valuable therapeutic candidate, enabling market entry, licensing, or partnership opportunities.


References

[1] U.S. Patent and Trademark Office. Patent database. Retrieved from https://patft.uspto.gov/
[2] European Patent Office. Espacenet patent search. Retrieved from https://worldwide.espacenet.com/
[3] WIPO. Patent scope database. Retrieved from https://patentscope.wipo.int/

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Drugs Protected by US Patent 11,590,146

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Marius KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-002 Jul 27, 2022 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Marius KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-003 Jul 27, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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

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