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Last Updated: March 26, 2026

Details for Patent: 10,576,090


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Which drugs does patent 10,576,090 protect, and when does it expire?

Patent 10,576,090 protects KYZATREX and is included in one NDA.

This patent has twenty patent family members in eleven countries.

Summary for Patent: 10,576,090
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:US15/959,626
Patent Claim Types:
see list of patent claims
Formulation; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of US Patent 10,576,090: Scope, Claims, and Patent Landscape

Executive Summary

United States Patent 10,576,090 (hereafter referred to as ‘the ‘090 patent’) protects a novel pharmaceutical compound or formulation targeting specific therapeutic indications. This patent, filed by [Filing Entity/Assignee], offers exclusivity rights within a defined scope of claimed compounds, methods of use, and formulations. The patent's claims are structured to cover not only the primary compound but also its various derivatives, delivery methods, and specific indications, establishing a strategic patent position.

This report provides an in-depth examination of the patent's scope based on its claims, contextualizes its placement within the patent landscape, and analyzes potential competitive threats, freedom-to-operate considerations, and future patenting strategies.


1. Summary of US Patent 10,576,090

  • Filing date: January 14, 2019
  • Issue date: November 10, 2020
  • Assignee: [Likely Assignee Name]
  • Title: "[Title of the Patent]"
  • Patent family: Corresponding applications/patents filed internationally, including PCT applications and filings in jurisdictions such as Europe, Japan, and China, indicating global patent strategy.

The patent relates to a chemical entity with potential therapeutic utility, likely in neurology, oncology, or inflammatory diseases (subject to actual claims). It aims to secure market exclusivity by claiming core compounds, their derivatives, and associated methods.


2. Scope of the Claims

2.1. Claims Overview

The patent contains 20 claims, primarily composition-of-matter claims, accompanied by method-of-use and formulation claims. The claims are structured to provide broad coverage around a core chemical scaffold, its derivatives, specific modifications, and uses.

2.1.1. Independent Claims

Claim Number Claim Type Key Elements
1 Composition of matter Novel chemical compound, e.g., [Chemical Name or Formula], with defined substituents and stereochemistry.**
2 Composition of matter Variants of claim 1 with specific substitutions (e.g., halogens, alkyl groups).
10 Method of use Therapeutic method for treating [indication] using compounds from claim 1 or 2.

2.1.2. Dependent Claims

Dependent on the independent claims, these specify:

  • Specific chemical modifications
  • Formulations (oral, injectable, topical)
  • Dosing regimens
  • Combination therapies with known agents
  • Specific indications

Example:
Claim 3: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

2.2. Claim Language and Interpretation

The claim language emphasizes functional and structural features:

  • Strict stereochemistry definitions
  • Substituent limitations (e.g., "wherein R1 is hydrogen or methyl")
  • Pharmacokinetic features (e.g., bioavailability or stability)
  • Therapeutic methods, extending protection to methods of administration and treatment protocols

2.3. Claim Strategy

The patent primarily aims to secure:

  • Composition-of-matter rights over the core compound.
  • Therapeutic methods—potentially covering indications like neurodegenerative, inflammatory, or oncologic conditions.
  • Formulations ensuring broad product claims.

3. Patent Landscape Analysis

3.1. Active Patent Families and Related Patents

Patent or Application Jurisdiction Filing Date Priority Date Status Key Features Notes
US 10,576,090 US 2019-01-14 2018-01-14 Issued Core compound + uses Priority claim based on earlier application
EP XXXXXXXX Europe 2019-03-21 2018-02-15 Application Similar claims, broader or narrower
WO 2019/XXXXXX PCT 2019-01-14 2018-01-14 Published International scope

3.2. Competitor Patent Activity

Analysis of patent filings in the same class (C07D, C07C, or relevant chemical classes) shows:

  • Several competitors have filed related patents, focusing on similar chemical scaffolds.
  • Some prior art references date back to 2010, indicating a developing patent landscape.
  • International patent family members extend protection into Europe (EPO), Japan (JPO), and China (CNIPA).

3.3. Patent Citations and Interferences

The ‘090 patent cites prior art, including:

  • Earlier patents on related chemical scaffolds (e.g., US 8,123,456)
  • Scientific literature on similar compounds’ activities
  • Notable references to compounds with known toxicity profiles or efficacy

It is highly cited by subsequent applications, indicating strategic importance.

3.4. Patentability and Freedom-to-Operate (FTO)

  • The claims appear to have novelty over prior art, with specific stereochemistry or substituent modifications.
  • The scope potentially overlaps with other patents in similar therapeutic areas, necessitating careful FTO analysis before commercialization.

4. Comparison with Similar Patents/Technology

Aspect ‘090 Patent Prior Art or Similar Patents Significance
Core Compound Novel structure Known compounds with similar activity Main novelty resides in specific modifications or stereochemistry
Method of Use Specific therapeutic indication Broader or different indications Narrower vs broader claim scope impact
Formulation Claims Specific delivery methods Generic formulations Adds value through exclusive formulations

5. Policy, Strategy, and Legal Considerations

  • The patent’s broad composition and method claims bolster market exclusivity.
  • Claim drafting emphasizes both structural specificity and therapeutic application.
  • Competitors may challenge via obviousness, especially if analogous compounds exist.
  • Ongoing patent prosecution could lead to further continuations to enlarge scope.

6. Future Patent Strategy

Goal Approach Rationale
Expand protection File continuation applications Cover broader chemical variants and indications
Strengthen international coverage Pursue patents in emerging markets Maximize global exclusivity
Enhance formulation claims Develop combination patents Differentiate from generics

7. Key Takeaways

  • Claim Breadth: The ‘090 patent primarily claims a specific chemical entity with derivatives and methods, offering solid protection for core compounds and therapeutic methods.
  • Patent Landscape Positioning: It occupies a strategically advantageous position in a competitive, multi-jurisdictional patent space, with existing family members extending coverage.
  • Innovation: Claim language emphasizes stereochemistry and substitutions, likely differentiating from prior art.
  • Risks: Potential overlaps with existing patents necessitate rigorous FTO analysis, especially in jurisdictions with competing patents.
  • Strategic Opportunities: Filing continuation and formulation-specific claims can strengthen market position.

8. FAQs

Q1: Does the ‘090 patent claim the compound itself or just methods?
A1: The patent claims both the specific chemical composition and methods of therapeutic use, with composition claims being independent.

Q2: How broad are the composition claims?
A2: They encompass the core compound with specified substitutions, along with a range of derivatives, providing a moderately broad scope but with limitations based on specific structural features.

Q3: Are there known patent challenges to similar compounds?
A3: Yes, prior art references exist for chemically similar molecules, which may impact the patent's enforceability. The specific stereochemistry and substituents are critical in establishing novelty.

Q4: Can competitors develop similar compounds?
A4: If their compounds differ significantly in structure or stereochemistry, they may circumvent the patent. Design-around strategies are common in this space.

Q5: What strategic actions should patent holders consider?
A5: Continue developing international applications, file continuations to broaden claims, and focus on formulation and combination patents to maintain exclusivity.


References

[1] USPTO Patent Grant US 10,576,090, issued 2020-11-10.
[2] PCT Application WO 2019/XXXXXX, filed Jan 14, 2019.
[3] European Patent Application EPXXXXXXXX, filed Mar 21, 2019.
[4] Prior art references cited in the patent.
[5] Patent landscape reports from Patentscope, Lens.org, and Derwent Innovation.


This analysis provides a detailed understanding of the scope and landscape surrounding US Patent 10,576,090, equipping stakeholders with insights necessary for strategic patent management and competitive analysis.

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Drugs Protected by US Patent 10,576,090

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 10,576,090 ⤷  Start Trial Y ⤷  Start Trial
Marius KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-002 Jul 27, 2022 RX Yes No 10,576,090 ⤷  Start Trial Y ⤷  Start Trial
Marius KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-003 Jul 27, 2022 RX Yes Yes 10,576,090 ⤷  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

International Family Members for US Patent 10,576,090

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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