Last Updated: May 11, 2026

Details for Patent: 10,576,089


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Which drugs does patent 10,576,089 protect, and when does it expire?

Patent 10,576,089 protects KYZATREX and is included in one NDA.

This patent has twenty patent family members in eleven countries.

Summary for Patent: 10,576,089
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:US13/936,036
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 10,576,089

What does U.S. Patent 10,576,089 cover?

U.S. Patent 10,576,089, granted on November 12, 2019, pertains to a specific class of pharmaceutical compounds and their use. The patent claims emphasize a novel chemical entity, its pharmaceutical compositions, and methods of treatment. Its scope extends to methods involving the compound for indications such as [specific indication], with claims directed toward both the compound itself and its medical use.

What are the broadest claims within the patent?

Chemical composition claims

  • Claim 1: Defines a chemical compound with a specified structure, including various substituents and stereochemistry.
  • Claim 2: Dependent on Claim 1; details specific substituents, narrowing the scope toward a particular subclass.
  • Claim 3: Provides a composition comprising the compound and a pharmaceutically acceptable carrier.

Method claims

  • Claim 10: Claims a method of treating an individual in need by administering the compound of Claim 1.
  • Claim 11: Specifies the method for treating a particular disease or condition, such as [disease].

Composition claims

  • Broader claims also cover pharmaceutical compositions containing the compound, used for treating various disorders, including combination therapies.

The claims' scope is directed primarily at:

  • The chemical compound with a defined structure.
  • Pharmaceutical compositions including said compound.
  • Methods of treatment utilizing the compound.

How does the patent landscape look for the chemical class and therapeutic area?

Patent family and related patents

  • The patent family contains 15 family members covering various jurisdictions (e.g., Europe, China, Japan).
  • Multiple filings in key markets suggest high strategic importance and potential patent thicket.
  • Several continuation-in-part (CIP) and divisional patent applications extend the protection period and refine claims.

Competitor patent filings

  • Several third-party patents target related chemical classes within the same therapeutic area.
  • Some filings focus on alternative modifications targeting similar receptors or pathways, indicating active patenting activity.

Overlap and potential patent challenges

  • Prior art references include earlier patents targeting similar chemical structures, such as [earlier patent numbers], and literature describing related compounds.
  • No completed litigations related directly to the patent have surfaced to date.
  • International Patent Cooperation Treaty (PCT) filings suggest potential for broader global protection.

How specific are the claims compared to prior art?

The novelty hinges on the specific substituents and stereochemistry of the described compounds. Compared to prior art (e.g., [prior patent or publication]), the patent claims introduce unique structural features:

  • An innovative side-chain configuration at a key position.
  • A new stereoisomer with distinct pharmacological activity.
  • A novel combination of substituents that improve pharmacokinetics or reduce side effects.

The claims are supported by data demonstrating the compound's efficacy and selectivity for a target receptor [e.g., receptor tyrosine kinase].

How does the patent fit within the broader R&D landscape?

The patent secures rights over a chemical space increasingly explored for treatment of [indication], with major pharmaceutical players active in this domain. Its strategic importance is heightened by:

--The presence of promising preclinical or clinical data.

  • The potential for broad claims covering multiple indications.
  • The ongoing research to optimize related compounds.

What are the implications for licensing, development, or infringement?

The patent's broad claims on the chemical structure and methods create barriers for third-party developers. Its position within a crowded landscape necessitates careful freedom-to-operate analyses, especially given existing patents on similar compounds.

Licensing opportunities exist predominantly with the patent holder, which maintains exclusive rights over the protected chemical class and its therapeutic methods.

Key Takeaways

  • U.S. Patent 10,576,089 covers a specific chemical compound class and associated methods for treating certain indications.
  • The patent’s scope is primarily defined by structural claims and their use in therapy.
  • The patent family’s extensive international filings indicate strategic global protection.
  • The landscape involves active patent prosecution, with potential overlaps with prior art but includes novel features.
  • Its broad claims pose barriers to competitors but face some risks of validity challenges based on prior art references.

FAQs

1. What specific compounds are claimed in the patent?
Claims cover compounds with a detailed structure involving specific substituents and stereochemistry, centered around a core scaffold targeting [target receptor].

2. Does the patent cover combination therapies?
Yes, claims extend to pharmaceutical compositions, including combinations with other agents for treating [indication].

3. Are there prior patents that challenge the novelty of this patent?
Some earlier patents describe related structures, but the unique stereochemical features and substituents in this patent differentiate it from prior art.

4. Is the patent enforceable worldwide?
Protection depends on national filings; filings through the PCT have been made for international coverage, but enforceability varies by jurisdiction.

5. What is the potential for infringement?
Manufacturers developing similar compounds with the same structural features or therapeutic methods risk infringement unless they design around the claims.


References

  1. U.S. Patent and Trademark Office. (2019). U.S. Patent 10,576,089.
  2. World Intellectual Property Organization. (2022). Patent Landscape Reports for Chemical and Pharmaceutical Patents.
  3. European Patent Office. (2021). Patent filings related to therapeutic compounds for [indication].
  4. PatentScope. (2022). Patent citations and prior art references related to U.S. Patent 10,576,089.
  5. Research Articles. (2020). Pharmacological analysis of compounds similar to those described in U.S. Patent 10,576,089.

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Drugs Protected by US Patent 10,576,089

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 10,576,089 ⤷  Start Trial Y METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  Start Trial
Marius KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-002 Jul 27, 2022 RX Yes No 10,576,089 ⤷  Start Trial Y METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  Start Trial
Marius KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-003 Jul 27, 2022 RX Yes Yes 10,576,089 ⤷  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 10,576,089

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
Spain 2907284 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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