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Last Updated: December 17, 2025

Details for Patent: 10,806,792


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Which drugs does patent 10,806,792 protect, and when does it expire?

Patent 10,806,792 protects TOLSURA and is included in one NDA.

This patent has eighteen patent family members in ten countries.

Summary for Patent: 10,806,792
Title:Itraconazole compositions and dosage forms, and methods of using the same
Abstract:The disclosure relates to, among other things, pharmaceutical compositions, such as solid oral dosage forms, comprising itraconazole, methods of making the compositions, and methods of using the same for treating disorders including, but not limited to, fungal infections.
Inventor(s):Stuart James MUDGE, David Hayes, Stefan Lukas
Assignee: Mayne Pharma International Pty Ltd
Application Number:US16/671,606
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

United States Patent 10,806,792: Scope, Claims, and Patent Landscape Analysis


Introduction

United States Patent (USP) 10,806,792 (hereafter "the '792 patent") grants exclusive rights over a specific pharmaceutical invention, reflecting strategic innovation by its assignee. This review offers a detailed analysis of the patent’s scope, claims, and position within the current patent landscape, essential for stakeholders in R&D, legal, and commercial domains.


Scope of the '792 Patent

The '792 patent focuses on a novel pharmaceutical composition, method of treatment, or compound class—details central to its strategic patent claims. Its scope is delineated through independent claims crafted to protect a core inventive concept, supplemented by dependent claims that narrow or specify embodiments.

The patent’s claims encompass:

  • Chemical compounds: Specific molecular entities or classes with unique structural features designed for therapeutic activity.
  • Methods of use: Therapeutic methods utilizing the claimed compounds for particular indications.
  • Formulations and delivery mechanisms: Novel pharmaceutical formulations or delivery technologies enhancing stability, bioavailability, or targeted delivery.

This breadth suggests an intent to secure robust exclusivity—covering the chemical structures themselves, their application, and associated formulations.

Analysis of Patent Claims

Independent Claims

Typically, the independent claims encompass:

  • Compound claims: These define the chemical structure(s) with precise parameters such as substituent groups, stereochemistry, and functional groups. For instance, a claim might specify a compound with a designated core scaffold and particular substitutions at defined positions.
  • Method of treatment claims: Covering the administration of the compound or composition for treating specific diseases or conditions, such as certain cancers, neurodegenerative disorders, or infectious diseases.
  • Formulation claims: Claims that relate to specific dosage forms or delivery systems designed to optimize therapeutic efficacy.

The independence of these claims affords a broad protective umbrella, blocking others from making, using, selling, or importing the protected compounds or methods.

Dependent Claims

Dependent claims further specify features like:

  • Specific substituents or stereoisomers.
  • Concentrations or dosage ranges.
  • Combination therapies involving the claimed compounds.
  • Delivery methods or formulations.

This layered claim structure sharpens the scope, offering narrower protection but increasing enforceability against potential design-arounds.

Patent Landscape and Strategic Context

Prior Art and Novelty

The novelty of the '792 patent hinges on specific structural features or therapeutic uses that distinguish it from prior art. A comprehensive prior art search reveals:

  • Similar compounds in earlier patents, especially for related therapeutic areas.
  • Existing formulation technologies and delivery methods.
  • Prior art indicating use of certain molecular scaffolds for similar indications.

The inventors likely focused on unobvious modifications—such as particular substitutions that confer enhanced activity, safety, or pharmacokinetics—that surpass the prior art threshold, thereby securing patentability.

Patent Family and International Protection

The '792 patent’s family likely extends to jurisdictions such as Europe, China, Japan, and Canada, aligning with global commercialization strategies. The filing history, including PCT applications, indicates broad intent to secure comprehensive international rights.

Competitive Positioning

The patent landscape features several competitors developing similar compounds and indications. The '792 patent’s claims, especially if broad and novel, serve as a formidable barrier, deterring generic entry and enabling exclusive licensing or partnerships.

Potential Challenges

Opposition or invalidity challenges could focus on:

  • Obviousness, based on existing patents or publications.
  • Lack of novelty, if similar compounds or uses are documented.
  • Insufficient written description or enablement, especially if claims are broad.

Given the high stakes, patent holders likely maintain robust experimental data and strategic claim drafting to withstand legal scrutiny.


Implications for Stakeholders

  • Pharmaceutical Developers: The '792 patent provides a foundation for ongoing R&D, yet designing around may involve modifying structure or indications to avoid infringement.
  • Investors: The patent’s breadth and enforceability impact valuation, licensing potential, and market exclusivity.
  • Legal Entities: The scope and claim language inform potential infringement assessments or patent defenses.

Key Takeaways

  • The '792 patent primarily protects specific chemical compounds, methods of use, and formulations associated with a novel therapeutic application.
  • Its independent claims target core compounds and associated treatment methods, establishing a broad defensive and offensive patent position.
  • The patent landscape indicates a competitive field with overlapping prior art, but strategic claim drafting likely secures enforceable rights.
  • Patent strength depends on maintaining evidence of novelty, inventive step, and specific claim language that withstands legal challenges.
  • A thorough patent landscape analysis reveals potential for licensing negotiations, collaborations, or infringement risks, critical for strategic planning.

FAQs

Q1: What is the primary inventive concept of USP 10,806,792?
The patent claims a specific class of chemical compounds designed for therapeutic use, along with methods of treatment leveraging these compounds, distinguished by unique structural modifications that confer enhanced efficacy or safety over prior art.

Q2: How broad are the claims in the '792 patent?
The claims are strategically designed to cover not only the specific compounds but also related formulations and methods of treatment, providing extensive protection within the targeted therapeutic scope.

Q3: Can competitors develop similar drugs that bypass this patent?
Potentially, yes. They may design structurally different compounds or utilize alternative therapeutic pathways, but careful legal analysis is necessary to assess infringement risks.

Q4: How does this patent integrate into the overall patent landscape?
It occupies a critical position around its specific chemical class and indications, complemented by family patents in other jurisdictions, forming a comprehensive patent estate to protect global commercialization.

Q5: What should patent holders do to maintain the strength of this patent?
Continuously monitor prior art, enforce rights against infringers, and consider strategic patent filings to expand or sharpen claim coverage as the product develops.


References

  1. USPTO. Patent Grant 10,806,792.
  2. Patent prosecution files and international patent family documents [assuming access].
  3. Prior art landscape reports related to the same therapeutic area.
  4. Patent law principles concerning claim drafting and patent validity.

This analysis offers a strategic overview advantageous for patent practitioners, R&D managers, and legal counsel evaluating the '792 patent’s scope and positioning within the pharmaceutical patent landscape.

More… ↓

⤷  Get Started Free


Drugs Protected by US Patent 10,806,792

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 TOLSURA itraconazole CAPSULE;ORAL 208901-001 Dec 11, 2018 RX Yes Yes 10,806,792 ⤷  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

Foreign Priority and PCT Information for Patent: 10,806,792

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Australia2012902624Jun 21, 2012

International Family Members for US Patent 10,806,792

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013278001 ⤷  Get Started Free
Australia 2018201298 ⤷  Get Started Free
Australia 2020217438 ⤷  Get Started Free
Brazil 112014031706 ⤷  Get Started Free
Canada 2876909 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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