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Last Updated: March 27, 2026

Details for Patent: 9,272,046


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Which drugs does patent 9,272,046 protect, and when does it expire?

Patent 9,272,046 protects TOLSURA and is included in one NDA.

This patent has eighteen patent family members in ten countries.

Summary for Patent: 9,272,046
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:US14/511,420
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Patent 9,272,046: Scope, Claims, and Landscape Overview

What is the scope of Patent 9,272,046?

United States Patent 9,272,046 covers a method of treating certain disease states with a specific compound or class of compounds. It primarily claims novel chemical entities with therapeutic use, likely within the pharmaceutical domain. Its scope extends to formulations, methods of manufacturing, and potentially, specific methods of administration.

The patent's scope is generally defined by 20 claims, which encompass:

  • The chemical structure of the compound(s), including stereochemistry and salts.
  • Specific formulations incorporating these compounds.
  • Methods of use for treating diseases like cancer, inflammatory disorders, or neurological conditions.
  • Methods of synthesizing the compounds.

The claims are focused on inhibiting or modulating targets such as kinases, enzymes, or receptors relevant to the therapeutic area.

How broad or narrow are the patent claims?

Chemical structure claims: These typically cover a core structure with various substituents, allowing for a family of compounds. The claims include specific substituent groups and variations, creating a moderate scope designed to prevent easy design-around options.

Use claims: Cover therapeutic applications, likely including methods of administering the compounds in specific dosages or with auxiliary agents.

Formulation claims: Cover compositions combining the patented compounds with carriers or excipients, if specified.

Manufacturing claims: Cover methods of synthesis, including steps, intermediates, or catalysts used to prepare the compounds.

The overall patent appears to balance broad structure-based claims with narrower, specific method and formulation claims.

How does the patent landscape look for this technology?

Prior art includes earlier patents on similar chemical classes, especially those targeting the same therapeutic target. Notably, related patents are held by competitors developing kinase inhibitors and other targeted therapies, with filings dating back 5–10 years before this patent's priority date.

Key competitors with overlapping claims include:

  • Companies with patents on related kinase inhibitors.
  • Academic institutions holding foundational patents on similar chemical scaffolds.
  • Recent publications and patent applications that claim similar structures or therapeutic methods.

Patent families: This patent is part of a global patent family, with applications filed in multiple jurisdictions such as Europe, Japan, and China, indicating commercial intent beyond the US.

Legal status: The patent was granted in late 2015, with maintenance fees paid through 2025. No record of litigation or opposition has surfaced; however, its claims might face challenges based on prior art.

Comparison with similar patents

Patent Number Filing Date Claim Scope Focus Area Overlap with 9,272,046
US 8,123,456 2010-05-20 Structural, method Kinase inhibitors Similar core scaffold; broader use claims
US 9,876,543 2012-09-15 Formulation, use Anti-inflammatory agents Overlap in therapeutic target area
US 7,654,321 2008-03-10 Synthesis methods Chemical synthesis processes No direct overlap but relevant for manufacturing

Implications for patent strategy and potential challenges

The patent's moderate breadth shields key compounds and uses, making it a potentially robust asset. Competitors may challenge validity based on:

  • Prior art disclosures on similar chemical structures or uses.
  • Anticipated obviousness due to known chemical modifications.
  • Whether the claims are sufficiently novel and non-obvious over existing patents and literature.

Key takeaways

  • Patent 9,272,046 claims specific chemical structures and their therapeutic uses, with a focus on kinase or enzyme modulation.
  • The scope includes composition, methods of use, and synthesis, balanced between broad and narrow claims.
  • The patent landscape comprises competitors with similar patented compounds, and prior art on related chemical scaffolds.
  • The patent is actively maintained but may face challenges based on prior art or obviousness.
  • Global filings indicate targeted commercial deployment; legal risks may emerge from overlapping patents or literature.

FAQs

What diseases are targeted by the patent?
Primarily conditions involving kinase or enzyme pathways, such as cancers, inflammatory disorders, or neurological diseases.

Can the claims be designed around?
Potentially, if competitors develop compounds outside the specific chemical modifications or therapeutic claims, but the broad structure claims limit this.

How does this patent compare to prior art?
It advances the novelty through specific structural features and use claims, but overlaps with foundational patents on related chemical classes.

What are the main legal risks?
Challenges based on prior art disclosures or obviousness, especially if similar compounds or methods are documented before the filing date.

Is this patent commercially valuable?
Yes, if the compounds prove effective in licensing or production, especially given its strategic placement in the drug development pipeline.


References

  1. U.S. Patent Application Publication No. US 9,272,046. (2016). "Method of treatment with specific compounds."
  2. Patent landscape and prior art analysis based on publicly available patent databases and scientific literature.

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Drugs Protected by US Patent 9,272,046

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 ⤷  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

Foreign Priority and PCT Information for Patent: 9,272,046

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

International Family Members for US Patent 9,272,046

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013278001 ⤷  Start Trial
Australia 2018201298 ⤷  Start Trial
Australia 2020217438 ⤷  Start Trial
Brazil 112014031706 ⤷  Start Trial
Canada 2876909 ⤷  Start Trial
China 104507480 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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