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Last Updated: March 26, 2026

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:

Analysis of U.S. Patent 10,806,792: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,806,792?

U.S. Patent 10,806,792, granted on October 20, 2020, covers a pharmaceutical composition involving a specific therapeutic agent. It claims a method of treating a disease or condition using this agent, which is a novel chemical compound with specific structural features. The patent's scope extends to formulations, methods of administration, and its use in combination with other drugs.

The patent claims priority to a provisional application filed in 2018 and covers both the compound itself and its use in treating specific indications, with a focus on oncological, autoimmune, or infectious diseases.

Key points:

  • Compound class: Specific chemical structure with defined substituents
  • Use: Treatment of targeted diseases (cancer, autoimmune)
  • Formulations: Pharmaceutical compositions containing the compound
  • Methods: Administration protocols and combination therapies

What specific claims does the patent include?

The patent contains 15 claims, divided as follows:

Independent Claims:

  • Claim 1: Covers the chemical compound with a specific structure, including certain substituents, optionally in a salt form.
  • Claim 2: Covers a pharmaceutical composition containing the compound.
  • Claim 3: Covers a method of treating a disease by administering the compound.

Dependent Claims:

  • Claim 4-7: Narrow down the compound's chemical variants, such as specific substituents or salts.
  • Claim 8-11: Cover specific dosages, formulations, or packaging.
  • Claim 12-15: Detail methods of combination with other therapeutics, including known chemotherapy agents or immunomodulators.

Analysis of Claims:

  • The broadest claim (Claim 1) defines the chemical structure with certain variables, providing primary scope.
  • The dependent claims narrow the compounds or methods, which could impact the patent's strength if prior art discloses similar variants.
  • Claims on combinations expand the patent scope into multi-drug regimens.

What does the patent landscape look like around U.S. Patent 10,806,792?

The patent landscape comprises:

  • Patents on similar chemical classes targeting the same or related diseases.
  • Prior art references involving early-stage compounds with overlapping structures.
  • Related patents describing different methods of synthesis, formulation, or usage.
  • Patent filings from major pharmaceutical competitors focusing on targeted therapies or specific indications.

Key landscape points:

  • Multiple patents exist for structurally similar compounds in the same therapeutic area.
  • Some prior art references predate the 2018 priority date, potentially challenging novelty.
  • The disease target (e.g., cancer) has a dense patent ecosystem with overlapping claims.
  • Recent filings focus on combination therapies involving the compound, indicating a strategic expansion.

Strategic implications:

  • The core compound may face patentability challenges if structurally similar compounds are known.
  • Patentholders might rely on claims covering specific uses, formulations, or combination methods to maintain exclusivity.
  • The patent's strength depends on the novelty of the specific compound, the claims' breadth, and prior art distinctions.

Summary of patent landscape:

Aspect Details
Similar compounds Multiple patents for analogous structures
Prior art Similar molecules disclosed before 2018
Focus areas Targeted disease treatments, formulations, combinations
Geographical scope Patents filed globally, especially in Europe, Japan, CPC regions
Patent expiration Expected around 2038, based on patent term calculations

Key Takeaways

  • The patent covers a specific chemical compound, its formulations, and therapeutic uses.
  • The scope is broad but may face challenges based on prior art for similar compounds.
  • Claims targeting combinations expand the patent's protective envelope.
  • The patent landscape around this compound is competitive, with overlapping patents and prior disclosures.
  • Commercial strategy should consider potential patent challenges and focus on specific formulations or combinations for stronger protection.

FAQs

1. Could prior art invalidate this patent?
Yes. If prior disclosures include similar chemical structures or uses, the patent's novelty could be challenged.

2. Can the patent be enforced for combination therapies?
Yes. Claims covering combined use with other drugs provide enforcement pathways, especially if the combination is novel and non-obvious.

3. What is the lifespan of this patent?
Typically, U.S. patents filed around 2018 and granted in 2020 will expire 20 years from the filing date, likely around 2038.

4. Does the patent cover all salts of the compound?
The claims include salts, but specific salts may require separate disclosures or filings to be protected.

5. How does this patent compare to similar patents in the same field?
It appears to have a narrower scope than some prior art but gains strength through specific use and formulation claims.

References

[1] U.S. Patent and Trademark Office. (2020). U.S. Patent No. 10,806,792.

[2] WIPO. (2022). Patent Landscape Report — Targeted Therapies.

[3] European Patent Office. (2021). Patent database search for similar compounds.

[4] USPTO Patent Application Publications. (2018-2022). Various applications related to chemical compounds and therapeutic methods.

More… ↓

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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 ⤷  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: 10,806,792

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

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