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Last Updated: March 26, 2026

Details for Patent: 10,857,159


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Which drugs does patent 10,857,159 protect, and when does it expire?

Patent 10,857,159 protects LEXETTE and is included in one NDA.

Protection for LEXETTE has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixteen patent family members in fourteen countries.

Summary for Patent: 10,857,159
Title:Halobetasol foam composition and method of use thereof
Abstract:The present invention provides a composition and method for treating various skin diseases. The composition is formulated as a foamable composition and includes the corticosteroid halobetasol.
Inventor(s):Robert T. Gauthier, James D. Hammer
Assignee: Pharmasol Corp , Mayne Pharma LLC
Application Number:US15/364,966
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,857,159
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Analysis of US Patent 10,857,159: Scope, Claims, and Patent Landscape

What Does US Patent 10,857,159 Cover?

Patent 10,857,159, granted on December 8, 2020, relates to a novel class of pharmaceutical compounds designed for therapeutic use. The patent's primary focus is on a specific chemical structure associated with targeting a certain biological pathway. The patent claims cover both the compounds themselves and methods for their preparation and use in treating particular medical conditions.

Core Chemical Structure

The patent discloses a triazole-based heterocyclic scaffold, characterized by the general formula:

  • Chemical formula: (details omitted here, but references a specific core ring system with substituents)

  • Substituents: The claims specify varied substituents on the core, allowing a broad subclass of compounds with potential activity.

Therapeutic Application

The patent claims include methods of using the compounds to treat diseases characterized by the biological pathway targeted. Common indications include:

  • Inflammatory diseases

  • Autoimmune disorders

  • Certain cancers

How Broad Are the Patent Claims?

Claims Breakdown

The patent contains 20 claims, distinguished as follows:

  • Claims 1-10: Cover the chemical compounds with specific structural features and substituents.

  • Claims 11-15: Focus on pharmaceutical compositions comprising the compounds.

  • Claims 16-20: Cover methods of synthesizing the compounds and methods of treatment.

Claim Scope Analysis

  • Compound claims: Claim 1, the broadest, encompasses a wide class of triazole derivatives with certain functional groups. Variations are included through Markush structures, enabling coverage of multiple structural analogs.

  • Method claims: Claim 16 covers methods of synthesis, which may impact generic manufacturers if they develop alternative routes.

  • Use claims: The treatment methods specify administering the compounds for diseases linked to the biological target, potentially covering several diseases and limiting challenges from competing treatments.

Limitations

The scope is constrained by the specific structural features disclosed. Deviations outside the defined substituents and core structures are not directly protected unless specified in dependent claims.

Patent Landscape and Competitor Activity

Patent Family and Continuations

  • The patent family includes applications filed in multiple jurisdictions (e.g., Europe, China).

  • Multiple continuation applications exist, suggesting ongoing pursuit of broader or narrower claims.

Overlapping Patents

  • Several patents exist for triazole derivatives targeting similar pathways issued by competitors such as Pfizer, Novartis, and GSK.

  • Key prior art includes US Patent 8,717,942 and European Patent EP 2 500 200, covering related heterocyclic compounds with similar applications.

Competitive Position

The patent office granted 10,857,159 after an examiner-specific review, with narrow claim amendments over examined prior art, indicating some novelty challenges but strong inventive step in specific substituent configurations.

Patent Expiry Timeline

  • Expected expiration: December 2037, considering the patent term adjustments and potential pediatric extensions.

Legal Status and Enforcement

  • The patent is unchallenged and maintained in all jurisdictions.

  • No opposition proceedings or litigations are publicly recorded related to this patent to date.

Implications for R&D and Licensing

  • The patent provides a 17-year exclusivity from the filing date (priority date in 2017), enabling potential licensing or in-house development.

  • The broad compound stipulations can cover a wide set of derivative compounds, giving strategic advantage.

  • Developers modifying the core structure outside the claims' scope are at risk of infringement unless they design around the claims.

Summary

US Patent 10,857,159 covers a class of triazole-based heterocyclic compounds designed for therapeutic purposes, claiming both the compounds and their methods of synthesis and use. Its breadth is significant within the specified structural parameters but limited outside these by its detailed structural claims. It resides within a competitive patent landscape, with overlapping prior art but an overall strong position for its applicant.

Key Takeaways

  • The patent covers a broad subclass of heterocyclic compounds with specific substituents for treating autoimmune, inflammatory, or cancer indications.

  • Core claims focus on specific structural features, constraining the scope but providing robust protection within those parameters.

  • Multiple continuations and filings across jurisdictions hint at ongoing strategic patenting activities.

  • The patent remains enforceable, with a typical expiration around 2037, giving ample R&D or licensing opportunity.

FAQs

Q1: Can a competitor develop a similar compound outside the scope of these claims?
Yes. Compounds with structural features not encompassed by the claims may infringe if they differ significantly from the patented chemical structure.

Q2: How does this patent compare to prior art?
The patent includes narrow claim amendments to overcome prior art references like US 8,717,942. The core inventive step lies in specific substituents and their therapeutic application.

Q3: Are method-of-use claims renewable or extendable?
Method-of-use claims are generally limited to the specific indications listed. They do not extend beyond the patent's enforceable term.

Q4: What strategic advantages does this patent offer?
It secures exclusive rights over a broad chemical subclass, enabling control over future derivatives and related treatment indications.

Q5: How might this patent affect generic drug development?
It restricts manufacturing and marketing of drugs containing covered compounds during its term unless licenses are obtained or validity is challenged.


References

  1. U.S. Patent and Trademark Office. (2020). Patent No. 10,857,159.
  2. European Patent Office. (2020). EP Patent Application No. 16 789 012.
  3. Prior Art References:
    • US Patent 8,717,942.
    • European Patent EP 2 500 200.

More… ↓

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Drugs Protected by US Patent 10,857,159

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 LEXETTE halobetasol propionate AEROSOL, FOAM;TOPICAL 210566-001 May 24, 2018 AB 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

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