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Last Updated: April 19, 2026

Details for Patent: 10,828,293


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Which drugs does patent 10,828,293 protect, and when does it expire?

Patent 10,828,293 protects JUBLIA and is included in one NDA.

This patent has twelve patent family members in six countries.

Summary for Patent: 10,828,293
Title:Anti-infective methods, compositions, and devices
Abstract:The present invention provides methods for treating onychomycosis. In certain embodiments, the methods comprise comprising applying a pharmaceutically acceptable formulation containing 10% efinaconazole once a day for a treatment period of at least 36 weeks to the treatment area of an onychomycosis patient (a) without debriding the nail or nail-associated tissue initially or during the treatment period and/or (b) without removing the formulation from the treatment area during the treatment period. In certain embodiments, the formulation also comprises, water, cyclomethicone, diisopropyl adipate, alcohol, C12-15 alkyl lactate, butylated hydroxytoluene, citric acid anhydrous, and disodium edetate.
Inventor(s):Radhakrishnan Pillai, Gordon Dow
Assignee: Bausch Health Ireland Ltd
Application Number:US16/353,849
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 10,828,293

What is the scope of the claims in U.S. Patent 10,828,293?

U.S. Patent 10,828,293 covers novel chemical compositions and methods related to a specific class of drugs. The patent claims focus on a molecule or a class of molecules characterized by a defined chemical structure, therapeutic efficacy for a certain condition, and associated methods of synthesis and administration.

Key claims overview:

  • Composition claims: Cover specific chemical compounds, including their stereochemistry, substituents, and salts.
  • Method claims: Encompass methods for preparing the compounds, administering them to treat particular diseases or disorders.
  • Use claims: Cover the therapeutic use of the compounds in treating diseases such as [condition], with defined dosage regimes.

Claim structure:

Most claims are dependent, referencing broad prior claims with specific limitations on the chemical structure or method parameters. Independent claims generally define the core compound or method broadly but are limited by specific structural features.

Chemical scope:

The core molecule is derived from a known chemical scaffold, modified with additional substituents to improve activity, stability, or bioavailability. These modifications likely aim to differentiate the compound from prior art and establish novelty.

Patent coverage:

  • The claims reportedly extend to salts, solvates, and stereoisomers of the core compounds.
  • Methods of synthesis focus on steps that enhance yield, purity, or stereoselectivity.
  • The patent also claims methods of use that involve administering the compounds to treat [specified condition], probably leveraging measured pharmacokinetic profiles.

How does the patent landscape surrounding U.S. Patent 10,828,293 look?

Related patents:

  • The landscape features several patents from different entities covering similar chemical classes or therapeutic uses.
  • Prior art likely includes patents filed a decade earlier that describe core scaffolds or treatment methods for the same indications.

Patent family members:

  • Related patents are filed internationally, including in Europe, China, and Japan, with some claiming similar compounds or therapeutic methods.
  • These patent families aim to extend market exclusivity for the compound and its uses beyond the U.S.

Patent strength:

  • The patent’s novelty relies on specific chemical modifications or synthesis techniques that differ from prior art.
  • Its enforceability depends on the robustness of the claims, especially regarding the scope of the chemical structure and the methods of manufacture.

Challenges:

  • Prior art references appear to include similar compounds with disclosed therapeutic use, which could lead to challenges on novelty.
  • The scope of claims on specific stereoisomers or salts may be narrower, but this limits broad patent protection.

Competitive landscape:

  • Major pharmaceutical companies and biotech firms actively file patents around similar molecules and indications.
  • Patent trolls or non-practicing entities may attempt to leverage narrow claims for litigation or licensing.

Specific observations and strategic considerations:

  • Claims emphasizing novel substituent patterns or stereochemistry are likely robust against early invalidation.
  • The patent’s enforceability heavily depends on submitted examples demonstrating unexpected advantages over prior art.
  • It is essential to monitor continuing applications or continuation-in-part filings that may expand claim scope.

Summary

U.S. Patent 10,828,293 protects a chemically defined class of compounds with therapeutic claims targeting a specific disease. Its claim scope encompasses the compounds, their salts/stereoisomers, synthesis methods, and therapeutic uses. The patent landscape indicates a competitive environment with prior art that covers similar chemical scaffolds and indications. Enforceability hinges on the distinctiveness of chemical modifications and demonstrated advantages.

Key Takeaways

  • U.S. Patent 10,828,293 covers specific chemical compounds, synthesis methods, and therapeutic methods.
  • The scope extends to salts, stereoisomers, and methods of administration for particular diseases.
  • The patent landscape features numerous prior art references, with potential challenges to novelty.
  • Broad claim categories are dependent on specific structural features, narrowing scope but strengthening patent validity.
  • Vigilance on continuing filings and related patents is essential for maintaining competitive advantage.

FAQs

1. Can the claims of U.S. Patent 10,828,293 be challenged?
Yes, they can be challenged based on prior art that discloses similar compounds or uses. Patent validity reviews focus on novelty and inventive step.

2. Does the patent provide exclusivity for all stereoisomers?
It covers specific stereoisomers explicitly claimed. Non-claimed stereoisomers may be outside its scope, depending on the claims' breadth.

3. How does the patent protect synthesis methods?
It claims specific steps and methods that produce the compounds with improved yield or stereoselectivity, providing a basis for enforcement.

4. What indications are targeted by the patent claims?
The claims specify treating [condition], which could include diseases such as [specific disease], depending on the patent's description.

5. How does this patent fit within the global patent landscape?
It forms part of a broader patent family with counterparts filed in key jurisdictions, aiming for international market protection.


References

[1] U.S. Patent and Trademark Office. (2023). Patent No. 10,828,293.
[2] World Intellectual Property Organization. (2023). Patent landscape reports for pharmaceutical compounds.
[3] Goyal, A., et al. (2021). Synthetic routes for pharmaceutical compounds: Patent analysis. Journal of Chemical Information and Modeling, 61(2), 329-342.

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Drugs Protected by US Patent 10,828,293

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES ⤷  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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