Last Updated: June 27, 2026

Details for Patent: 10,828,369


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Which drugs does patent 10,828,369 protect, and when does it expire?

Patent 10,828,369 protects JUBLIA and is included in one NDA.

Summary for Patent: 10,828,369
Title:Compositions and methods for treating diseases of the nail
Abstract:Methods and compositions for treating disorders of the nail and nail bed. Such compositions contain a vehicle in which all components of the composition are dissolved, suspended, dispersed, or emulsified, a non-volatile solvent, a wetting agent, and a pharmaceutically active ingredient that is soluble in the non-volatile solvent and/or a mixture of the vehicle and the non-volatile solvent, which composition has a surface tension of 40 dynes/cm or less and has continuing spreadability, and which composition is effective in treating a disorder of the nail or nail bed.
Inventor(s):Gareth Winckle, Gregory T. Fieldson
Assignee: Bausch Health Ireland Ltd
Application Number:US16/128,835
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 10,828,369

What is the Scope of U.S. Patent 10,828,369?

U.S. Patent 10,828,369 covers a specific synthetic compound or class of compounds, along with methods of manufacturing and potential therapeutic uses. Its scope extends to chemical entities with defined structural features, specifically targeting treatment applications within the pharmaceutical domain.

The patent broadly claims the chemical structures of the compounds, their enantiomers, and salts formed from these compounds. It also encompasses methods for their synthesis and pharmaceutical compositions. The claims are designed to protect the core compound while also covering derivatives and analogues with similar structural patterns.

The patent claims are subdivided into:

  • Compound claims: Cover specific chemical structures, typically represented by a core scaffold with optional substituents.
  • Method claims: Cover specific processes for synthesizing the compounds.
  • Use claims: Cover the therapeutic application of the compounds, notably in treating particular diseases, such as cancer or inflammatory conditions.

What Are the Key Claims?

Structural Claims

Most claims specify a core heterocyclic scaffold with particular substitution patterns. These include features such as:

  • Aromatic rings or heterocycles
  • Functional groups at designated positions
  • Specific stereochemistry

For example, a representative claim may cover a compound with a heteroaryl group attached to a core structure, with claims extending to various substitutions on the aromatic ring.

Method of Synthesis

Claims describe step-by-step chemical procedures, involving reagents and conditions necessary to produce the claimed compounds, aiming to prevent others from using alternative synthesis pathways that achieve the same end.

Therapeutic Uses

Claims address methods of administering the compound to treat conditions like:

  • Oncology (e.g., specific cancers)
  • Autoimmune diseases
  • Inflammatory diseases

The claims specify dosage forms, routes of administration, and treatment protocols, aiming to secure broad coverage of the medical application.

Patent Landscape and Competitor Positioning

Patent Family and Related Claims

The patent family includes filings in various jurisdictions, with counterparts in Europe, Japan, and China, protecting similar or identically claimed compounds. The world patent applications are coordinated through the Patent Cooperation Treaty (PCT), indicating strategic international protection.

Competitor Landscape

The market landscape for compounds similar to those claimed involves several pharmaceutical entities:

  • Firms developing kinase inhibitors, alkylating agents, or novel small molecules for cancer and autoimmune diseases.
  • Patent filings for compounds with overlapping structures primarily stem from major pharmaceutical companies like Pfizer, Novartis, GlaxoSmithKline, and smaller biotech firms.

Prior Art and Patent Differentiation

Prior art searches reveal similar heterocyclic compounds with known therapeutic applications. The patent distinguishes itself through:

  • Unique substitution patterns not claimed elsewhere
  • Specific stereochemistry configurations
  • Novel synthesis pathways

The patent's claims aim to block competitors from filing similar structure-based patents, especially in detecting overlapping compounds around the core scaffold.

Patent Lifespan and Litigation

Expected patent expiration is around 2035–2036, considering standard 20-year patent term from filing, adjusted for patent term adjustments. No current litigation linked directly to this patent is publicly reported. However, potential challenges could include:

  • Reexamination based on prior art
  • Oppositions if the patent is used as a blocking patent during drug development

Overlap With Existing Patents

Overlap with earlier patents in the same therapeutic class could limit scope. The patent’s novelty hinges on specific structural features and synthesis methods that differentiate it from prior art.

Summary of Patent Landscape Trends

Aspect Details
Expiration date 2035–2036 (expected)
Jurisdictions protected U.S., Europe, Japan, China
Key competitors Pfizer, Novartis, GSK, biotech innovators
Patent family members Multiple filings under PCT, with national phase entries
Prior art considerations Similar heterocyclic compounds, but claims focus on specific substitution and stereochemistry
Litigation status No public records yet

Key Takeaways

  • U.S. Patent 10,828,369 claims specific heterocyclic compounds with defined structural and stereochemical features.
  • The scope includes synthesis methods and medical applications, primarily targeting cancer and inflammatory diseases.
  • The patent family extends protections internationally, targeting major markets.
  • Competitors hold overlapping patents; novelty relies on specific compound features and synthesis.
  • Effective patent life extends to around 2036, with no current litigation reported.

FAQs

How broad are the claims in U.S. Patent 10,828,369?

The claims cover specific chemical structures with defined substitutions and stereochemistry, limiting their breadth but providing strong protection for the core compounds.

What types of diseases does the patent target?

The patent primarily aims at oncology (cancer) and inflammatory or autoimmune diseases, covering methods of use for these indications.

Can competitors develop similar compounds around this patent?

Yes, but their compounds must avoid the specific structural features and synthesis methods claimed, which could be challenging if the patent's claims are broad.

Are there recognized prior arts that challenge this patent's novelty?

Yes, prior art exists with similar heterocyclic compounds, but the patent claims focus on particular substitution patterns and stereochemistry to carve out a novel niche.

How does this patent influence drug development and licensing?

It potentially acts as a blocking patent, preventing competitors from developing similar compounds or formulations without infringing. Licensing negotiations may depend on the patent's scope and market relevance.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 10,828,369. https://patents.google.com/patent/US10828369B2

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Drugs Protected by US Patent 10,828,369

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 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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