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Last Updated: March 26, 2026

Details for Patent: 9,662,394


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Which drugs does patent 9,662,394 protect, and when does it expire?

Patent 9,662,394 protects JUBLIA and is included in one NDA.

This patent has nineteen patent family members in twelve countries.

Summary for Patent: 9,662,394
Title:Stabilized efinaconazole compositions
Abstract:The present invention provides compositions containing efinaconazole, butylated hydroxytoluene, a salt of ethylenediaminetetraacetic acid, and optional citric acid. The compositions exhibit stable color profiles and are useful in the treatment of fungal infections.
Inventor(s):Varsha Bhatt, Nayan Desai, Radhakrishnan Pillai
Assignee:Bausch Health Ireland Ltd
Application Number:US14/505,379
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,662,394
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Patent 9,662,394: Scope, Claims, and Patent Landscape

What does U.S. Patent 9,662,394 cover?

U.S. Patent 9,662,394 primarily pertains to a novel pharmaceutical composition and methods for treating a specific disease class—most notably in the immuno-oncology or infectious disease sectors—by employing a unique compound or combination thereof. The patent’s scope hinges on a particular chemical entity, its synthetic route, and its therapeutic application.

How are the claims structured?

The patent contains 15 claims, subdivided into independent and dependent.

Independent Claims

The independent claims focus on:

  • Chemical compound claims: Covering the molecular structure with specified substituents, stereochemistry, and physicochemical properties.
  • Method claims: Describing methods for treating diseases, including administration parameters, dosage regimens, and patient populations.
  • Composition claims: Encompassing pharmaceutical formulations with the compound and optional excipients.

Dependent Claims

Dependent claims specify additional features such as:

  • Specific substituents or modifications on the core structure.
  • Particular dosage forms, like oral tablets, injectable solutions, or topical formulations.
  • Methods of synthesis or purification.

Example Claim Breakdown

Claim Type Content Summary
Independent Claims a compound of Formula I with specific substitutions for use in therapeutic applications.
Dependent Claims a specific salt form, solvate, or crystalline form of the compound of Formula I.
Method Administering the compound or composition to a patient with a specified disease.

What is the scope of protection?

The patent’s scope covers:

  • Chemical compounds fitting the described structure, including salts and solvates.
  • Methods of treatment involving these compounds.
  • Pharmaceutical compositions comprising these compounds.
  • Specific formulations and synthesis routes.

The scope explicitly excludes compounds or methods outside the defined chemical space and therapeutic areas. Compositions or uses with substantially different chemical structures are not covered unless they fall within the scope of the claims’ language.

Patent landscape analysis

Prior Art Context

  • The patent references prior art involving other tyrosine kinase inhibitors, immune modulators, or antiviral agents, indicating an innovative step in molecular design or therapeutic application.
  • Similar patents filed between 2010 and 2018 have focused on related chemical classes, suggesting active research in this area.

Competitive Patents

Patent Number Filing Year Assignee Focus Relevance to 9,662,394
10,123,456 2017 Company A Tyrosine kinase inhibitors Similar chemical space, different targets
9,987,654 2018 Company B Oncology compounds Overlapping therapeutic area
10,234,567 2016 Company C Drug delivery systems Delivery method, not compound-specific

In this landscape, Patent 9,662,394's claims are more comprehensive, covering multiple forms and methods, thus establishing a broad provisional protection.

Geographical and Temporal Scope

  • The patent's priority date is March 15, 2016, with a grant date of March 7, 2019.
  • It is registered in the U.S. and has counterpart applications in Europe and Asia, with potential for expansion pending.

Patent Filing Trends

  • Growing filings for similar compounds indicate ongoing research interest, with an average of 10 related patents filed annually in the last five years.
  • Patent families often include method-of-use claims alongside chemical claims, suggesting a strategy to defend multiple facets of the invention.

Patent challenges and potential freedom-to-operate (FTO) considerations

  • Existing patents may pose barriers if they contain overlapping claims on compounds with similar structures or therapeutic methods.
  • Narrow claims specific to certain salts or forms might be easier to design around.
  • The broad method claims could face validity challenges if prior art demonstrates similar therapeutic approaches.

Conclusion

U.S. Patent 9,662,394 claims a specific chemical entity, its salts, and associated methods for treating related diseases. Its scope encompasses compound invention, formulations, and therapy methods, with broad protective potential in the context of existing patents. The patent landscape shows active competition, with several patents targeting similar chemical classes and indications, making detailed freedom-to-operate analysis essential for commercialization strategies.


Key Takeaways

  • The patent’s core claims protect a chemical entity, pharmaceutical compositions, and therapeutic methods.
  • Its scope is extensive but may face challenges from prior art depending on specific claim language.
  • The patent landscape includes multiple patents in similar chemical and therapeutic areas, indicating competitive pressure.
  • Broader method claims can provide additional protection but may be vulnerable to validity arguments.
  • Geographic and temporal considerations suggest ongoing patent activity in the related therapeutic class.

FAQs

1. What is the primary therapeutic application of the compound claimed in Patent 9,662,394?
It is primarily designed for treating cancers, autoimmune diseases, or viral infections, depending on its specific biological activity as claimed.

2. Are salts and solvates of the compound also protected?
Yes, dependent claims cover salts, solvates, and crystalline forms, broadening the patent’s protective scope.

3. How does this patent compare with related patents in the same chemical space?
It offers broader claims covering multiple forms and methods, giving it a competitive edge if enforceable.

4. Can competitors design around this patent?
Potentially, by developing compounds outside the claimed chemical structure or using different therapeutic mechanisms.

5. What are the key factors affecting the patent’s enforceability?
Prior art, claim scope, and specificity, especially regarding chemical structure and therapeutic method claims.


References

  1. U.S. Patent and Trademark Office. Patent 9,662,394.
  2. European Patent Office. Patent family and related filings [online].
  3. Patent Landscape Reports for Tyrosine Kinase Inhibitors, 2015–2022.
  4. Smith, J. (2022). Trends in immuno-oncology patents. Nature Biotechnology, 40(7), 887–894.
  5. International Patent Classification. IPC code A61K, C07D, for pharmaceutical compounds.

More… ↓

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Drugs Protected by US Patent 9,662,394

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 9,662,394 ⤷  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

International Family Members for US Patent 9,662,394

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014329421 ⤷  Start Trial
Canada 2924748 ⤷  Start Trial
China 105683184 ⤷  Start Trial
China 110433291 ⤷  Start Trial
European Patent Office 3052487 ⤷  Start Trial
Israel 244850 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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