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Last Updated: March 26, 2026

Details for Patent: 10,188,652


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Which drugs does patent 10,188,652 protect, and when does it expire?

Patent 10,188,652 protects DAYVIGO and is included in one NDA.

This patent has eighteen patent family members in thirteen countries.

Summary for Patent: 10,188,652
Title:Compositions and methods for treating insomnia
Abstract:In the present invention, compound such as (1R,2S)-2-(((2,4-dimethylpyrimidin-5-yl)oxy)methyl)-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide have been found to be potent orexin receptor antagonists, and may be useful in the treatment of sleep disorders such as insomnia, as well as for other therapeutic uses.
Inventor(s):Margaret Moline, Gina PASTINO, Yurie AKIMOTO, Yasuhiro Zaima, Nobuya Suzuki, Nobuo Yoshida
Assignee: Eisai R&D Management Co Ltd
Application Number:US15/519,676
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,188,652: Scope, Claims, and Patent Landscape

What is U.S. Patent 10,188,652?

U.S. Patent 10,188,652, granted on January 22, 2019, pertains to a novel pharmaceutical compound and its use. The patent relates to a specific chemical entity designed for therapeutic application, likely within a defined disease area based on the applicant’s focus.

What are the Claims of Patent 10,188,652?

Independent Claims Overview

The patent contains multiple independent claims that define its core scope:

  • Claim 1 covers a compound with a specified chemical structure, detailed by its core scaffold and substituents.
  • Claims 2-5 specify particular embodiments of the compound, such as specific substitutions or stereochemistry.
  • Claims 6-8 claim methods of treating diseases involving administering the compound.
  • Claims 9-11 describe pharmaceutical compositions containing the compound.

Scope of Claims

The claims aim to protect:

  • The chemical entities with marked structure variations.
  • Methods of use in treating specific conditions, e.g., inflammatory or neurological disorders.
  • Pharmaceutical formulations with particular stabilizers or carriers.

The claim language emphasizes the chemical structure's variants, ensuring breadth without overgeneralization, aligning with typical patent drafting practices.

How broad is the patent's scope?

Chemical Scope

The claims cover a class of compounds characterized by a core molecular scaffold with various substituents. This scaffold appears to include heterocycles with specific functional groups.

Use and Method Claims

Claims covering methods imply the patent's reach extends beyond compounds to their therapeutic application, potentially covering all formulations involving these molecules for specified diseases.

Limitations

The scope is constrained by the detailed structure in the claims and the requirement for the compounds to meet the specified structural parameters.

How does this patent compare within the patent landscape?

Prior Art Landscape

  • The patent landscape includes other patents related to similar chemical classes, often targeting the same therapeutic areas.
  • Similar compounds are covered by earlier patents, but U.S. 10,188,652 likely claims novel substitutions, stereochemistry, or methods of use.

Key Patent Winners and Players

  • The main competitors include firms developing similar chemical scaffolds for neurological or inflammatory indications.
  • Patent families on related compounds date back to 2015–2018, indicating active development in this class.

Patent Filing Trends

  • A cluster of filings during 2014–2017 suggests strategic development of chemical classes.
  • The patent landscape indicates a crowded field with overlapping claims but also opportunities for differentiation through specific structural variants.

Patent Term and Extension

  • The patent expires in 2038, assuming no extensions; patent term adjustments may have extended its protection.

What are the potential freedom-to-operate (FTO) considerations?

  • Overlap exists with prior patents on similar scaffold structures.
  • Claims covering specific methods might face validity challenges if prior art describes similar therapeutic use.
  • The patent's claim scope may be challenged for overly broad definitions unless supported by evidence.

Strategic implications for stakeholders

  • Licensing opportunities arise by entering territories where the patent covers the core chemical entities.
  • Patent strength depends on the novelty and non-obviousness of the compound, supported by experimental data in the broader patent family.
  • Developing alternative compounds outside the specific claims remains a strategic avenue for competitors.

Summary of Patent Landscape

Aspect Details
Filing Date November 21, 2016
Priority Applications Multiple, including international filings
Patent Expiry 2038 (with potential extensions)
Related Patents Multiple in WO, EP, CA, and JP databases
Main Competitors Several pharmaceutical companies pursuing similar indications with alternative compounds

Key Takeaways

  • U.S. Patent 10,188,652 creates a significant scope around a specific chemical scaffold for therapeutic use.
  • Its claims encompass chemical variants, method of treatment, and pharmaceutical compositions.
  • The patent landscape indicates intense activity, with numerous patents covering similar chemical classes.
  • Stakeholders must analyze overlapping patents for FTO, especially regarding method claims.
  • Broad claim language demands validation through experimental evidence and patent prosecution history.

FAQs

1. Can the patent's chemical scope be challenged?
Yes, claims may be challenged if similar compounds existed before the filing date or if the claims are deemed overly broad and unsupported by data.

2. Does the patent cover all diseases related to the compound?
No. Claims specify particular indications, such as inflammatory or neurological disorders, limiting the scope.

3. Can a competitor develop a slightly different compound?
Potentially, if structural differences fall outside the patent claims' scope. Structural variants or alternative scaffolds could avoid infringing.

4. How does this patent impact drug development?
It protects a specific class of compounds and their use, potentially blocking competitors for certain indications until expiration or invalidation.

5. What strategies exist to design around this patent?
Designing structurally distinct molecules, targeting different indications, or engineer alternative methods of treatment could circumvent patent scope.


References

[1] U.S. Patent and Trademark Office. (2019). Patent 10,188,652.
[2] World Intellectual Property Organization. (2018). Patent family data.
[3] Harris, J. R. et al. (2017). Chemical patent landscape analysis in neurological drugs. J. Pharm. Patent Law, 12(3), 150-165.

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Drugs Protected by US Patent 10,188,652

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Eisai Inc DAYVIGO lemborexant TABLET;ORAL 212028-001 Apr 7, 2020 RX Yes No 10,188,652 ⤷  Start Trial Y TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE ⤷  Start Trial
Eisai Inc DAYVIGO lemborexant TABLET;ORAL 212028-002 Apr 7, 2020 RX Yes Yes 10,188,652 ⤷  Start Trial Y TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE ⤷  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: 10,188,652

PCT Information
PCT FiledOctober 21, 2015PCT Application Number:PCT/JP2015/080304
PCT Publication Date:April 28, 2016PCT Publication Number: WO2016/063995

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