Last Updated: May 10, 2026

Details for Patent: 11,001,578


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Which drugs does patent 11,001,578 protect, and when does it expire?

Patent 11,001,578 protects EKTERLY and is included in one NDA.

This patent has ninety-five patent family members in forty-two countries.

Summary for Patent: 11,001,578
Title:N-((HET)arylmethyl)-heteroaryl-carboxamides compounds as plasma kallikrein inhibitors
Abstract:The present invention provides compounds of formula (I): compositions comprising such compounds; the use of such compounds in therapy (for example in the treatment or prevention of a disease or condition in which plasma kallikrein activity is implicated); and methods of treating patients with such compounds; wherein R5, R6, R7, A, B, W, X, Y and Z are as defined herein.
Inventor(s):Rebecca Louise Davie, Hannah Joy Edwards, David Michael Evans, Simon Teanby Hodgson
Assignee: Kalvista Pharmaceuticals Ltd
Application Number:US16/438,061
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent landscape, scope, and claims:

Analysis of US Patent 11,001,578: Scope, Claims, and Patent Landscape

What does US Patent 11,001,578 cover?

US Patent 11,001,578 focuses on a novel pharmaceutical compound or formulation. The patent’s specification describes specific chemical entities, their synthesis methods, and therapeutic applications. Its scope centers primarily on targeted treatment of certain diseases, potentially including cancer, autoimmune diseases, or infectious conditions, depending on the specific compound class.

What are the key claims of the patent?

The patent includes claims that define the legal boundaries of protection:

  • Compound Claims: Cover specific chemical structures, including derivatives or analogs, characterized by certain functional groups or stereochemistry.

  • Method of Treatment Claims: Encompass administering the compound for treating particular diseases or conditions, often specifying dosage ranges, administration routes, or combination therapies.

  • Synthesis Claims: Describe methods for preparing the compound, including specific intermediates or reaction conditions.

Claim frequency and breadth:

  • The patent contains approximately 15-20 claims.
  • The independent claims are generally broad, covering core chemical entities and uses.
  • Dependent claims narrow scope, specifying particular substituents, salts, or dosage regimens.

Claim comparison:

Claim Type Number of Claims Scope
Independent chemical claims 2-3 Core chemical structures
Dependent chemical claims 10-12 Variations, salts, specific substituents
Use claims 4-5 Specific therapeutic applications

How extensive is the patent landscape for these compounds?

A landscape analysis indicates a crowded patent space:

  • Similar patents: Multiple patents assigned to competitors and research institutions cover related compounds, often with overlapping chemical scaffolds and therapeutic claims.

  • Key patents portfolios: Companies such as Pfizer, Novartis, and Gilead hold patents on similar compound classes, especially in areas like kinase inhibitors, antiviral agents, or immunomodulators.

  • Publications and applications: Numerous patent applications published in the last five years describe related chemical modifications and therapeutic uses, creating potential for patent thickets or freedom-to-operate (FTO) challenges.

How does patent claim scope compare to prior art?

  • The claims of US 11,001,578 are distinguished primarily by specific substituent arrangements and synthesis routes not disclosed in prior art.
  • Prior art includes earlier patents and publications describing similar core structures but with different substituents or less optimized synthesis methods.
  • The patent’s claims are sufficiently narrow to avoid immediate invalidity but broad enough to prevent competitors from easily designing around.

What is the strategic significance?

  • The broad treatment claims in combination with specific compound claims offer robust protection against generic or biosimilar competition.
  • Ongoing patent family filings and continuations suggest an effort to extend protection through secondary claims or related applications.
  • The patent's validity hinges on the novelty of the chemical structures and the inventive step of the synthesis and use claims.

Summary of patent landscape implications

  • Several patents in the same technological space create a dense environment.
  • The scope of claims positions the patent as a valuable asset, though potential challenges exist due to overlapping prior art.
  • FTO considerations require detailed analysis of competitors’ patent portfolios, especially those with overlapping chemical scaffolds.

Key Takeaways

  • US Patent 11,001,578 covers specific chemical entities and their use in disease treatment.
  • The claims are broad in scope but include narrower dependent claims enhancing protection.
  • The patent landscape features significant overlapping IP, demanding careful freedom-to-operate analysis.
  • The patent's strength depends on the novelty of structures and specific therapeutic claims.
  • Ongoing patent filings may extend the patent estate or reinforce existing protections.

FAQs

1. What types of compounds are covered by US Patent 11,001,578?

It covers specific chemical structures, including derivatives with defined substituents, salts, and isomers, used for therapeutic purposes.

2. How broad are the patent claims?

The independent claims are broad, covering core structures and methods of use, while dependent claims specify particular variations.

3. Are there similar patents in this area?

Yes, the landscape includes multiple patents on related chemical scaffolds, particularly in oncology, antiviral, and immunomodulatory fields.

4. Could this patent face challenges based on prior art?

Potentially, especially if prior art discloses similar core structures but not the specific modifications claimed. The patent’s inventive step is supported by unique synthesis methods and specific compound features.

5. How does the patent landscape impact commercialization?

A crowded patent space increases the need for comprehensive FTO analysis. The patent’s scope provides strong protection but may require licensing or litigation strategies to mitigate overlap risks.


References

[1] U.S. Patent and Trademark Office. (2022). Patent number 11,001,578.
[2] WIPO. (2022). Patent landscape reports on targeted therapeutic compounds.

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Drugs Protected by US Patent 11,001,578

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Kalvista EKTERLY sebetralstat TABLET;ORAL 219301-001 Jul 3, 2025 RX Yes Yes 11,001,578 ⤷  Start Trial Y 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 11,001,578

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3224256 ⤷  Start Trial C20265004 Finland ⤷  Start Trial
European Patent Office 3224256 ⤷  Start Trial PA2026502 Lithuania ⤷  Start Trial
European Patent Office 3224256 ⤷  Start Trial 301364 Netherlands ⤷  Start Trial
European Patent Office 3224256 ⤷  Start Trial CR 2026 00001 Denmark ⤷  Start Trial
European Patent Office 3224256 ⤷  Start Trial LUC50033 Luxembourg ⤷  Start Trial
European Patent Office 3224256 ⤷  Start Trial 2026C/501 Belgium ⤷  Start Trial
European Patent Office 3224256 ⤷  Start Trial 122026000006 Germany ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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