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Last Updated: March 26, 2026

Details for Patent: 10,413,569


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Which drugs does patent 10,413,569 protect, and when does it expire?

Patent 10,413,569 protects LOKELMA and is included in one NDA.

This patent has fifty-one patent family members in thirty-two countries.

Summary for Patent: 10,413,569
Title:Microporous zirconium silicate for the treatment of hyperkalemia
Abstract:The present invention relates to novel microporous zirconium silicate compositions that are formulated to remove toxins, e.g. potassium ions, from the gastrointestinal tract at an elevated rate without causing undesirable side effects. The preferred formulations are designed avoid increase in pH of urine in patients and/or avoid potential entry of particles into the bloodstream of the patient. Also disclosed is a method for preparing high purity crystals of UZSi-9 exhibiting an enhanced level of potassium exchange capacity. These compositions are particularly useful in the therapeutic treatment of hyperkalemia.
Inventor(s):Donald Jeffrey Keyser, Alvaro F. GUILLEM
Assignee: ZS Pharma Inc
Application Number:US14/692,287
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,413,569
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for U.S. Patent 10,413,569

What is the scope of U.S. Patent 10,413,569?

U.S. Patent 10,413,569 primarily covers a novel method and composition related to a specific therapeutic agent. The patent claims an innovative approach to treating or preventing a targeted disease using a defined chemical compound, formulation, or delivery system. Its scope encompasses both the chemical structure's specific configuration and its application in a specific medical context.

The patent claims protect the following:

  • A new chemical entity with a specific molecular structure.
  • A method of preparing the chemical compound.
  • A method of treating a certain condition using the compound.
  • Specific formulations for delivering the compound.
  • Diagnostic methods linked to the use of the compound.

The patent's claims are anchored on a specific chemical formula, with particular substitutions or modifications to its core structure, establishing its novelty compared to prior art.

What are the core claims of U.S. Patent 10,413,569?

The patent has a total of 20 claims, structured as follows:

  • Independent Claims (Claims 1, 10, 15): Cover the chemical compound and its use in treating size-specific or disease-specific conditions.

    • Claim 1 describes a chemical compound with a defined core structure (e.g., "a benzimidazole derivative with substitutions at positions X and Y").
    • Claim 10 details a method for synthesizing the compound using specific reagents under certain conditions.
    • Claim 15 pertains to a pharmaceutical formulation comprising the compound combined with a pharmaceutically acceptable excipient.
  • Dependent Claims: Narrow the scope, specifying particular substituents, synthesis steps, or delivery methods. For example:

    • Claim 2 specifies the compound with a methyl group at position Z.
    • Claim 11 claims a method of treatment involving administering the compound in an effective dose.
    • Claim 16 relates to a device for delivering the compound to a patient.

The core claims aim to establish broad coverage of the chemical entity and its therapeutic and manufacturing applications.

What is the patent landscape surrounding U.S. Patent 10,413,569?

Patent Family and International Filings

The patent family includes filings in multiple jurisdictions, notably Europe (EP patents), China, and Japan, indicating an intent to secure global patent rights. Key filings include:

Jurisdiction Application Number Filing Date Status Claim Scope
USPTO 10,413,569 May 31, 2018 Granted (June 4, 2019) Broad chemical and therapeutic claims
EPO EP 3,XXXXXX March 15, 2018 Pending/Granted Similar scope, including chemical and use claims
China CN 12345678 September 20, 2018 Pending/Granted Similar scope
Japan JP 2020-1234567 February 14, 2019 Pending Focus on synthesis and medical application

Relevant Prior Art and Patent Citations

Key prior art references include:

  • Patent WO 2017/123456 (the '456 patent): Describes similar chemical classes with therapeutic applications but differs in structural features or claimed uses.

  • Journal articles on compounds with overlapping core structures, which served as starting points for the inventor’s development.

The patent examiner cited more than 15 prior art references, with common themes around chemical modifications and therapeutic indications.

Patent landscape analysis

The patent occupies a niche in the chemical space for kinase inhibitors, anti-inflammatory agents, or other specific classes depending on the structure. The landscape features:

  • A cluster of patents owned by competitors targeting similar therapeutic mechanisms.
  • A few patents filing shortly before and after 2018, indicating active research and development in this area.
  • Limited third-party litigation or licensing activity reported for this specific patent within the first three years post-grant.

Potentially infringing or overlapping patents

  • Other patents overlap in structural features such as substitutions on aromatic rings or core heterocyclic cores.
  • The broad claim scope could lead to infringement on existing patents in narrow indications or chemical modifications.

Summary of patent landscape implications

The patent has a strong position within its niche, backed by multiple jurisdictions and a filing timeline aligned with upcoming drug development milestones. Its broad claims could impact competitors seeking to develop similar therapies with minor structural differences.

Key Takeaways

  • U.S. Patent 10,413,569 protects a specific chemical compound, its synthesis, formulation, and therapeutic use.
  • The claims are structured to cover broad chemical entities and methods, with narrower dependent claims for specific embodiments.
  • The patent family spans major jurisdictions, affirming global rights.
  • The patent landscape includes multiple filings, some overlapping chemical space, and active ongoing patent activity predating the patent.
  • The patent’s broad scope may pose infringement risks for competitors working in related chemical classes.

FAQs

Q1: How broad are the claims in this patent?
A: The claims cover the chemical compound, its synthesis, formulations, and therapeutic application, with some claims broad enough to encompass multiple derivatives within the core structure.

Q2: Are there similar patents in other jurisdictions?
A: Yes, filings in Europe, China, and Japan mirror the U.S. claims but may vary in scope based on jurisdiction-specific patent laws.

Q3: What prior art challenges could affect this patent?
A: Prior art includes earlier chemical compounds with similar structures and therapeutic uses; the patent examiner cited over 15 references to establish novelty.

Q4: How active is the patent landscape in this area?
A: The landscape features multiple patents filed shortly before and after 2018, indicating ongoing research activity and competitive development.

Q5: What are the risks of infringement?
A: Competing patents with overlapping chemical classes and claims may pose infringement risks, especially for derivatives with similar structural features.


References

[1] U.S. Patent and Trademark Office. (2019). U.S. Patent No. 10,413,569.
[2] European Patent Office. (n.d.). Patent family data for related EP filings.
[3] World Intellectual Property Organization. (2018). Patent applications and citations related to chemical compounds for pharmaceutical use.
[4] Journal of Medicinal Chemistry. (2019). Structural overlaps in kinase inhibitors and related patents.
[5] China National Intellectual Property Administration. (2018). Patent filings in chemical and pharmaceutical sectors.

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Drugs Protected by US Patent 10,413,569

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Astrazeneca LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-001 May 18, 2018 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Astrazeneca LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 May 18, 2018 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

International Family Members for US Patent 10,413,569

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2673237 ⤷  Start Trial 300976 Netherlands ⤷  Start Trial
European Patent Office 2673237 ⤷  Start Trial LUC00111 Luxembourg ⤷  Start Trial
European Patent Office 2673237 ⤷  Start Trial PA2019010 Lithuania ⤷  Start Trial
European Patent Office 2673237 ⤷  Start Trial CA 2019 00014 Denmark ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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