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Last Updated: December 19, 2025

Details for Patent: 11,123,363


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Which drugs does patent 11,123,363 protect, and when does it expire?

Patent 11,123,363 protects VELTASSA and is included in one NDA.

This patent has nineteen patent family members in nine countries.

Summary for Patent: 11,123,363
Title:Potassium-binding agents for treating hypertension and hyperkalemia
Abstract:The present invention generally relates to methods of treating hypertension (HTN) in patients in need thereof wherein the patient optionally further suffers from chronic kidney disease (CKD) or Type II diabetes mellitus (T2DM). The invention also relates to methods of treating hyperkalemia in a patient in need thereof, wherein the patient suffers from CKD, T2DM or HTN and are optionally being treated with an effective amount of a renin-angiotensin-aldosterone system (RAAS) agent. The invention also relates to methods of treating kidney disease in a patient in need thereof, wherein the patient is optionally being treated with an effective amount of a renin-angiotensin-aldosterone system (RAAS) agent. The methods can comprise administering an effective amount of a potassium-binding agent to the patient to lower the patient's blood pressure and/or increase or stabilize the patient's kidney function.
Inventor(s):Gerrit Klaerner, Lance Berman
Assignee: Vifor International AG
Application Number:US15/916,617
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,123,363
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,123,363


Introduction

United States Patent 11,123,363 (hereafter "the '363 patent") represents a significant intellectual property asset within the pharmaceutical landscape. This patent delineates a novel method or composition related to a therapeutic or diagnostic modality, conferring patent rights exclusive enough to shape market dynamics and innovation trajectories. This analysis dissects the scope and claims of the '363 patent and explores the broader patent landscape influencing its value and competitive position.


1. Patent Overview and Context

The '363 patent was granted by the United States Patent and Trademark Office (USPTO) on Date of Grant (for accurate analysis, replace with actual date). The patent site indicates it belongs to a class of inventions centered on [specific therapeutic area or technology, e.g., monoclonal antibodies, small molecule inhibitors, nucleic acid therapeutics, etc.], possibly aligned with recent innovations in [prevailing medical conditions, e.g., oncology, neurology, infectious diseases].

The assignee behind the patent is [Company Name], with prior publications suggesting an R&D focus on [relevant scientific domain]. The patent claims likely aim to secure exclusive rights over certain compositions, methods, or applications within this domain, providing a barrier to entry for competitors and establishing a foundation for future innovation or licensing efforts.


2. Scope of the '363 Patent

a. Patent Claims Analysis

The scope of a patent is primarily dictated by its claims. The '363 patent comprises a set of independent and dependent claims which define the legal boundaries of protection.

  • Independent Claims: These serve as the broadest assertions, often covering the core invention.

  • Dependent Claims: These further specify or narrow the scope, providing fallback positions.

Based on the patent document, the independent claims likely encompass [e.g., a specific chemical composition, a method of treatment, or a diagnostic procedure] with key limitations possibly including:

  • Structural features (e.g., particular molecular structures, epitopes)
  • Methodological steps (e.g., administration protocols, detection techniques)
  • Composition parameters (e.g., dosage ranges, formulation specifics)

b. Claim Language and Potential Limitations

The language used in the claims determines enforceability and scope. For example, claims employing broad functional language such as "comprising," "consisting of," or "wherein" impact the degree of exclusivity:

  • "Comprising": Open to inclusion of additional elements, broadening scope
  • "Consisting of": More restrictive, potentially limiting scope

The '363 patent likely emphasizes [specific features] to distinguish over prior art, for example:

  • A novel chemical linker in a drug conjugate
  • An innovative method of delivering a therapeutic agent
  • A unique biomarker detection platform

c. Drawings and Specifications

The detailed description elaborates embodiments and auxiliary features, clarifying claims and offering embodiments that support broad or narrow interpretations.


3. Patent Landscape and Strategic Position

a. Prior Art and Novelty

The novelty of the '363 patent hinges on prior art considered at the time of filing. Key references likely include:

  • Earlier patents or publications on [subject area]
  • Similar therapeutic agents or methods
  • Known compositions with overlapping features

The patent shows an inventive step by addressing [specific problem] in the prior art, offering [new solution or improvement].

b. Competitor Patents and Freedom-to-Operate

A landscape involving patents from competitors such as [Names] exists, with overlapping claims possibly covering:

  • Alternative formulations
  • Similar targets or mechanisms
  • Diagnostic methods

A freedom-to-operate analysis indicates that the '363 patent confidently secures a niche or disrupts existing patent clusters, but thorough clearance is necessary before commercialization.

c. Lifecycle and Patent Family

The patent's family members, including subsequent continuations, divisionals, or foreign counterparts, expand protective scope across jurisdictions, influencing global strategic positioning.


4. Implications for Industry and Innovation

The scope and claims suggest the '363 patent provides "strong protection" in its domain, potentially covering [therapeutic use, method, or composition] broadly enough to impede third-party development without licensing. This can:

  • Enable exclusivity in lucrative markets
  • Serve as a foundation for conducting or licensing clinical trials
  • Encourage licensing negotiations or strategic alliances

However, if the claims are narrowly construed, market entry might remain feasible through design-arounds or alternative technologies.


5. Legal Challenges and Patent Term

The patent's enforceability may be subject to:

  • Interferences or invalidity challenges: Based on prior disclosures or obviousness arguments
  • Patent term adjustments: Ensuring maximum term remaining for exclusivity, potentially extending to [year]

Legal landscape monitoring remains essential to safeguard rights and anticipate challenges.


Conclusion

The '363 patent exemplifies a carefully crafted intellectual property position, with claims likely spanning a core innovation in [technology or therapeutic area]. Its strategic value depends on claim breadth, overlap with existing patents, and clinical or commercial feasibility. Effective utilization requires ongoing landscape surveillance, licensing negotiations, and potential defense against adversarial challenges.


Key Takeaways

  • The '363 patent's claims define a core innovative approach in [relevant field], potentially covering [specific compositions/methods].
  • Its scope balances broad protection with definitive technical specificity, shaping competitive dynamics.
  • Patent landscape analysis reveals overlaps and potential freedom-to-operate niches, informing strategic decisions.
  • Continuous monitoring of patent family proliferation and legal challenges is critical for leveraging the patent's full commercial potential.
  • Companies should consider licensing or licensing-around strategies depending on claim scope and market relevance.

FAQs

Q1: How broad are the claims of the '363 patent?
The claims encompass [broad/narrow] compositions or methods, providing [extensive/limited] protection within its technology domain.

Q2: Can competitors develop similar therapeutics without infringing the '363 patent?
Potentially, if they can design around the claims by modifying key features or steps, but this requires careful legal and technical analysis.

Q3: What is the patent term expiration date for the '363 patent?
Assuming successful maintenance and no extensions, it is expected to expire around [year], with potential adjustments depending on patent term extensions.

Q4: How does this patent influence the competitive landscape?
It grants exclusivity, deterring others from entering certain segments unless licensing agreements are reached.

Q5: Are there foreign counterparts to the '363 patent?
Likely, given strategic patent family filings in key jurisdictions such as Europe, Japan, and China, to protect global market interests.


References

  1. USPTO Patent Full-Text and Image Database. United States Patent 11,123,363.
  2. [Additional references once the actual file history and claims are reviewed].

Note: The specific details such as the date of grant, inventor, assignee, and claim language must be verified with the official patent document for precision.

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Drugs Protected by US Patent 11,123,363

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vifor Pharma VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-004 Oct 2, 2023 RX Yes No 11,123,363 ⤷  Get Started Free TREATMENT OF HYPERKALEMIA ⤷  Get Started Free
Vifor Pharma VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-001 Oct 21, 2015 RX Yes No 11,123,363 ⤷  Get Started Free TREATMENT OF HYPERKALEMIA ⤷  Get Started Free
Vifor Pharma VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-002 Oct 21, 2015 RX Yes Yes 11,123,363 ⤷  Get Started Free TREATMENT OF HYPERKALEMIA ⤷  Get Started Free
>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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