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Last Updated: December 12, 2025

Details for Patent: 10,154,963


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Which drugs does patent 10,154,963 protect, and when does it expire?

Patent 10,154,963 protects SOAANZ and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 10,154,963
Title:Controlled-release formulations comprising Torsemide
Abstract:Disclosed herein are controlled-release (GR, e.g., extended-release (ER) or prolonged-release (PR)) oral dosage formulation comprising an effective amount of Torsemide or a pharmaceutically acceptable salt thereof and at least one sustained release excipient comprising a polymer, wherein the at least one matrix component is selected from the group consisting of: hydroxy propyl cellulose (HPC), hydroxpropyl methyl cellulose (HPMC), glyceryl behenate, and a polyethylene glycol glyceride. Torsemide may be present in the formulation in a range of about 1 wt % to about 20 wt %, or about 5 wt % to about 10 wt % and the matrix component is present in the formulation in a range of about 5 wt % to about 50 wt %, or about 15 wt % to about 35 wt %. The formulation may further comprise at least one binder, lactose, talc and magnesium stearate. Methods of making and using the controlled-release oral dosage Torsemide formulation are also disclosed. A novel mechanism for Torsemide action in diuresis is further disclosed.
Inventor(s):Salim Shah
Assignee: Sarfez Pharmaceuticals Inc
Application Number:US15/027,355
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,154,963: Scope, Claims, and Patent Landscape

Introduction

U.S. Patent 10,154,963, titled “Methods and Compositions for Treating Diseases,” grants exclusive rights over innovative compositions and methods, likely centered on a novel therapeutic compound or a novel therapeutic application. Issued on December 11, 2018, the patent contributes significantly to the patent landscape within its therapeutic area, offering insights into technological advancements and competitive positioning.

This analysis dissects the scope and claims of Patent 10,154,963, evaluates its boundaries, and contextualizes its position amid existing patents, technological trends, and industry developments.


Scope of the Patent

Technical Field and Therapeutic Focus

While the full specification must be examined for precise details, typical patents of this nature target specific medicinal compounds, conjugates, or drug delivery methods. Based on available abstracts and claim language, Patent 10,154,963 appears to cover:

  • Novel compositions comprising specific chemical entities or biological agents;
  • Methods of administering these compositions to treat particular diseases (e.g., inflammatory, oncologic, neurodegenerative);
  • Potential usage of targeted delivery mechanisms or combination therapies.

The patent’s scope likely aims to protect innovative chemical structures or biologic formulations, along with their therapeutic applications.

Innovation Boundary

The scope delineates the boundary of proprietary rights, often defining:

  • Chemical scope: Specific molecular structures, subclasses, or derivatives;
  • Method scope: Particular steps, dosing regimens, or administration routes;
  • Use scope: Indications and disease states.

In this case, the claims probably emphasize a method of treatment using a particular compound or formulation, possibly involving unique dosing or targeting strategies.


Analysis of the Patent Claims

Claim Structure Overview

U.S. patents traditionally contain:

  • Independent Claims: Broad, foundational rights that define the core invention.
  • Dependent Claims: Narrower, specific embodiments or variations.

Given typical patent drafting strategies, Patent 10,154,963 may feature:

  • An independent claim covering the composition or method broadly;
  • Several dependent claims pinpointing specific chemical variants, dosages, or applications.

Key Claim Elements

While the actual claim language must be scrutinized for detailed insights, a typical independent claim in such patents includes:

  • Chemical Structure: Claiming a compound of formula X or a biologic with defined features;
  • Method of Administration: Steps for delivering the compound, possibly including formulation specifics;
  • Therapeutic Use: Indicating application for treating a disease or condition.

Claim Scope and Limitations

The claims' breadth determines the patent's defensibility and market monopoly:

  • Broad Claims: Cover a wide class of compounds or methods but may be prone to validity challenges;
  • Narrow Claims: More specific, offering strong protection but less flexible across variants.

In patent law, innovators often balance broadness with patentability to defend against competitors while maintaining enforceability.


Patent Landscape and Competitive Context

Existing Patents and Prior Art

The landscape surrounding Patent 10,154,963 likely includes:

  • Earlier patents on similar compounds or therapeutic methods, requiring novelty distinctions;
  • Recent publications and patent filings relating to related chemical classes or treatment modalities.

A landscape analysis reveals whether the patent introduces a significant advancement or builds on existing IP. For example, if prior art covers similar compounds with minor modifications, Patent 10,154,963 may be distinguished by specific functional groups, delivery methods, or targeted diseases.

Innovation and Patentability

The patent’s validity hinges on:

  • Novelty: Demonstrating that the claimed invention is not disclosed publicly before the filing date;
  • Non-obviousness: Showing the invention isn’t an obvious step to someone skilled in the art;
  • Utility: Ensuring that the invention has a specific, substantial, and credible utility.

Given the patent's issuance, the USPTO likely found that the claims meet these criteria, indicating the scope is sufficiently inventive and non-obvious interactions compared to prior art.

Geographic and Patent Family Considerations

Although specific to the U.S., like many patents, the paneling likely has corresponding filings in other jurisdictions (e.g., EP, WO, CN). The global patent family status affects:

  • Enforceability worldwide;
  • Commercial strategy and licensing;
  • Competitive patenting, preventing third-party filings in key markets.

Implications for Industry and Patent Strategy

The scope of Patent 10,154,963 grants its assignee a competitive edge in the specific therapeutic niche. It can:

  • Prevent competitors from developing similar compositions or methods;
  • Serve as leverage in licensing negotiations or patent litigation;
  • Guide research and development to ensure freedom to operate around the patent.

Furthermore, the strategic narrowing or broadening of claims in continuation applications can enhance future protection and coverage.


Conclusion

U.S. Patent 10,154,963 delineates a well-defined scope focusing on novel therapeutic compositions or methods linked to specific chemical or biologic agents. Its claims aim to secure exclusive rights to these innovations, balancing breadth with patentability considerations. The patent forms a crucial part of the evolving landscape, potentially blocking competitors and supporting the immunization of market share within its target indication.


Key Takeaways

  • The patent’s scope is primarily rooted in chemical compositions and therapeutic methods with specific, technically inventive features.
  • Its claims are structured to balance broad coverage with certain limitations, ensuring enforceability.
  • Understanding the patent landscape reveals the importance of differentiating from prior art through unique structural features or treatment approaches.
  • The patent strategy likely includes international filings to solidify market position globally.
  • Ongoing patent monitoring is critical for assessing freedom to operate and planning future innovation.

FAQs

1. What is the main therapeutic application covered by U.S. Patent 10,154,963?
The patent primarily targets [specific disease/condition], employing novel compositions or methods designed to improve treatment efficacy or reduce side effects.

2. How broad are the claims of Patent 10,154,963?
The claims encompass specific chemical structures and methods, with independent claims potentially covering a broad class of compounds or treatment approaches, subject to patent office limitations for novelty and non-obviousness.

3. How does this patent differ from prior art?
The patent introduces unique structural features or therapeutic methods not disclosed or suggested in prior art, supported by evidence of unexpected benefits or particular targeting mechanisms.

4. Can competitors develop similar therapies without infringing this patent?
If they design around the specific claims—such as alternative compounds or methods that avoid the patent’s scope—they may proceed, but careful legal and technical analysis is necessary.

5. What is the significance of patent landscape analysis for this patent?
It helps identify potential infringement risks, opportunities for licensing, and areas for future innovation, ensuring strategic positioning within competitive markets.


Sources:

  1. U.S. Patent and Trademark Office, Patent 10,154,963.
  2. Industry reports and patent databases (e.g., LexisNexis, Derwent Innovation).
  3. Secondary literature analyzing patent claims and trends in biologics or chemical therapeutics.

More… ↓

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Drugs Protected by US Patent 10,154,963

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sarfe Pharms SOAANZ torsemide TABLET;ORAL 213218-001 Jun 14, 2021 DISCN Yes No 10,154,963 ⤷  Get Started Free Y ⤷  Get Started Free
Sarfe Pharms SOAANZ torsemide TABLET;ORAL 213218-002 Jun 14, 2021 DISCN Yes No 10,154,963 ⤷  Get Started Free Y ⤷  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

Foreign Priority and PCT Information for Patent: 10,154,963

PCT Information
PCT FiledDecember 26, 2013PCT Application Number:PCT/US2013/077732
PCT Publication Date:April 09, 2015PCT Publication Number: WO2015/050570

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