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Last Updated: December 22, 2024

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SODIUM POLYSTYRENE SULFONATE - Generic Drug Details


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What are the generic drug sources for sodium polystyrene sulfonate and what is the scope of patent protection?

Sodium polystyrene sulfonate is the generic ingredient in five branded drugs marketed by Kvk Tech, Concordia, Ani Pharms, Belcher, Chartwell Rx, Citrusphrma, Cmp Pharma Inc, Epic Pharma Llc, Nuvo Pharms Inc, Pai Holdings Pharm, Upsher Smith Labs, Hikma, Morton Grove, and Roxane, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for sodium polystyrene sulfonate. Twelve suppliers are listed for this compound.

Summary for SODIUM POLYSTYRENE SULFONATE
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Recent Clinical Trials for SODIUM POLYSTYRENE SULFONATE

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SponsorPhase
University of California, IrvinePhase 4
Tris Pharma, Inc.Phase 4
The Rogosin InstitutePhase 4

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US Patents and Regulatory Information for SODIUM POLYSTYRENE SULFONATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms SODIUM POLYSTYRENE SULFONATE sodium polystyrene sulfonate SUSPENSION;ORAL, RECTAL 090590-001 May 13, 2011 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms KIONEX sodium polystyrene sulfonate SUSPENSION;ORAL, RECTAL 040028-001 Sep 17, 2007 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms KIONEX sodium polystyrene sulfonate POWDER;ORAL, RECTAL 040029-001 Feb 6, 1998 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upsher Smith Labs SODIUM POLYSTYRENE SULFONATE sodium polystyrene sulfonate POWDER;ORAL, RECTAL 090313-001 Dec 21, 2011 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roxane SODIUM POLYSTYRENE SULFONATE sodium polystyrene sulfonate SUSPENSION;ORAL, RECTAL 088453-001 Nov 17, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Belcher SODIUM POLYSTYRENE SULFONATE sodium polystyrene sulfonate POWDER;ORAL, RECTAL 205727-001 Feb 23, 2016 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SODIUM POLYSTYRENE SULFONATE Market Analysis and Financial Projection Experimental

Sodium Polystyrene Sulfonate Market Dynamics and Financial Trajectory

Introduction

Sodium polystyrene sulfonate (SPS) is a medication primarily used to manage and treat hyperkalemia, a condition characterized by elevated potassium levels in the blood. The market for SPS has been experiencing significant growth, driven by various factors. Here, we delve into the market dynamics and financial trajectory of SPS.

Market Size and Forecast

The global sodium polystyrene sulfonate market is anticipated to grow at a compound annual growth rate (CAGR) of 3 to 5 percent from 2023 to 2031. This growth is expected to result in a substantial increase in the market's valuation, which was estimated to be in the millions of USD as of 2023[1][3][4].

Segmentation

The SPS market is segmented based on several key factors:

Application

  • Emulsifier: Used in various industrial processes.
  • Water Treatment Agent: Employed to remove impurities from water.
  • Pharmaceutical: The primary use for treating hyperkalemia.
  • Other: Includes technical applications such as removing excess calcium and sodium from solutions[1][3].

Product Type

  • Industrial Grade: Used in non-pharmaceutical applications.
  • Medical Grade: Specifically designed for pharmaceutical use[1][3].

Geographical Regions

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle-East and Africa Each region contributes to the overall market growth, with varying demand and market dynamics[1][3].

Market Drivers

Several factors are driving the growth of the SPS market:

Increasing Prevalence of Hyperkalemia

Hyperkalemia is a serious condition that can arise from various medical issues, including kidney disease, heart failure, and certain medications. The rising incidence of these underlying conditions is increasing the demand for SPS[5].

Technological Advancements

Improvements in the formulation and delivery of SPS, such as better oral and rectal formulations, are enhancing its efficacy and patient compliance, thereby driving market growth[5].

Expanding Applications

Beyond its primary use in treating hyperkalemia, SPS is being explored for other technical applications, such as water treatment and as an emulsifier, which is broadening its market scope[1][3].

Market Restraints

Despite the growth, there are several challenges facing the SPS market:

Adverse Effects

SPS can cause significant adverse effects, including bowel injury and colitis, which can lead to high mortality rates. The lack of high-quality data on these adverse events makes it challenging to fully assess the risk-benefit profile of the medication[2].

Competition from Alternative Treatments

The emergence of alternative treatments for hyperkalemia, such as patiromer and zirconium cyclosilicate, is posing a competitive threat to SPS. These alternatives may offer faster onset of action or fewer side effects, potentially reducing the market share of SPS[5].

Market Opportunities

There are several opportunities that could further boost the SPS market:

Growing Healthcare Expenditure

Increasing healthcare expenditure globally, particularly in developing regions, is expected to enhance the accessibility and affordability of SPS, leading to higher demand[4].

Research and Development

Ongoing research aimed at improving the safety and efficacy of SPS could lead to new formulations or delivery methods, expanding its market potential. For instance, randomized controlled trials with larger patient cohorts could provide clearer insights into the utility and safety of SPS[2].

Market Challenges

The SPS market faces several challenges that need to be addressed:

Regulatory Scrutiny

Given the potential adverse effects of SPS, regulatory bodies are likely to scrutinize its use closely. Ensuring compliance with regulatory standards will be crucial for market growth[2].

Economic Factors

Economic fluctuations and changes in healthcare policies can impact the affordability and accessibility of SPS, affecting market dynamics[4].

Financial Analysis

The financial trajectory of the SPS market is characterized by:

Revenue Growth

The market is expected to see significant revenue growth, driven by increasing demand and expanding applications. The CAGR of 3 to 5 percent indicates a steady and robust growth pattern[1][3][4].

Regional Performance

Different regions are expected to contribute differently to the overall market growth. For example, the Asia-Pacific region is likely to see rapid growth due to increasing healthcare expenditure and a large patient population[1][3].

Competitive Landscape

The market is competitive, with several key players involved in the production and distribution of SPS. Competitive analysis, including SWOT analysis and Porter's Five Forces analysis, can provide insights into the market positioning of these players[4].

Key Players and Market Share

The SPS market includes several key players, each with a significant market share. These players are involved in continuous research and development to improve the product and expand its applications. Market share analysis and competitor profiling are essential for understanding the competitive landscape[4].

Regional Analysis

The market performance varies across different regions:

North America and Europe

These regions have a well-established healthcare infrastructure and high demand for SPS due to the prevalence of hyperkalemia. However, they also face stringent regulatory environments and high competition from alternative treatments[1][3].

Asia-Pacific

This region is expected to be a high-growth market due to increasing healthcare expenditure, a large patient population, and growing awareness of hyperkalemia treatment options[1][3].

South America and Middle-East and Africa

These regions present opportunities for growth, driven by increasing healthcare investment and expanding access to healthcare services. However, they also face challenges related to affordability and regulatory compliance[1][3].

Consumer Behavior and Economic Landscape

Consumer behavior and economic factors play a crucial role in shaping the SPS market:

Consumer Awareness

Increasing awareness about hyperkalemia and its treatment options is driving demand for SPS. Patient education programs and healthcare provider recommendations are key factors influencing consumer behavior[5].

Economic Factors

Changes in healthcare policies, economic fluctuations, and insurance coverage can significantly impact the affordability and accessibility of SPS, affecting market dynamics[4].

Technological Trends

Technological advancements are crucial for the growth of the SPS market:

Improved Formulations

Research into better oral and rectal formulations of SPS is ongoing, aiming to enhance efficacy and reduce side effects. These advancements can improve patient compliance and overall market performance[5].

Alternative Delivery Methods

Exploring alternative delivery methods, such as oral suspensions or capsules, could expand the market by offering more convenient treatment options[5].

SWOT Analysis

A SWOT analysis provides a comprehensive view of the market's strengths, weaknesses, opportunities, and threats:

Strengths

  • Established use in treating hyperkalemia.
  • Expanding applications beyond pharmaceutical use.
  • Growing demand driven by increasing prevalence of hyperkalemia.

Weaknesses

  • Potential for adverse effects such as bowel injury and colitis.
  • Competition from alternative treatments.
  • Regulatory scrutiny due to safety concerns.

Opportunities

  • Growing healthcare expenditure globally.
  • Ongoing research and development to improve safety and efficacy.
  • Expanding into new geographical regions.

Threats

  • Economic fluctuations and changes in healthcare policies.
  • Regulatory challenges and compliance issues.
  • Emergence of new competitors and alternative treatments[4].

PESTEL Analysis

A PESTEL analysis helps in understanding the broader environmental factors affecting the market:

Political

  • Healthcare policies and regulations impact the market.
  • Government initiatives to improve healthcare infrastructure can boost demand.

Economic

  • Economic fluctuations affect healthcare expenditure and affordability.
  • Changes in insurance coverage can impact market dynamics.

Social

  • Increasing awareness about hyperkalemia drives demand.
  • Patient education programs influence consumer behavior.

Technological

  • Advancements in formulations and delivery methods enhance market growth.
  • Research into new applications expands market potential.

Environmental

  • Environmental factors are less directly impactful but can influence raw material availability and production costs.

Legal

  • Regulatory compliance is crucial for market growth.
  • Legal challenges related to safety concerns can affect market dynamics[4].

Key Takeaways

  • The sodium polystyrene sulfonate market is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031.
  • The market is driven by increasing demand for hyperkalemia treatment, technological advancements, and expanding applications.
  • Adverse effects and competition from alternative treatments are significant challenges.
  • Regional performance varies, with the Asia-Pacific region expected to see rapid growth.
  • Continuous research and development are essential for improving safety and efficacy.

FAQs

What is the primary use of sodium polystyrene sulfonate?

Sodium polystyrene sulfonate (SPS) is primarily used to treat hyperkalemia, a condition characterized by elevated potassium levels in the blood[5].

What are the potential adverse effects of sodium polystyrene sulfonate?

SPS can cause significant adverse effects, including bowel injury and colitis, which can lead to high mortality rates[2].

How does sodium polystyrene sulfonate work?

SPS is an insoluble polymer cation-exchange resin that exchanges sodium with potassium ions from the intestinal cells, leading to the elimination of potassium in the feces[5].

What are the market segments for sodium polystyrene sulfonate?

The market is segmented based on application (emulsifier, water treatment agent, pharmaceutical, other), product type (industrial grade, medical grade), and geographical regions[1][3].

What are the key drivers of the sodium polystyrene sulfonate market?

Key drivers include the increasing prevalence of hyperkalemia, technological advancements, and expanding applications beyond pharmaceutical use[1][3][5].

Sources

  1. Market Research Intellect. Global Sodium Polystyrene Sulfonate Market Size and Forecast. November 2024.
  2. World Journal of Gastroenterology. Comprehensive analysis of sodium polystyrene sulfonate-induced colitis. December 2023.
  3. Market Research Intellect. Global Sodium Polystyrene Sulfonate Market Size And Forecast 2. November 2024.
  4. Cognitive Market Research. Global Sodium Polystyrene Sulfonate Market Report 2024 Edition. 2024.
  5. NCBI Bookshelf. Sodium Polystyrene Sulfonate - StatPearls. July 2023.

More… ↓

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