You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 14, 2025

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for magnesium sulfate; potassium chloride; sodium sulfate and what is the scope of freedom to operate?

Magnesium sulfate; potassium chloride; sodium sulfate is the generic ingredient in one branded drug marketed by Braintree Labs and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE
Generic Entry Date for MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assiut UniversityPHASE3
Cairo UniversityPHASE4
Assiut UniversityPHASE4

See all MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE clinical trials

Paragraph IV (Patent) Challenges for MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUTAB Tablets magnesium sulfate; potassium chloride; sodium sulfate 1.479 g/0.225 g/ 0.188 g 213135 1 2023-03-03

US Patents and Regulatory Information for MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Braintree Labs SUTAB magnesium sulfate; potassium chloride; sodium sulfate TABLET;ORAL 213135-001 Nov 10, 2020 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Braintree Labs SUTAB magnesium sulfate; potassium chloride; sodium sulfate TABLET;ORAL 213135-001 Nov 10, 2020 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Braintree Labs SUTAB magnesium sulfate; potassium chloride; sodium sulfate TABLET;ORAL 213135-001 Nov 10, 2020 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Braintree Labs SUTAB magnesium sulfate; potassium chloride; sodium sulfate TABLET;ORAL 213135-001 Nov 10, 2020 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Magnesium Sulfate, Potassium Chloride, and Sodium Sulfate

Last updated: July 29, 2025

Introduction

The global pharmaceutical and industrial markets for magnesium sulfate, potassium chloride, and sodium sulfate are characterized by distinct supply-demand drivers, regulatory landscapes, and profitability trajectories. These compounds, though chemically related, serve diverse sectors—ranging from healthcare to agriculture and manufacturing—shaping their respective market dynamics. Analyzing their market forces and financial prospects provides valuable insights for stakeholders aiming to capitalize on emerging opportunities or mitigate risks.

Market Overview and Applications

Magnesium Sulfate

Primarily known as Epsom salt, magnesium sulfate boasts a wide application spectrum including medical therapeutics (e.g., preeclampsia treatment, magnesium deficiency correction), agricultural fertilizer, and industrial uses (textile processing, paper manufacturing). The pharmaceutical sector dominates demand, especially in hospital settings for intravenous (IV) therapy and obstetrics, with supplemental contributions from industrial sectors.

Potassium Chloride

Predominantly utilized as a fertilizer (about 95% of its market share), potassium chloride is essential for crop yield enhancement and is critical for global food security. It also finds applications in medical IV therapy, as a potassium supplement, and in industrial processes such as brine production. The expanding global population, advances in modern agriculture, and infrastructure projects support the rising demand.

Sodium Sulfate

Mainly used in the manufacture of detergents, paper products, and in chemical synthesis, sodium sulfate's application scope ranges from industrial manufacturing to pharmaceutical excipients. Its bulk demand correlates strongly with the chemical and detergent industries' growth, notably in emerging economies.

Market Dynamics

Supply Chain and Production Trends

Magnesium Sulfate:
Major producers include China, India, and the United States. China remains the dominant supplier, supported by expansive natural mineral deposits and established manufacturing capacity. Recent capacity expansions and technological advancements in extraction and processing have driven supply increases, often leading to competitive pricing.

Potassium Chloride:
The global supply hinges on large potash reserves in Canada, Russia, Belarus, and Jacmel (Israel). Market consolidation through mergers (e.g., Nutrien's acquisitions) has reduced price volatility, although geopolitical tensions—particularly in Eastern Europe—pose procurement risks.

Sodium Sulfate:
Producers are predominantly in China, India, and Europe. The availability of sodium sulfate as a byproduct of chemical manufacturing and desalination has provided supply flexibility, but environmental regulations influence production costs and capacity planning.

Demand Drivers

Magnesium Sulfate:

  • Medical demand persists due to its proven efficacy and safety profile.
  • Rising awareness of its therapeutic benefits sustains hospital procurement, especially in developing countries.
  • Industrial demand grows modestly, buoyed by expanding manufacturing sectors.

Potassium Chloride:

  • Agricultural sector is the primary driver, with global fertilizer consumption increasing at a compound annual growth rate (CAGR) of around 3-4%.
  • Climate change impacts and food security initiatives bolster demand.
  • Industrial applications are relatively stable but sensitive to macroeconomic fluctuations.

Sodium Sulfate:

  • Growth correlates with industrial output, especially in emerging economies investing in chemical and detergent industries.
  • Environmental regulations and shifts toward eco-friendly products could constrain future expansion.

Regulatory Environment

Magnesium Sulfate:
Highly regulated due to its pharmaceutical applications. The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) enforce strict standards on manufacturing practices, quality, and labeling. These regulations influence market entry and pricing.

Potassium Chloride:
Subject to agricultural input regulations and international trade policies. Export restrictions, tariffs, and sanctions, notably in Russia and Belarus, can influence availability and prices.

Sodium Sulfate:
Primarily affected by chemical manufacturing regulations and environmental standards. Compliance costs impact production economics, especially in regions with stringent environmental policies.

Financial Trajectory and Market Forecasts

Market Size and Growth Projections

  • Magnesium Sulfate:
    The global market size was valued at approximately USD 1 billion in 2022, with forecasts indicating a CAGR of 4-5% through 2030, driven by expanding healthcare infrastructure in emerging economies and ongoing demand in industrial applications.

  • Potassium Chloride:
    Estimated at USD 15 billion in 2022, the market is projected to grow at a CAGR of 3-4%, propelled by sustained agricultural demand and technological innovations in fertilizer formulations.

  • Sodium Sulfate:
    Market size roughly USD 1.5 billion; anticipated to grow at a CAGR of 2-3%, influenced by steady industrial consumption and the expansion of chemical manufacturing capacities.

Profitability and Investment Trends

Magnesium Sulfate:
Due to high raw material availability and established manufacturing processes, profit margins for pharmaceutical-grade magnesium sulfate remain moderate (around 10-15%). The focus on quality standards and regulatory compliance necessitates ongoing capital expenditure. The recent demand surge in developing regions presents lucrative expansion opportunities.

Potassium Chloride:
Favorable market prices and economies of scale contribute to relatively high profit margins (up to 20%). However, price sensitivity and geopolitical risks can cause revenue volatility. Investment in capacity expansion and supply chain resilience forms a core strategy for leading producers.

Sodium Sulfate:
Margins tend to be lower (around 8-12%), constrained by intense competition and commoditized markets. Innovations in application fields and valorization as a byproduct are key to improving financial performance.

Emerging Trends Impacting Financial Trajectory

  • Innovation & Product Diversification: The development of specialty-grade potassium-based fertilizers and pharmaceutical-grade magnesium sulfate enhances revenue streams. For example, targeted formulations for precision agriculture or injectable therapeutic preparations command premium pricing.

  • Sustainability and Circular Economy: Adoption of environmentally friendly extraction and processing methods, coupled with waste valorization, influence cost structures and investor perceptions.

  • Supply Chain Resilience: Geopolitical tensions, trade tariffs, and transportation disruptions necessitate strategic stockpiling and diversification of supply sources, affecting procurement costs and profitability.

  • Regulatory Changes: Stricter pharmaceutical manufacturing standards could elevate qualification hurdles but also enable premium pricing for compliant products.

Investment Outlook

Investors should monitor capacity expansions in key producing regions, technological innovations that improve efficiency, and evolving regulatory standards. Companies diversifying their application portfolios, integrating sustainable practices, and establishing resilient supply chains are positioned for superior financial performance.

Conclusion and Key Takeaways

  • Diverse Applications Drive Market Stability: While magnesium sulfate's mainstay remains healthcare, potassium chloride's dominance in agriculture and sodium sulfate's industrial uses impart different resilience profiles.

  • Supply-Driven by Geopolitics and Resources: China's leadership in magnesium sulfate production, Canada's and Russia's dominance in potassium chloride, and China and India in sodium sulfate underscore regional dependencies influencing global markets.

  • Regulatory and Environmental Factors Are Critical: Compliance costs and environmental regulations significantly shape manufacturing economics and entry barriers, especially in the pharmaceutical and chemical sectors.

  • Steady Growth Prospects: Forecasts indicate modest but consistent growth over the next decade, with opportunities centered on technological innovation, market diversification, and sustainability initiatives.

  • Strategic Positioning Is Essential: Companies capable of navigating geopolitical risks, investing in supply chain resilience, and aligning with environmental standards will likely outperform.

FAQs

1. How does geopolitical tension influence the potassium chloride market?
Geopolitical tensions, particularly involving major producers like Russia and Belarus, can disrupt supply chains, causing price volatility and prompting buyers to seek alternative sources or stockpile reserves.

2. What regulatory hurdles affect the pharmaceutical use of magnesium sulfate?
Strict manufacturing standards mandated by agencies like the FDA and EMA require rigorous quality control, high purity levels, and compliance documentation, potentially raising entry barriers but ensuring safety and enabling premium pricing.

3. Is sodium sulfate a sustainable choice for industrial manufacturing?
Its sustainability depends on the sourcing method. Production as a byproduct of chemical processes or desalination can reduce environmental impact, but traditional mining practices may face stricter regulations.

4. What are the major growth drivers for magnesium sulfate in emerging markets?
Growing healthcare infrastructure, increased awareness of its therapeutic benefits, and expanding industrial use cases contribute to rising demand, especially in Asia and Africa.

5. How does innovation impact profitability in these compounds markets?
Technological advancements, such as more efficient extraction methods and the development of specialty-grade products, can command higher prices and expand application scopes, thereby driving profitability.


References

[1] Markets and Markets. "Magnesium Sulfate Market." 2023.
[2] Fortune Business Insights. "Potassium Chloride Market Size & Trends." 2022.
[3] Grand View Research. "Sodium Sulfate Industry Analysis." 2023.
[4] International Fertilizer Association. "Fertilizer Market Reports." 2022.
[5] U.S. Food and Drug Administration. "Regulations for Pharmaceutical Magnesium Sulfate." 2023.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.