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

What are the generic sources for magnesium sulfate; potassium sulfate; sodium sulfate and what is the scope of patent protection?

Magnesium sulfate; potassium sulfate; sodium sulfate is the generic ingredient in three branded drugs marketed by Gator Pharms, Alkem Labs Ltd, Annora Pharma, Bionpharma, Novel Labs Inc, Pai Holdings, Strides Pharma Intl, Taro, and Braintree Labs, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

US Patents:	0
Tradenames:	3
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	10
Clinical Trials:	10
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE
DailyMed Link:	MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE at DailyMed

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

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

Sponsor	Phase
Daewoong Pharmaceutical Co. LTD.	Phase 3
Jinling Hospital, China	N/A
Litholink Corp	Early Phase 1

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

Pharmacology for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Drug Class	Calculi Dissolution Agent Osmotic Laxative Potassium Salt
Mechanism of Action	Magnesium Ion Exchange Activity Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

Anatomical Therapeutic Chemical (ATC) Classes for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

A12CA	Sodium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

A12CC	Magnesium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

V04CC	Tests for bile duct patency
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

Paragraph IV (Patent) Challenges for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUPREP BOWEL PREP KIT	Oral Solution	magnesium sulfate; potassium sulfate; sodium sulfate	17.5 g/3.13 g/1.6 g	022372	1	2010-11-08

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	206431-001	Mar 19, 2024	AA	RX	No	No
Braintree Labs	SUPREP BOWEL PREP KIT	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	022372-001	Aug 5, 2010	AA	RX	Yes	Yes
Strides Pharma Intl	SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	215469-001	Nov 22, 2023	AA	RX	No	No
Pai Holdings	SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	209941-001	Jul 15, 2024	AA	RX	No	No
Novel Labs Inc	SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	202511-001	Feb 23, 2017	AA	RX	No	No
Alkem Labs Ltd	SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	213924-001	Dec 29, 2023	AA	RX	No	No

Expired US Patents for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Braintree Labs	SUPREP BOWEL PREP KIT	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	022372-001	Aug 5, 2010

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

Last updated: July 28, 2025

Introduction

The global landscape for pharmaceutical-grade inorganic salts—namely magnesium sulfate, potassium sulfate, and sodium sulfate—has seen notable shifts driven by emerging healthcare needs, manufacturing advancements, and regulatory changes. These compounds, traditionally utilized in medical, agricultural, and industrial applications, continue to evolve in their market positioning amid a complex web of supply chains, end-market demands, and technological innovations. This article delineates the current market dynamics and forecasts the financial trajectory of these key sulfate compounds.

Market Overview

Magnesium Sulfate

Magnesium sulfate, widely recognized as Epsom salt, has long-standing applications in obstetrics, neurology, and cardiology, primarily for magnesium deficiency, pre-eclampsia, and as a laxative. Its pharmaceutical segment accounts for a significant proportion of global demand, complemented by industrial uses such as cement manufacturing and agriculture.

Potassium Sulfate

Predominantly used as a fertilizer, potassium sulfate supplies essential potassium to crops, especially when chloride-based fertilizers are unsuitable. The compound's importance is accentuated by the growing global agricultural sector, with increasing focus on crop yield optimization and soil health.

Sodium Sulfate

Sodium sulfate serves vital roles in detergent manufacturing, paper pulping, and glass production. Its pharmaceutical use is relatively niche, mainly in electrolyte formulations and certain dermatological preparations.

Market Drivers

Healthcare Sector Expansion

The rising prevalence of conditions like pre-eclampsia, magnesium deficiency, and electrolyte imbalances propels the demand for magnesium sulfate. The expanding healthcare infrastructure in emerging markets further fuels pharmaceutical consumption.

Agricultural Innovation and Demand

The global push for sustainable agriculture and increased crop productivity elevates the need for efficient fertilizers. Potassium sulfate's role as a chloride-free potassium source aligns with environmental regulations and crop-specific needs, ensuring sustained growth.

Industrial and Manufacturing Growth

Sodium sulfate’s utility in manufacturing sectors benefits from global industrial expansion, especially in the textile, detergent, and glass industries. Advancements in manufacturing processes bolster demand and supply chain efficiencies.

Regulatory and Environmental Policies

Stricter environmental standards promote the adoption of sulfate compounds as eco-friendly alternatives in industrial processes, fostering market growth.

Market Challenges

Supply Chain Disruptions

Global logistics issues, customs delays, and raw material shortages—exacerbated by events such as the COVID-19 pandemic—impact production and distribution.

Price Volatility

Fluctuations in raw material costs, especially in sulfur and magnesium minerals, induce price instability, impacting profit margins and market competitiveness.

Environmental and Regulatory Constraints

The environmental footprint of extraction and processing poses regulatory risks. Policies aimed at greener production techniques could necessitate capital investments, influencing financial trajectories.

Financial Trajectory and Market Forecasts

Market Size and Growth Projections

According to industry reports, the global magnesium sulfate market is projected to reach approximately USD 300 million by 2030, growing at a compound annual growth rate (CAGR) of 4.5% from 2023. The agricultural sector dominates its demand, with a growing trend towards medical and industrial uses.

The potassium sulfate market is estimated to expand from USD 1.2 billion in 2023 to over USD 1.8 billion by 2030, at a CAGR of 6.0%. The surge correlates strongly with agricultural innovations and environmental regulations restricting chloride-based fertilizers.

Sodium sulfate’s industrial segment is forecasted to grow modestly, from USD 1.0 billion in 2023 to about USD 1.3 billion in 2030, driven by ongoing expansion in textiles and glass industries, despite environmental scrutiny.

Investment and Revenue Trends

Major producers such as Fosfates, GEO Specialty Chemicals, and Solvay are investing in technology upgrades, sustainable extraction, and diversification of product lines. The integration of automation, digitization, and environmentally compliant manufacturing enhances profit margins and competitive positioning.

Innovations in pharmaceutical formulation, such as controlled-release magnesium sulfate products, are expected to command premium pricing, thereby boosting revenue streams. Conversely, price pressures from emerging suppliers and commoditization could temper profit growth.

Emerging Markets and Regional Dynamics

Emerging economies in Asia-Pacific, Africa, and Latin America are increasingly significant consumers. Government policies promoting rural development, healthcare infrastructure, and sustainable agriculture amplify regional market growth prospects. Market entries by multinational firms are facilitated by favorable regulatory environments and cost-effective manufacturing bases.

Risks to Financial Growth

Market expansion remains susceptible to geopolitical tensions, tariffs, and raw material access issues. Additionally, shifts in environmental policies could impose compliance costs, impacting cash flows and investment returns.

Key Market Players

Leading companies include:

• Fosfates (India)
• GEO Specialty Chemicals (USA)
• Solvay (Belgium)
• Tessenderlo Group (Belgium)
• Nippon Shokubai (Japan)

Strategic mergers, acquisitions, and capacity expansions by these players exemplify the competitive intensification within the sulfate compound market.

Concluding Insights

The market for magnesium sulfate, potassium sulfate, and sodium sulfate is poised for steady growth, driven by healthcare needs, agricultural productivity demands, and industrial expansion. However, the trajectory will depend significantly on raw material availability, regulatory landscapes, and technological innovations aimed at sustainability. Companies that adapt to these dynamics—through investment in R&D, sustainable practices, and regional expansion—will enhance their market positioning and financial performance.

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Key Takeaways

• The magnesium sulfate market is expected to grow at a CAGR of 4.5%, driven by medical and industrial applications, with emerging markets playing an increasingly vital role.
• Potassium sulfate’s rapid 6.0% CAGR underscores its importance as an eco-friendly fertilizer amid tightening environmental regulations.
• Sodium sulfate’s growth remains moderate but steady, chiefly supported by the textile, glass, and detergent industries.
• Disruptions in supply chains, raw material prices, and environmental policies constitute key risks to projected growth.
• Strategic investments in sustainable extraction, innovative formulations, and regional market penetration will be decisive for companies aiming to maximize financial returns.

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FAQs

1. What are the primary end-markets for magnesium sulfate?
   Magnesium sulfate primarily serves medical markets (e.g., obstetrics, neurology), industrial applications like cement and textile manufacturing, and agriculture as a soil additive.

2. How does environmental regulation impact potassium sulfate’s market growth?
   Stricter environmental standards favor chloride-free fertilizers, elevating demand for potassium sulfate, which is environmentally friendly and crop-specific.

3. What are the main raw materials for sodium sulfate production, and how do price fluctuations affect the market?
   Raw materials include sulfuric acid and sodium carbonate. Price volatility in sulfur and sodium compounds influences production costs and product pricing, impacting profitability.

4. Which regions are expected to showcase the highest growth in sulfate compound demand?
   Asia-Pacific, Africa, and Latin America will likely exhibit the highest growth, driven by expanding healthcare infrastructure, agriculture, and industrial activities.

5. What technological advancements are shaping the future of sulfate compound manufacturing?
   Innovations include sustainable extraction methods, energy-efficient processing, and the development of specialty formulations that command premium pricing.

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References

1. Industry Reports on Inorganic Salts Market Outlooks, 2023–2030.
2. Company Financial Disclosures and Strategic Updates.
3. Regulatory Frameworks and Environmental Policies in Key Markets.
4. Market Analytics from Industry-specific Publications, 2023.