Magnesium sulfate; potassium chloride; sodium sulfate - Generic Drug Details

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 Azurity 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

US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	32
DailyMed Link:	magnesium sulfate; potassium chloride; sodium sulfate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for magnesium sulfate; potassium chloride; sodium sulfate

Constraining patent/regulatory exclusivity:

11,382,864

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

Sponsor	Phase
Assiut University	PHASE1
Assiut University	PHASE3
Cairo University	PHASE4

See all magnesium sulfate; potassium chloride; sodium sulfate clinical trials

Pharmacology for magnesium sulfate; potassium chloride; 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 chloride; 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

A12BA	Potassium
A12B	POTASSIUM
A12	MINERAL SUPPLEMENTS
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

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 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
Azurity	SUTAB	magnesium sulfate; potassium chloride; sodium sulfate	TABLET;ORAL	213135-001	Nov 10, 2020		RX	Yes	Yes	11,382,864
Azurity	SUTAB	magnesium sulfate; potassium chloride; sodium sulfate	TABLET;ORAL	213135-001	Nov 10, 2020		RX	Yes	Yes	10,143,656		Y
Azurity	SUTAB	magnesium sulfate; potassium chloride; sodium sulfate	TABLET;ORAL	213135-001	Nov 10, 2020		RX	Yes	Yes	11,033,498
Azurity	SUTAB	magnesium sulfate; potassium chloride; sodium sulfate	TABLET;ORAL	213135-001	Nov 10, 2020		RX	Yes	Yes	11,638,697		Y

Magnesium sulfate; potassium chloride; sodium sulfate Market Analysis and Financial Projection

Last updated: February 15, 2026

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

Overview of the Market Landscape

The pharmaceutical and industrial markets for magnesium sulfate, potassium chloride, and sodium sulfate are characterized by distinct demand drivers, manufacturing trends, and pricing dynamics. Each compound serves specific medical, agricultural, or industrial purposes, affecting their market growth prospects and revenue potential.

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What Are the Key Market Drivers for Magnesium Sulfate, Potassium Chloride, and Sodium Sulfate?

Magnesium Sulfate

• Medical use: Primarily utilized in obstetrics for eclampsia management and as a treatment for hypomagnesemia.
• Market growth factors:
  • Rising global birth rates increase demand for obstetric treatments.
  • Increasing awareness about pre-eclampsia and eclampsia treatments.
  • Supply chain challenges caused by geopolitical factors influence availability and pricing.
• Production trends:
  • Typically produced via extraction from mineral sources or salt lakes.
  • Countries with extensive mineral deposits (e.g., China, Chile) dominate manufacturing.

Potassium Chloride

• Major applications:
  • Medical: Electrolyte replenishment in hypokalemia.
  • Agricultural: As a key fertilizer component.
  • Industrial: Used in de-icing and water treatment.
• Market growth factors:
  • Growing agricultural output necessitates increased fertilizer use.
  • Aging populations requiring electrolyte management boost pharmaceutical demand.
• Production trends:
  • Mined from potash deposits mostly in Canada, Belarus, and Russia.
  • Mined potassium chloride prices are sensitive to mining costs and geopolitical stability.

Sodium Sulfate

• Applications:
  • In the paper, detergent, and glass industries.
  • Less prominent in pharmaceuticals but used for formulations requiring sulfates.
• Market growth factors:
  • Demand in construction and manufacturing sectors.
  • Rising environmental regulations impact production costs.
• Production trends:
  • Mainly produced as a byproduct of other chemical processes or mined from natural deposits.
  • Price fluctuations tied to the chemical industry’s cycle and raw material costs.

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How Do Pricing and Revenue Trends Differ Among the Three?

Compound	Typical Price Range (per ton)	Main Revenue Drivers	Market Volatility Factors
Magnesium sulfate	$300–$600	Medical demand, supply chain stability	Supply disruptions, raw material costs
Potassium chloride	$700–$1,000	Fertilizer demand, medical and industrial applications	Agricultural cycles, geopolitical risks, fertilizer tariffs
Sodium sulfate	$100–$300	Industry consumption, industrial cycles	Raw material costs, environmental regulations

Data is indicative and varies by region and market conditions (Q4 2022 to Q1 2023).

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What Are the Future Revenue and Growth Projections?

Magnesium Sulfate

• Expected Compound Annual Growth Rate (CAGR): 4–6% over the next five years.
• Growth considerations:
  • Increased healthcare infrastructure in emerging markets.
  • Potential for newer indications (e.g., neuroprotective applications) extending market reach.

Potassium Chloride

• Expected CAGR: 3–5% through 2028.
• Growth considerations:
  • Rising demand for fertilizers, driven by global food security initiatives.
  • Potential supply constraints due to geopolitical tensions and modernization efforts in mining.

Sodium Sulfate

• Expected CAGR: 2–3% over the forecast period.
• Growth considerations:
  • Steady industrial demand, but limited medical market penetration.
  • Environmental regulations may lead to supply chain adjustments and price shifts.

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What Are the Main Risks and Opportunities?

Risks

• Regulatory changes affecting production and sales (e.g., environmental and safety standards).
• Supply chain disruptions, notably for raw materials or geopolitical conflicts.
• Price volatility driven by raw material costs and demand fluctuations.

Opportunities

• Development of new formulations and applications, especially for magnesium sulfate.
• Expansion in emerging markets' healthcare sectors.
• Advancements in mining and extraction technologies reducing costs.

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Key Takeaways

• The magnesium sulfate market benefits from increasing obstetric treatments but faces raw material supply challenges.
• Potassium chloride's growth aligns with agricultural demand, with prices sensitive to geopolitical and environmental issues.
• Sodium sulfate's industrial application keeps its growth steady but less lucrative compared to the others.
• Market volatility remains driven by geopolitical stability, raw material availability, and regulatory changes.
• Future growth hinges on technological advancements, expanding applications, and market diversification.

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FAQs

1. Which region dominates the magnesium sulfate market?
Asia-Pacific, led by China and India, accounts for the largest share, driven by expanding healthcare infrastructure.

2. How are raw material costs impacting potassium chloride pricing?
Rising costs in mining operations and geopolitical tensions in key producing countries, such as Belarus and Russia, cause pricing volatility.

3. Are there new applications for sodium sulfate in pharmaceuticals?
Rare; its primary use remains industrial, limiting its growth potential in the pharmaceutical segment.

4. How might regulatory policies influence the markets?
Stricter environmental standards could increase production costs, affecting prices and supply stability across all three compounds.

5. What investment opportunities exist in these markets?
Investing in mining and manufacturing facilities with advanced extraction technologies, or companies developing new formulations based on magnesium sulfate, may offer growth potential.

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Sources

1. Grand View Research, "Magnesium Sulfate Market Size & Share," 2022.
2. MarketsandMarkets, "Potassium Chloride Market," 2022.
3. Allied Market Research, "Sodium Sulfate Market," 2022.
4. United States Geological Survey, "Mineral Commodities" Reports, 2022.
5. Global Industry Analysts, "Chemical Industry Outlook," 2022.