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

What are the generic drug 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, Taro, and Braintree Labs, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

Seven 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:	7
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
North Denmark Regional Hospital	Phase 4

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
Bionpharma	SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	204135-001	Jun 24, 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
Gator Pharms	COLPREP KIT	magnesium sulfate; potassium sulfate; sodium sulfate	POWDER;ORAL	204553-001	Dec 27, 2016		DISCN	Yes	No
Strides Pharma	SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	215469-001	Nov 22, 2023	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

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	6,946,149

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

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

Introduction

The market for magnesium sulfate, potassium sulfate, and sodium sulfate is driven by a combination of factors including agricultural demand, industrial applications, and consumer trends. Here, we will delve into the market dynamics and financial trajectories of these sulfates.

Magnesium Sulfate Market Dynamics

Market Size and Growth

The global magnesium sulfate market was valued at USD 980.4 million in 2023 and is projected to grow to USD 1,583.9 million by 2032, at a CAGR of 5.5% during the 2024-2032 period[4].

Key Drivers

• Agricultural Demand: Magnesium sulfate is crucial for correcting magnesium deficiencies in soil, which is essential for the growth of cash crops and vegetables. The increasing global population and the need for higher agricultural output are driving this demand[4].
• Personal Care Industry: The use of magnesium sulfate in personal care products such as bath salts, due to its muscle and joint pain-relieving properties, is another significant driver[4].
• Pharmaceutical Applications: Magnesium sulfate is used to treat conditions like eclampsia and preeclampsia, and its analgesic properties for migraines, further boosting its demand[4].

Challenges

• Price Volatility: Fluctuations in energy prices and raw material costs affect the overall cost of magnesium sulfate, which can hinder market growth[4].
• Health Concerns: Adverse effects of magnesium compound-based drugs, such as hives, diarrhea, and difficulty in breathing, can also impact demand[4].

Potassium Sulfate Market Dynamics

Market Size and Growth

The global potassium sulfate market is expected to grow from $5.06 billion in 2023 to $7.89 billion by 2028, at a CAGR of 9.4%. In the United States, the market is projected to grow from USD 5,194.6 million in 2024 to USD 8,301.7 million by 2034, at a CAGR of 4.8%[1][2].

Key Drivers

• Agricultural Expansion: Increasing demand for high-quality crops, especially in regions with high soil salinity, drives the use of potassium sulfate as a low-chloride fertilizer[1][2].
• Organic and Sustainable Farming: The rise in organic farming practices and the need for sustainable agriculture solutions are making potassium sulfate a preferred choice[1][2].
• Government Initiatives: Support for agricultural innovation and the promotion of high-value crops further bolster the market[2].

Restraints

• Raw Material Supply Challenges: Shortages and fluctuations in raw material supply can impact production and market growth[3].
• High Prices: The higher cost of potassium sulfate compared to other fertilizers like potassium chloride can dent growth in some regions[3].

Sodium Sulfate Market Dynamics

Market Size and Growth

The global sodium sulfate market was valued at USD 2.10 billion in 2023 and is projected to grow at a CAGR of 4.5% from 2024 to 2030, reaching USD 2.85 billion by 2030[5].

Key Drivers

• Detergent Industry: The growing demand from the detergent industry, where sodium sulfate is used as a filler to enhance performance and texture, is a significant driver[5].
• Urbanization and Consumer Trends: Increasing urbanization and rising disposable incomes lead to higher consumption of cleaning products, particularly in emerging markets[5].

Regional Growth

• Asia Pacific: China's low production costs and substantial supply capabilities make it a key player in the sodium sulfate market, driving regional growth[5].

Financial Trajectory

Magnesium Sulfate

• The market is expected to grow significantly, driven by agricultural and personal care applications. However, price volatility and health concerns may pose challenges to sustained growth.
• Projected Growth: USD 980.4 million in 2023 to USD 1,583.9 million by 2032[4].

Potassium Sulfate

• The market is poised for strong growth, driven by agricultural expansion and the shift towards sustainable farming practices.
• Projected Growth: $5.06 billion in 2023 to $7.89 billion by 2028 globally, and USD 5,194.6 million in 2024 to USD 8,301.7 million by 2034 in the United States[1][2].

Sodium Sulfate

• The market is expected to grow steadily, driven by the detergent industry and consumer trends.
• Projected Growth: USD 2.10 billion in 2023 to USD 2.85 billion by 2030[5].

Segmentation and End-Use Industries

Potassium Sulfate

• By Form: Solid and liquid forms, with granular potassium sulfate dominating the market[1][3].
• By Grade: Agricultural, food, technical, and pharmaceutical grades[1].
• By End-Use Industry: Agriculture, industrial, pharmaceuticals, cosmetics, and food and beverages[1].

Sodium Sulfate

• By End-Use Industry: Detergents, paper & pulp, glass, food & beverage, and others[5].

Regional Analysis

Magnesium Sulfate

• Asia Pacific: Dominates the market with a 41.1% share in 2023, driven by agricultural and personal care applications[4].

Potassium Sulfate

• Asia Pacific: Expected to see increased usage due to agricultural modernization and food security concerns[2].
• North America: The Midwest region in the USA and the fertilizer industries in Canada are key drivers[3].

Sodium Sulfate

• Asia Pacific: China is a major player due to its low production costs and substantial supply capabilities[5].

Key Players and Market Consolidation

Potassium Sulfate

• The market is highly consolidated with key players such as K+S AG, Tessenderlo Group, Compass Minerals, Haifa Chemicals Ltd., and Yara International. These companies maintain strong market positions through strategic alliances and investments in R&D[2].

Sodium Sulfate

• While specific key players are not highlighted, the market is driven by companies that supply to the detergent and other end-use industries[5].

Conclusion

The markets for magnesium sulfate, potassium sulfate, and sodium sulfate are each driven by unique factors but share common themes such as agricultural demand and industrial applications. Here are the key takeaways:

• Magnesium Sulfate: Driven by agricultural and personal care applications, with significant growth projected despite challenges like price volatility.
• Potassium Sulfate: Strong growth anticipated due to agricultural expansion and the shift towards sustainable farming practices.
• Sodium Sulfate: Steady growth expected, driven by the detergent industry and consumer trends.

Key Takeaways

• Agricultural demand is a common driver across all three sulfates.
• Sustainable and organic farming practices are boosting the demand for potassium sulfate.
• Personal care and pharmaceutical applications are significant for magnesium sulfate.
• The detergent industry is a key driver for sodium sulfate.

FAQs

What are the primary drivers of the magnesium sulfate market?

The primary drivers include agricultural demand to correct magnesium deficiencies in soil and the increasing use in personal care products due to its health benefits.

How is the potassium sulfate market expected to grow?

The potassium sulfate market is expected to grow from $5.06 billion in 2023 to $7.89 billion by 2028, driven by agricultural expansion and the shift towards sustainable farming practices.

What is the projected growth of the sodium sulfate market?

The sodium sulfate market is projected to grow from USD 2.10 billion in 2023 to USD 2.85 billion by 2030, driven by the detergent industry and consumer trends.

Which region dominates the magnesium sulfate market?

The Asia Pacific region dominates the magnesium sulfate market with a 41.1% share in 2023.

Who are the key players in the potassium sulfate market?

Key players include K+S AG, Tessenderlo Group, Compass Minerals, Haifa Chemicals Ltd., and Yara International.

Sources

1. The Business Research Company - Potassium Sulphate Global Market Report 2024
2. GlobeNewswire - Unites States Potassium Sulfate Market Set for 2.8% CAGR Growth by 2034
3. Future Market Insights - USA and Canada Potassium Sulfate Market Size & Forecast 2032
4. Fortune Business Insights - Magnesium Sulfate Market Size, Share & Growth Report
5. Grand View Research - Sodium Sulfate Market Size, Share & Growth Report, 2030