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 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

US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	27
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	N/A
Daewoong Pharmaceutical Co. LTD.	Phase 3
Jinling Hospital, China	N/A

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

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE Market Analysis and Financial Projection Experimental

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

Introduction

Magnesium sulfate, potassium chloride, and sodium sulfate are crucial compounds used in various industries, including pharmaceuticals, agriculture, and food production. Understanding the market dynamics and financial trajectory of these substances is essential for stakeholders, investors, and industry professionals.

Market Overview

Pharmaceutical Sector

In the pharmaceutical sector, these compounds are often used as active ingredients or excipients in various formulations. For instance, magnesium sulfate, potassium sulfate, and sodium sulfate are used in oral solutions for bowel preparation, which can cause significant side effects such as dehydration and electrolyte imbalances if not managed properly[4].

Agricultural Sector

In agriculture, potassium chloride is a key fertilizer, essential for plant growth, nutrient absorption, and overall crop health. The increasing global demand for food has driven the use of potassium chloride, with the market valued at $727.05 million in 2024 and projected to reach $1.018 billion by 2031, growing at a CAGR of 4.30%[3].

Market Drivers

Increasing Global Food Demand

The growing global population and the subsequent increase in food demand are significant drivers for the potassium chloride market. Farmers rely on potassium chloride to enhance crop yield and quality, making it a vital component in agricultural practices[3].

Pharmaceutical Demand

The demand for generic drugs, including those containing magnesium sulfate, potassium chloride, and sodium sulfate, has increased due to the growing Medicare and Medicaid populations, as well as the expansion of ACA plans and high-deductible commercial plans. This increased demand has led to a shift in the demand curve, making it more elastic[5].

Market Challenges

Drug Shortages

The pharmaceutical market faces challenges such as drug shortages, which can be persistent and periodic. These shortages are often due to complexities in demand, supply, and manufacturing processes. The concentration of generic drug markets, with fewer manufacturers entering and more exiting, exacerbates these issues[5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of these compounds. FDA guidances, such as the draft guidance on magnesium sulfate, potassium chloride, and sodium sulfate, provide recommendations but do not establish legally enforceable responsibilities. Compliance with these guidances is essential for manufacturers to ensure product approval and market entry[2].

Financial Trajectory

Market Valuation

The potassium chloride market is expected to grow significantly, with a projected valuation of $1.018 billion by 2031. This growth is driven by its increasing use in agriculture and industrial sectors[3].

Generic Drug Market

The generic drug market, which includes formulations containing magnesium sulfate, potassium sulfate, and sodium sulfate, is highly concentrated. The median number of manufacturers in each drug market is two, and the mean is five. This concentration has led to reduced competition and falling prices over time[5].

Industry Applications

Agricultural Use

Potassium chloride is primarily used as a fertilizer to improve crop performance and ensure optimal growth. Its effectiveness in enhancing crop yield and quality makes it an essential component in agricultural practices[3].

Pharmaceutical Use

Magnesium sulfate, potassium sulfate, and sodium sulfate are used in various pharmaceutical formulations, including oral solutions for bowel preparation. These solutions are critical for medical procedures but require careful management to avoid serious side effects[4].

Industrial Use

Potassium chloride is also employed in the industrial sector for producing potassium-based chemicals, such as potassium hydroxide and potash, which are critical in manufacturing processes[3].

Quality and Stability

Analytical Standards

The quality and stability of these compounds are crucial for their effective use. Studies have shown that magnesium sulfate, potassium sulfate, and sodium sulfate meet high standards of accuracy and repeatability, with minimal variations in flow rate, column temperature, and solution stability[1].

Expert Insights

"The increasing demand for potassium chloride in agriculture is driven by its effectiveness in enhancing crop yield and quality. This trend is expected to continue as the global population grows and food demand increases."[3]

Statistics and Trends

• Potassium Chloride Market Valuation: Expected to reach $1.018 billion by 2031, growing at a CAGR of 4.30% from 2024 to 2031[3].
• Generic Drug Market Concentration: 40% of markets are supplied by a single manufacturer, and the share supplied by one or two manufacturers has been increasing[5].
• Solution Stability: Magnesium sulfate, potassium sulfate, and sodium sulfate solutions remain stable over 35 hours, with minimal assay differences[1].

Key Takeaways

• The market for magnesium sulfate, potassium chloride, and sodium sulfate is driven by increasing global food demand and pharmaceutical needs.
• The potassium chloride market is expected to grow significantly, driven by its use in agriculture and industrial sectors.
• The generic drug market is highly concentrated, leading to reduced competition and falling prices.
• Quality and stability standards are crucial for the effective use of these compounds.
• Regulatory compliance is essential for manufacturers to ensure product approval and market entry.

FAQs

Q: What are the primary uses of potassium chloride in the market? A: Potassium chloride is primarily used as a fertilizer in agriculture to enhance crop yield and quality, and in the industrial sector for producing potassium-based chemicals.

Q: What are the potential side effects of magnesium sulfate, potassium sulfate, and sodium sulfate oral solutions? A: These solutions can cause serious side effects including dehydration, electrolyte imbalances, abnormal heartbeats, seizures, and kidney problems.

Q: How is the generic drug market for these compounds structured? A: The generic drug market is highly concentrated, with 40% of markets supplied by a single manufacturer, and the share supplied by one or two manufacturers has been increasing.

Q: What are the regulatory considerations for manufacturers of these compounds? A: Manufacturers must comply with FDA guidances, which provide recommendations but do not establish legally enforceable responsibilities.

Q: What is the projected growth of the potassium chloride market? A: The potassium chloride market is expected to grow at a CAGR of 4.30% from 2024 to 2031, reaching a valuation of $1.018 billion by 2031.

Sources

1. MDPI: Determination of Sodium, Potassium, and Magnesium as Sulfate...
2. FDA: Draft Guidance on Magnesium Sulfate; Potassium Chloride; Sodium Sulfate
3. Verified Market Research: Potassium Chloride Market Size, Share, Trends & Forecast
4. Duke Health Policy: Identifying the Root Causes of Drug Shortages and Finding Solutions
5. FDA: ANDA 202511 - Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution[1][2][4]