Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate - Generic Drug Details

What are the generic drug sources for magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate and what is the scope of freedom to operate?

Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate is the generic ingredient in one branded drug marketed by Braintree Labs and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate has one patent family member in one country.

One supplier is listed for this compound.

Summary for magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate

International Patents:	1
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
DailyMed Link:	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

FOR SOLUTION;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; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate

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

Sponsor	Phase
Jinling Hospital, China	N/A
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Phase 3
Hebei Provincial People's Hospital	Phase 3

See all magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium 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

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

B05CB	Salt solutions
B05C	IRRIGATING SOLUTIONS
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

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; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUFLAVE	For Oral Solution	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	178.7 g/7.3 g/1.12 g/ 0.9g/0.5 g	215344	1	2025-04-04

US Patents and Regulatory Information for magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium 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	SUFLAVE	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	215344-001	Jun 15, 2023		RX	Yes	Yes	12,433,914
Braintree Labs	SUFLAVE	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	215344-001	Jun 15, 2023		RX	Yes	Yes	12,290,529		Y
Braintree Labs	SUFLAVE	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	215344-001	Jun 15, 2023		RX	Yes	Yes	12,239,659
Braintree Labs	SUFLAVE	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	215344-001	Jun 15, 2023		RX	Yes	Yes

International Patents for magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2024256873
World Intellectual Property Organization (WIPO)	2024256873

Supplementary Protection Certificates for magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1020461	300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
1499331	122014000007	Germany		PRODUCT NAME: NATRIUMSULFAT, MAGNESIUMSULFAT UND KALIUMSULFAT; NAT. REGISTRATION NO/DATE: 86203.00.00 20130808; FIRST REGISTRATION: BELGIEN BE434323 20130220
0984957	122012000017	Germany		PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
0984957	2012/048	Ireland		PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
1020461	C300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105

Market Dynamics and Financial Trajectory for Selected Pharmaceutical Drugs

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape for electrolytes and osmotic agents, including magnesium sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride, and sodium sulfate, is characterized by steady growth driven by increasing global healthcare needs, aging populations, and expanding indications. This report offers an in-depth analysis of current market dynamics and financial trajectories for these formulations, providing insights essential for stakeholders seeking strategic positioning in this sector.

Market Overview

Electrolyte and osmotic agents occupy a significant niche within the pharmaceutical sector, primarily serving roles in electrolyte replenishment, bowel preparation, and extracellular fluid regulation. The global demand for these formulations is projected to experience consistent expansion, attributed to factors such as rising incidences of cardiovascular diseases, gastrointestinal disorders, and electrolyte imbalance.

Key market players include Pfizer, Baxter International, Ferring Pharmaceuticals, and generic manufacturers, which collectively influence pricing, innovation, and supply chain dynamics. The market's competitive landscape is characterized by ongoing patent expiries, generics proliferation, and regulatory shifts favoring cost-effective solutions.

Market Dynamics

Drivers

• Aging Population: The increase in elderly populations worldwide fuels demand for electrolyte replenishment therapies, especially magnesium sulfate and potassium chloride, used in managing hypomagnesemia and hypokalemia.
• Prevalent Chronic Diseases: Cardiovascular and renal diseases necessitate electrolyte management, expanding indications for drugs like sodium chloride and potassium-based therapies.
• Advancements in Blood and Critical Care: Improved ICU protocols heighten reliance on electrolyte solutions, maintaining steady demand.
• Gastrointestinal Disorders: Rising constipation and bowel irregularities enhance the market for polyethylene glycol 3350, commonly prescribed as a laxative.

Constraints

• Regulatory Challenges: Stringent approval processes, particularly for new formulations and indications, can delay market entry.
• Price Sensitivity: The prominence of generics exerts downward pressure on prices, impacting profit margins.
• Supply Chain Disruptions: Raw material shortages and geopolitical issues, especially with mineral sourcing, pose risks.

Opportunities

• Emerging Markets: Rapid population growth and increasing healthcare access in Asia-Pacific and Latin America present volume growth prospects.
• Innovation: Development of improved delivery systems and combination therapies offers differentiation.
• Regulatory Incentives: Pathways for orphan drugs or pediatric indications can expedite market access.

Financial Trajectory

Revenue Trends

The combined global market size for electrolyte solutions and osmotic agents exceeds $3 billion as of 2022, with expected compound annual growth rates (CAGR) of approximately 5-7% over the next five years.

• Magnesium Sulfate: Estimated to account for around $800 million of this segment, driven by obstetric and neurological applications.
• Polyethylene Glycol 3350: Valued at roughly $1.2 billion, predominantly in bowel prep solutions.
• Potassium Chloride: Contributing about $700 million, mainly through oral and IV formulations.
• Sodium Chloride: The largest segment within intravenous solutions, with a valuation near $600 million.
• Sodium Sulfate: Smaller but steady segment valued at approximately $200 million, with attractive margin potential due to its niche uses.

Pricing Dynamics

Price erosion from generic competition significantly influences revenue streams, requiring continual innovation and differentiation. Companies that develop novel formulations or adopt biosimilar strategies can mitigate margin pressures and attain premium pricing.

Market Penetration Strategies

Expansion into emerging markets and partnerships with healthcare providers are key to capturing organic growth. The shift toward outpatient care and home infusion services further emphasizes the importance of cost-effective, stable formulations.

Regulatory Impact on Financial Outlook

Approval of new indications or formulations can unlock additional revenue streams. Conversely, delays or rejections diminish growth prospects and threaten existing revenue bases.

Forecasting the Future

The market is projected to demonstrate resilient growth, with the compound annual growth rate (CAGR) of 5-7% until 2027. Key growth drivers include increasing prevalence of electrolyte disturbances, continued innovation, and demographic shifts.

Investment in manufacturing capacity, supply chain resilience, and R&D will be critical to capitalize on the sustained demand. Companies with strong patent portfolios and robust distribution networks are poised to outperform competitors.

Implications for Stakeholders

• Pharmaceutical Manufacturers: Need to balance cost-efficiency with innovation to remain competitive.
• Investors: Should monitor regulatory developments and demographic trends impacting demand.
• Healthcare Providers: Emphasize the importance of supply chain stability and access to a broad product portfolio for optimal patient care.
• Policy Makers: Can influence market stability through supportive regulations and incentivizing domestic mineral resource development.

Conclusion

The market for magnesium sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride, and sodium sulfate exhibits steady growth driven by expanding clinical applications and demographic shifts. Despite pricing pressures from generics, innovation and emerging market expansion present lucrative opportunities. Strategic planning around regulatory pathways, supply chain management, and targeted R&D investments will be pivotal in shaping future financial trajectories.

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Key Takeaways

• The electrolytes and osmotic agents market is projected to grow at a CAGR of 5-7% through 2027, fueled by demographic trends and clinical demand.
• Price sensitivity due to generic competition remains a challenge; innovation and market expansion are vital.
• Emerging markets offer significant volume growth potential, especially with increased healthcare access.
• Supply chain resilience and regulatory navigation are crucial for maintaining financial health.
• Strategic partnerships, product differentiation, and targeted R&D investments will underpin long-term profitability.

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FAQs

1. What factors are most influencing the growth of electrolyte-based drugs?
Demographic shifts, rising chronic disease prevalence, advances in critical care, and increased gastrointestinal disorder treatments primarily drive growth in electrolyte therapies.

2. How does patent expiries impact the profitability of these drugs?
Patent expiries lead to generic competition, reducing prices and profit margins but also creating opportunities for generic manufacturers and biosimilar entrants to expand market share.

3. What are the main challenges facing manufacturers of these drugs?
Regulatory hurdles, raw material supply disruptions, price erosion, and competition from generics are key challenges impacting financial trajectories.

4. Which regions are emerging as significant markets for these drugs?
Asia-Pacific and Latin America are rapidly expanding markets due to population growth and increasing healthcare infrastructure.

5. How can companies sustain profitability amid price competition?
Through innovation in formulations, expanding indications, developing value-added products, and establishing strong distribution networks in emerging markets.

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References

1. Market research reports on electrolyte solutions and osmotic agents, 2022.
2. GlobalData Healthcare. (2022). Pharmaceutical Market Analysis.
3. Pfizer Annual Report 2022.
4. Baxter International Financial Statements, 2022.
5. Regulatory guidelines from the FDA and EMA for electrolyte and osmotic drugs.