MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE - Generic Drug Details

What are the generic 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 Azurity 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.

Two suppliers are 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:	2
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:

12,290,529

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 Hospital of Integrated Traditional Chinese and Western Medicine	Phase 3
Henan 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
Azurity	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
Azurity	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
Azurity	SUFLAVE	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	215344-001	Jun 15, 2023		RX	Yes	Yes
Azurity	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

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
0984957	C300483	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
1499331	122014000007	Germany		PRODUCT NAME: NATRIUMSULFAT, MAGNESIUMSULFAT UND KALIUMSULFAT; NAT. REGISTRATION NO/DATE: 86203.00.00 20130808; FIRST REGISTRATION: BELGIEN BE434323 20130220
1499331	C300615	Netherlands		PRODUCT NAME: NATRIUMSULFAAT, MAGNESIUMSULFAAT EN KALIUMSULFAAT; NAT. REGISTRATION NO/DATE: RVG 110863 20130417; FIRST REGISTRATION: BE 434323 20130220

Last updated: February 15, 2026

Market Dynamics for Selected Pharmaceutical Drugs

Magnesium Sulfate

Market Size and Use Cases:
Magnesium sulfate, primarily used as an anticonvulsant in preeclampsia and eclampsia management, has a global market value estimated at $200 million in 2022. The drug is also used in treatments for magnesium deficiency and hypomagnesemia. Growth is driven by increasing maternal health interventions and expanding hospital infrastructure in emerging markets.

Key Players:
Pfizer, Hikma Pharmaceuticals, and Sandoz dominate supply. Pfizer's supply chain focuses on North American and European markets; Hikma expands in Middle Eastern and African regions.

Market Drivers:
Rising incidence of preeclampsia, clinical guidelines supporting magnesium sulfate use, and expanding healthcare infrastructure in Asian and African countries.

Constraints:
Limited indications restrict growth, with off-label use being minimal. Price sensitivity in emerging markets influences adoption.

Polyethylene Glycol 3350 (PEG 3350)

Market Size and Use Cases:
PEG 3350 is a common laxative for chronic constipation. The global market was valued at approximately $1.2 billion in 2022. Over-the-counter (OTC) formulations dominate, though prescription versions persist.

Key Players:
Baxter International, Ferring Pharmaceuticals, and SNG. Baxter's MoviPrep and Ferring's Glycolax are prominent brands.

Market Drivers:
Aging populations in North America and Europe increase demand. Increasing awareness about constipation treatment and OTC accessibility boost sales.

Constraints:
Regulatory hurdles for prescription formulations vary globally, impacting distribution. Competition from natural and fiber-based remedies pressures pricing.

Potassium Chloride

Market Size and Use Cases:
Used in treating and preventing hypokalemia, potassium chloride's global market approached $1.5 billion in 2022. It is supplied as tablets, liquids, and injectable forms.

Key Players:
Akorn, Novartis, and Fresenius Kabi.

Market Drivers:
Prevalence of electrolyte imbalances in hospitalized patients. Growing chronic diseases such as kidney disease further increase demand.

Constraints:
Potential side effects, including hyperkalemia, influence prescribing practices. Regulatory oversight for formulations varies by country.

Sodium Chloride

Market Size and Use Cases:
Used in saline solutions, intravenous therapy, and wound cleansing, sodium chloride holds an estimated market size of $2 billion globally (2022). The dominant form is 0.9% isotonic saline.

Key Players:
Multiple generic manufacturers, with key brands supplied by Baxter, Hospira, and Fresenius.

Market Drivers:
Increased hospitalization rates and demand for IV therapy sustain growth. Growing outpatient care also influences demand.

Constraints:
Environmental concerns over waste salt and manufacturing are emerging considerations.

Sodium Sulfate

Market Size and Use Cases:
Primarily used as a laxative (e.g., in Magnesia Sulfate), sodium sulfate's market valuation is around $150 million. Its use extends into industrial applications, such as in detergents.

Key Players:
Ineos, Solvay, and Chemsystems.

Market Drivers:
Demand for saline cathartics and preparations for bowel cleansing procedures.

Constraints:
Market growth limited by competition from other laxatives (e.g., polyethylene glycol) and regulatory restrictions on over-the-counter laxative use.

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Comparative Market Insights

Drug	Estimated Market Size (2022)	Main Use	Key Drivers	Constraints
Magnesium sulfate	$200 million	Eclampsia, magnesium deficiency	Maternal health needs, hospital expansion	Limited indications
PEG 3350	$1.2 billion	Constipation	Aging populations, OTC sales	Regulatory hurdles, competition
Potassium chloride	$1.5 billion	Hypokalemia	Electrolyte imbalance prevalence	Side effect concerns
Sodium chloride	$2 billion	IV therapy, wound care	Hospitalizations, outpatient care	Environmental issues
Sodium sulfate	$150 million	Laxative, industrial uses	Bowel cleansing demand	Competition from alternatives

Financial Trajectory Projections (2023–2028)

Forecast growth varies by drug class:

• Magnesium sulfate: CAGR of 2-3%, driven by maternal health trends.
• PEG 3350: CAGR of 4-5%, supported by aging demographics and OTC demand.
• Potassium chloride: CAGR of 3-4%, with hospital volume increases.
• Sodium chloride: Moderate growth at 1-2%; globalization stabilizes demand.
• Sodium sulfate: Near stagnant at 1%, constrained by competing treatments.

Regulatory and Policy Environment

• Magnesium sulfate: WHO guidelines endorse for preeclampsia, encouraging usage.
• PEG 3350: Regulations differ globally; some regions require Rx for higher doses.
• Potassium chloride: Strict controls on formulations due to toxicity risks.
• Sodium chloride: Widely accepted; sterilization and purity standards vary.
• Sodium sulfate: Over-the-counter sales controlled in some jurisdictions.

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Key Takeaways

• The market sizes for these compounds are tightly linked to specific medical indications and demographic trends.
• The primary growth drivers include aging populations, maternal health initiatives, and hospital inpatient care expansion.
• Price sensitivity, regulatory variation, and competition from alternative treatments influence market adoption.
• Industrial uses, especially for sodium sulfate, add a secondary revenue stream but do not significantly alter the pharmaceutical market trajectory.
• Investment opportunities may focus on emerging markets where healthcare infrastructure development accelerates demand.

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FAQs

Q1: How does regulatory approval impact the growth prospects of these drugs?
A1: Regulatory approvals determine market access. Stricter regulations can delay entry or limit formulations, impacting sales. Conversely, approved indications and stable regulatory environments facilitate market expansion.

Q2: Are natural or alternative remedies affecting the demand for these drugs?
A2: Yes. For example, fiber-based or natural laxatives compete with PEG 3350 and sodium sulfate, which can suppress sales growth.

Q3: What are potential risks associated with market expansion?
A3: Risks include regulatory changes, price controls, supply chain disruptions, and shifts in clinical guidelines.

Q4: How does hospital infrastructure development influence these markets?
A4: Increased hospital capacity boosts demand for injectable forms (potassium, sodium chloride) and IV saline solutions. It also supports the use of magnesium sulfate in obstetric settings.

Q5: Which geographic markets offer the highest growth opportunities?
A5: Asia-Pacific and Africa present significant expansion potential due to increasing healthcare investments and maternal health programs.

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References

[1] MarketWatch, "Magnesium Sulfate Market Size," 2022.
[2] Grand View Research, "Polyethylene Glycol Market," 2022.
[3] ReportLinker, "Global Electrolyte Solutions Market," 2022.
[4] IMARC Group, "Sodium Chloride Market," 2022.
[5] MarketsandMarkets, "Laxatives Market," 2022.