Magnesium sulfate - Generic Drug Details

What are the generic sources for magnesium sulfate and what is the scope of patent protection?

Magnesium sulfate is the generic ingredient in eleven branded drugs marketed by B Braun Medical, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, Pharmobedient, Amneal, Gland, Milla Pharms, Mylan Labs Ltd, Aspiro, Exela Pharma, Braintree Labs, Baxter Hlthcare, Gator Pharms, Alkem Labs Ltd, Annora Pharma, Bionpharma, Novel Labs Inc, Pai Holdings, Strides Pharma Intl, and Taro, and is included in thirty-four NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for magnesium sulfate. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for magnesium sulfate

US Patents:	7
Tradenames:	11
Applicants:	22
NDAs:	34
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	392
Patent Applications:	5,455
What excipients (inactive ingredients) are in magnesium sulfate?	magnesium sulfate excipients list
DailyMed Link:	magnesium sulfate at DailyMed

Recent Clinical Trials for magnesium sulfate

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

Sponsor	Phase
Hennepin Healthcare Research Institute	PHASE1
Nebraska Methodist Health System	PHASE3
Swiss Cancer Institute	PHASE2

See all magnesium sulfate clinical trials

Generic filers with tentative approvals for MAGNESIUM SULFATE

Applicant	Application No.	Strength	Dosage Form
		1.6GM/BOT; 3.13GM/BOT; 17.5GM/BOT	SOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for magnesium sulfate

Drug Class	Calculi Dissolution Agent Osmotic Laxative
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

Medical Subject Heading (MeSH) Categories for magnesium sulfate

Analgesics

Anesthetics

Anti-Arrhythmia Agents

Anticonvulsants

Calcium Channel Blockers

Tocolytic Agents

Anatomical Therapeutic Chemical (ATC) Classes for magnesium sulfate

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
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

US Patents and Regulatory Information for magnesium sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	206486-001	Mar 7, 2016	AP	RX	No	No
Milla Pharms	MAGNESIUM SULFATE IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	209642-002	Nov 8, 2021	AP	RX	No	No
Braintree Labs	SUTAB	magnesium sulfate; potassium chloride; sodium sulfate	TABLET;ORAL	213135-001	Nov 10, 2020		RX	Yes	Yes	11,382,864
Fresenius Kabi Usa	MAGNESIUM SULFATE	magnesium sulfate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	019316-002	Sep 8, 1986	AP	RX	Yes	Yes
Braintree Labs	SUPREP BOWEL PREP KIT	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	022372-001	Aug 5, 2010	AA	RX	Yes	Yes
Baxter Hlthcare Corp	MAGNESIUM SULFATE IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	211966-003	Jun 1, 2020	AP	RX	No	No

Market Dynamics and Financial Trajectory for Magnesium Sulfate in the Pharmaceutical Sector

Last updated: September 8, 2025

Introduction

Magnesium sulfate, a chemical compound with the formula MgSO₄, has long-standing applications in medical, industrial, and agricultural domains. In the pharmaceutical landscape, magnesium sulfate primarily serves as an anticonvulsant, tocolytic agent, and magnesium supplement. Its diverse usage, coupled with evolving clinical practices, impacts market trajectories and investor outlooks. This article explores the current market dynamics, growth drivers, challenges, and future financial prospects for magnesium sulfate within the pharmaceutical industry, offering stakeholders a comprehensive understanding of its market landscape.

Market Overview

The global pharmaceutical magnesium sulfate market was valued at approximately USD 400 million in 2022, with projections estimating a compound annual growth rate (CAGR) of around 4.2% from 2023 to 2030 [1]. Its core markets include North America, Europe, and Asia-Pacific, regions characterized by extensive obstetric care, childbirth management, and hospital infrastructure.

Magnesium sulfate's demand correlates strongly with obstetric practices, especially the management of preeclampsia and eclampsia in pregnant women. Additionally, it is employed in the treatment of hypomagnesemia, certain arrhythmias, and as a muscle relaxant, providing a broad application base that sustains steady demand.

Market Dynamics

Driving Factors

1. Rising Prevalence of Preeclampsia and Eclampsia:
Preeclampsia affects approximately 2-8% of pregnancies globally, leading to increased utilization of magnesium sulfate as the gold-standard treatment for seizure prevention. The World Health Organization (WHO) recommends magnesium sulfate as the first-line therapy, catalyzing consistent medical adoption [2].

2. Expanding Hospital Infrastructure and Maternal Care Programs:
Developing healthcare systems in Asia-Pacific and Africa have prioritized maternal healthcare, elevating demand for magnesium sulfate in obstetric management. Investments in hospital infrastructure and training programs enhance accessibility to magnesium sulfate treatments.

3. Growing Awareness and Clinical Guidelines:
Updated clinical guidelines and evidence-based protocols endorse magnesium sulfate usage, reinforcing its role in obstetric emergencies. The integration of such standards into national healthcare policies boosts market stability.

4. Cost-Effective Nature and Ease of Administration:
Magnesium sulfate’s low manufacturing costs and straightforward administration protocols make it a preferred intervention, particularly in resource-constrained settings, ensuring consistent demand and facilitating broader distribution.

Challenging Factors

1. Competition from Alternative Therapies:
While magnesium sulfate remains the mainstay for eclampsia, alternative treatments such as diazepam have been considered, albeit with lower efficacy. The market’s dependence on clinical adherence rather than active competition limits disruption but signals avenues for innovation.

2. Quality Control and Supply Chain Concerns:
Variability in raw material quality, manufacturing standards, and regulatory compliance pose supply chain risks. Poor-quality products could undermine clinical confidence, impacting market growth.

3. Regulatory and Patent Constraints:
Although magnesium sulfate is a generic compound, regulatory hurdles around manufacturing practices and quality standards influence market entry and expansion strategies, especially across different geographic regions.

4. Limited R&D Investment:
Research into new formulations or alternative compounds has been sparse, constraining innovation-driven market growth. The focus remains largely on established formulations.

Market Segmentation and Regional Analysis

By Application:

• Obstetrics & Gynecology (preeclampsia, eclampsia management) accounts for approximately 75% of global demand.
• Critical care and neurology utilize magnesium sulfate for arrhythmias and hypomagnesemia.
• Agricultural and industrial uses are outside the scope of this pharmaceutical analysis.

By Route of Administration:

• Parenteral administration (intravenous or intramuscular) dominates, with formulations optimized for hospital settings.
• Oral magnesium sulfate products serve as dietary supplements in select markets.

Regional Insights:

• North America: Dominates the market (approx. 40%) due to advanced healthcare infrastructure and high obstetric care standards.
• Europe: Accounts for around 25%, driven by stringent clinical guidelines and regulatory standards.
• Asia-Pacific: The fastest-growing segment (CAGR > 5%) driven by expanding healthcare access, rising maternal health awareness, and increasing hospitalizations.
• Emerging Markets: Africa and Latin America show potential growth owing to improved healthcare programs, albeit constrained by supply chain and affordability issues.

Financial Trajectory and Investment Trends

The steady demand for magnesium sulfate is reflected in consistent revenue flows within pharmaceutical supply chains. Manufacturers predominantly focus on generic production, with large players such as Pfizer, Fresenius, and Hikma Pharmaceuticals spearheading supply. Market entries are constrained by regulatory compliance, but high-volume manufacturing ensures economies of scale.

Pricing Dynamics:
Magnesium sulfate's low unit cost maintains high margins despite burgeoning volume sales. Pricing remains competitive globally, but regional regulation influences pricing strategies.

Investment and R&D Outlook:
Investors exhibit cautious optimism. While current demand sustains revenue, prospects for high-value innovations remain limited. Nonetheless, growth in emerging markets, coupled with government-funded health initiatives, is expected to support sales.

Emerging Trends:

• Development of alternative formulations with improved bioavailability or stability.
• Focused investments in supply chain resilience amidst geopolitical uncertainties.
• Expansion into nutraceuticals, leveraging magnesium's health benefits in non-medical segments.

Regulatory and Compliance Considerations

Magnesium sulfate's production and distribution are governed by pharmacopoeial standards, such as USP, EP, and JP monographs. Regulatory bodies like FDA, EMA, and respective national agencies enforce strict manufacturing practices. Ensuring compliance and achieving quality certifications remains pivotal for market access, especially in high-growth regions.

Future Outlook

Forecasts suggest moderate but sustained growth driven primarily by obstetric uses. Emerging markets represent the most dynamic segment, and innovations in formulation and global health policy adoption could further enhance market stability. However, ongoing regulatory challenges and the necessity for quality assurance remain critical considerations for market participants.

Key Challenges and Opportunities

• Challenges: Supply chain disruptions, regulatory variances, quality control issues, and limited R&D investment.
• Opportunities: Expansion into emerging markets, strengthening supply networks, and leveraging analytical advances to improve product quality.

Key Takeaways

• The magnesium sulfate pharmaceutical market is characterized by stable demand, predominantly driven by obstetric indications like preeclampsia and eclampsia management.
• Growth prospects are favorable in Asia-Pacific and emerging markets due to healthcare infrastructure expansion and increased maternal health awareness.
• Regulatory compliance and supply chain integrity are critical for sustaining market share.
• Limited innovation in formulations presents both a challenge and an opportunity for stakeholders to differentiate offerings.
• Cost-effectiveness and established clinical protocols underpin market stability, but ongoing policy developments and global health initiatives could catalyze future growth.

FAQs

1. What are the main medical applications of magnesium sulfate?
Magnesium sulfate is primarily used to treat preeclampsia and eclampsia in pregnant women, manage magnesium deficiency, control certain arrhythmias, and relax skeletal muscles during surgeries.

2. How does regional regulation impact magnesium sulfate marketing?
Regulatory standards influence manufacturing practices, quality assessments, and market approval processes. Regions with stringent standards, such as Europe and North America, require rigorous compliance, whereas emerging markets may face supply chain hurdles due to inconsistent enforcement.

3. Are there any notable R&D developments for magnesium sulfate?
Research has primarily focused on optimizing formulations for better stability and bioavailability. No significant R&D innovations have disrupted the market recently, owing to the compound’s established clinical use.

4. How do supply chain issues affect the magnesium sulfate market?
Supply chain disruptions can lead to shortages, affecting hospital procurement and patient care continuity. Raw material quality variability and geopolitical factors further exacerbate these issues.

5. What is the long-term growth outlook for magnesium sulfate in pharmaceuticals?
Stable demand driven by obstetric care suggests moderate growth over the next decade. Market expansion into emerging economies, coupled with potential product innovations, could stimulate higher growth rates.

References

[1] Market Research Future. "Global Magnesium Sulfate Market Analysis." 2022.

[2] World Health Organization. "Guidelines for the Management of Preeclampsia and Eclampsia." 2018.