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Last Updated: March 18, 2026

MAGNESIUM SULFATE Drug Patent Profile


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Which patents cover Magnesium Sulfate, and what generic alternatives are available?

Magnesium Sulfate is a drug marketed by B Braun Medical, Baxter Hlthcare Corp, Aspiro, Exela Pharma, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, Pharmobedient, Amneal, Gland, Milla Pharms, and Mylan Labs Ltd. and is included in twenty NDAs.

The generic ingredient in MAGNESIUM SULFATE is magnesium sulfate. There are one hundred and forty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the magnesium sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Magnesium Sulfate

A generic version of MAGNESIUM SULFATE was approved as magnesium sulfate by FRESENIUS KABI USA on September 8th, 1986.

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Summary for MAGNESIUM SULFATE
US Patents:0
Applicants:12
NDAs:20

US Patents and Regulatory Information for MAGNESIUM SULFATE

MAGNESIUM SULFATE is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hq Spclt Pharma MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 207350-002 Dec 6, 2017 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 206485-002 Mar 15, 2016 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mylan Labs Ltd MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 209911-002 Sep 14, 2018 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Milla Pharms MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 209642-001 Nov 8, 2021 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 206485-003 Mar 15, 2016 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Gland MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 213917-001 Jul 10, 2020 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 206485-004 Mar 15, 2016 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Magnesium Sulfate: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Magnesium sulfate, a critical pharmaceutical and industrial compound, exhibits diverse applications ranging from obstetrics and cardiology to industrial uses. Its market position is influenced by clinical demand, regulatory environment, manufacturing capacity, and global supply chain dynamics. This report analyzes the current investment landscape, examining key market drivers, competitive trends, regulatory factors, and future financial trajectories.


What Are the Market Fundamentals for Magnesium Sulfate?

Global Production and Consumption

Parameter Data (2021-2022) Source
Global production volume Estimated 160,000 metric tons Industry reports, [1]
Leading producers China (around 65%), India, USA, Belgium Market analyses
Major consumers Medical sector (OB, ICU), industrial sector Industry reports

Market Segments

Segment Application/Usage Market Share (2022)
Medical use Obstetric management (pre-eclampsia), eclampsia ~70% of total demand
Industrial use Textiles, paper, fireproofing, agriculture ~25% of total demand
Laboratory and research Laboratory agents, reagent purposes ~5% of total demand

Key Market Drivers

  • Rising obstetric cases: Pre-eclampsia and eclampsia cases are increasing in high-birth-rate countries, boosting demand.
  • Industrial expansion: Growing textile, paper manufacturing, and fireproofing industries reinforce industrial needs.
  • COVID-19 impact: Increased demand for critical care treatments temporarily elevated medical use requirements.
  • Supply chain stability: Supply reliance on China and India introduces geopolitical risks, fostering market volatility.

Current Market Dynamics

Regulatory Environment

Regulation/Policy Impact Details
US FDA and EMA approvals Validate safety/efficacy for medical use Magnesium sulfate classified as an essential medicine globally
Import/export tariffs and trade policies Affect supply chain costs and margins US-China trade tensions impacting Chinese exports
Quality standards and Good Manufacturing Practices (GMP) Ensure product safety, influence manufacturing compliance Stringent regulations can elevate initial costs

Supply Chain Considerations

  • Concentration risk: ~65% of global magnesium sulfate production occurs in China, impacting supply security.
  • Logistics constraints: Pandemic-related disruptions have historically caused shortages and price volatility.
  • Raw material prices: Magnesium metal and sulfuric acid costs influence manufacturing costs.

Competitive Landscape

Major Players Market Share Capabilities Notable Attributes
Jiangsu Guoxin Group, China ~25% Large-scale bulk production Lower-cost manufacturing
Thermo Fisher Scientific ~10% Specialty chemicals & research supplies High-quality standards
Sigma-Aldrich (Merck) ~8% Laboratory and pharmaceutical supply Wide distribution network
Other regional manufacturers Remaining stake Focused regional supply Niche focus, lower scale

Price Trends (Last 5 Years)

Year Average Price (USD/kg) Trend Commentary
2018 $2.50 Stable Consistent with industrial expansion
2019 $2.60 Slight upward movement Cost pressures from raw materials
2020 $3.00 Sharp increase, pandemic impact Medical demand surge
2021 $3.20 Slight stabilization Supply chain disruptions continue
2022 $3.50 Incremental rise Rebalancing of supply and demand dynamics

Note: Price fluctuations are influenced heavily by raw material costs, geopolitical factors, and demand shifts, with notable volatility during the pandemic.


Financial Trajectory and Investment Outlook

Market Size and Growth Projections

Parameter 2022 Estimate Projected 2027 CAGR Source
Market value Approximately USD 150 million 5-7% Industry reports [1], [2]
Compound annual growth rate (CAGR) 6% Market forecasts
Regional growth drivers North America, Asia-Pacific Market analyses

Revenue Projections by Market Segment

Segment 2022 (USD millions) 2027 (USD millions) CAGR Major Factors
Medical (Obstetrics, ICU) 105 140 6% Increasing obstetric cases, prevalence of pre-eclampsia
Industrial 37 52 7% Industrial expansion, environmental policies
Laboratory and Research 8 10 4% Global research needs, supply stability

Potential Investment Avenues

  • Manufacturing capacity expansion: Opportunities for new entrants or existing players to scale production domestically.
  • Value-added formulations: Development of specialized pharmaceutical preparations for targeted conditions.
  • Supply chain diversification: Investing in diversified manufacturing locations outside China and India.
  • Research & development: Novel applications and delivery systems (e.g., sustained-release formulations).

Risks and Challenges

Risk Factor Impact Mitigation Strategies
Supply chain disruptions Price volatility, shortages Diversification, localized manufacturing
Regulatory hurdles Delay in approvals, increased costs Strategic alignment with regulators, compliance investments
Raw material price fluctuations Margins compression Forward contracts, raw material sourcing diversification
Market competition Price pressures, reduced margins Differentiation through quality, establishing branding alliances
Geopolitical tensions Import/export restrictions, tariffs fall into supply shifts Geographical diversification, trade agreements

Comparative Analysis: Medical vs. Industrial Applications

Aspect Medical Use Industrial Use
Market Size (2022) USD 105 million USD 37 million
Growth Potential High, driven by obstetrics and critical care needs Moderate, linked with industry and environmental regulation
Regulation & Standards Stringent (FDA, EMA approval, GMP compliance) Less restrictive, quality standards vary
Pricing & Margins Higher margins, premium pricing Competitive pricing, volume-driven
R&D Investment Focus on formulations, clinical trials Process optimization, new industrial applications

FAQs

Q1: What are the primary uses of magnesium sulfate in the pharmaceutical industry?
A: The primary uses include management of pre-eclampsia and eclampsia in obstetric care, treatment of hypomagnesemia, and as a tocolytic agent. It is also used in critical care settings to manage arrhythmias and facilitate convulsion control.

Q2: How does geopolitical risk influence magnesium sulfate market investment?
A: Over 65% of global magnesium sulfate production originates in China, exposing markets to supply disruptions due to trade tensions or export restrictions. Diversification of production and supply sources is crucial for investment security.

Q3: What are the key factors impacting the price of magnesium sulfate?
A: Raw material costs (magnesium metal, sulfuric acid), manufacturing efficiency, geopolitical factors, and demand surges during health crises significantly influence prices.

Q4: What is the outlook for clinical applications of magnesium sulfate beyond obstetrics?
A: Emerging research explores its utility in neurology, cardiology, and critical care. However, commercial translation depends on clinical trial validation, regulatory approval, and clinical guideline updates.

Q5: What are the opportunities for new investors entering this market?
A: Opportunities include establishing localized manufacturing to mitigate geopolitical risks, developing specialized pharmaceutical formulations, and investing in supply chain resilience and R&D for new applications.


Key Takeaways

  • Market Growth: Mg sulfate market is projected to grow at 6% CAGR through 2027, driven primarily by medical demands and industrial expansion.
  • Supply Chain Risks: Over-reliance on Chinese production necessitates diversification strategies; geopolitical tensions remain key risk factors.
  • Pricing Dynamics: Prices have shown volatility, notably during pandemic peaks, influenced by raw material costs and demand fluctuations.
  • Investment Opportunities: Expansion of manufacturing capacity, R&D for new indications, and supply chain localization offer promising avenues.
  • Regulatory Environment: Compliance with GMP, FDA, and EMA standards is vital for medical applications; industrial uses face less regulatory burden.

References

[1] Market Research Future, "Global Magnesium Sulfate Market Analysis," 2022.
[2] IBISWorld, "Chemical Manufacturing Industry Reports," 2022.

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