Magnesium sulfate - Generic Drug Details

What are the generic sources for magnesium sulfate and what is the scope of freedom to operate?

Magnesium sulfate is the generic ingredient in eleven branded drugs marketed by B Braun Medical Inc, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, Mylan Labs Ltd, Amneal, Gland Pharma Ltd, Milla Pharms, Exela Pharma, Braintree Labs, Baxter Hlthcare, Gator Pharms, Alkem Labs Ltd, Annora Pharma, Bionpharma, Novel Labs Inc, Pai Holdings, Strides Pharma, and Taro, and is included in thirty-three NDAs. There are four 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. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for magnesium sulfate

US Patents:	4
Tradenames:	11
Applicants:	20
NDAs:	33
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	324
Patent Applications:	1,386
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
University of Oklahoma	Early Phase 1
Daewoong Pharmaceutical Co. LTD.	Phase 3
Cairo University	Phase 1/Phase 2

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
Baxter Hlthcare Corp	MAGNESIUM SULFATE IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	211966-003	Jun 1, 2020	AP	RX	No	No
Baxter Hlthcare Corp	MAGNESIUM SULFATE IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	211966-002	Jun 1, 2020	AP	RX	No	No
B Braun Medical Inc	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	207966-001	Oct 27, 2020	AP	RX	No	No

Magnesium sulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Magnesium Sulfate

Global Market Outlook

The magnesium sulfate market is poised for significant growth, driven by diverse and expanding applications across various industries. Here are the key dynamics and financial projections for this market.

Market Size and Growth Projections

The global magnesium sulfate market is expected to grow substantially over the next decade. By 2023, the market was valued at approximately USD 1 billion and is projected to reach USD 1.68 billion by 2033, growing at a compound annual growth rate (CAGR) of 5.7%[1][4].

Drivers of Market Growth

Agricultural Applications

Magnesium sulfate is an essential nutrient for plants, enhancing soil structure, increasing nutrient availability, and boosting crop yields. Its use in agriculture, particularly for crops like fruits, vegetables, and nuts, is a major driver of market growth[3][4].

Pharmaceutical Applications

The pharmaceutical sector is another significant driver, with magnesium sulfate being used in medical treatments such as managing eclampsia during pregnancy and as a magnesium supplement. The growing demand from the pharmaceutical industry for various drugs and therapeutic solutions further fuels market growth[3].

Food and Beverage Industry

Magnesium sulfate is used as a stabilizer, firming agent, flavor enhancer, and nutrient supplier in the food and beverage industry. The increasing demand for processed meat, dairy products, and seafood, driven by preferences for healthy and functional foods, also contributes to market expansion[4].

Construction Industry

In the construction sector, magnesium sulfate is used as a setting retarder in cement and concrete, particularly in large-scale projects requiring controlled setting times. This application is expected to contribute to market growth in the construction sector[3].

Regional Market Dynamics

United States

The U.S. magnesium sulfate market is growing at a CAGR of 3.5% from 2023 to 2033, with the market value expected to increase from USD 33.3 million in 2023 to USD 100.5 million by 2033. This growth is largely attributed to increased pharmaceutical applications[1].

China

China leads the magnesium sulfate market with a CAGR of 4.1% from 2023 to 2033. The market in China is projected to grow from USD 242.4 million in 2023 to USD 470.8 million by 2033, driven by its prominent role as a producer and exporter of magnesium sulfate[1].

Supply-Side Trends

Raw Materials and Production

The magnesium sulfate industry is interconnected with several other industries, sourcing raw materials and chemicals while distributing finished products. This interdependence fuels market growth and stability[1].

Research and Development

Higher research and development activities, particularly in pharmaceutical applications, are driving innovation and growth in the magnesium sulfate market. The advent of heptahydrate magnesium sulfate in pharmaceuticals is a notable example[1].

Demand-Side Trends

End-Use Industries

The demand for magnesium sulfate is driven by its diverse applications in agriculture, pharmaceuticals, food and beverage, and construction. Growing demand from these end-use industries is expected to augment market growth[1][3].

Healthcare Sector

The growth of the healthcare sector and changing health practices also influence the dynamics of the magnesium sulfate market. Its use in medical treatments and as a supplement continues to drive demand[3].

Challenges and Restraints

COVID-19 Impact

The COVID-19 pandemic had a significant impact on the magnesium sulfate market, particularly affecting chemical research and development facilities and logistical operations. However, the market has shown resilience and is now on a recovery path[1][5].

Organic Farming Trends

The rise of organic farming has had an adverse impact on the demand for conventional agricultural-grade magnesium sulfate. However, conventional farming remains the dominant form, ensuring continued sales[1].

Mid-term and Long-term Growth

Short-term Growth (2023 to 2026)

During this period, the rising utilization of magnesium sulfate in chemicals, agriculture, pharmaceuticals, and other end-use industries will be a key driver of market growth. The market is expected to experience rapid growth and hold a significant share by the end of this period[1].

Mid-term Growth (2026 to 2029)

Growth in this period will be attributed to expanding agricultural growth and significant developments in end-use industries. The growing demand from the food and beverage industry will further augment market growth[1].

Key Statistics and Projections

• Global Market Value: Expected to reach USD 1.68 billion by 2033 from USD 1 billion in 2023, growing at a CAGR of 5.7%[1].
• Heptahydrate Magnesium Sulfate: Generated almost 40% of the total revenue in 2022[1].
• China Market: Projected to grow at a CAGR of 4.1% from 2023 to 2033, reaching USD 470.8 million by 2033[1].
• U.S. Market: Expected to grow at a CAGR of 3.5% from 2023 to 2033, reaching USD 100.5 million by 2033[1].

Expert Insights and Quotes

"The growing use of magnesium sulfate in agriculture is boosting its sales in current years," - Market Research Future[3].

Illustrative Statistics

• The global magnesium sulfate heptahydrate market is expected to reach USD 290.41 million by 2030[2].
• The magnesium sulfate market size was valued at USD 815.22 million in 2023 and is projected to grow to USD 1136.74 million by 2032, exhibiting a CAGR of 3.79%[3].

Key Takeaways

• The magnesium sulfate market is driven by its applications in agriculture, pharmaceuticals, food and beverage, and construction.
• The market is expected to grow at a CAGR of 5.7% from 2023 to 2033.
• Regional markets, particularly China and the U.S., are significant contributors to the global growth.
• The heptahydrate magnesium sulfate segment is a major revenue generator.
• The market faces challenges from the rise of organic farming but remains resilient due to the dominance of conventional farming.

FAQs

1. What are the primary applications of magnesium sulfate?

Magnesium sulfate is used in agriculture to improve soil structure and crop yields, in pharmaceuticals for medical treatments, in the food and beverage industry as a stabilizer and firming agent, and in construction as a setting retarder in cement and concrete.

2. How is the global magnesium sulfate market expected to grow?

The global magnesium sulfate market is expected to grow at a CAGR of 5.7% from 2023 to 2033, reaching a value of USD 1.68 billion by 2033.

3. Which region is leading the magnesium sulfate market?

China is leading the magnesium sulfate market with a CAGR of 4.1% from 2023 to 2033, projected to reach USD 470.8 million by 2033.

4. What impact did the COVID-19 pandemic have on the magnesium sulfate market?

The COVID-19 pandemic adversely affected the magnesium sulfate market by impacting chemical research and development facilities and logistical operations, but the market is now recovering.

5. How does organic farming affect the demand for magnesium sulfate?

The rise of organic farming has had an adverse impact on the demand for conventional agricultural-grade magnesium sulfate, but conventional farming remains dominant, ensuring continued sales.

Cited Sources:

1. Future Market Insights - Magnesium Sulfate Market - Growth Drivers & Opportunities
2. News Channel Nebraska - Global Magnesium Sulfate Heptahydrate Market [2024-2032] Booming
3. Market Research Future - Magnesium Sulphate Market Analysis
4. Fact.MR - Magnesium Sulphate Market Size & Growth Analysis | By 2034
5. Global Banking and Finance - Magnesium Sulphate Market Projections & Key Insights