Cupric sulfate; manganese sulfate; selenious acid; zinc sulfate - Generic Drug Details

What are the generic drug sources for cupric sulfate; manganese sulfate; selenious acid; zinc sulfate and what is the scope of freedom to operate?

Cupric sulfate; manganese sulfate; selenious acid; zinc sulfate is the generic ingredient in two branded drugs marketed by Am Regent and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cupric sulfate; manganese sulfate; selenious acid; zinc sulfate has six patent family members in six countries.

One supplier is listed for this compound.

Summary for cupric sulfate; manganese sulfate; selenious acid; zinc sulfate

International Patents:	6
US Patents:	5
Tradenames:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cupric sulfate; manganese sulfate; selenious acid; zinc sulfate
DailyMed Link:	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cupric sulfate; manganese sulfate; selenious acid; zinc sulfate

Dosage:

SOLUTION;INTRAVENOUS

^*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.

Pharmacology for cupric sulfate; manganese sulfate; selenious acid; zinc sulfate

Drug Class	Copper Absorption Inhibitor Paramagnetic Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity
Physiological Effect	Decreased Copper Ion Absorption

Anatomical Therapeutic Chemical (ATC) Classes for cupric sulfate; manganese sulfate; selenious acid; zinc sulfate

A12CB	Zinc
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

Paragraph IV (Patent) Challenges for CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRALEMENT	Injection	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	0.3 mg/mL, 55 mcg/mL, 60 mcg/mL, 3 mg/mL (5 mL)	209376	1	2023-11-16
TRALEMENT	Injection	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	0.3 mg/mL, 55 mcg/mL, 60 mcg/mL, 3 mg/mL (5 mL)	209376	3	2023-11-14

US Patents and Regulatory Information for cupric sulfate; manganese sulfate; selenious acid; zinc sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-001	Jul 2, 2020		RX	Yes	Yes
Am Regent	MULTRYS	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-003	Jun 30, 2021		RX	Yes	Yes
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-001	Jul 2, 2020		RX	Yes	Yes			Y
Am Regent	MULTRYS	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-003	Jun 30, 2021		RX	Yes	Yes
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-002	Dec 2, 2020		RX	Yes	Yes
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-002	Dec 2, 2020		RX	Yes	Yes

International Patents for cupric sulfate; manganese sulfate; selenious acid; zinc sulfate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2022006426
Canada	3186578	COMPOSITIONS D'OLIGO-ELEMENTS, LEURS PROCEDES DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE)
European Patent Office	4175615
China	116096423
China	116096423	微量元素组合物、制备方法及应用 (Microelement composition, preparation method and application)
South Korea	20230058047

Market Dynamics and Financial Trajectory for Copper Sulfate, Manganese Sulfate, Selenious Acid, and Zinc Sulfate

Last updated: July 29, 2025

Introduction

The global pharmaceutical and agricultural sectors heavily depend on mineral salts such as copper sulfate, manganese sulfate, selenious acid, and zinc sulfate. These compounds serve critical roles—from nutritional supplements and animal feed additives to industrial applications—driving substantial market demand. This report analyzes their market forces, growth trajectory, and financial outlook, providing stakeholders with actionable insights into their evolving landscape.

Market Overview

Copper Sulfate

Renowned for its fungicidal properties, copper sulfate (CuSO₄) finds extensive use in agriculture, water treatment, and industrial processes [1]. Its demand is closely tethered to global agriculture practices and environmental regulations. The global copper sulfate market was valued at approximately USD 500 million in 2022, with expectations to grow at a CAGR of 5% through 2028.

Manganese Sulfate

Manganese sulfate (MnSO₄) primarily serves as an animal feed additive and a fertilizer component. Its ascendancy in livestock nutrition and crop enhancement sustains a steady growth trend, with the market projected to reach USD 475 million by 2028, growing at an estimated 4.8% CAGR [2].

Selenious Acid

A vital trace element, selenious acid (H₂SeO₃), is mainly utilized as a dietary supplement and in pharmaceuticals for its antioxidant properties. Although market size remains niche, increasing awareness around selenium deficiency and its health implications propels market expansion, forecasted at a 4.2% CAGR till 2028.

Zinc Sulfate

With broad applications in animal nutrition, pharmaceuticals, and industrial domains, zinc sulfate (ZnSO₄) exhibits one of the most expansive markets among mineral salts. Estimated to be worth USD 1.2 billion in 2022, its growth is driven by rising health consciousness and regulatory pressures on food quality.

Market Drivers

Growing Demand for Mineral-Based Pharmaceuticals & Supplements

Increased consumer health consciousness and aging populations worldwide are accelerating demand for mineral supplements containing zinc, selenium, and manganese [3].

Agricultural Intensification & Sustainable Practices

Government policies favoring sustainable farming practices, including micronutrient fortification, bolster demand for mineral salts like copper and zinc in fertilizers and pesticides.

Regulatory Landscape & Environmental Compliance

Tighter regulations on water treatment and industrial waste management in North America, Europe, and Asia-Pacific necessitate mineral salts in treatment processes, sharpening the market for copper sulfate and manganese sulfate.

Emerging Markets & Industrialization

Rapid industrial growth in Asia, Latin America, and Africa amplifies the need for mineral salts in manufacturing, agriculture, and infrastructure projects, further strengthening market trajectories.

Market Challenges

Environmental and Health Regulations

Restrictions on the use of certain mineral salts owing to environmental impacts—particularly copper and zinc runoff—may dampen growth prospects [4].

Supply Chain Disruptions

Geopolitical tensions, mining regulations, and logistical bottlenecks threaten consistent supply, escalating raw material costs.

Volatility in Raw Material Prices

Fluctuations in mineral extraction costs directly influence the profitability and pricing strategy for manufacturers.

Technological and Competitive Risks

The advent of synthetic or alternative compounds could disrupt traditional mineral salt markets.

Financial Trajectory & Investment Outlook

Revenue Growth Expectations

The combined market value of these mineral salts is projected to grow from USD 2.7 billion in 2022 to over USD 3.4 billion by 2028, representing a CAGR of approximately 4.7%. The agricultural sector will continue to dominate, accounting for nearly 65% of total demand.

Profitability and Investment Trends

Leading players like Quintech, American Elements, and Chemtrade Logistics are investing heavily in capacity expansion and quality enhancement, signaling confidence in sustained growth. Margins are expected to remain stable, supported by technological improvements and growing application diversity.

Mergers & Acquisitions

Consolidation emerges as a strategic trend, with several acquisitions aimed at expanding product portfolios and geographic footprint, especially in emerging markets.

Emerging Opportunities

Innovative formulations integrating mineral salts into functional foods, pharmaceuticals, and eco-friendly crop protection agents open new revenue streams. Additionally, the integration of sustainable extraction practices will appeal to environmental-conscious investors.

Regional Analysis

North America

Dominates due to stringent regulations enhancing demand for water treatment additives and animal nutrition products. Market growth is projected at 4.2% CAGR.

Europe

Focus on sustainable agriculture and stringent environmental policies propel growth, with major investments aimed at eco-friendly mineral extractants.

Asia-Pacific

The fastest-growing regional market, fueled by rising agricultural productivity and increasing industrialization. CAGR estimated at 6%, driven by China, India, and Southeast Asia.

Latin America & Africa

Emerging markets offer significant untapped potential, especially in livestock and crop supplementation, albeit with infrastructural challenges.

Future Outlook and Strategic Recommendations

Stakeholders should prioritize sustainable sourcing, regulatory compliance, and innovation in formulations. Investing in R&D to develop bio-based or low-environmental-impact mineral salts can open premium markets. Strategic partnerships across regions will mitigate supply risks and optimize distribution channels.

The integration of digital supply chain management and predictive analytics will enhance market responsiveness, ensuring resilience against geopolitical or economic shocks.

Key Takeaways

• The global market for copper sulfate, manganese sulfate, selenious acid, and zinc sulfate is poised for steady growth driven by agriculture, health supplements, and industrial applications.

• Regulatory pressures, environmental considerations, and technological innovation will influence market dynamics, requiring adaptive strategies.

• Regional markets display varied growth patterns, with Asia-Pacific emerging as a high-growth zone.

• Investment opportunities exist in sustainable extraction, formulation innovation, and supply chain optimization.

• Mergers and acquisitions will play a crucial role in market consolidation and expansion.

FAQs

1. What factors most influence the pricing of mineral salts like copper sulfate and zinc sulfate?
Primarily, raw material costs, environmental regulations, supply chain stability, and demand in agriculture and industry influence pricing.

2. How do environmental regulations impact the manufacturing of these mineral salts?
Stringent regulations on discharge pollutants and mining practices can increase compliance costs, potentially constraining production and raising prices.

3. Are there emerging markets for mineral salts in the pharmaceutical sector?
Yes, increasing awareness of micronutrient deficiencies and the development of nutraceuticals stimulate demand, especially for selenium and zinc in dietary supplements.

4. What technological innovations could disrupt the current mineral salt markets?
Development of synthetic alternatives, biofortification techniques, and environmentally friendly extraction methods could reshape demand.

5. How does regional economic growth influence demand for these mineral salts?
Rapid industrialization and agricultural expansion in emerging economies directly correlate with increased consumption of mineral fertilizers and supplements.

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Sources

[1] MarketsandMarkets, "Copper Sulfate Market," 2022.
[2] Future Market Insights, "Manganese Sulfate Market," 2022.
[3] Expert Reports, "Mineral Supplements Industry Analysis," 2023.
[4] Environmental Protection Agency, "Regulations and Market Impact," 2022.