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 patent protection?

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

Constraining patent/regulatory exclusivity:

12,150,957

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	11,975,022
Am Regent	MULTRYS	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-003	Jun 30, 2021		RX	Yes	Yes	12,150,957
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-002	Dec 2, 2020		RX	Yes	Yes	11,975,022
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-001	Jul 2, 2020		RX	Yes	Yes	11,998,565		Y
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-001	Jul 2, 2020		RX	Yes	Yes	11,786,548		Y
Am Regent	MULTRYS	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-003	Jun 30, 2021		RX	Yes	Yes	11,786,548		Y
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-002	Dec 2, 2020		RX	Yes	Yes	12,150,956

International Patents for CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE

Country	Patent Number	Title	Estimated Expiration
South Korea	20230058047
Australia	2021300384	Trace element compositions, methods of making and use
Australia	2021300384
European Patent Office	4175615	COMPOSITIONS D'OLIGO-ÉLÉMENTS, LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE)
World Intellectual Property Organization (WIPO)	2022006426
South Korea	20230058047	미량 원소 조성물, 그 제조 및 사용 방법
Canada	3186578	COMPOSITIONS D'OLIGO-ELEMENTS, LEURS PROCEDES DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE)

Market overview for Cupric Sulfate, Manganese Sulfate, Selenious Acid, and Zinc Sulfate

Last updated: February 14, 2026

The global market for these industrial and pharmaceutical compounds is governed by diverse factors, including agricultural demand, pharmaceutical applications, industrial use, and regulatory shifts. Their market performances differ regionally, influenced by raw material availability, manufacturing capacity, regulatory environments, and application-specific demand drivers.

---

Cupric Sulfate (CuSO₄): Market Size and Trends

Cupric sulfate, widely used in agriculture (fungicide, herbicide), water treatment, and as a molluscicide, has an estimated global market size of over $2 billion in 2022. The compound's market is expected to grow at a compound annual growth rate (CAGR) of 4.2% from 2023 to 2030.

Regional drivers include:

• North America: High adoption in water treatment.
• Asia-Pacific: Leading in agricultural use due to expanding farming activities.

Key factors influencing growth include increased demand for fungicides, regulatory compliance for water treatment, and sustainable pest control practices. Market expansion is limited by environmental regulations regarding copper accumulation, especially in water and soil.

Market dynamics:

Factor	Impact
Agricultural use	Growing demand for crop protection boosts market
Water treatment	Stringent regulations increase demand
Eco-regulation	Limits on copper accumulation pose constraints

---

Manganese Sulfate (MnSO₄): Market Size and Trends

Manganese sulfate is used primarily in animal feed, fertilizers, and industrial applications such as battery manufacturing. The market size stood at approximately $1.3 billion in 2022, projected to grow at a CAGR of 3.8% through 2030.

Key regional markets:

• China: Major producer and consumer due to large agricultural sector.
• North America & Europe: Demand driven by animal husbandry standards and fertilizer use.

Growth drivers include the rising demand for manganese in lithium-ion batteries and bioavailability enhancements in agriculture. Challenges include toxicity concerns and fluctuating raw material prices.

Market dynamics:

Factor	Impact
Battery industry	Increasing demand for manganese in lithium-ion batteries
Agriculture	Continued need for micronutrients enhances market
Regulatory issues	Concerns over manganese toxicity influence regulatory landscape

---

Selenious Acid (H₂SeO₃): Market Size and Trends

Selenious acid's niche applications include pharmaceuticals, dietary supplements, and research chemicals. Its global market size was approximately $400 million in 2022, with an expected CAGR of 5.0% up to 2030, driven by growing interest in selenium supplementation.

Market growth is concentrated in:

• North America: High supplement consumption.
• Europe: Increased pharmaceutical applications.

Supply constraints stem from limited selenium extraction capacity and environmental concerns over selenium mining. The compound's market is sensitive to regulatory policies surrounding selenium use in supplements and pharmaceuticals.

Market dynamics:

Factor	Impact
Nutritional supplementation	Rising health awareness fuels demand
Pharmaceutical use	Selenium-based drugs and diagnostics increase consumption
Supply constraints	Tightening environmental and mining regulations impact availability

---

Zinc Sulfate (ZnSO₄): Market Size and Trends

Zinc sulfate remains a versatile compound used in agriculture (fertilizers), animal feed, and healthcare products. The global market was valued at around $1.7 billion in 2022, growing at a CAGR of 4.5% through 2030.

Primary demand regions include:

• Asia-Pacific: Largest consumer due to extensive agriculture.
• North America and Europe: Strong pharmaceutical market for zinc supplements.

Growth is driven by increasing zinc supplementation in livestock, expanding organic farming practices, and zinc's antiviral properties. Constraints involve zinc ore resource limitations and environmental regulations around mining and processing.

Market dynamics:

Factor	Impact
Agriculture and animal feed	Sustains demand with increased focus on nutrition
Healthcare	Zinc's role in immune health boosts supplement sales
Regulatory environment	Stricter mining and environmental policies may limit supply

---

Summary of Key Market Drivers and Constraints

Compound	Key Drivers	Constraints
Cupric sulfate	Agriculture, water treatment, pest control	Environmental regulators on copper buildup
Manganese sulfate	Battery manufacturing, agriculture	Toxicity, raw material prices
Selenious acid	Supplements, pharmaceuticals	Limited supply, regulatory scrutiny
Zinc sulfate	Agriculture, health, nutrition	Mining restrictions, resource limitations

---

Financial Trajectory Outlook

Most compounds exhibit steady growth driven by industrial and pharmaceutical applications. The primary financial considerations include raw material costs, regulatory compliance expenses, and shifts in end-use markets.

Compared to general market growth, the pharmaceutical segment's CAGR for selenious acid and zinc sulfate is higher due to increasing health and nutritional demand, despite supply constraints. The agricultural segment for cupric sulfate and zinc sulfate benefits from expanding crop protection needs but faces increasing environmental regulations.

Investment opportunities exist in manufacturing capacity expansion, particularly in regions with favorable regulatory environments and raw material access. Early adoption of sustainable practices and innovative formulations may provide competitive advantages.

---

Key Takeaways

• Cupric sulfate’s growth is shaped by agriculture and water treatment needs but faces tightening environmental regulations.
• Manganese sulfate is increasingly relevant in batteries and agriculture, with supply chain considerations.
• Selenious acid’s niche lies in health and pharmaceuticals, with a supply constrained by selenium sourcing.
• Zinc sulfate remains vital for nutrition and agriculture, with growth influenced by health trends and resource management.
• Overall market growth remains stable, around 3.8%-5.0% annually, with regional variations affecting opportunities and risks.

---

FAQs

1. Which compound offers the highest market growth potential?
Selenious acid could outperform others due to increasing selenium supplementation and pharmaceutical application growth.

2. How do regulatory policies impact these compounds?
Stringent environmental regulations, especially for copper and zinc mining, limit supply expansion; pharmaceutical and supplement regulations influence market entry and innovation.

3. Are raw material shortages a concern?
Yes. Selenium and zinc resource constraints could disrupt supply chains, especially if environmental policies tighten globally.

4. What is the outlook for sustainable production practices?
Sustainable practices, including recycling and cleaner extraction techniques, are emerging as market differentiators, especially in copper and zinc sectors.

5. Who are the major producers?
Major producers include China, India, and countries in Europe and North America. Chinese capacity dominates manganese sulfate and zinc sulfate markets, while selenium production is concentrated in the US and China.

---

Sources

1. Market Research Future, "Global Cupric Sulfate Market," 2022.
2. Grand View Research, "Manganese Sulfate Market Size, Share & Trends," 2022.
3. Persistence Market Research, "Selenious Acid Market," 2022.
4. Markets and Markets, "Zinc Sulfate Market," 2022.