Zinc sulfate - Generic Drug Details

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

Zinc sulfate is the generic ingredient in one branded drug marketed by Abraxis Pharm, Am Regent, Apotex, Aspiro, Fresenius Kabi Usa, Gland, Nivagen Pharms Inc, Rk Pharma, Somerset Theraps Llc, and Zydus Pharms, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for zinc sulfate. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for zinc sulfate

US Patents:	0
Tradenames:	1
Applicants:	10
NDAs:	10
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	1,203
Patent Applications:	6,454
Drug Sales Revenues:	Drug sales revenues for zinc sulfate
What excipients (inactive ingredients) are in zinc sulfate?	zinc sulfate excipients list
DailyMed Link:	zinc sulfate at DailyMed

See drug sales revenues for zinc sulfate

Recent Clinical Trials for zinc sulfate

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

Sponsor	Phase
Ganesh M. Shankar	PHASE2
Nebraska Methodist Health System	PHASE3
Hennepin Healthcare Research Institute	PHASE1

See all zinc sulfate clinical trials

Generic filers with tentative approvals for ZINC SULFATE

Applicant	Application No.	Strength	Dosage Form
		3UG/1ML	INJECTION
		6UG/1ML	INJECTION
		1000UG/1ML	INJECTION

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 zinc sulfate

Drug Class	Copper Absorption Inhibitor
Physiological Effect	Decreased Copper Ion Absorption

Medical Subject Heading (MeSH) Categories for zinc sulfate

Astringents

Anatomical Therapeutic Chemical (ATC) Classes for 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

US Patents and Regulatory Information for zinc sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	218059-001	Jun 10, 2024	AP	RX	No	No
Somerset Theraps Llc	ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	216135-002	Jul 17, 2024	AP	RX	No	No
Am Regent	ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	209377-003	Apr 15, 2020	AP	RX	Yes	Yes
Aspiro	ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	219585-003	May 1, 2025	AP	RX	No	No
Am Regent	ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	209377-002	Jul 18, 2019	AP	RX	Yes	Yes
Gland	ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	216249-003	Sep 1, 2023	AP	RX	No	No

Market Dynamics and Financial Trajectory for Zinc Sulfate

Last updated: July 29, 2025

Introduction

Zinc sulfate, an inorganic compound with the chemical formula ZnSO₄, serves a broad spectrum of applications in pharmaceuticals, agriculture, and industrial practices. The pharmaceutical segment has notably leveraged zinc sulfate for its efficacy in treating zinc deficiency, dermatological conditions, and as an adjunct in managing various health disorders. Understanding its market dynamics and financial trajectory is crucial for stakeholders seeking investment opportunities, strategic expansion, or competitive positioning within the sector.

Pharmaceutical Applications of Zinc Sulfate

In the pharmaceutical industry, zinc sulfate is primarily utilized as an oral supplement to treat and prevent zinc deficiency, which underpins immune health, skin integrity, and cellular function [1]. Its therapeutic use extends to managing dermatological conditions such as acne vulgaris, warts, and eczema, owing to its anti-inflammatory and antimicrobial properties [2]. Zinc sulfate is also incorporated into multivitamin formulations and used in topical preparations, making it a versatile compound with steady demand in healthcare products.

Market Drivers

Growing Prevalence of Zinc Deficiency

The incidence of zinc deficiency globally fuels the demand for zinc sulfate. According to WHO, zinc deficiency affects about 17% of the population worldwide, predominantly in developing countries where nutritional deficits are prevalent [3]. As awareness heightens and health monitoring improves, the need for zinc supplementation escalates, impacting market growth positively.

Rising Healthcare Expenditure

An increase in healthcare spending, particularly in emerging economies, complements the growth, enabling broader distribution of zinc sulfate-based pharmaceuticals. Governments and NGO programs target micronutrient deficiencies, translating to sustained demand.

Expansion of Pharmaceutical Formulations

Innovative drug delivery systems and the integration of zinc sulfate into new formulations, including combination therapies, promote ongoing market expansion. The focus on pediatric and geriatric nutritional supplementation further sustains demand.

Regulatory and Economic Factors

Regulatory approvals in various jurisdictions foster market stability. Conversely, the affordability and accessibility of zinc sulfate make it a preferred choice in public health interventions, particularly in low- and middle-income countries.

Market Challenges

High Competition and Price Sensitivity

The market is highly competitive, with multiple producers across regions. Price volatility, raw material costs, and regulatory barriers influence profitability, especially amid commoditized zinc sulfate products.

Stringent Regulatory Frameworks

Different jurisdictions impose varying standards for pharmaceutical ingredients, necessitating compliance costs for manufacturers. These regulatory demands can slow product approval and market entry.

Environmental and Supply Chain Concerns

Environmental considerations related to mining and processing zinc impact supply stability and cost. Disruptions in raw material availability or geopolitical factors may pose logistical challenges.

Market Segmentation

Application-Based Segmentation

• Pharmaceuticals: Zinc sulfate tablets, capsules, topical ointments.
• Agricultural: As a micronutrient fertilizer.
• Industrial: Used in electroplating and chemical manufacturing.

Geographical Segmentation

• North America: Dominates due to high healthcare expenditure.
• Europe: Growing awareness drives demand.
• Asia-Pacific: Fastest growth, particularly in India and China, driven by population size and nutritional deficiencies.
• Latin America and Africa: Emerging markets with increasing investment in health infrastructure.

Financial Trajectory and Market Forecasts

The global zinc sulfate market's valuation was approximately USD 250 million in 2022, with projections indicating a compound annual growth rate (CAGR) of 4-6% over the next five years [4]. The growth rate is supported by rising demand in emerging markets, increased healthcare awareness, and ongoing research into zinc's therapeutic benefits.

The pharmaceutical segment specifically is expected to maintain steady growth, driven by demand for zinc supplements amid aging populations and endemic nutritional deficiencies. Innovations such as slow-release formulations and combination therapies could further bolster revenue streams.

Competitive Landscape

Major players include firms like Archer Daniels Midland Company, GlaxoSmithKline, and local chemical manufacturers in Asia. Their strategies encompass expanding production capacities, acquiring smaller competitors, and investing in R&D to develop enhanced delivery forms.

Strategic partnerships and compliance with international standards like USP, EP, and JP are critical to market penetration.

Future Outlook

The outlook for zinc sulfate in pharmaceuticals remains positive, with diversification into emerging markets and integration into broader nutritional and dermatological health products. Market players that prioritize sustainable sourcing, regulatory compliance, and innovation are poised to capitalize on the growing demand.

Technological advancements, particularly in nanotechnology and drug delivery systems, may create opportunities for higher-margin products and novel therapeutic applications.

Key Opportunities

• Expansion into underserved markets with high zinc deficiency prevalence.
• Development of advanced formulations to improve bioavailability.
• Strategic alliances with healthcare providers and public health agencies.
• Sustainable sourcing practices aligned with environmental regulations.

Risks and Considerations

• Potential regulatory hurdles delaying product launches.
• Price fluctuations of zinc raw materials due to geopolitical or environmental factors.
• Market saturation in mature economies.
• Competitive pressures from alternative micronutrient therapies.

Key Takeaways

• The zinc sulfate market is driven by global health concerns around zinc deficiency, with the pharmaceutical sector serving as a primary growth vector.
• Emerging markets, especially in Asia-Pacific, represent significant growth opportunities owing to demographic and nutritional trends.
• Steady CAGR projections of 4-6% over the coming years underscore resilience but require strategic agility to navigate competitive and regulatory landscapes.
• Investment in innovation, sustainable sourcing, and regulatory compliance remains crucial for market participants aiming for long-term growth.
• Market volatility may arise from raw material prices and geopolitical impacts, necessitating robust supply chain management.

FAQs

1. How is the demand for zinc sulfate expected to change in the pharmaceutical industry over the next decade?
Demand is projected to grow steadily, driven by increasing awareness of zinc deficiency, aging populations requiring nutritional supplementation, and expanded therapeutic applications. Emerging markets will be particularly influential.

2. What are the primary regulatory challenges impacting zinc sulfate's pharmaceutical market?
Regulatory challenges include compliance with quality standards (USP, EP, JP), approval processes for new formulations, and environmental regulations impacting sourcing and manufacturing.

3. Which regions are leading in zinc sulfate market growth?
Asia-Pacific leads in growth, fueled by large populations and nutritional deficiencies. North America and Europe maintain significant markets due to high healthcare expenditure and established pharmaceutical industries.

4. How do raw material costs influence the financial trajectory of zinc sulfate producers?
Fluctuations in zinc ore prices impact production costs. Price volatility can affect profit margins, prompting manufacturers to seek cost-effective sourcing and innovate supply chain strategies.

5. What future innovations could influence zinc sulfate's pharmaceutical applications?
Advancements include nanotechnology-based delivery systems, slow-release formulations, and combination therapies which could enhance bioavailability and therapeutic efficacy, opening new revenue streams.

References

[1] World Health Organization (WHO). "Micronutrients: Zinc." 2021.
[2] Patel, S., et al. "Clinical applications of zinc sulfate in dermatology." Journal of Dermatological Therapy, 2020.
[3] WHO. "Zinc Deficiency." 2022.
[4] MarketResearch.com. "Global Zinc Sulfate Market Forecasts." 2022.