SELENIOUS ACID Drug Patent Profile

Which patents cover Selenious Acid, and when can generic versions of Selenious Acid launch?

Selenious Acid is a drug marketed by Am Regent, Aspiro, Cipla, Fresenius Kabi Usa, Gland, and Sun Pharm. and is included in six NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has six patent family members in six countries.

The generic ingredient in SELENIOUS ACID is selenious acid. Three suppliers are listed for this compound. Additional details are available on the selenious acid profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Selenious Acid

A generic version of SELENIOUS ACID was approved as selenious acid by AM REGENT on April 30^th, 2019.

Summary for SELENIOUS ACID

International Patents:	6
US Patents:	2
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	3
Patent Applications:	3,441
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SELENIOUS ACID
What excipients (inactive ingredients) are in SELENIOUS ACID?	SELENIOUS ACID excipients list
DailyMed Link:	SELENIOUS ACID at DailyMed

Recent Clinical Trials for SELENIOUS ACID

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

Sponsor	Phase
American Regent, Inc.	Phase 4
Shanghai Changzheng Hospital	N/A
Shanghai Zhongshan Hospital	N/A

See all SELENIOUS ACID clinical trials

Paragraph IV (Patent) Challenges for SELENIOUS ACID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SELENIOUS ACID	Intravenous Solution	selenious acid	600 mcg/10 mL	209379	11	2024-06-11

US Patents and Regulatory Information for SELENIOUS ACID

SELENIOUS ACID is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-003	Aug 30, 2021	AP	RX	Yes	Yes	12,150,957
Aspiro	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	219633-001	Jun 11, 2025	AP	RX	No	No
Am Regent	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-002	Jan 25, 2021		RX	Yes	Yes	11,998,565		Y
Gland	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	219629-001	Jul 8, 2025	AP	RX	No	No
Aspiro	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	219633-002	Jun 11, 2025	AP	RX	No	No
Am Regent	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-003	Aug 30, 2021	AP	RX	Yes	Yes	11,998,565		Y
Am Regent	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-002	Jan 25, 2021		RX	Yes	Yes	12,150,957

International Patents for SELENIOUS ACID

See the table below for patents covering SELENIOUS ACID around the world.

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)
China	116096423
China	116096423	微量元素组合物、制备方法及应用 (Microelement composition, preparation method and application)
Australia	2021300384	Trace element compositions, methods of making and use
European Patent Office	4175615	COMPOSITIONS D'OLIGO-ÉLÉMENTS, LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE)
Canada	3186578

Market Dynamics and Financial Trajectory for Selenious Acid

Last updated: November 7, 2025

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Introduction

Selenious acid (hydrogen selenite, H₂SeO₃) is a selenium-containing compound primarily used as a dietary supplement, in industrial applications, and in the synthesis of pharmaceuticals and agrochemicals. Its market landscape is influenced by regulatory environments, technological advancements, and shifting consumer preferences towards selenium's health benefits. This article examines the current market dynamics and projects the financial trajectory of selenious acid, highlighting key trends, growth drivers, and challenges shaping its industrial landscape.

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Overview of Selenious Acid

Selenious acid is recognized for its antioxidant properties and essential role as a trace mineral. Its applications extend to nutritional supplements, where it supports immune function and thyroid health; in manufacturing, as a precursor in selenium-based compounds; and in electronics and glassmaking industries. The compound is available in various grades—pharmaceutical, food-grade, and industrial—each dictated by stringent purity standards and regulatory frameworks.

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Global Market Size and Growth Trends

Market Valuation and Historical Growth

The global selenious acid market has historically seen modest growth, driven predominantly by the expanding dietary supplement industry and increasing awareness of selenium's health benefits. Reported figures estimate the market size at approximately USD 150–200 million in 2022, reflecting a compound annual growth rate (CAGR) of around 4–6% over the past five years.

Projected Market Growth

Forecasts project the market will continue expanding at a CAGR of approximately 5–7% between 2023 and 2030, reaching USD 250–300 million by the end of this period. This growth is sustained by rising health consciousness, expansion into emerging markets, and increasing demand for selenium-enriched products across various industries.

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Key Market Drivers

Increasing Demand for Dietary Supplements

The rising global prevalence of selenium deficiency, driven by changing diets and soil depletion, has amplified demand for selenious acid as a key ingredient in supplements. Countries including the United States, China, and India are leading growth, prompted by government health initiatives and consumer awareness campaigns advocating for mineral supplementation.

Advancements in Industrial and Pharmaceutical Applications

Innovation in pharmaceutical formulations leveraging selenious acid's antioxidant properties supports its application in cancer prevention and radioprotection. Additionally, the compound's use in manufacturing selenium-based compounds enhances its industrial relevance, stimulating demand for high-purity grades.

Regulatory Support and Evolving Standards

Regulatory bodies such as the FDA and EFSA recognize selenium's role in health, facilitating a conducive environment for product approvals and market expansion. Moreover, increasing standards for trace mineral content in functional foods and nutraceuticals propel the need for high-quality selenious acid.

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Market Challenges

Toxicity and Regulatory Hurdles

Selenium’s narrow therapeutic window presents toxicity concerns, necessitating strict compliance with regulatory standards. Variations in regulatory requirements across regions can stifle market expansion, and incidents of selenosis (selenium poisoning) pose safety risks, demanding rigorous manufacturing controls.

Pricing Volatility and Raw Material Supply

Fluctuations in selenium feedstock prices—primarily derived from selenium-rich ores and byproducts of metal refining—impact manufacturing costs. Geopolitical factors and seasonal variations influence supply stability, affecting pricing and overall profitability.

Environmental and Ethical Concerns

Environmental risks associated with selenium runoff, especially from mining and industrial processes, prompt stringent environmental regulations and potential liabilities for manufacturers. Sustainable sourcing remains a critical challenge for market participants.

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Competitive Landscape

The market is characterized by a handful of key players, including industry giants and specialty chemical producers such as Sigma-Aldrich (Merck KGaA), Wako Chemicals, and industries in China and India. Innovation in synthesis methods—such as eco-friendly extraction and production—serves as differentiation strategies. Consolidation, strategic alliances, and capacity expansions are evident trends, aiming to secure supply chains and diversify applications.

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Financial Trajectory and Investment Outlook

Revenue Streams and Profit Margins

Revenue generation stems mainly from bulk sales to supplement manufacturers and industrial clients. Premium-grade selenious acid commands higher margins due to quality assurances and regulatory compliance. While raw material costs are volatile, proprietary synthesis processes can mitigate cost pressures and improve margins through economies of scale.

Investment in R&D and New Applications

Investments in research aim to uncover novel therapeutic uses of selenium compounds, improve manufacturing efficiency, and develop sustainable sourcing methods. Such initiatives enhance market value and open pathways for premium products with higher profit margins.

Emerging Markets and Regional Growth

Asia-Pacific dominates consumption owing to large populations, increasing health awareness, and industrial development. Rapid growth in China and India offers lucrative opportunities for localized production and lower-cost manufacturing, bolstering global supply.

Impact of Regulatory Developments

Tighter regulations, especially concerning maximum allowable intake and purity standards, heighten compliance costs but also create barriers to entry, favoring established players. Conversely, regulatory harmonization can streamline market entry across jurisdictions.

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Future Outlook and Strategic Recommendations

The selenious acid market is positioned for steady growth driven by diversified applications. Key strategic initiatives include:

• Investment in sustainable synthesis technologies reducing environmental impact.
• Expansion into emerging markets through partnerships and localized manufacturing.
• Diversification into high-margin pharmaceutical and nutraceutical segments.
• Strengthening regulatory compliance frameworks to mitigate market entry barriers.

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Key Market Trends

• Selenium Enrichment in Food and Beverages: Rising integration of selenium into functional foods boosts demand for high-quality selenious acid.
• Innovation in Delivery Formats: Development of compounds with enhanced bioavailability and reduced toxicity.
• Environmental Standards: Adoption of green chemistry practices aligns market growth with sustainability goals.
• Regulatory Milestones: Increasing global harmonization of selenium supplement regulations facilitates international trade.
• Digital and Data-Driven Market Insights: Leveraging analytics for supply chain optimization and consumer preferences.

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Conclusion

The global selenious acid market exhibits robust growth potential over the next decade, driven by the health benefits of selenium, industrial applications, and technological innovation. While regulatory hurdles and environmental concerns persist, strategic investments and compliance adherence will be pivotal for market participants seeking long-term competitiveness and profitability.

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Key Takeaways

• The selenious acid market is expected to grow at a CAGR of 5–7%, reaching approximately USD 250–300 million by 2030.
• Demand is predominantly fueled by the dietary supplement industry, especially in Asia-Pacific.
• Technological innovation and regulatory compliance are critical success factors.
• Environmental sustainability and quality assurance will influence procurement and manufacturing strategies.
• Emerging markets present significant growth opportunities, provided companies adapt to regional regulatory landscapes.

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FAQs

1. What are the primary industrial applications of selenious acid?
   Selenious acid is mainly used in the manufacturing of selenium-based compounds, in pharmaceuticals for antioxidant and therapeutic purposes, and in industries such as glassmaking and electronics for doping and additive functions.

2. How does regulatory framework influence the market for selenious acid?
   Regulations dictate purity standards, permissible daily intake, and labeling requirements, affecting manufacturing, pricing, and international trade. Stricter standards can increase costs but also enhance market confidence and safety.

3. What are the main challenges faced by manufacturers of selenious acid?
   Challenges include raw material supply volatility, toxicity concerns, environmental regulations, and maintaining high purity levels, all of which impact production costs and market expansion.

4. What opportunities exist for growth in emerging markets?
   Large populations with increasing health awareness, expanding nutraceutical sectors, and lower manufacturing costs make regions like China and India attractive for growth and investment.

5. How will innovation impact the future of selenious acid?
   Innovations in eco-friendly synthesis, improved bioavailability of selenium supplements, and novel therapeutic indications will create premium opportunities and foster market differentiation.

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Sources:
[1] Global Market Insights, "Selenium Compounds Market," 2022.
[2] Research and Markets, "Selenious Acid Market Analysis," 2023.
[3] European Food Safety Authority (EFSA), "Selenium Dietary Reference Values," 2021.
[4] Industry Reports, "Selenium in Pharmaceuticals and Nutraceuticals," 2022.