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Last Updated: December 18, 2025

SELENOMETHIONINE SE 75 Drug Patent Profile


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When do Selenomethionine Se 75 patents expire, and when can generic versions of Selenomethionine Se 75 launch?

Selenomethionine Se 75 is a drug marketed by Ge Healthcare, Mallinckrodt, and Pharmalucence. and is included in three NDAs.

The generic ingredient in SELENOMETHIONINE SE 75 is selenomethionine se-75. There is one drug master file entry for this compound. Additional details are available on the selenomethionine se-75 profile page.

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Summary for SELENOMETHIONINE SE 75
Drug patent expirations by year for SELENOMETHIONINE SE 75
Recent Clinical Trials for SELENOMETHIONINE SE 75

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

SponsorPhase
University of Auckland, New ZealandPhase 1
Cancer Trials New ZealandPhase 1
Waikato HospitalPhase 1

See all SELENOMETHIONINE SE 75 clinical trials

US Patents and Regulatory Information for SELENOMETHIONINE SE 75

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare SELENOMETHIONINE SE 75 selenomethionine se-75 INJECTABLE;INJECTION 017257-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mallinckrodt SELENOMETHIONINE SE 75 selenomethionine se-75 INJECTABLE;INJECTION 017098-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmalucence SELENOMETHIONINE SE 75 selenomethionine se-75 INJECTABLE;INJECTION 017322-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Selenium Methionine SE 75

Last updated: July 27, 2025


Introduction

Selenium Methionine SE 75 (hereafter referred to as SE 75) embodies a compound leveraging selenium's essential micronutrient properties. Incorporated primarily within the nutraceutical and pharmaceutical sectors, SE 75 is promoted for its antioxidant benefits, immune support, and potential roles in managing oxidative stress-related disorders. Its market trajectory is influenced by multifaceted factors, including evolving scientific research, regulatory landscapes, consumer health trends, and competitive positioning within the broader selenium supplement market.


Market Overview and Key Drivers

1. Increasing Awareness of Selenium's Health Benefits

Research consistently underscores selenium’s role as an essential trace element vital for optimal immune function, thyroid health, and antioxidant defense mechanisms [1]. The body of evidence supporting selenium’s efficacy in reducing oxidative stress has propelled consumer and healthcare provider interest. Notably, selenium amino acid chelates like SE 75 are favored due to higher bioavailability compared to inorganic options such as sodium selenite [2].

2. Growing Demand for Nutraceuticals and Dietary Supplements

The global nutraceuticals market surpassed USD 400 billion in 2022, with a compounded annual growth rate (CAGR) of approximately 7-8% projected through 2028 [3]. This momentum is driven by aging populations, increased health consciousness, and rising chronic disease prevalence. Selenium-based supplements, particularly in the form of amino acid chelates like SE 75, are increasingly incorporated into dietary regimens.

3. Regulatory Environment and Industry Standards

While selenium supplements are generally regarded as safe, regulatory scrutiny varies across geographies. The U.S. FDA and European authorities set maximum permissible levels due to selenium's narrow therapeutic window [4]. The approval pathways for new selenium formulations require rigorous documentation of bioavailability, safety, and efficacy, influencing manufacturing and commercialization strategies.

4. Competition and Market Positioning

SE 75 competes within the niche of organic, highly bioavailable selenium compounds. Key competitors include methylselenocysteine, selenomethionine from other suppliers, and inorganic selenium sources favored for cost-efficiency. The positioning of SE 75 hinges on its superior absorption profiles and targeted health claims.


Financial Trajectory Analysis

1. Revenue Streams and Market Segmentation

The primary revenue streams for SE 75 emanate from:

  • Nutraceutical Manufacturers: Formulating into capsules, tablets, and functional foods.
  • Pharmaceutical Sector: Developing adjunct therapies, especially in oncology and immunology.
  • Private Label Products: Retail brands marketing selenium supplements.

The market segmentation emphasizes aging adults, individuals with selenium deficiencies, and health-conscious consumers seeking antioxidant support.

2. Investment in R&D and Innovation

The financial trajectory depends significantly on ongoing research validating SE 75's benefits. Companies investing in human clinical trials and bioavailability studies can command premium pricing and secure regulatory approvals. Investment in novel delivery mechanisms (e.g., nano-formulations) can also bolster competitive edge.

3. Pricing Strategy and Profit Margins

Given the niche positioning, SE 75's premium formulation commands higher margins compared to inorganic selenium. However, production costs—stemming from high-purity synthesis, quality control, and regulatory compliance—must be managed effectively to sustain profitability.

4. Market Penetration and Growth Forecast

Analysts project the selenium supplement market to expand at a CAGR of approximately 6-8% over the next five years. With increased adoption of bioavailable compounds like SE 75, sales trajectories are expected to mirror or surpass industry averages. Expansion into emerging markets, especially Asia-Pacific and Latin America, will be critical to sustained growth.

5. Risks and Challenges

Key risks include regulatory restrictions, supply chain disruptions of raw materials, and competitive pressures. Additionally, conflicting research on selenium’s safety at high doses may temper demand expansion if not carefully managed by evidence-based claims.


Forecasting and Strategic Considerations

  • Short-term Outlook (1-2 years): Steady growth driven by incremental formulations and regional expansion. Companies should focus on securing regulatory clearances and increasing visibility through scientific publishing.
  • Mid-term Outlook (3-5 years): Potential market saturation may occur unless product differentiation (e.g., novel delivery systems,clinical validation) is prioritized.
  • Long-term Outlook (5+ years): Market consolidation and increased emphasis on personalized nutrition could redefine positioning. Partnerships with research institutions may unlock new therapeutic applications, fostering higher revenue streams.

Regulatory and Market Opportunities

Emerging scientific research suggests roles for selenium in managing COVID-19, cancer, and autoimmune diseases, presenting new avenues for SE 75 commercialization [5]. Regulatory approvals expanding into functional foods or medical foods could diversify revenue. Furthermore, potential patent protection of unique formulations enhances market exclusivity.


Conclusion

The financial trajectory of Selenium Methionine SE 75 hinges on robust scientific validation, strategic regulatory navigation, and effective market positioning within the growing nutraceutical space. As consumer preferences skew toward bioavailable and scientifically supported supplements, SE 75's premium attributes may facilitate sustained revenue growth. Nonetheless, rapid innovation, proactive regulatory compliance, and strategic global expansion will be essential to capitalize on its full market potential.


Key Takeaways

  • The selenium supplement market, especially premium chelated forms like SE 75, is poised for growth driven by increased health awareness and aging demographics.
  • Scientific validation of bioavailability and efficacy enhances market positioning, enabling premium pricing.
  • Navigating complex regulatory landscapes is essential to expand into diverse geographies and therapeutic sectors.
  • Investment in R&D and innovative delivery mechanisms can differentiate SE 75 from competitors and foster long-term revenue streams.
  • Market expansion into emerging regions offers significant growth opportunities, provided regulatory and supply chain risks are well-managed.

FAQs

1. What makes Selenium Methionine SE 75 stand out from other selenium sources?
SE 75 offers higher bioavailability due to its amino acid chelate structure, ensuring more efficient absorption and utilization compared to inorganic selenium forms like selenite or selenate.

2. Is SE 75 safe for long-term consumption?
When used within established safe dosage ranges, SE 75 is considered safe. However, exceeding recommended doses may lead to selenium toxicity, emphasizing the importance of regulatory compliance and consumer education.

3. What therapeutic areas could benefit from SE 75?
Potential applications include immune support, antioxidant therapy, thyroid health, cancer adjunct treatment, and autoimmune disorder management, supported by ongoing research.

4. How does regulatory oversight impact the commercialization of SE 75?
Regulatory authorities impose strict guidelines on selenium content, health claims, and manufacturing practices. Securing approvals requires comprehensive safety and efficacy data, influencing market entry timelines and costs.

5. What strategies should companies pursue for market growth with SE 75?
Focus on scientific validation, regulatory compliance, innovative formulations, strategic partnerships, and targeted marketing campaigns to enhance visibility and adoption across global markets.


Sources

[1] Rayman, M. P. (2012). Selenium and human health. The Lancet, 379(9822), 1256-1268.
[2] Fairweather-Tait, S. J., et al. (2010). Selenium bioavailability: current knowledge and future research requirements. The American Journal of Clinical Nutrition, 91(5), 1174S-1184S.
[3] Zion Market Research. (2022). Nutraceuticals Market by Ingredient, Form, and Application.
[4] U.S. Food and Drug Administration. (2021). Selenium - Dietary Supplement Guidance.
[5] Moghaddam, H. F., et al. (2020). Selenium supplementation and COVID-19: A review of potential benefits. Science of the Total Environment, 750, 141586.

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