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Last Updated: December 23, 2024

SELENOMETHIONINE SE-75 - Generic Drug Details


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What are the generic drug sources for selenomethionine se-75 and what is the scope of freedom to operate?

Selenomethionine se-75 is the generic ingredient in two branded drugs marketed by Ge Healthcare, Mallinckrodt, Pharmalucence, and Bracco, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Summary for SELENOMETHIONINE SE-75
Recent Clinical Trials for SELENOMETHIONINE SE-75

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

SponsorPhase
Counties Manukau HealthPhase 1
University of Auckland, New ZealandPhase 1
Cancer Trials New ZealandPhase 1

See all SELENOMETHIONINE SE-75 clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for SELENOMETHIONINE SE-75

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
Mallinckrodt SELENOMETHIONINE SE 75 selenomethionine se-75 INJECTABLE;INJECTION 017098-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pharmalucence SELENOMETHIONINE SE 75 selenomethionine se-75 INJECTABLE;INJECTION 017322-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ge Healthcare SELENOMETHIONINE SE 75 selenomethionine se-75 INJECTABLE;INJECTION 017257-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bracco SETHOTOPE selenomethionine se-75 INJECTABLE;INJECTION 017047-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SELENOMETHIONINE SE-75 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Selenomethionine Se-75

Introduction

Selenomethionine Se-75, a form of the essential trace element selenium, is increasingly recognized for its therapeutic and nutritional benefits. This article delves into the market dynamics and financial trajectory of Selenomethionine Se-75, exploring its uses, market trends, and potential financial implications.

Uses and Applications of Selenomethionine Se-75

Therapeutic Uses

Selenomethionine Se-75 is used in the treatment of various health conditions, most notably autoimmune thyroiditis. Studies have shown that daily intake of 200 μg of selenomethionine can significantly decrease serum TPOAb levels, indicating its efficacy in managing autoimmune thyroid diseases[1].

Nutritional Supplements

It is also used as a dietary supplement to ensure adequate selenium intake, which is crucial for maintaining redox homeostasis and supporting the function of selenoproteins[5].

Market Trends

Growing Demand for Selenium Supplements

The global market for selenium supplements is experiencing growth due to increasing awareness of the health benefits of selenium. The demand is driven by the rising incidence of thyroid disorders and other conditions where selenium deficiency is a contributing factor.

Expansion in Healthcare and Wellness

The healthcare and wellness industry is expanding, with a greater focus on preventive care and nutritional supplements. This trend is expected to boost the demand for selenomethionine and other selenium-based products.

Regulatory Environment

Safety and Efficacy Standards

Regulatory bodies such as the FDA play a crucial role in ensuring the safety and efficacy of selenomethionine supplements. Incidents of selenium toxicity, such as the one involving a misformulated dietary supplement, highlight the importance of strict regulatory oversight[2].

Labeling and Dosage Compliance

Manufacturers must comply with labeling and dosage regulations to avoid adverse health effects. The case of a dietary supplement containing 200 times the labeled concentration of selenium underscores the need for rigorous quality control measures[2].

Financial Trajectory

Revenue Growth

The market for selenomethionine Se-75 is expected to see revenue growth driven by increasing demand for selenium supplements and therapeutic applications. As more studies validate the health benefits of selenium, the market is likely to expand.

Investment in Research and Development

Pharmaceutical and supplement companies are investing in research to explore new applications of selenomethionine. This investment is expected to yield new products and therapies, further driving market growth.

Cost and Pricing

The cost of selenomethionine Se-75 can vary based on the form (organic vs. inorganic), dosage, and manufacturer. The pricing strategy will need to balance the cost of production with the willingness of consumers to pay for these supplements.

Competitive Landscape

Key Players

The market for selenomethionine Se-75 includes a mix of pharmaceutical companies, dietary supplement manufacturers, and research institutions. Key players are those that have established strong research and development capabilities and robust distribution networks.

Market Share

The competitive landscape is dynamic, with market share shifting based on innovation, regulatory compliance, and marketing strategies. Companies that can demonstrate the efficacy and safety of their products are likely to gain a larger market share.

Challenges and Opportunities

Toxicity Risks

One of the significant challenges is the risk of selenium toxicity, which can occur if the supplement is not formulated correctly or if consumers exceed the recommended dosage. This risk necessitates careful formulation and clear labeling[2].

Expanding into New Markets

There is an opportunity to expand the market for selenomethionine Se-75 into regions where selenium deficiency is prevalent. Educational campaigns and partnerships with local healthcare providers can help increase awareness and adoption.

Future Outlook

Emerging Applications

Research is ongoing to explore new therapeutic applications of selenomethionine, such as its potential role in cardiovascular health and other diseases. These emerging applications could significantly expand the market.

Technological Advancements

Advancements in technology, such as better methods for selenium uptake and accumulation in plants, could improve the efficiency and cost-effectiveness of producing selenomethionine supplements[3].

Key Takeaways

  • Growing Demand: The market for selenomethionine Se-75 is driven by increasing demand for selenium supplements and therapeutic applications.
  • Regulatory Compliance: Strict regulatory oversight is crucial to ensure safety and efficacy.
  • Financial Growth: The market is expected to see revenue growth driven by expanding applications and increasing awareness.
  • Competitive Landscape: Key players must innovate and comply with regulations to maintain market share.
  • Challenges and Opportunities: Managing toxicity risks and expanding into new markets are critical for market growth.

FAQs

What are the primary uses of Selenomethionine Se-75?

Selenomethionine Se-75 is primarily used in the treatment of autoimmune thyroiditis and as a dietary supplement to ensure adequate selenium intake.

What are the risks associated with Selenomethionine Se-75?

The primary risk is selenium toxicity, which can occur if the supplement is not formulated correctly or if consumers exceed the recommended dosage.

How does the regulatory environment impact the market for Selenomethionine Se-75?

Regulatory bodies ensure the safety and efficacy of selenomethionine supplements through strict labeling and dosage compliance, which is crucial for consumer safety and market trust.

What are the future outlook and emerging applications of Selenomethionine Se-75?

Research is ongoing to explore new therapeutic applications, such as cardiovascular health, and technological advancements could improve production efficiency.

Who are the key players in the market for Selenomethionine Se-75?

Key players include pharmaceutical companies, dietary supplement manufacturers, and research institutions with strong R&D capabilities and distribution networks.

Sources

  1. Selenium treatment in autoimmune thyroiditis: 9-month follow-up - Journal of Endocrinology[1]
  2. Acute Selenium Toxicity Associated With a Dietary Supplement - JAMA Internal Medicine[2]
  3. Uptake Dynamics of Ionic and Elemental Selenium Forms and Their Accumulation in Alfalfa - MDPI[3]
  4. Selenomethionine Se-75: Uses, Interactions, Mechanism of Action - DrugBank[4]
  5. Effect of dietary selenium intake on CVD: a retrospective cohort study - PMC[5]

More… ↓

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