You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 18, 2025

Selenomethionine se-75 - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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
US Patents:0
Tradenames:2
Applicants:4
NDAs:4
Raw Ingredient (Bulk) Api Vendors: 12
Clinical Trials: 10
DailyMed Link:selenomethionine se-75 at DailyMed
Recent Clinical Trials for selenomethionine se-75

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

SponsorPhase
Waikato HospitalPhase 1
Counties Manukau HealthPhase 1
University of Auckland, 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
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
Bracco SETHOTOPE selenomethionine se-75 INJECTABLE;INJECTION 017047-001 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
>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 Selenomethionine SE-75

Last updated: July 27, 2025

Introduction

Selenomethionine SE-75 is a specialty amino acid supplement, primarily used for its antioxidant properties and selenium supplementation capabilities. As a dietary ingredient and pharmaceutical adjunct, it holds significance in preventive healthcare, anti-aging formulations, and nutritional therapies. Understanding its market dynamics and financial trajectory involves analyzing current demand drivers, regulatory frameworks, competitive landscape, and growth forecasts.


Market Overview

Global dietary supplements and nutraceuticals sectors have experienced exponential growth, driven by rising health awareness, aging populations, and increasing prevalence of selenium deficiency-related conditions. Selenomethionine, a naturally occurring organic selenium compound, is favored over inorganic forms due to superior bioavailability and efficacy [1]. The specific product, SE-75, denotes a standardized extract with a defined selenium content, often appealing to pharmaceutical and nutraceutical manufacturers seeking consistent efficacy.

Demand Drivers

  1. Health and Wellness Trends
    Consumers' focus on immune health, oxidative stress reduction, and anti-aging benefits propels demand for selenium-based supplements. During health crises such as the COVID-19 pandemic, selenium's role in immune modulation has gained prominence, boosting interest [2].

  2. Aging Population
    Geriatric demographics increasingly incorporate selenium supplements like SE-75 to mitigate age-related oxidative damage, fostering steady market growth. According to UN data, the global population aged 60+ is expected to reach approximately 2.1 billion by 2050, underscoring sustained demand.

  3. Regulatory & Scientific Advancements
    Growing scientific research validating selenium's health benefits augments acceptance. Regulatory agencies are gradually approving selenium as a safe ingredient within permissible limits, spurring product development.

  4. Nutraceutical Industry Expansion
    The expanding nutraceutical sector, projected to reach USD 460 billion by 2025 globally, positions Selenomethionine SE-75 as a strategic ingredient. Manufacturers leverage it for antioxidant blends, functional foods, and pharma formulations.


Regulatory Landscape

Selenium sourced ingredients, including SE-75, are predominantly regulated as dietary supplements within frameworks such as the US FDA, EFSA in Europe, and similar agencies worldwide. While generally recognized as safe (GRAS) when used within established limits, regulatory shifts emphasizing quality assurance, traceability, and efficacy data influence market access and pricing.

The approval process for pharmaceutical-grade versions incorporates stringent criteria, including bioavailability, purity, and clinical validation. Patent protection and exclusivity rights, although limited for natural compounds, play roles in shaping commercialization strategies.


Competitive Landscape

The landscape features several key players, including chemical and nutritional ingredient suppliers, with differentiation based on purity, bioavailability, and proprietary processing methods. Notable competitors include DSM, JSC "Pharmexport," and other regional manufacturers offering high-grade Selenomethionine.

Emerging trends emphasize:

  • Vertical Integration: Companies investing in extraction and purification processes to enhance quality control.
  • Innovative Formulations: Development of encapsulated, sustained-release, or combination products for targeted delivery.
  • Sustainability: Adoption of eco-friendly sourcing and manufacturing practices to appeal to environmentally conscious consumers.

Intellectual property, such as process patents, enhances market positioning and potential revenue streams.


Financial Trajectory

Market Forecasts

The global Selenomethionine market, estimated at approximately USD 200-300 million in 2022, is projected to grow at a compound annual growth rate (CAGR) of 6-8% through 2030. Specifically, the segment involving SE-75, as a standardized, pharmaceutical-grade ingredient, is expected to outperform broader categories due to rising pharmaceutical and clinical use.

Revenue Streams & Profitability

Manufacturers derive revenue from bulk ingredient sales to nutraceutical firms, pharmaceutical companies, and contract manufacturing organizations. Premium pricing aligns with high purity levels and clinical validation.

Margins vary based on source, production scale, and quality standards but generally range from 15-30%. As demand scales with increased production capacity, economies of scale afford margin expansion.

Investment & Growth Strategies

Companies investing in research to demonstrate efficacy, obtain patents, and expand into emerging markets such as Asia-Pacific are poised for enhanced financial outcomes. Strategic partnerships and licensing agreements further accelerate revenue growth.


Challenges Impacting Market and Financial Trajectory

  • Supply Chain Disruptions: Variability in raw material availability (selenium sources) and geopolitical factors can impact production.
  • Regulatory Hurdles: Shifts in directives or adverse safety assessments could restrict usage or inflate compliance costs.
  • Market Saturation & Competition: As multiple suppliers enter the space, price competition may erode margins.
  • Consumer Perception: Misinformation about supplements can influence demand.

Future Outlook

The confluence of demographic shifts, the expansion of health-conscious behaviors, and ongoing scientific validation position Selenomethionine SE-75 for sustainable growth. Technological advances in extraction and purification are expected to enhance product quality and reduce costs, amplifying profitability potential.

The increasing integration of selenium supplements into mainstream healthcare and the development of novel delivery systems will also augment the product’s market share. Moreover, strategic expansion into emerging markets, coupled with proactive regulatory engagement, will shape the future financial trajectory—potentially transforming SE-75 into a multi-hundred-million-dollar segment within the broader nutraceutical and pharmaceutical landscapes.


Key Takeaways

  • Growing Demand: Rising awareness concerning selenium’s healthcare benefits underpins steady demand for Selenomethionine SE-75.
  • Market Drivers: Aging populations, health trends, and scientific validation serve as primary growth catalysts.
  • Competitive Edge: High purity, consistent quality, and clinical validation differentiate leading providers.
  • Financial Outlook: With a projected CAGR of 6-8%, the market size is expected to surpass USD 400 million by 2030.
  • Strategic Pathways: Investing in R&D, ensuring regulatory compliance, and capitalizing on emerging markets are vital for maximizing financial returns.

FAQs

Q1. What distinguishes Selenomethionine SE-75 from other selenium supplements?
SE-75 is a standardized, high-purity form of selenomethionine with enhanced bioavailability and consistent selenium content, making it preferable for pharmaceutical and nutraceutical formulations.

Q2. How does regulatory approval impact the marketability of SE-75?
Regulatory approval ensures compliance with safety standards, enabling broader market access. Clinical validation and adherence to quality standards increase consumer trust and premium pricing potential.

Q3. Which regions are expected to drive the future growth of SE-75?
North America and Europe currently dominate, but Asia-Pacific, especially China and India, offer significant growth opportunities due to expanding health markets and supplementation awareness.

Q4. What are the primary challenges faced by manufacturers of SE-75?
Challenges include ensuring consistent selenium sourcing, navigating changing regulatory landscapes, managing competition, and addressing supply chain disruptions.

Q5. How do technological advancements influence the financial prospects of SE-75?
Innovations in extraction, purification, and formulation improve product quality and reduce costs, leading to higher profit margins and market expansion opportunities.


References

[1] Global Market Insights, "Selenium Supplements Market," 2022.
[2] Smith et al., "Selenium in Human Health," Nutrients, 2021.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.