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Last Updated: December 19, 2025

SOYBEAN OIL - Generic Drug Details


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What are the generic sources for soybean oil and what is the scope of freedom to operate?

Soybean oil is the generic ingredient in twelve branded drugs marketed by Fresenius, Hospira, B Braun, Alpha Thera, and Baxter Hlthcare, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for soybean oil. Five suppliers are listed for this compound.

Summary for SOYBEAN OIL
Recent Clinical Trials for SOYBEAN OIL

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SponsorPhase
Anhui Medical UniversityNA
The Salvation Army Toronto Grace Health CentreNA
ScotiadermNA

See all SOYBEAN OIL clinical trials

Pharmacology for SOYBEAN OIL
Drug ClassLipid Emulsion
Anatomical Therapeutic Chemical (ATC) Classes for SOYBEAN OIL

US Patents and Regulatory Information for SOYBEAN OIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius INTRALIPID 30% soybean oil INJECTABLE;INJECTION 019942-001 Dec 30, 1993 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare TRAVAMULSION 10% soybean oil INJECTABLE;INJECTION 018660-001 Feb 26, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius INTRALIPID 10% soybean oil INJECTABLE;INJECTION 017643-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Alpha Thera SOYACAL 20% soybean oil INJECTABLE;INJECTION 018786-001 Jun 29, 1983 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare TRAVAMULSION 20% soybean oil INJECTABLE;INJECTION 018758-001 Feb 15, 1983 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun NUTRILIPID 10% soybean oil INJECTABLE;INJECTION 019531-001 May 28, 1993 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun NUTRILIPID 20% soybean oil INJECTABLE;INJECTION 019531-002 May 28, 1993 AP RX Yes Yes ⤷  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 Soybean Oil in the Pharmaceutical Sector

Last updated: July 30, 2025


Introduction

While traditionally recognized as a vital ingredient in food and industrial applications, soybean oil has gained relevance in the pharmaceutical industry due to its health-related properties and the extraction of bioactive compounds. Its multifaceted role spans from nutraceuticals to excipient uses, influencing market dynamics and financial trajectories in emerging segments. This analysis explores key drivers, market trends, competitive landscape, and financial outlook for soybean oil within the pharmaceutical domain.


Market Overview and Industry Significance

Soybean oil, derived from Glycine max, is the most widely consumed vegetable oil globally, with an estimated production volume exceeding 57 million metric tons in 2022 [1]. The expanding consumer focus on health, wellness, and plant-based ingredients underpin increased interest in soybean-derived products for pharmaceutical and nutraceutical applications. Its rich content of unsaturated fats, antioxidants, phytosterols, and omega-3 fatty acids positions it as a functional ingredient in medicine manufacturing and dietary supplements.

Pharmaceutical applications of soybean oil are primarily centered on:

  • Excipient use in drug formulations for emulsification.
  • Nutritional supplements targeting lipid deficiencies.
  • Bioactive compound extraction, especially isoflavones, with claimed therapeutic benefits.

The confluence of rising health awareness and evolving regulatory frameworks substantiates soybean oil’s emerging pharmaceutical significance.


Market Drivers

1. Increasing Demand for Plant-Based Pharmaceuticals

The growing consumer preference for plant-based and natural-origin medicines has catalyzed demand for soybean oil derivatives. The global shift towards organic and non-synthetic compounds aligns with sustainability initiatives, pushing pharmaceutical companies to incorporate soybean oil as a renewable raw material [2].

2. Rising Prevalence of Chronic Diseases

The global burden of cardiovascular disease, diabetes, and inflammatory conditions benefits from soybean oil’s lipid profile. Its high content of omega-3 and omega-6 fatty acids supports cardiovascular health and anti-inflammatory functions, prompting formulation of nutraceuticals and functional foods with pharmaceutical claims [3].

3. Regulatory Support and Safety Profile

Soybean oil’s well-documented safety, coupled with its GRAS (Generally Recognized as Safe) status from US FDA, facilitates its integration into pharmaceutical products. This regulatory backing encourages innovation and commercialization of soybean-derived medicinal ingredients.

4. Advancements in Extraction and Purification Technologies

Innovative extraction methods, such as supercritical fluid extraction and enzymatic processes, improve yield quality, enabling the production of high-purity soybean oil fractions suitable for pharmaceutical use. These technological advances underpin the scalability and reliability of supply chains [4].

5. Strategic Partnerships and Investments

Major agrochemical firms and pharmaceutical giants have invested in soybean oil supply chains and derivative development, fostering market growth. Notably, collaborations for functional ingredient development bolster research and commercialization prospects.


Market Trends and Challenges

1. Diversification of Soybean Oil Derivatives

Emerging markets for bioactive soybean components, such as phytosterols and isoflavones, are expanding pharmaceutical applications. These compounds serve as active ingredients or supplement additives, creating new revenue streams.

2. Quality and Standardization Concerns

Ensuring consistency in composition, purity, and bioavailability remains a challenge. Variability in soybean cultivars and extraction processes necessitates rigorous standardization to meet pharmaceutical regulatory standards.

3. Competition from Alternative Oils and Synthetic Compounds

Other plant oils (e.g., sunflower, flaxseed) and synthetic lipids pose competitive threats depending on efficacy, cost, and consumer perception. Soybean oil’s market share relies on its unique compositional advantages and supply stability.

4. Sustainability and Ethical Sourcing

Environmental considerations, such as deforestation and monoculture practices, attract scrutiny. Sustainable sourcing and traceability are critical to maintain consumer trust and compliance with environmental regulations.


Financial Trajectory and Investment Outlook

Market Valuation

The global market for soybean oil in pharmaceutical applications remains niche but is poised for accelerated growth. Projected compound annual growth rates (CAGR) for soybean oil-derived nutraceuticals and bioactive compounds stand at approximately 8-10% through 2030, driven by downstream innovations [5].

Revenue Streams and Profitability

  • Raw Material Sales: Stable supply contracts with upstream suppliers.
  • Extraction and Processing: High-margin operations for specialized soybean oil fractions.
  • Formulation and Innovation: Licensing patented extracts (e.g., soybean isoflavones) commands premium pricing.
  • Research and Development: Continued innovation enhances product efficacy and market value.

Investment Drivers

Capital investments are directed toward scaling extraction capacities, quality assurance, and R&D for novel derivatives. Governments and private investors project soybean oil’s potential to contribute significantly to sustainable bioactive ingredient markets, especially in the context of plant-based pharmaceuticals.

Risks and Mitigation

  • Supply Chain Disruptions: Climate change and geopolitical issues could impact soybean cultivation.
  • Regulatory Hurdles: Approval timelines for plant-based pharmaceuticals may span multiple years.
  • Market Acceptance: Consumer skepticism regarding efficacy necessitates clinical validation.

Emerging Opportunities

  • Nanotechnology Integration: Encapsulation of soybean oil bioactives enhances bioavailability.
  • Personalized Medicine: Tailoring soybean oil derivatives for specific therapeutic niches.
  • Sustainable Certification: Adoption of eco-labels to meet environmental standards and appeal to ethically conscious consumers.

Conclusion

Soybean oil’s evolving role in the pharmaceutical domain underscores a convergence of plant-based health benefits, technological innovations, and sustainability principles. While existing market size remains modest, the trajectory indicates robust growth driven by consumer demand, R&D advancements, and regulatory support. Strategic positioning and investment in high-quality extraction, standardization, and innovative product development will be pivotal to capitalize on soybean oil’s full potential in pharmaceutical applications.


Key Takeaways

  • The pharmaceutical relevance of soybean oil is expanding, with notable growth in nutraceuticals, bioactive compounds, and excipient markets.
  • Innovating extraction and refining methods enhances product quality, fostering regulatory approval and market acceptance.
  • Global demand is bolstered by rising chronic disease prevalence, consumer health consciousness, and sustainability commitments.
  • Market growth is susceptible to supply chain risks, regulatory challenges, and competitive pressures from alternative oils.
  • Investment opportunities are strongest in R&D, sustainable sourcing, and advanced formulations leveraging soybean oil derivatives.

FAQs

1. How does soybean oil compare to other plant oils in pharmaceutical applications?
Soybean oil offers a favorable fatty acid profile, abundant phytosterols, and established safety, making it a preferred choice. Its scalability and regulatory acceptance give it an edge over some alternative oils, though competition exists depending on specific bioactive requirements.

2. What are the primary bioactive compounds derived from soybean oil for pharmaceutical use?
Key compounds include soybean isoflavones, phytosterols, and lecithins. These exhibit antioxidant, anti-inflammatory, and hormone-like activities relevant to therapeutic formulations.

3. Are there regulatory barriers to using soybean oil derivatives in medicines?
Generally recognized as safe (GRAS) status facilitates use in nutraceuticals and dietary supplements. However, for pharmaceutical drugs, strict approvals via FDA or EMA are required, demanding rigorous testing for purity, efficacy, and safety.

4. What technological innovations are supporting soybean oil's pharmaceutical development?
Supercritical fluid extraction, enzymatic fractionation, and nanotechnology enable high-purity product manufacturing, improved bioavailability, and tailored delivery systems.

5. What sustainability considerations influence the market for soybean-derived pharmaceuticals?
Environmental impact from cultivation, deforestation, and monoculture practices are scrutinized. Adoption of sustainable farming practices, certifications, and traceability are integral to market acceptance and regulatory compliance.


References

[1] USDA Foreign Agricultural Service. "Oilseeds: World markets and trade." 2022.
[2] MarketsandMarkets. "Plant-Based Pharma Market Analysis," 2023.
[3] WHO. "Cardiovascular Diseases Fact Sheet," 2022.
[4] Kumar, S., et al. "Advances in extraction technologies for soybean oil," Journal of Food Engineering, 2021.
[5] Grand View Research. "Bioactive Compounds Market Size & Trends," 2023.

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