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Last Updated: June 14, 2025

Drugs in MeSH Category Surface-Active Agents


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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Elkins Sinn SOTRADECOL sodium tetradecyl sulfate INJECTABLE;INJECTION 005970-005 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Mylan Institutional SOTRADECOL sodium tetradecyl sulfate INJECTABLE;INJECTION 040541-002 Nov 12, 2004 AP RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hikma SODIUM TETRADECYL SULFATE sodium tetradecyl sulfate INJECTABLE;INJECTION 209937-001 Dec 9, 2019 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Mylan Institutional SOTRADECOL sodium tetradecyl sulfate INJECTABLE;INJECTION 040541-001 Nov 12, 2004 RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Elkins Sinn SOTRADECOL sodium tetradecyl sulfate INJECTABLE;INJECTION 005970-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Surface-Active Agents Market Analysis and Financial Projection

The market for surface-active agents (SAAs) in pharmaceuticals and related industries demonstrates robust growth driven by expanding applications and innovation, while the patent landscape reveals intensive R&D efforts focused on sustainability and advanced drug delivery systems.

Market Dynamics

The global surface-active agents market is projected to grow from $33.63 billion in 2024 to $47 billion by 2029 at a 6.8% CAGR[1][5]. Key drivers include:

  • Demand for Bio-Based Surfactants: Increasing environmental awareness and regulatory pressures are accelerating the shift toward renewable, biodegradable surfactants, particularly in personal care and pharmaceuticals[4][10].
  • Pharmaceutical Growth: SAAs are critical in drug delivery systems, stabilizing formulations, enhancing bioavailability, and enabling nanotechnology applications. The pharmaceutical surfactants market alone is forecasted to grow at a 10.5% CAGR, reaching $5.2 billion by 2028[9][13].
  • Regional Expansion: Asia-Pacific dominates the market (44% share)[1], fueled by industrialization and healthcare investments, while North America shows the fastest growth due to sustainability initiatives and advanced R&D[4][7].

Segmentation:

  • By Product: Non-ionic surfactants (e.g., fatty alcohol ethoxylates) lead due to low toxicity and versatility in formulations[1][5].
  • By Application: Pharmaceuticals and healthcare account for 25% of demand, driven by applications in emulsions, ophthalmic solutions, and protein stabilization[3][15].

Patent Landscape

Over 4,000 patents related to SAAs have been filed since 2010, with innovation focusing on:

  1. Drug Delivery Enhancements:

    • Stabilization Technologies: Patents like US10576187B2 cover layer-by-layer bioactive coatings for controlled drug release[11]. ReForm Biologics’ surfactant replacements (US10,016,513) reduce protein aggregation in biologics, addressing immunogenicity risks[15].
    • Ophthalmic Applications: SAAs improve corneal permeability in eye drops and contact lens solutions, with patents emphasizing biocompatibility[3].
  2. Sustainability and Bio-Based Formulations:

    • Microbial glycolipids (e.g., rhamnolipids) are patented for eco-friendly detergents and cosmetics, offering comparable performance to synthetic surfactants[16].
    • 35% of recent filings focus on green surfactants derived from renewable feedstocks[4][10].
  3. Combination Therapies and Biosimilars:

    • Expired patents for biologic drugs like trastuzumab have spurred biosimilar development, with formulations leveraging SAAs to circumvent original IP[6].
    • Patent clusters around liquid dosage forms and polymorph stabilization aim to extend product lifecycles[8][17].

Competitive and Regulatory Factors

  • Key Players: BASF, Evonik, and Croda International dominate through bio-based innovations and strategic acquisitions[4][13].
  • Challenges: Raw material volatility (e.g., petrochemical prices) and stringent regulatory compliance (e.g., EPA guidelines) hinder cost-effective scaling[7].

MeSH Classification and Industry Impact

The NLM MeSH class Surface-Active Agents (D013501) encompasses emulsifiers, detergents, and wetting agents critical to drug formulation[14]. Over 15% of patents cite MeSH terms to align with biomedical applications, particularly in:

  • Anticancer Therapies: SAAs improve solubility of hydrophobic drugs like paclitaxel[9].
  • Pulmonary Surfactants: Used in neonatal respiratory distress treatments, with patents targeting synthetic analogs for enhanced stability[14].

Future Outlook

The intersection of nanotechnology and bio-surfactants will drive next-gen drug delivery systems, while patent battles over biosimilars and formulation tweaks will intensify[6][16]. With 60% of industry leaders prioritizing sustainability, bio-based SAAs are poised to capture 40% of the market by 2030[10].

References

  1. https://www.thebusinessresearchcompany.com/report/surface-active-agents-global-market-report
  2. https://patents.google.com/patent/US3444242A/en
  3. https://pubmed.ncbi.nlm.nih.gov/30684539/
  4. https://www.stratviewresearch.com/3746/surfactants-market.html
  5. https://www.thebusinessresearchcompany.com/market-insights/global-surface-active-agents-market-2024
  6. https://pmc.ncbi.nlm.nih.gov/articles/PMC7188399/
  7. https://www.databridgemarketresearch.com/reports/u-s-surfactant-market
  8. https://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946.pdf
  9. https://github.com/rajvarma2516/Market-Research-Analysis/blob/main/1/Pharmaceutical-Surfactants-Market-Size-and-Opportunity-Analysis.md
  10. https://www.globenewswire.com/news-release/2024/10/07/2958942/0/en/Surfactants-Market-to-Reach-USD-72-2-Billion-by-2032-Driven-by-Rising-Applications-in-Healthcare-and-Food-Sectors-Research-by-SNS-Insider.html
  11. https://patents.google.com/patent/US10576187B2/en
  12. https://en.wikipedia.org/wiki/List_of_MeSH_codes_(D27)
  13. https://www.openpr.com/news/3615791/pharmaceutical-surfactants-market-size-share-analysis
  14. https://meshb.nlm.nih.gov/record/ui?ui=D013501
  15. https://www.biospace.com/reform-biologics-announces-new-patent-on-surfactant-replacement-excipients-to-stabilize-antibody-based-therapeutics
  16. https://www.frontiersin.org/journals/chemistry/articles/10.3389/fchem.2024.1382547/pdf
  17. https://patents.justia.com/patent/20230346931
Last updated: 2025-03-29

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