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Last Updated: December 12, 2025

Cetyl alcohol; colfosceril palmitate; tyloxapol - Generic Drug Details


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What are the generic sources for cetyl alcohol; colfosceril palmitate; tyloxapol and what is the scope of freedom to operate?

Cetyl alcohol; colfosceril palmitate; tyloxapol is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for cetyl alcohol; colfosceril palmitate; tyloxapol
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:cetyl alcohol; colfosceril palmitate; tyloxapol at DailyMed

US Patents and Regulatory Information for cetyl alcohol; colfosceril palmitate; tyloxapol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline EXOSURF NEONATAL cetyl alcohol; colfosceril palmitate; tyloxapol FOR SUSPENSION;INTRATRACHEAL 020044-001 Aug 2, 1990 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

Expired US Patents for cetyl alcohol; colfosceril palmitate; tyloxapol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline EXOSURF NEONATAL cetyl alcohol; colfosceril palmitate; tyloxapol FOR SUSPENSION;INTRATRACHEAL 020044-001 Aug 2, 1990 4,312,860 ⤷  Get Started Free
Glaxosmithkline EXOSURF NEONATAL cetyl alcohol; colfosceril palmitate; tyloxapol FOR SUSPENSION;INTRATRACHEAL 020044-001 Aug 2, 1990 5,110,806 ⤷  Get Started Free
Glaxosmithkline EXOSURF NEONATAL cetyl alcohol; colfosceril palmitate; tyloxapol FOR SUSPENSION;INTRATRACHEAL 020044-001 Aug 2, 1990 4,826,821 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Market Dynamics and Financial Trajectory for Cetyl Alcohol, Colfosceril Palmitate, and Tyloxapol

Last updated: August 3, 2025

Overview

The pharmaceutical and related markets for cetyl alcohol, colfosceril palmitate, and tyloxapol exhibit distinct yet interconnected market dynamics driven by technological advances, regulatory landscapes, and evolving medical needs. Each compound plays specialized roles in drug formulation, respiratory therapy, or as excipients, creating diverse pathways for growth and investment.


1. Cetyl Alcohol: Market Dynamics and Financial Outlook

Introduction and Uses

Cetyl alcohol, a fatty alcohol derived from natural fats and oils, is an essential ingredient in pharmaceutical formulations, cosmetics, and personal care products. Its primary functions include serving as an emollient, thickening agent, and stabilizer [1].

Market Drivers

  • Cosmetic and Personal Care Industries: The global cosmetics sector has experienced sustained growth, with cetyl alcohol demand paralleling this expansion due to its widespread use in creams, lotions, and hair care products [2].

  • Pharmaceutical Application: In drug formulations, cetyl alcohol functions as an excipient in topical and transdermal medications, bolstering the stability and delivery of active compounds.

  • Natural and Sustainable Sources: Growing consumer preference for plant-based and sustainable ingredients is fostering increased demand for natural-derived fatty alcohols, including cetyl alcohol [3].

Market Challenges

  • Supply Chain Vulnerabilities: Dependence on vegetable oil sources exposes the supply chain to environmental and geopolitical risks, potentially impacting production costs.

  • Regulatory Scrutiny: As an ingredient classified under cosmetic and pharmaceutical excipients, cetyl alcohol must adhere to safety and purity standards, with evolving regulations possibly requiring reformulation or certification.

Financial Trajectory

The global cetyl alcohol market size was valued at approximately USD 600 million in 2022, with projections estimating a compound annual growth rate (CAGR) of 4-5% over the next five years [2]. Market expansion is anticipated primarily in Asia-Pacific, owing to rising cosmetic consumption and manufacturing capabilities.

Strategic Opportunities

  • Vertical Integration: Companies investing in sustainable sourcing and refining could achieve cost advantages and quality control.

  • Product Innovation: Developing functionalized fatty alcohol derivatives may open new application avenues within pharmaceuticals and personal care.


2. Colfosceril Palmitate: Market Dynamics in Pulmonary Therapy

Introduction and Therapeutic Role

Colfosceril palmitate, a synthetic phospholipid resembling natural lung surfactants, is used primarily in the treatment and prevention of neonatal respiratory distress syndrome (RDS) and other pulmonary conditions [4].

Market Drivers

  • Birth Rates and Neonatal Care: Increasing global birth rates in emerging economies elevate the demand for pulmonary surfactants like colfosceril palmitate, particularly in regions with developing healthcare infrastructure [5].

  • Advancements in Neonatal Intensive Care: Improved neonatal care techniques, allowing for better management of preterm infants, drive the adoption of surfactant therapies.

  • Pipeline Development: Ongoing clinical trials investigating improved formulations or alternative delivery methods can impact market size and perception.

Market Challenges

  • Limited Market Players: Few manufacturers dominate this niche, with research and production barriers maintaining high market entry thresholds.

  • High Production Costs and Regulatory Burdens: Manufacturing complex lipid-based drugs involves sophisticated technology, stringent regulatory approvals, and high compliance costs.

  • Competition from Alternatives: Natural surfactant extracts derived from animal lungs or recombinant sources pose competitive challenges.

Financial Outlook

The colfosceril palmitate market is relatively niche, valued at approximately USD 200-250 million in 2022, with modest growth projections of around 3-4% CAGR [4]. The future trajectory depends heavily on technological innovations and regulatory approvals.

Opportunities

  • Expanding Application Spectrum: Exploring use in adult Acute Respiratory Distress Syndrome (ARDS) could open new markets.

  • Biotechnology Advances: Synthetic manufacturing advances lowering costs or enhancing efficacy could improve market share.


3. Tyloxapol: Market Evolution and Commercial Prospects

Introduction and Application

Tyloxapol is a non-ionic surfactant used primarily as an expectorant in respiratory therapies and as an excipient in various formulations. It enhances mucolytic effects and facilitates drug delivery in pulmonary conditions [6].

Market Drivers

  • Respiratory Disease Prevalence: Rising incidences of chronic bronchitis, COPD, and influenza-related respiratory issues sustain demand for expectorants like tyloxapol.

  • Inhalation Therapy Market Growth: Increased adoption of inhalable medications accelerates interest in surfactant agents that improve drug efficacy.

  • Regulatory and Safety Profile: Widely used with a well-understood safety profile, tyloxapol remains a staple in certain markets, especially in Europe and Asia.

Market Challenges

  • Regulatory Variability: Different approval statuses across jurisdictions restrict market expansion potential.

  • Competition from Alternatives: Other surfactants and expectorants with similar efficacy may limit market share growth.

  • Manufacturing and Quality Assurance: As an excipient, maintaining consistent quality standards is critical, with regulatory agencies increasing scrutiny on excipient sourcing.

Financial Outlook

The global tyloxapol market is estimated at around USD 100-150 million in 2022, with a modest CAGR forecasted at 2-3%, driven by continued respiratory disease prevalence and ongoing clinical applications [6].

Opportunities

  • Formulation Innovations: Combining tyloxapol with novel active ingredients may enhance therapeutic outcomes.

  • Market Penetration in Emerging Economies: Expanding distribution channels in Asia-Pacific and Latin America could augment revenues.


Integrated Market Trends and Competitive Landscape

Across all three compounds, a clear trend is the increasing focus on formulation innovation, regulatory compliance, and sourcing sustainability. The pharmaceutical and personal care industries’ steady expansion underpins demand, though each compound faces distinct market challenges, such as technological complexity, supply chain dependencies, or regulatory hurdles.

Key players include multinational chemical firms like Croda International, BASF, and local specialty suppliers, which differentiate themselves via innovation, quality standards, and supply chain robustness [2,4,6].

The COVID-19 pandemic underscored the importance of respiratory therapeutics and excipients, leading to increased R&D investments and regulatory support in related markets. Post-pandemic, these markets are expected to stabilize but retain growth potential driven by unmet needs and technological advances.


Conclusion and Future Outlook

The financial trajectory for cetyl alcohol, colfosceril palmitate, and tyloxapol reflects a landscape of moderate, steady growth, shaped by macroeconomic factors, technological innovation, and shifting regulatory frameworks. While cetyl alcohol benefits from broad application in cosmetics, its growth is tied to sustainability trends. Colfosceril palmitate's niche role in neonatal respiratory care remains vital but limited by high entry barriers, whereas tyloxapol's utility in respiratory therapy sustains its relevance amid competitive forces.

The evolving health landscape, driven by aging populations and rising respiratory conditions, presents targeted opportunities, particularly in improving formulations, expanding indications, and supply chain resilience. Industry players that invest in research, innovation, and sustainable sourcing are poised to capitalize on these trends.


Key Takeaways

  • The cetyl alcohol market is projected to grow at 4-5% CAGR, driven by cosmetics and sustainability trends; supply chain and regulatory shifts pose risks.

  • Colfosceril palmitate’s niche in neonatal respiratory therapy faces opportunities through pipeline advancements but remains constrained by technological and regulatory complexities.

  • Tyloxapol maintains a modest growth trajectory, supported by its role in respiratory therapies; innovation and geographic expansion offer upside.

  • Across all compounds, technological innovation, regulatory compliance, and sustainable sourcing will be critical success factors.

  • Strategic diversification and investment in formulation improvements will enhance market resilience amid competitive and regulatory challenges.


FAQs

1. What are the main factors influencing the demand for cetyl alcohol in the pharmaceutical industry?
Demand is primarily driven by its use as an excipient in topical formulations within the cosmetics and pharmaceutical sectors, with growth fueled by expansion in the cosmetics industry and consumer preferences for natural, sustainable ingredients.

2. How does regulatory stability affect the market growth of colfosceril palmitate?
Stable and supportive regulatory environments facilitate clinical adoption and production expansion, while stringent or evolving regulations can impose barriers, impacting market growth and investment returns.

3. What are the competitive advantages of tyloxapol in respiratory therapy?
Tyloxapol offers a well-established safety profile, ease of formulation, and proven efficacy as an expectorant and surfactant, giving it a sustained market presence despite competition from other agents.

4. How are sustainability trends impacting the supply chain for cetyl alcohol?
Growing consumer and regulatory emphasis on sustainability incentivizes sourcing from renewable and environmentally friendly sources, influencing supply chain practices and potentially increasing costs.

5. What technological innovations could drive future growth for these compounds?
Advances in green chemistry, scalable synthetic methodologies, and novel delivery systems (such as liposomal or nanocarrier formulations) hold potential to enhance efficacy, reduce costs, and open new application pathways.


Sources:

[1] Market Research Future, "Cetyl Alcohol Market Analysis," 2022.

[2] Grand View Research, "Fatty Alcohol Market Size & Share," 2022.

[3] Transparency Market Research, "Natural-derived Fatty Alcohols," 2021.

[4] MarketsandMarkets, "Phospholipids Market," 2022.

[5] UNICEF, "Global Neonatal Care Trends," 2021.

[6] Statista, "Respiratory Drugs Market," 2022.

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