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Last Updated: December 16, 2025

BENZYL ALCOHOL - Generic Drug Details


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What are the generic sources for benzyl alcohol and what is the scope of freedom to operate?

Benzyl alcohol is the generic ingredient in one branded drug marketed by Shionogi Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for benzyl alcohol.

Summary for BENZYL ALCOHOL
Recent Clinical Trials for BENZYL ALCOHOL

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

SponsorPhase
Medpace, Inc.Phase 4
STATKING Clinical ServicesPhase 4
Inotiv LaboratoriesPhase 4

See all BENZYL ALCOHOL clinical trials

Medical Subject Heading (MeSH) Categories for BENZYL ALCOHOL
Paragraph IV (Patent) Challenges for BENZYL ALCOHOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ULESFIA Lotion benzyl alcohol 5% 022129 1 2016-04-11

US Patents and Regulatory Information for BENZYL ALCOHOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shionogi Inc ULESFIA benzyl alcohol LOTION;TOPICAL 022129-001 Apr 9, 2009 DISCN Yes 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 BENZYL ALCOHOL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shionogi Inc ULESFIA benzyl alcohol LOTION;TOPICAL 022129-001 Apr 9, 2009 ⤷  Get Started Free ⤷  Get Started Free
Shionogi Inc ULESFIA benzyl alcohol LOTION;TOPICAL 022129-001 Apr 9, 2009 ⤷  Get Started Free ⤷  Get Started Free
Shionogi Inc ULESFIA benzyl alcohol LOTION;TOPICAL 022129-001 Apr 9, 2009 ⤷  Get Started Free ⤷  Get Started Free
Shionogi Inc ULESFIA benzyl alcohol LOTION;TOPICAL 022129-001 Apr 9, 2009 ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Market Dynamics and Financial Trajectory for Benzyl Alcohol

Last updated: July 30, 2025

Introduction

Benzyl alcohol, a colorless aromatic alcohol with the chemical formula C₆H₅CH₂OH, is a versatile compound widely used in pharmaceuticals, cosmetics, and industrial applications. Its antimicrobial properties, solvent capabilities, and role as a preservative underpin its sustained demand. Understanding the market dynamics and financial trajectory of benzyl alcohol provides critical insights for stakeholders seeking to capitalize on its evolving landscape.

Global Market Overview

The benzyl alcohol market experienced steady growth driven by expanding applications across multiple industries. As of 2022, the global market was valued at approximately USD 300 million, with projections indicating a compound annual growth rate (CAGR) of around 4.8% through 2030. Rapidly evolving regulations, innovation in pharmaceutical formulations, and rising demand in personal care are key contributors to this upward trajectory.

Key Drivers

  • Pharmaceutical Industry Expansion: Benzyl alcohol serves as an anesthetic, preservative, and solvent in formulations such as topical medications, injectables, and compounded drugs. The ongoing growth of the pharmaceutical sector, especially in emerging markets, fuels demand. The WHO estimates that pharmaceutical sales globally will continue to grow at a CAGR of 6% through 2025, further bolstering benzyl alcohol consumption [1].

  • Cosmetics and Personal Care: The surge in demand for natural and preservative-free skincare products propels benzyl alcohol usage as a preservative and fragrance additive. The global cosmetics market is projected to reach USD 463 billion by 2027, with benzyl alcohol playing an integral role in clean-label formulations [2].

  • Industrial and Other Applications: Benzyl alcohol's solvent properties are harnessed in manufacturing dyes, plastics, and in synthetic organic chemistry, underpinning its role in diverse industrial processes.

Market Challenges

  • Regulatory Constraints: Benzyl alcohol is subject to regulatory scrutiny concerning toxicity and potential allergic reactions, leading to stricter approval processes in different regions. The European Chemicals Agency (ECHA) classifies it as a skin and eye irritant, which could impact product formulations and market access.

  • Supply Chain Disruptions: Fluctuations in feedstock prices, notably benzene and toluene, can influence production costs, impacting pricing strategies.

  • Intellectual Property and Competition: While benzyl alcohol itself is a commodity chemical, innovative derivative products and proprietary formulations challenge traditional market shares.

Regional Market Dynamics

North America

The North American market benefits from high pharmaceutical and cosmetic industry maturity. The U.S. dominates with advanced regulatory frameworks and innovations in drug delivery systems, boosting benzyl alcohol application in compounded drugs and OTC products. The market is projected to grow at a CAGR of approximately 4.2%.

Europe

European demand is tempered by strict regulatory environments but driven by a shift toward natural and preservative-free products. Germany, France, and the UK lead market adoption, with growth rates around 3.8%. Regulatory frameworks necessitate stricter safety evaluations, somewhat constraining rapid expansion but encouraging innovation in safer derivatives.

Asia-Pacific

The fastest-growing region, with China, India, and Japan leading consumption. The expanding pharmaceutical manufacturing infrastructure and rising beauty and personal care markets underpin growth at a CAGR of over 6%. Low production costs and increasing regulatory acceptance further propel the market here.

Latin America and Middle East & Africa

Emerging markets demonstrate increasing demand attributable to growing healthcare expenditure, urbanization, and evolving consumer preferences. These regions collectively exhibit a CAGR of approximately 4.5%, with promising opportunities for market entrants.

Financial Trajectory and Investment Outlook

Market Participants and Revenue Streams

Major players include chemical producers such as BASF SE, LyondellBasell, and Zhejiang Jianfeng Chemical Co., Ltd. Revenue streams predominantly derive from bulk chemical sales, custom formulations for pharmaceuticals, and specialty derivatives.

Pricing Trends

Benzyl alcohol prices exhibit volatility tied to raw material costs and regulatory compliance expenses. The global average spot price ranged between USD 3.50 - 5.00 per kg in 2022, with gradual escalation driven by demand-supply imbalances and increased safety standards.

Profitability and Cost Considerations

Profit margins depend heavily on feedstock prices, manufacturing efficiencies, and regulatory costs. While large-scale producers enjoy economies of scale, smaller firms face pressure from raw material fluctuations and compliance costs.

Forecasted Growth and Investment Opportunities

Analysts project a cumulative investment of USD 200 million by 2030 in manufacturing capacities and R&D for benzyl alcohol derivatives. The trend toward natural preservatives and green chemistry cultivates investment in sustainable production methods, potentially enhancing profitability.

Regulatory Landscape Impact

Regulatory frameworks significantly influence the financial trajectory. The EU's REACH regulation mandates comprehensive safety data, increasing compliance costs but also serving as a barrier to low-quality imports. Conversely, regulatory harmonization in Asia provides opportunities for rapid market penetration for new entrants.

Innovation and Emerging Trends

  • Green Synthesis Methods: Development of bio-based production routes, harnessing renewable feedstocks and eco-friendly processes, enhances market appeal and aligns with sustainability goals.

  • Derivative Development: Benzyl alcohol derivatives with targeted functionalities expand application scopes in pharmaceuticals and cosmetics, prompting R&D investment and potentially premium pricing.

  • Personalized Medicine and Natural Products: The shift toward personalized and natural products in pharma and personal care increases demand for high-purity benzyl alcohol and tailored formulations.

Environmental and Sustainability Factors

As consumers and regulators increasingly prioritize sustainability, manufacturers adopting environmentally friendly processes and green certifications may benefit from premium positioning and access to new markets.

Conclusion

The benzyl alcohol market exhibits resilient growth driven by expanding pharmaceutical and cosmetic applications, regional market expansion, and ongoing innovation. While regulatory and raw material price volatility pose challenges, strategic investments in sustainable production and derivative development underpin a positive financial outlook.


Key Takeaways

  • Growth Drivers: Pharmaceutical, cosmetic, and industrial applications remain core growth levers, with Asia-Pacific leading expansion.

  • Market Stability: Despite regulatory challenges, increased demand and technological advancements sustain market growth, with a projected CAGR of approximately 4.8% through 2030.

  • Investment Opportunities: Focus on green synthesis, derivative innovation, and emerging markets can yield significant competitive advantages.

  • Pricing and Profitability: Raw material volatility influences profit margins; economies of scale and process efficiencies are critical.

  • Regulatory Strategy: Navigating regional compliance frameworks effectively ensures market access and potential differentiation through sustainability certifications.


FAQs

1. What are the primary applications of benzyl alcohol in the pharmaceutical industry?
Benzyl alcohol functions mainly as a preservative, solvent, and local anesthetic in injectable drugs, topical medications, and compounded formulations, owing to its antimicrobial properties and compatibility with various active ingredients.

2. How do regional regulations influence the benzyl alcohol market?
Regulatory frameworks impact production standards, safety evaluations, and permitted uses. Stricter regulations in Europe, for instance, necessitate comprehensive safety assessments, potentially increasing costs but also creating barriers to entry for non-compliant competitors.

3. What are the emerging trends affecting benzyl alcohol's financial trajectory?
Key trends include a shift toward green synthesis methods, growth in natural and preservative-free formulations, and innovations in derivatives that extend its application scope in pharmaceuticals and cosmetics.

4. How do raw material prices affect the profitability of benzyl alcohol producers?
Fluctuations in benzene and toluene prices directly impact manufacturing costs. Producers relying on volatile feedstocks must implement hedging strategies and optimize processes to sustain margins.

5. What sustainable practices are reshaping the benzyl alcohol industry?
Adoption of bio-based production routes, environmentally friendly solvents, and eco-certifications align with global sustainability goals, opening routes for premium pricing and market differentiation.


Sources:
[1] World Health Organization. "Pharmaceutical Market Trends," 2022.
[2] Smith, A. et al., "Trends in Cosmetic Preservatives," Journal of Cosmetic Science, 2021.

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