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Last Updated: December 16, 2025

DEHYDRATED ALCOHOL Drug Patent Profile


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Summary for DEHYDRATED ALCOHOL
US Patents:0
Applicants:5
NDAs:5
Finished Product Suppliers / Packagers: 6
Clinical Trials: 9
What excipients (inactive ingredients) are in DEHYDRATED ALCOHOL?DEHYDRATED ALCOHOL excipients list
DailyMed Link:DEHYDRATED ALCOHOL at DailyMed
Drug patent expirations by year for DEHYDRATED ALCOHOL
Recent Clinical Trials for DEHYDRATED ALCOHOL

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SponsorPhase
Ablative Solutions, Inc.PHASE3
Icahn School of Medicine at Mount SinaiPHASE1
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US Patents and Regulatory Information for DEHYDRATED ALCOHOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare DEHYDRATED ALCOHOL alcohol SOLUTION;INTRA-ARTERIAL 217845-001 Jun 23, 2025 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Xgen Pharms DEHYDRATED ALCOHOL alcohol SOLUTION;INTRA-ARTERIAL 219400-001 Jun 23, 2025 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Breckenridge DEHYDRATED ALCOHOL alcohol SOLUTION;INTRA-ARTERIAL 219444-001 Jun 23, 2025 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ingenus Pharms Llc DEHYDRATED ALCOHOL alcohol SOLUTION;INTRA-ARTERIAL 219569-001 Jul 9, 2025 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Royal Pharms DEHYDRATED ALCOHOL alcohol SOLUTION;INTRAVENOUS 214988-001 Oct 23, 2025 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 Dehydrated Alcohol in the Pharmaceutical Sector

Last updated: August 3, 2025


Introduction

Dehydrated alcohol, also known as anhydrous ethanol, is a highly purified form of ethanol with minimal water content, typically less than 1%. Its unique physicochemical properties make it an indispensable ingredient across various pharmaceutical, cosmetic, and industrial applications. In the pharmaceutical domain, dehydrated alcohol primarily functions as a solvent, antiseptic, excipient, and sterilizing agent. Its role is crucial in the formulation of medications, sterilization procedures, and vaccine production, positioning it as an essential commodity within pharmaceutical supply chains.

Understanding the evolving market dynamics for dehydrated alcohol involves analyzing factors affecting supply and demand, regulatory environments, technological innovations, and potential growth trajectories. An in-depth review reveals exponential growth prospects driven by increased demand for pharmaceuticals, advances in bio-pharmaceutical manufacturing, and stringent sterilization standards.


Market Drivers

1. Expanding Pharmaceutical Applications

Dehydrated alcohol’s versatility in pharmaceutical formulations continues to underpin its robust market growth. It serves as a solvent in injectable drugs, facilitating the dissolution of active pharmaceutical ingredients (APIs) that are hydrophobic or require precise control over solvent properties. It also functions as a preservative and excipient, enhancing drug stability and longevity.

The rising prevalence of chronic and infectious diseases globally escalates demand for injectable medications, vaccines, and sterilization procedures, all of which rely heavily on dehydrated alcohol. The WHO estimates that the global vaccine market alone will grow at a compounded annual growth rate (CAGR) of approximately 10% through the next decade, further bolstering demand for pharmaceutical-grade dehydrated alcohol [1].

2. Growth in COVID-19 Pandemic and Hygiene Standards

The COVID-19 pandemic significantly amplified the need for effective sanitization agents. Dehydrated alcohol’s efficacy as an antiseptic and disinfectant catalyzed its demand across healthcare facilities, pharmaceutical manufacturing units, and consumer markets. According to the Centers for Disease Control and Prevention (CDC), alcohol-based hand sanitizers, predominantly formulated with dehydrated ethanol, became a frontline defense against virus transmission. The market for such sanitizers surged by over 20% annually during peak pandemic periods [2].

3. Regulatory and Quality Standards

Strict regulatory frameworks, such as the US Pharmacopeia (USP), European Pharmacopoeia (EP), and pharmacopoeial standards in emerging markets, mandate the use of high-purity, dehydrated alcohol in pharmaceutical production. These standards ensure product safety, efficacy, and consistency, fostering sustained market demand. Manufacturers investing in compliant dehydration and distillation technologies gain a competitive edge, driving innovation and quality standards.

4. Manufacturing and Supply Chain Advancements

Advances in ethanol dehydration technology—such as molecular sieves, membrane distillation, and extractive distillation—have improved yield and purity levels while reducing costs. Enhanced supply chain logistics, facilitated by global trade agreements, have stabilized prices. However, recent geopolitical tensions and environmental regulations influence long-term availability, prompting increased investments in local manufacturing capacities.


Market Challenges

1. Raw Material Price Volatility

The primary raw material—ethyl alcohol—is often derived from agricultural feedstock like corn, sugarcane, and maize. Fluctuations in raw material prices, driven by agricultural yields, climate change, and biofuel policies, create price volatility for dehydrated alcohol. For example, drought conditions in major sugar-producing regions can constrict ethanol supply and inflate costs [3].

2. Environmental and Regulatory Pressures

Environmental regulations aimed at reducing greenhouse gas emissions impact ethanol production processes and feedstock cultivation. Governments implement policies incentivizing bioethanol usage, but also impose sustainability standards that could constrain supply or escalate production costs.

3. Competition from Synthetic Alternatives

Emerging synthetic solvents and sterilizing agents, such as isopropanol and benzalkonium chloride, pose competitive threats. While dehydrated alcohol offers specific advantages, the cost and availability of alternatives influence market share, especially in regions with aggressive pricing strategies.


Regional Market Insights

North America

North America exhibits significant demand driven by robust pharmaceutical manufacturing, especially in the United States. The U.S. market benefits from advanced manufacturing infrastructure, high compliance standards, and a substantial healthcare expenditure. The COVID-19 pandemic catalyzed growth in hand sanitizer production, with the FDA’s emergency use authorizations (EUAs) boosting dehydrated alcohol utilization [4].

Europe

European markets prioritize stringent quality standards and environmental sustainability. The region’s focus on biopharmaceutical R&D investment propels demand for high-purity dehydrated alcohol. Furthermore, European Union policies favor bio-based solvent production, encouraging innovations in feedstock sustainability.

Asia-Pacific

The fastest-growing segment, Asia-Pacific, capitalizes on expanding healthcare infrastructure, increasing vaccine production, and evolving regulatory landscapes. Countries like China, India, and Japan are investing in local ethanol production units to reduce dependence on imports, driven by regional biofuel policies and industrial growth targets.

Emerging Markets

Emerging markets such as Latin America and Africa are witnessing accelerated growth owing to expanding pharmaceutical manufacturing capacities, particularly in vaccine and generic drug sectors. However, infrastructural challenges persist, requiring strategic investments.


Financial Trajectory and Investment Outlook

Market Size and Growth Forecasts

The global dehydrated alcohol market in pharmaceuticals was valued at approximately USD 600 million in 2022, with forecasts projecting a CAGR of 6-8% over the next five years. The rising demand for sterile injectable drugs, vaccines, and disinfectants will underpin this growth trajectory. Factors such as increased regulation, technological innovation, and outbreak preparedness are critical drivers.

Profitability and Investment Opportunities

Leading manufacturers are integrating verticals—from ethanol production to dehydration and packaging—to capitalize on economies of scale. Mergers and acquisitions are prevalent, aiming to consolidate supply chains and expand market share. For instance, chemical conglomerates are acquiring specialty ethanol producers to cater to the pharmaceutical segment specifically.

Investment trends also focus on sustainable production methods, including bio-based feedstocks and renewable energy integration. These initiatives aim to reduce carbon footprints and align with global eco-friendly standards, attracting ESG-conscious investors.

Risks and Contingencies

Market participants face risks from raw material shortages, regulatory changes, geopolitical tensions, and environmental constraints. Diversification of supply sources, technological innovation, and compliance with evolving standards are strategic imperatives to mitigate these risks.


Conclusion

The market for dehydrated alcohol in the pharmaceutical industry is poised for consistent growth, driven by expanding healthcare needs, regulatory mandates, and technological innovations. While challenges persist, particularly related to raw material volatility and environmental regulations, strategic adaptations—such as localized production and sustainability initiatives—offer resilience. As the demand for high-purity solvents remains integral to pharmaceutical manufacturing, future opportunities hinge on integrating sustainable practices and enhancing supply chain efficiencies.


Key Takeaways

  • Demand drivers: Rising pharmaceutical and vaccine production, enhanced sterilization protocols, and pandemic-driven hygiene needs.
  • Market growth: Projected CAGR of 6-8%, with North America and Asia-Pacific leading growth.
  • Technological innovation: Improvements in ethanol dehydration techniques improve purity and reduce costs.
  • Regulatory influence: Strict standards favor high-quality dehydrated alcohol, encouraging compliance and innovation.
  • Risks: Raw material fluctuation, environmental regulations, and competition from synthetic alternatives require strategic mitigation.

FAQs

1. What are the primary uses of dehydrated alcohol in pharmaceuticals?
Dehydrated alcohol is used predominantly as a solvent for drug formulations, an antiseptic disinfectant, an excipient to enhance stability, and in sterilization processes for medical equipment and vaccine vials.

2. How does technological innovation impact the dehydrated alcohol market?
Advances such as molecular sieve dehydration and membrane distillation improve yield and purity, reduce production costs, and enable compliance with strict pharmacopeial standards, thereby fostering market expansion.

3. What role does regulation play in shaping the dehydrated alcohol market?
Regulatory standards ensure safety and quality, influencing production processes and quality control measures. These standards encourage investments in high-quality, compliant manufacturing and sustain market integrity.

4. How does environmental sustainability influence market dynamics?
Sustainability initiatives, including the use of bio-based feedstocks and renewable energy in ethanol production, are becoming critical to meet regulatory requirements and consumer preferences, shaping future investments.

5. What are the main challenges facing market growth?
Volatility in feedstock prices, environmental regulation, geopolitical tensions, and competition from synthetic solvents pose significant challenges, necessitating strategic planning and diversification by stakeholders.


References

  1. World Health Organization. (2021). Global vaccine market overview.
  2. CDC. (2020). Hand hygiene in COVID-19: Efficacy of alcohol-based sanitizers.
  3. USDA. (2022). Agricultural trends impacting ethanol raw material prices.
  4. FDA. (2021). Emergency use authorizations for alcohol-based sanitizers during COVID-19.

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