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Last Updated: March 16, 2026

Dehydrated alcohol - Generic Drug Details


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Summary for dehydrated alcohol
US Patents:0
Tradenames:2
Applicants:6
NDAs:6
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 9
Clinical Trials: 9
What excipients (inactive ingredients) are in dehydrated alcohol?dehydrated alcohol excipients list
DailyMed Link:dehydrated alcohol at DailyMed
Recent Clinical Trials for dehydrated alcohol

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

SponsorPhase
Ablative Solutions, Inc.PHASE3
Icahn School of Medicine at Mount SinaiPHASE1
Oslo University HospitalN/A

See all dehydrated alcohol clinical trials

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
Xgen Pharms DEHYDRATED ALCOHOL dehydrated alcohol SOLUTION;INTRA-ARTERIAL 219400-001 Jun 23, 2025 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bpi Labs ABLYSINOL dehydrated alcohol SOLUTION;INTRA-ARTERIAL 207987-002 Jun 21, 2018 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ingenus Pharms Llc DEHYDRATED ALCOHOL dehydrated 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 dehydrated alcohol SOLUTION;INTRAVENOUS 214988-001 Oct 23, 2025 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bpi Labs ABLYSINOL dehydrated alcohol SOLUTION;INTRA-ARTERIAL 207987-001 Jun 21, 2018 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Breckenridge DEHYDRATED ALCOHOL dehydrated alcohol SOLUTION;INTRA-ARTERIAL 219444-001 Jun 23, 2025 AP RX 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

Market Dynamics and Financial Trajectory for Dehydrated Alcohol in Pharmaceuticals

Last updated: March 4, 2026

What is the Role of Dehydrated Alcohol in Pharmaceutical Applications?

Dehydrated alcohol, also known as anhydrous ethanol, is used primarily as a solvent, antiseptic, and sterilizing agent in pharmaceutical manufacturing. Its core attribute is high purity (≥99% ethanol), removing water to prevent microbial growth and enhance stability of formulations.

How Is Demand for Dehydrated Alcohol Shaped?

Key Drivers

  • Sterilization and Disinfection: Increased hygiene standards, especially during pandemics, boost demand.
  • Pharmaceutical Production: Solvent use in drug synthesis and extraction processes.
  • Vaccine Development: Use as a stabilizer or component in vaccine formulations.

Market Trends

  • Growing Pharmaceutical R&D: Expansion of biopharmaceutical and small-molecule pipeline increases solvent needs.
  • Stringent Regulatory Standards: Enforcement of purity standards for active pharmaceutical ingredients (APIs) heightens demand for anhydrous alcohol.
  • Clean Label Movement: Preference for solvent purity fosters market growth.

Regional Influences

  • North America: Significant due to high pharmaceutical R&D activity and healthcare expenditures.
  • Europe: Strict regulatory environment and focus on infection control.
  • Asia-Pacific: Rapid production growth, expansion of pharmaceutical manufacturing capacity, and increasing healthcare awareness.

What Are the Market Constraints?

  • Price Volatility: Fluctuations in ethanol raw material costs affect margins.
  • Regulatory Compliance: Strict pharmaceutical standards require rigorous quality control, increasing production complexity.
  • Environmental Regulations: Waste management and ethanol emissions controls impose additional costs.

How Have Market Players Positioned Themselves?

Key Companies

  • SABIC: Supplies high-purity dehydrated alcohol for pharma and industrial use.
  • ExxonMobil Chemical: Offers ethanol grades meeting pharmaceutical standards.
  • LyondellBasell: Focuses on bio-ethanol derivatives.
  • Indian suppliers: Large ethanol production capacity catering to domestic and export markets.

Strategic Initiatives

  • Increasing capacity to meet rising demand.
  • Pursuing expansions in emerging markets.
  • Investing in quality assurance and regulatory compliance.

What Is the Financial Trajectory?

Historical Data

  • Global ethanol market valued approximately USD 50 billion in 2021.
  • Pharmaceutical-grade dehydrated alcohol accounts for an estimated 15-20% of overall ethanol sales.
  • CAGR (2017-2022): 7.5% driven by healthcare industry growth.

Forecasts

  • Compound Annual Growth Rate (CAGR): Expected to remain around 7% from 2023 to 2030.
  • Market Size Projections (2023): Estimated at USD 55 billion globally, with pharmaceutical application segment reaching USD 11 billion.
  • Pricing Trends: Market prices for pharmaceutical-grade dehydrated alcohol range from USD 3 to USD 6 per liter, influenced by purity requirements and raw material costs.

Investment Considerations

  • R&D investments to develop higher purity grades.
  • Vertical integration in ethanol supply chains for cost control.
  • Geographic expansion toward emerging markets to leverage lower production costs.

How Do Regulatory Policies Impact Financial Outcomes?

  • FDA and EMA Standards: Stringent regulations for purity and manufacturing practices lead to higher compliance costs but enable premium pricing.
  • Environmental Policies: Cap-and-trade and emissions regulations increase operational costs, impacting profit margins.
  • Import/Export Policies: Tariffs and trade agreements influence regional market access and pricing.

Summary of Financial Risks and Opportunities

Risks Opportunities
Raw material price fluctuations Growing healthcare sector globally
Regulatory compliance costs Expansion into emerging markets
Environmental regulation costs Innovation in purification processes

Key Takeaways

  • Market demand for dehydrated alcohol in pharmaceuticals hinges on sterilization needs and formulation requirements.
  • Supply is concentrated among large chemical and ethanol producers, with regional growth driven by healthcare infrastructure expansion.
  • The market exhibits a steady CAGR of approximately 7% through 2030, influenced by healthcare trends and regulatory standards.
  • Pricing is sensitive to raw material costs, regulatory compliance, and regional economic conditions.
  • Strategic investments focus on capacity expansion, quality control, and geographic diversification.

FAQs

1. What is the main use of dehydrated alcohol in pharmaceuticals?

It functions primarily as a solvent and sterilizing agent, essential in formulation, manufacturing, and preservative applications.

2. How does regulatory compliance affect market profitability?

Compliance increases costs due to quality standards but allows companies to command higher prices and access regulated markets.

3. Which regions present the highest growth potential?

Emerging markets in Asia-Pacific show rapid capacity expansion and demand growth, while North America leads in R&D activity.

4. How do raw material prices influence market dynamics?

Fluctuations in ethanol prices, driven by feedstock costs and supply-demand imbalance, directly impact profit margins.

5. What are future investment opportunities?

Investing in higher purity production, vertical integration, and regional market expansion offers growth potential amid rising pharmaceutical applications.


References

[1] MarketsandMarkets. (2022). Ethanol Market by Production Process, Application, and Region.
[2] Grand View Research. (2022). Pharmaceutical Solvent Market Size and Share.
[3] U.S. Food and Drug Administration. (2022). Good Manufacturing Practices (GMP) for Pharmaceuticals.
[4] European Medicines Agency. (2022). Guidelines on Pharmaceutical Regulations.
[5] International Trade Administration. (2022). Ethanol Trade and Market Reports.

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