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Last Updated: July 10, 2025

Isopropyl alcohol - Generic Drug Details


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What are the generic drug sources for isopropyl alcohol and what is the scope of patent protection?

Isopropyl alcohol is the generic ingredient in one branded drug marketed by Zurex Pharma and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Isopropyl alcohol has sixty-five patent family members in twenty-two countries.

There is one drug master file entry for isopropyl alcohol.

Summary for isopropyl alcohol
International Patents:65
US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 384
Clinical Trials: 54
Patent Applications: 5,166
What excipients (inactive ingredients) are in isopropyl alcohol?isopropyl alcohol excipients list
DailyMed Link:isopropyl alcohol at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for isopropyl alcohol
Generic Entry Date for isopropyl alcohol*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for isopropyl alcohol

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

SponsorPhase
Yaneve FongePhase 4
University of CalgaryPhase 2
State University of New York at BuffaloPhase 2/Phase 3

See all isopropyl alcohol clinical trials

US Patents and Regulatory Information for isopropyl alcohol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 OTC Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 OTC Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 OTC Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 OTC Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  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

Expired US Patents for isopropyl alcohol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 ⤷  Try for Free ⤷  Try for Free
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for isopropyl alcohol

Country Patent Number Title Estimated Expiration
Brazil PI0606969 solução de bloqueio de cateter compreendendo citrato e um parabeno ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2009142760 ⤷  Try for Free
China 105377323 ⤷  Try for Free
China 102105055 Antimicrobial compositions and methods of use ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for isopropyl alcohol

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 2014029 Norway ⤷  Try for Free PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
2447254 2018015 Norway ⤷  Try for Free PRODUCT NAME: 2-4-(N-(5,6-DIFENYLPYRAZIN-2- YL)-N- ISOPROPYLAMINO)BUTYLOKSY-N-; REG. NO/DATE: EU/1/15/1083 20160530
1448186 2012C/051 Belgium ⤷  Try for Free PRODUCT NAME: MELANGE DE CATECHOLS ISOLES D'UN EXTRAIT DE THE (CAMELLIA SINENSIS (L.) O. KUNTZE) AVEC DU MYRISTATE D'ISOPROPYLE; AUTHORISATION NUMBER AND DATE: BE424383 20120719
1448186 C300550 Netherlands ⤷  Try for Free PRODUCT NAME: MENGSEL VAN CATECHOLEN GEISOLEERD UIT EEN EXTRACT VAN GROENE THEE, CAMELLIA SINENSIS, L. O. KUNTZE MET ISOPROPYLMYRISTAAT; NATL. REGISTRATION NO/DATE: RVG 110904 20120920; FIRST REGISTRATION: DE 73486.00.00 20090831
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for Isopropyl Alcohol in Pharmaceuticals

Last updated: July 7, 2025

Introduction

Isopropyl alcohol, a versatile chemical compound, plays a pivotal role in the pharmaceutical industry as an antiseptic, solvent, and disinfectant. Its widespread use surged during the COVID-19 pandemic, underscoring its importance in global health infrastructure. This article examines the current market dynamics and financial trajectory of isopropyl alcohol within pharmaceuticals, offering business professionals actionable insights into supply chains, revenue trends, and future growth opportunities.

Overview of Isopropyl Alcohol in Pharmaceuticals

Isopropyl alcohol, also known as isopropanol, serves as a critical ingredient in pharmaceutical formulations. This colorless, flammable liquid with a molecular formula of C3H8O acts primarily as a topical antiseptic in hand sanitizers and wound cleaners, while also functioning as a solvent in drug manufacturing processes. Pharmaceutical companies rely on it to ensure sterility and efficacy, particularly in injectable drugs and oral medications.

Demand for isopropyl alcohol escalated in recent years, driven by heightened hygiene standards and regulatory mandates for infection control. For instance, the U.S. Food and Drug Administration (FDA) has emphasized its use in over-the-counter antiseptics, making it indispensable for companies like Johnson & Johnson and Procter & Gamble. Despite its commodity status, innovations in sustainable production methods—such as bio-based synthesis—have enhanced its appeal, allowing firms to differentiate their offerings in a competitive landscape.

Market Dynamics

The pharmaceutical-grade isopropyl alcohol market exhibits robust fluctuations influenced by global events, regulatory shifts, and technological advancements. This section delves into key factors shaping its supply, demand, and competitive environment.

Supply and Demand Trends

Global demand for isopropyl alcohol in pharmaceuticals has grown steadily, propelled by the ongoing emphasis on public health. In 2023, the market reached approximately 1.2 million metric tons annually, with pharmaceuticals accounting for about 25% of total consumption, according to industry reports [1]. The COVID-19 era amplified this trend, with demand spiking by 40% in 2020 alone due to sanitizer production [2]. However, supply chain disruptions—stemming from raw material shortages and geopolitical tensions, such as those in the Red Sea region—have led to price volatility, with costs rising 15-20% in 2023 [3].

Emerging markets in Asia-Pacific, particularly China and India, now dominate production, supplying over 60% of the world's pharmaceutical-grade isopropyl alcohol [1]. This shift reflects investments in large-scale facilities, like those by LyondellBasell in China, which have increased output efficiency. On the demand side, aging populations in North America and Europe continue to drive needs for sterile medical products, projecting a compound annual growth rate (CAGR) of 5.7% through 2030 [4]. Yet, environmental regulations, such as the European Union's REACH directive, are pushing manufacturers toward greener alternatives, potentially capping unchecked expansion.

Key Players and Competition

The isopropyl alcohol market features a mix of established chemical giants and niche pharmaceutical suppliers, fostering intense competition. Leading players include Dow Chemical, ExxonMobil, and Shell, which control significant market share through integrated supply chains. For example, Dow's strategic expansions in the U.S. have enabled it to capture 15% of the global pharmaceutical segment [5]. These companies compete on cost, purity levels, and customization, with pharmaceutical-specific variants requiring 99.9% purity to meet FDA standards.

New entrants, such as India's Deepak Fertilisers, are disrupting the market by offering cost-effective alternatives through advanced catalytic processes. This competition intensifies as firms vie for contracts with major pharmaceutical players like Pfizer and AstraZeneca, who demand reliable, high-volume supplies. Mergers and acquisitions, such as ExxonMobil's acquisition of a production facility in 2022, further consolidate the landscape, enhancing bargaining power and innovation [6].

Regulatory Environment

Regulations significantly influence isopropyl alcohol's market dynamics, with agencies like the FDA and European Medicines Agency (EMA) imposing strict guidelines on its use. In pharmaceuticals, it must comply with Good Manufacturing Practices (GMP), ensuring minimal impurities to avoid adverse reactions. Recent updates, including the FDA's 2023 guidance on alcohol-based antiseptics, have tightened quality controls, compelling manufacturers to invest in testing and certification [7].

Globally, environmental regulations are reshaping operations. The U.S. Environmental Protection Agency (EPA) classifies isopropyl alcohol as a volatile organic compound, mandating emission reductions that could increase production costs by 10% for non-compliant firms [8]. These factors create barriers for smaller players but open doors for sustainable innovations, such as bio-isopropanol derived from renewable feedstocks, which some companies are adopting to gain regulatory favor.

Financial Trajectory

Isopropyl alcohol's financial outlook in pharmaceuticals reflects steady growth amid economic uncertainties, with revenue streams bolstered by expanding applications and strategic investments.

Revenue and Growth Projections

The global isopropyl alcohol market generated around $3.5 billion in revenue in 2023, with the pharmaceutical sector contributing roughly $800 million [1]. This segment is poised for expansion, forecasting a CAGR of 6.2% from 2024 to 2030, driven by increasing healthcare expenditures and pandemic-related stockpiling [4]. In the U.S., pharmaceutical companies reported a 12% year-over-year revenue increase for isopropyl alcohol-based products in 2023, fueled by demand from hospitals and clinics [9].

Financial performance varies by region, with Asia-Pacific leading growth at 7.5% CAGR due to rising exports from China [1]. However, inflation and energy costs have pressured margins, as seen in Dow Chemical's 2023 earnings report, where raw material expenses eroded profits by 8% [5]. Looking ahead, digital supply chain tools and AI-driven demand forecasting are helping firms optimize revenues, potentially boosting returns by 15% in the next five years [10].

Investment and Funding

Investment in isopropyl alcohol production has surged, with pharmaceutical-focused projects attracting over $1.2 billion in funding since 2021 [11]. Major investments include LyondellBasell's $500 million expansion in sustainable manufacturing, targeting eco-friendly variants for pharma applications [12]. Venture capital is also flowing into startups developing bio-based alternatives, such as those using fermentation processes to reduce carbon footprints.

Public companies like ExxonMobil have allocated funds to R&D, spending 5% of revenues on isopropyl alcohol innovations, including patents for enhanced purification techniques [6]. These efforts not only secure intellectual property but also position firms for premium pricing in the pharmaceutical market. Overall, strategic investments are critical for navigating financial risks, such as commodity price swings, and capitalizing on emerging opportunities in personalized medicine.

Impact of Patents and Intellectual Property

Although isopropyl alcohol itself is a generic compound, patents surrounding its derivatives and production methods play a key role in financial trajectories. For instance, patents for high-purity formulations, like those held by Dow for pharmaceutical-grade variants, provide competitive edges and licensing revenues [5]. In 2023, the U.S. Patent and Trademark Office granted 15 new patents related to isopropyl alcohol applications in drug delivery systems, highlighting innovation in this space [13].

These intellectual property assets influence market entry and profitability, with companies leveraging them to form partnerships and avoid litigation. However, the expiration of older patents could intensify generic competition, potentially compressing margins by 2025 [14]. Business professionals should monitor these developments to assess investment risks and opportunities.

Challenges and Opportunities

Isopropyl alcohol faces challenges like supply volatility and regulatory hurdles, which could hinder growth. Fluctuating raw material prices and environmental concerns may limit expansion in certain regions. Conversely, opportunities abound in sustainable production and emerging markets, where demand for affordable antiseptics is rising. Companies that innovate in green technologies or expand into telemedicine applications stand to gain significantly.

Conclusion

In summary, isopropyl alcohol remains a cornerstone of the pharmaceutical industry, with market dynamics shaped by global demand surges and regulatory pressures. Its financial trajectory points to sustained growth, supported by strategic investments and technological advancements, despite inherent risks from economic fluctuations.

Key Takeaways

  • Demand for isopropyl alcohol in pharmaceuticals is projected to grow at a 6.2% CAGR through 2030, driven by hygiene needs and healthcare expansion.
  • Supply chain disruptions have caused price increases of 15-20% in 2023, impacting profit margins for key players.
  • Investments in sustainable production, totaling over $1.2 billion since 2021, are enhancing competitiveness and regulatory compliance.
  • Patents for advanced formulations provide revenue opportunities but face risks from generic competition.
  • Asia-Pacific leads market growth, offering high-potential avenues for business expansion amid global uncertainties.

FAQs

  1. What factors are driving the current demand for isopropyl alcohol in pharmaceuticals?
    Demand is primarily fueled by increased hygiene requirements post-COVID-19 and regulatory mandates for sterile products, with global consumption rising by 40% in 2020.

  2. How do regulatory changes affect isopropyl alcohol's market dynamics?
    Stricter FDA and EPA guidelines on purity and emissions are raising production costs but encouraging innovations in sustainable alternatives, potentially stabilizing long-term supply.

  3. What are the revenue projections for isopropyl alcohol in the pharmaceutical sector?
    The sector is expected to generate $800 million in 2023, with revenues climbing to over $1.2 billion by 2030 due to expanding healthcare applications.

  4. Which companies dominate the isopropyl alcohol market and why?
    Firms like Dow Chemical and ExxonMobil lead through efficient supply chains and patented technologies, capturing significant shares by meeting pharmaceutical-grade standards.

  5. What investment opportunities exist in isopropyl alcohol production?
    Opportunities lie in bio-based manufacturing and R&D for new formulations, with investments yielding high returns in emerging markets like Asia-Pacific.

Sources

  1. Grand View Research. (2023). Isopropyl Alcohol Market Size, Share & Trends Analysis Report.
  2. Statista. (2021). Impact of COVID-19 on Chemical Markets.
  3. IHS Markit. (2023). Global Chemical Price Report.
  4. MarketsandMarkets. (2024). Isopropanol Market Forecast.
  5. Dow Chemical. (2023). Annual Financial Report.
  6. ExxonMobil. (2022). Corporate Acquisitions and Investments.
  7. U.S. Food and Drug Administration. (2023). Guidance on Alcohol-Based Antiseptics.
  8. U.S. Environmental Protection Agency. (2023). Volatile Organic Compounds Regulations.
  9. Pharmaceutical Research and Manufacturers of America. (2023). Industry Revenue Data.
  10. McKinsey & Company. (2024). AI in Supply Chain Management.
  11. PitchBook. (2023). Venture Capital Funding in Chemicals.
  12. LyondellBasell. (2022). Sustainability Investment Report.
  13. U.S. Patent and Trademark Office. (2023). Patent Database Search.
  14. World Intellectual Property Organization. (2023). Patent Trends in Chemicals.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.