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Last Updated: December 12, 2025

ACETIC ACID Drug Patent Profile


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When do Acetic Acid patents expire, and when can generic versions of Acetic Acid launch?

Acetic Acid is a drug marketed by Chartwell Rx, Kv Pharm, Rising, Sciegen Pharms Inc, Sun Pharma Canada, B Braun, Baxter Hlthcare, Otsuka Icu Medcl, and Bausch And Lomb. and is included in ten NDAs.

The generic ingredient in ACETIC ACID is acetic acid, glacial; hydrocortisone. There are thirty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the acetic acid, glacial; hydrocortisone profile page.

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SponsorPhase
Consorci Sanitari de l'Alt Penedès i GarrafPHASE3
University of Alabama at BirminghamNA
Cameroon Baptist Convention Health CoreNA

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US Patents and Regulatory Information for ACETIC ACID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx ACETIC ACID acetic acid, glacial SOLUTION/DROPS;OTIC 040166-001 Jul 26, 1996 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare ACETIC ACID 0.25% IN PLASTIC CONTAINER acetic acid, glacial SOLUTION;IRRIGATION, URETHRAL 018523-001 Feb 19, 1982 AT RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sciegen Pharms Inc ACETIC ACID acetic acid, glacial SOLUTION/DROPS;OTIC 040607-001 Feb 24, 2005 AT RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl ACETIC ACID 0.25% IN PLASTIC CONTAINER acetic acid, glacial SOLUTION;IRRIGATION, URETHRAL 017656-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Kv Pharm ACETIC ACID acetic acid, glacial SOLUTION/DROPS;OTIC 085493-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Rising ACETIC ACID acetic acid, glacial SOLUTION/DROPS;OTIC 207280-001 Mar 9, 2018 AT RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun ACETIC ACID 0.25% IN PLASTIC CONTAINER acetic acid, glacial SOLUTION;IRRIGATION, URETHRAL 018161-001 Approved Prior to Jan 1, 1982 AT 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 the Pharmaceutical Drug: Acetic Acid

Last updated: July 31, 2025

Introduction

Acetic acid, a fundamental chemical compound with the molecular formula CH₃COOH, is integral to various industrial and medical applications. While commonly associated with vinegar, its pharmaceutical relevance primarily revolves around its use as a precursor and excipient in drug formulations, alongside antimicrobial and antiseptic applications. This analysis explores the evolving market landscape, financial trends, regulatory environment, and future prospects for acetic acid within the pharmaceutical sector, offering insights valuable for stakeholders and investors.

1. Overview of Acetic Acid in Pharmaceutical Applications

Medical and Pharmaceutical Uses

Acetic acid’s pharmaceutical applications include:

  • Antimicrobial Agent: Used in otic solutions for ear infections (e.g., otitis media), where its efficacy against Pseudomonas aeruginosa and Staphylococcus aureus is well-documented [1].
  • Precursor in Drug Synthesis: Serves as a raw material in manufacturing various drugs, antibiotics, and intermediates.
  • Pharmaceutical Excipients: Utilized to adjust pH and stabilize formulations.

Its safety profile and established manufacturing processes have positioned acetic acid as a reliable compound in pharmaceutical procurement.

Recent Trends in Pharmaceutical Use

The rising prevalence of ear infections and antibiotic-resistant bacteria has sustained demand for acetic acid-based otic solutions. Moreover, increasing research into acetic acid derivatives and conjugates may diversify applications, further expanding the market.

2. Market Dynamics

Supply Chain and Production

Global acetic acid supply is dominated by key manufacturing regions, notably China, the US, and Europe, with China accounting for approximately 50% of global output [2]. Production shifts, such as environmental regulations and cost considerations, influence supply stability.

Demand Drivers

  • Healthcare Needs: Growing incidence of ear infections, particularly in pediatric and elderly populations, drives steady demand for acetic acid-based treatments.
  • Pharmaceutical Manufacturing: The expanding pipeline of drugs utilizing acetic acid intermediates underpins sustained industrial demand.
  • End-use Industry Growth: The food, textile, and chemical industries indirectly influence the supply chain, impacting raw material costs for pharmaceutical-grade acetic acid.

Regulatory Environment

Stringent regulations governing the production of pharmaceutical excipients and active pharmaceutical ingredients (APIs) influence manufacturing standards and market entry barriers. The US FDA and EMA compliance requirements can extend approval timelines but ensure product quality, impacting market dynamics.

Emerging Opportunities

  • Innovative Formulations: Nanotechnology and sustained-release formulations integrating acetic acid derivatives could unlock new therapeutic avenues.
  • Biosourcing and Green Chemistry: Trend toward bio-based acetic acid production using renewable feedstocks aligns with sustainability goals, potentially reducing costs and environmental impact [3].

Competitive Landscape

Major players such as Eastman Chemical Company, Celanese Corporation, and inefficient regional producers compete based on price, quality, and regulatory compliance. Patent expirations and shifts toward bio-based production could alter competitive dynamics.

3. Financial Trajectory Analysis

Historical Market Performance

The global acetic acid market was valued at approximately USD 6-7 billion in 2022, with steady growth projected at a CAGR of around 5% over the next five years, driven predominantly by industrial demand and healthcare needs [4].

Cost Structures and Pricing Trends

Raw material costs, chiefly methanol and carbon monoxide, significantly influence production economics. Fluctuations in methanol prices, driven by crude oil dynamics, impact acetic acid pricing. Over the past decade, prices have exhibited volatility, with recent stabilization owing to increased regional production capacity.

Revenue Forecasts

Given current demand and technological advancements, revenues from pharmaceutical-grade acetic acid are expected to grow proportionally with the pharmaceutical industry’s expansion. In particular, demand from emerging markets in Asia and Latin America is forecasted to grow faster, owing to improving healthcare infrastructure.

Investment and R&D Outlay

Pharmaceutical manufacturers may invest in bio-based production technologies and purification processes to meet regulatory and sustainability standards, likely elevating R&D expenditure. This may initially increase costs but potentially improve margins once scaled.

4. Challenges and Risks

Regulatory and Safety Concerns

Adherence to rigorous manufacturing and safety standards limits flexibility and increases capital expenditure. Non-compliance risks include market bans and legal hurdles.

Supply Chain Disruptions

Geopolitical tensions, trade restrictions, and environmental regulations threaten the stability of raw material supply and production continuity.

Market Volatility

Price fluctuations in raw materials, particularly methanol, pose financial risks. Additionally, emerging synthetic alternatives or novel antimicrobial agents could threaten traditional demand.

Environmental Impact and Sustainability

Environmental concerns about petrochemical-based acetic acid production may prompt stricter regulations, incentivizing bio-based alternatives, which could alter market dynamics.

5. Future Outlook and Strategic Opportunities

Innovative Production Technologies

Advances in bio-fermentation processes for acetic acid, such as acetic acid fermentation from renewable biomass, could significantly impact the market by reducing costs and environmental footprint [5].

Expanded Therapeutic Applications

Research into acetic acid derivatives with enhanced antimicrobial or anti-inflammatory properties could stimulate new pharmaceutical formulations, expanding market size.

Integration with Digital and Precision Medicine

Customization of formulations and delivery systems involving acetic acid derivatives may align with precision medicine trends, enhancing market relevance.

Sustainability and Circular Economy Initiatives

Investments in green chemistry and circular economy models will likely influence future supply chains and pricing, presenting both risks and opportunities.

6. Conclusion

The pharmaceutical segment of the acetic acid market exhibits steady growth fueled by clinical applications, industrial demand, and technological advancements. Market stability and profitability hinge on technological innovation, regulatory compliance, and sustainable production practices. While supply chain challenges and raw material price volatility present risks, emerging bio-based processes and expanded therapeutic applications underpin a positive long-term outlook. Companies that adapt to sustainability imperatives and innovate in formulations and manufacturing will be best positioned to capitalize on future growth opportunities.


Key Takeaways

  • Demand for pharmaceutical-grade acetic acid remains stable, driven by antimicrobial applications and drug synthesis needs.
  • Supply chain consolidation and bio-based manufacturing innovations are shaping the competitive landscape.
  • Market growth is projected at a CAGR of approximately 5%, with emerging markets contributing to increased demand.
  • The evolving regulatory environment emphasizes compliance, quality, and sustainability, influencing production costs and market access.
  • Future growth hinges on technological innovation, sustainable production methods, and expanded therapeutic applications.

FAQs

Q1: How does the regulatory environment affect the pharmaceutical acetic acid market?
Strict manufacturing standards from entities like the FDA and EMA increase compliance costs but ensure product safety and quality, essential for market acceptance and expansion.

Q2: What are the main raw materials influencing acetic acid prices?
Methanol and carbon monoxide are primary feedstocks; their price volatility, influenced by crude oil markets and environmental policies, directly impacts acetic acid costs.

Q3: Are bio-based acetic acid options commercially viable?
Yes, bio-based acetic acid, produced via fermentation of renewable biomass, is increasingly cost-competitive and environmentally favorable, with several pilot and commercial-scale projects underway.

Q4: What are potential future therapeutic uses of acetic acid derivatives?
Research explores anti-inflammatory, antimicrobial, and anti-cancer applications, promising diversification into novel drug classes and formulations.

Q5: How can companies mitigate supply chain risks associated with acetic acid?
Diversification of supply sources, investment in regional production facilities, and adoption of sustainable manufacturing processes can reduce dependency and enhance resilience.


Sources

  1. [1] Pharmaceutical Applications of Acetic Acid and its Derivatives. Journal of Drug Discovery & Therapeutics. 2021.
  2. [2] Global Acetic Acid Market Overview. Market Research Future. 2022.
  3. [3] Bio-Based Acetic Acid Production: Trends and Technologies. GreenChem Series. 2020.
  4. [4] Acetic Acid Market Size & Forecast. Fortune Business Insights. 2022.
  5. [5] Sustainable Technologies in Acetic Acid Production. Industrial Biotechnology Review. 2021.

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