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Last Updated: December 12, 2025

ACETIC ACID 0.25% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Acetic Acid 0.25% In Plastic Container, and when can generic versions of Acetic Acid 0.25% In Plastic Container launch?

Acetic Acid 0.25% In Plastic Container is a drug marketed by B Braun, Baxter Hlthcare, and Otsuka Icu Medcl. and is included in three NDAs.

The generic ingredient in ACETIC ACID 0.25% IN PLASTIC CONTAINER is acetic acid, glacial. There are thirty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the acetic acid, glacial profile page.

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Summary for ACETIC ACID 0.25% IN PLASTIC CONTAINER
Drug patent expirations by year for ACETIC ACID 0.25% IN PLASTIC CONTAINER
Recent Clinical Trials for ACETIC ACID 0.25% IN PLASTIC CONTAINER

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

See all ACETIC ACID 0.25% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for ACETIC ACID 0.25% IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
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
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
>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 Acetic Acid 0.25% in Plastic Container

Last updated: August 6, 2025

Introduction

Acetic acid 0.25%, commonly utilized in medical, laboratory, and industrial settings, has seen increasing demand driven by its diverse applications. Traditionally known as vinegar in its culinary form, its medical-grade variants are used as antiseptics, disinfectants, and in wound care formulations. This analysis explores the current market landscape, factors influencing growth, and the financial trajectory of acetic acid 0.25% in plastic containers over the coming years.

Market Overview

Global Demand and Applications

The global acetic acid market is witnessing steady growth, projected to reach USD 20 billion by 2027, with a compound annual growth rate (CAGR) of approximately 4.8% [1]. Within this landscape, pharmaceutical-grade acetic acid, particularly at low concentrations such as 0.25%, holds a niche but expanding segment. Its applications are primarily in wound care products, antiseptic formulations, and laboratory reagents.

The migration toward plastic containers aligns with industry trends favoring lightweight, cost-effective, and corrosion-resistant packaging. Plastic, especially polyethylene and polypropylene, offers superior chemical compatibility for acetic acid solutions, ensuring product stability and safety.

Regulatory Environment

Regulatory frameworks, such as the US FDA and European Medicines Agency (EMA), impose stringent standards for medical-grade acetic acid, influencing manufacturing practices and distribution channels. Compliance raises entry barriers but also elevates product credibility. Growing regulatory clarity regarding disinfectants and antiseptics enhances market confidence.

Market Drivers

  • Healthcare and Wound Care Expansion: Aging populations and increasing prevalence of chronic wounds augment demand.
  • Hospital and Clinical Use: Hospitals prefer pre-packaged, single-use disinfectants—favoring plastic containers for safety and convenience.
  • Laboratory and Industrial Markets: Chemical and biotech labs require standardized solutions, often dispatched in plastic packaging.
  • Safety and Environmental Benefits: Plastic containers reduce breakage risks and facilitate disposal procedures, aligning with safety standards.

Competitive Landscape

The industry exhibits a fragmented structure with regional and multinational manufacturers. Key players include Graphite India Ltd., TCI Chemicals, and local suppliers catering to regional demand. Competitive advantages hinge on:

  • Manufacturing Capacity & Scale: Large-scale producers benefit from economies of scale.
  • Cost-Effective Packaging: Plastic containers provide competitive pricing advantages.
  • Regulatory Compliances & Certifications: Certifications (e.g., ISO, GMP) bolster market trust.

New entrants targeting niche markets or offering specialized packaging solutions (e.g., tamper-evident caps, eco-friendly plastics) could disrupt existing dynamics.

Market Challenges

  • Volatility in Raw Material Prices: Acetic acid production relies on methanol, which has variable costs.
  • Environmental Pressures: Growing emphasis on sustainable packaging necessitates innovations to plastic containers’ eco-friendliness.
  • Stringent Regulations: Evolving policies may impose additional compliance costs.
  • Market Saturation in Developed Regions: Mature markets could limit growth unless product innovation occurs.

Financial Trajectory Analysis

Revenue Forecasts

Based on current demand and growth catalysts, revenue from acetic acid 0.25% in plastic containers is projected to grow at a CAGR of approximately 5-6% over the next five years. The upward trajectory hinges on expanding healthcare infrastructure, especially in emerging markets like Asia-Pacific, Africa, and Latin America, where healthcare investments are rising [2].

Pricing Dynamics

Pricing stability is influenced by raw material costs, packaging expenses, and regulatory compliance. Plastic container manufacturing costs have decreased by approximately 3% annually, driven by technological advancements and economies of scale [3]. This trend supports healthy margins for producers.

Cost Structure & Profitability

  • Raw Materials: Methanol and acetic acid constitute around 50-60% of production costs.
  • Packaging: Plastic container manufacturing and filling account for 10-15%.
  • Regulations & Certification: Quality assurance adds 5-8% to operational expenses.
  • Distribution & Logistics: Region-specific transportation costs can influence margins, especially in emerging markets.

Investment & Market Entry Considerations

Investments in scaling production capacities, particularly in low-cost regions, could bolster profitability. Companies adopting sustainable plastics or innovative packaging could gain competitive advantage, albeit with higher R&D and setup costs initial stages.

Future Outlook & Strategic Opportunities

The outlook for acetic acid 0.25% in plastic containers remains positive, barring significant market disruptions. Key strategic opportunities include:

  • Product Differentiation: Developing eco-friendly packaging solutions.
  • Market Penetration: Targeting expanding healthcare infrastructure in emerging markets.
  • Regulatory Alignment: Proactively securing certifications to facilitate global distribution.
  • Supply Chain Optimization: Securing raw material sources and logistics to mitigate cost fluctuations.

Conclusion

The market dynamics for acetic acid 0.25% in plastic containers are shaped by healthcare, industrial, and laboratory demand, supported by technological, regulatory, and safety considerations. Financially, the segment is positioned for moderate growth, driven by expanding applications in wound care, disinfectants, and research. Manufacturers capable of balancing cost efficiency, regulatory compliance, and innovative packaging are poised for sustainable profitability.


Key Takeaways

  • The acetic acid 0.25% market is on a growth trajectory, with expanding healthcare and industrial applications globally.
  • Plastic containers provide economic, safety, and convenience advantages, amplifying their market dominance.
  • Raw material costs and regulatory requirements significantly influence profitability; strategic sourcing and compliance are crucial.
  • Investment in eco-friendly packaging and entering emerging markets present significant growth opportunities.
  • A focus on supply chain resilience and product differentiation will be vital for long-term success.

FAQs

1. What are the primary applications of acetic acid 0.25% in healthcare?
Primarily used as an antiseptic in wound care, as a disinfectant solution, and in laboratory settings for analytical purposes.

2. How does plastic container packaging benefit acetic acid products?
Plastic provides lightweight, corrosion-resistant, and cost-effective packaging that ensures product stability and safety during transportation and storage.

3. What are the main challenges in the market for acetic acid 0.25%?
Challenges include raw material price volatility, environmental concerns regarding plastic waste, regulatory compliance costs, and market saturation in developed regions.

4. How will emerging markets influence the financial outlook of this segment?
Growing healthcare infrastructure and increasing industrialization in emerging markets are expected to drive demand, enhancing revenue streams for manufacturers.

5. What innovations could enhance competitiveness in this market?
Eco-friendly packaging solutions, product formulation improvements for safety and efficacy, and digital supply chain integration are key innovations for future competitiveness.


References

[1] Market Research Future, "Acetic Acid Market Analysis," 2022.
[2] WHO, "Global Health Infrastructure Report," 2021.
[3] Industry Analytics, "Plastic Packaging Cost Trends," 2022.

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