ACETIC ACID, GLACIAL - Generic Drug Details

What are the generic sources for acetic acid, glacial and what is the scope of patent protection?

Acetic acid, glacial is the generic ingredient in fifteen branded drugs marketed by Actavis Mid Atlantic, Chartwell Rx, Kv Pharm, Rising, Sciegen Pharms, Sun Pharma Canada, Warner Chilcott, Hikma, B Braun, Baxter Hlthcare, Otsuka Icu Medcl, Bausch And Lomb, Pharmafair, Bayer Pharms, Cosette, Taro, Wockhardt, and Saptalis Pharms, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for ACETIC ACID, GLACIAL

US Patents:	0
Tradenames:	15
Applicants:	18
NDAs:	24
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	375
Clinical Trials:	1
DailyMed Link:	ACETIC ACID, GLACIAL at DailyMed

Recent Clinical Trials for ACETIC ACID, GLACIAL

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

Sponsor	Phase
National Institute of Perinatology	Phase 4
National Council of Science and Technology, Mexico	Phase 4

See all ACETIC ACID, GLACIAL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ACETIC ACID, GLACIAL

G01AD	Organic acids
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ACETIC ACID, GLACIAL

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
Sciegen Pharms	ACETIC ACID	acetic acid, glacial	SOLUTION/DROPS;OTIC	040607-001	Feb 24, 2005	AT	RX	No	Yes
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
Bayer Pharms	TRIDESILON	acetic acid, glacial; desonide	SOLUTION/DROPS;OTIC	017914-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Hikma	VOSOL	acetic acid, glacial	SOLUTION/DROPS;OTIC	012179-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Warner Chilcott	ORLEX HC	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	086844-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Glacial Acetic Acid

Last updated: February 15, 2026

Overview

Glacial acetic acid (99.5% anhydrous acetic acid) is a chemical primarily used in manufacturing acetic anhydride, vinyl acetate monomer, acetic esters, and as a solvent. It also finds application in the production of cellulose acetate, vinegar, and as a cleaning agent.

Market Size and Growth Trends

• The global market for glacial acetic acid was valued at approximately USD 2.1 billion in 2021.
• Expected compound annual growth rate (CAGR) from 2022 to 2030: 4.2% (Research and Markets, 2022).
• Key demand drivers include increasing vinyl acetate monomer (VAM) production, growth in the textile and paper sectors, and expanding use in the food and beverage industry.

Supply Chain and Production

• Major producers: Eastman Chemical Company, Celanese Corporation, Dow Chemical Company, and East Asia-Pacific regional producers.
• Feedstock: Primarily methanol and acetylene-based processes.
• Production costs are influenced by methanol prices, energy costs, and regulatory compliance costs related to environmental standards.

Regional Market Dynamics

• Asia-Pacific dominates the market, accounting for over 45% of global consumption in 2021.
• China leads in both production and consumption, driven by expanding chemical manufacturing capacity and infrastructure projects.
• North America and Europe face supply constraints due to stricter environmental regulations and aging infrastructure, but benefit from higher-margin specialty applications.

Market Drivers

• Demand for VAM in adhesives, paints, and coatings.
• Growth in the textile industry, especially in Asia, which uses acetic acid derivatives.
• Increased investment in chemical manufacturing capacity in emerging economies.
• Rising applications in the food industry, such as vinegar production and food additives.

Market Challenges

• Fluctuations in methanol and energy prices increase production costs.
• Stringent environmental policies in Europe and North America elevate compliance costs.
• Alternatives to acetic acid in certain applications may limit market growth.

Financial Trajectory

• Revenue is projected to grow at a CAGR of 4.2%, reaching approximately USD 3.1 billion by 2030.
• Profit margins are influenced by raw material costs; high methanol prices compress margins in volatile markets.
• Capital expenditure has been increasing in recent years to expand capacity and retrofit facilities for cleaner production methods.

Investment and R&D Outlook

• Companies are investing in sustainable production methods, like bio-based acetic acid, to mitigate regulatory risks.
• R&D efforts aim to reduce production costs and improve process efficiency.
• Mergers and acquisitions are active, focusing on expanding regional presence and technological capabilities.

Key Market Segments and Applications

Segment	Share (2021)	Growth Drivers
Vinyl acetate monomer (VAM)	35%	Construction, adhesives, paints
Acetic anhydride	25%	Pharmaceuticals, textiles
Food and beverages	15%	Vinegar, food additives
Solvents and other chemicals	25%	Coatings, cleaning agents

Regulatory Impact

• The transition toward greener acetylation processes influences market structure.
• Restrictions on emissions and effluents require manufacturers to adopt cleaner technology.
• Stringent regulations can cause regional market shifts as compliance costs vary.

Conclusion

Glacial acetic acid market maintains steady growth, supported by expanding downstream industries and regional demand trends. Cost factors and regulatory compliance significantly influence profitability and capacity investments.

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Key Takeaways

• The market is projected to grow at approximately 4.2% annually through 2030.
• Asia-Pacific dominates demand, with China leading in both supply and consumption.
• Price volatility of raw materials like methanol and energy affects profit margins.
• Sustainability initiatives and regulatory pressures are shaping future production processes.
• Mergers and R&D investments aim to capture efficiency gains and meet environmental standards.

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FAQs

1. What are the main applications driving demand for glacial acetic acid?
   Vinyl acetate monomer production, acetic anhydride manufacturing, food additives like vinegar, and solvents.

2. How do regional regulations impact the market?
   Stricter environmental policies in Europe and North America increase compliance costs, influencing regional production and trade flows.

3. What distinguishes bio-based acetic acid?
   It is produced from renewable biomass, offering a sustainable alternative to fossil-based methods amid rising environmental regulations.

4. Who are the leading producers globally?
   Eastman Chemical, Celanese, Dow Chemical, and regional producers in China and Southeast Asia.

5. What are future growth opportunities?
   Expansion in Asia-Pacific, adoption of greener processes, and innovations in process efficiencies offer growth avenues.

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Citations

[1] Research and Markets. "Global Glacial Acetic Acid Market Analysis," 2022.