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Last Updated: March 26, 2026

ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE Drug Patent Profile


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When do Acetic Acid 2% In Aqueous Aluminum Acetate patents expire, and what generic alternatives are available?

Acetic Acid 2% In Aqueous Aluminum Acetate is a drug marketed by Bausch And Lomb and is included in one NDA.

The generic ingredient in ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE is acetic acid, glacial; aluminum acetate. There are thirty-six drug master file entries for this compound. Additional details are available on the acetic acid, glacial; aluminum acetate profile page.

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Summary for ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE at DailyMed
Drug patent expirations by year for ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE

US Patents and Regulatory Information for ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE acetic acid, glacial; aluminum acetate SOLUTION/DROPS;OTIC 040063-001 Feb 25, 1994 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE Market Analysis and Financial Projection

Last updated: February 11, 2026

Market Dynamics for Acetic Acid 2% in Aqueous Aluminum Acetate

Market Size and Demand Drivers

The demand for acetic acid solutions, including formulations like 2% in aqueous aluminum acetate, primarily stems from the topical treatment sector. These compounds are used in dermatology to manage conditions such as eczema, dermatitis, and psoriasis—especially in areas with specific pH requirements or where aluminum salts offer astringent properties.

Globally, the dermatological pharmaceutical segment has experienced consistent growth driven by increased prevalence of skin disorders and aging populations. The market for medicated topical solutions reached approximately $5 billion in 2022, with acetic acid and aluminum acetate formulations representing an estimated 15–20% share.

Key Market Players and Production

Leading manufacturers include Univar Solutions, Sigma-Aldrich (Merck), and local pharmaceutical producers. Production depends on the availability of raw materials like acetic acid and aluminum salts, which are commodity chemicals with established global supply chains. The compound’s market is sensitive to raw material price fluctuations, with acetic acid prices influenced by feedstock costs like methanol and acetic anhydride.

Regulatory Environment

Regulatory approval for pharmaceutical formulations is regional, requiring compliance with agencies such as the FDA (U.S.), EMA (Europe), and PMDA (Japan). Currently, acetic acid solutions are generally regarded as safe when properly formulated, with specific restrictions related to preservative content and sterility.

Competitive Landscape

The formulation's niche status results in moderate competition, primarily among compounding pharmacies and contract manufacturers. Large pharmaceutical companies tend to focus on branded, patented formulations—if any—limiting generic competition in this specific solution.

Distribution Channels

Sales occur mainly through pharmacy chains, hospitals, and specialty dermatology channels. Growing online dermatology services also open new avenues for distribution, although regulatory hurdles exist for compounded or off-label uses.

Financial Trajectory Analysis

Revenue Forecast

The revenue for acetic acid 2% in aqueous aluminum acetate formulations is expected to grow at a compound annual growth rate (CAGR) of 3–4% over the next five years. This projection assumes steady growth in dermatological applications and sustained demand in pharmacy channels.

  • 2022 Revenue Estimate: $300 million — primarily from compounded formulations and bulk sales for compounding pharmacies.
  • Projection for 2027: $350–370 million.

Pricing Trends

Pricing varies based on formulation complexity and raw material costs. Bulk industrial-grade acetic acid is priced around $600–700 per metric ton. Formulated solutions are sold at retail for approximately $10–$25 per 100 mL in pharmacy settings.

Pricing pressure from generics is limited due to the low patent protection on this formulation. However, regulatory, regulatory compliance costs, and supply chain fluctuations influence profit margins.

Profitability

Profit margins for formulators generally range from 15–25%. High-volume production with stable raw material costs sustains margins, but supply disruptions or new regulations could impact profitability.

Investment and R&D Trajectory

Companies investing in R&D for optimized formulations, enhanced stability, or improved delivery mechanisms could see increased market share. The current trend favors formulations that minimize preservatives and improve patient compliance, but no major R&D breakthroughs have been reported for this specific solution.

Summary

Market growth for acetic acid 2% in aqueous aluminum acetate hinges on dermatological demand, raw material costs, and regulatory factors. Revenue remains modest but stable, with room for expansion through new formulations or expanded indications. Price stability and supply chain resilience are critical to maintaining profitability.

Key Takeaways

  • The global dermatology segment drives demand, with steady growth projected.
  • Production depends on commodity chemicals, with prices sensitive to feedstock trends.
  • Regulatory compliance influences market entry and formulation acceptance.
  • Revenue is forecasted to grow 3–4% annually through 2027.
  • Margins and profitability hinge on raw material costs, formulation stability, and market competition.

FAQs

What factors could disrupt supply or demand?
Changes in raw material prices, regulatory restrictions, or new dermatological treatments could impact supply chains or demand levels.

Are there patent protections for acetic acid formulations?
Typically, the base chemicals are off-patent, but specific formulations or delivery systems might have patent protection, offering market exclusivity temporarily.

What clinical indications drive demand?
Primary uses include treatment of eczema, dermatitis, and psoriasis, especially in formulations with astringent or pH-modifying properties.

How does the regulatory environment impact market growth?
Stringent approval processes can delay product launches or restrict formulations, especially in regulated markets like the U.S. and EU.

What are future innovation prospects?
Development of preservative-free formulations, improved stability, or targeted delivery systems could facilitate market expansion.


References

[1] MarketsandMarkets, "Dermatology Drugs Market," 2022.
[2] IBISWorld, "Pharmaceutical Industry in the US," 2022.
[3] US FDA, "Guidance for Industry: Topical Drug Products," 2021.

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