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Last Updated: March 26, 2026

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, 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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Summary for ACETIC ACID
Drug patent expirations by year for ACETIC ACID
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Recent Clinical Trials for ACETIC ACID

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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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare ACETIC ACID 0.25% IN PLASTIC CONTAINER acetic acid, glacial SOLUTION;IRRIGATION, URETHRAL 018523-001 Feb 19, 1982 AT RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sciegen Pharms ACETIC ACID acetic acid, glacial SOLUTION/DROPS;OTIC 040607-001 Feb 24, 2005 AT RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Kv Pharm ACETIC ACID acetic acid, glacial SOLUTION/DROPS;OTIC 085493-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rising ACETIC ACID acetic acid, glacial SOLUTION/DROPS;OTIC 207280-001 Mar 9, 2018 AT RX 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

Market Dynamics and Financial Trajectory for Acetic Acid as a Pharmaceutical Agent

Last updated: February 20, 2026

What is the Role of Acetic Acid in Pharmaceutical Applications?

Acetic acid, a simple carboxylic acid known for its role in vinegar, has limited direct application as a pharmaceutical active ingredient. Its primary medical use involves its derivative, formic acid derivatives, or in the synthesis of pharmaceutical compounds. It is also used in topical treatments, disinfectants, and as a solvent.

In medicine, acetic acid solutions at specific concentrations are employed for procedures like vaginal acetic acid for detection of cervical lesions ([1]). It is also a precursor in the manufacturing of pharmaceuticals such as glyceryl esters and acetic acid derivatives used in anti-inflammatory drugs.

What Are the Market Drivers and Constraints?

Market Drivers

  • Medical Diagnostic Use: The use in colposcopy procedures to visualize cervical intraepithelial neoplasia (CIN) triggers steady demand.
  • Pharmaceutical Synthesis: The demand for acetic acid derivatives in drug manufacturing sustains industry activity.
  • Industrial Growth: Increased manufacturing of acetylated pharmaceuticals and disinfectants drives overall demand.
  • Regulatory Environment: Approved applications in medical diagnostics and sterilization maintain a predictable usage pattern.

Market Constraints

  • Limited Direct Pharmacological Use: Acetic acid does not function as a primary therapeutic agent, limiting its standalone pharmaceutical market size.
  • Environmental and Safety Regulations: Stringent disposal and handling restrictions influence production costs.
  • Competition from Alternatives: Other solvents and diagnostic agents compete with acetic acid derivatives.

What Are the Market Trends and Future Outlook?

Industry Size and Growth

The global chemical industry reports a steady growth in acetic acid consumption, with estimates of approximately 11.5 million metric tons used industrially in 2020 ([2]). The pharmaceutical sector accounts for a modest but consistent fraction, driven by diagnostic and synthetic applications.

Investment and Production Capacity

Major global producers include Eastman Chemical, Celanese, and Mitsubishi, with total capacity exceeding 20 million metric tons annually ([3]). Over the next five years, capacities are expected to expand at a compounded annual growth rate (CAGR) of approximately 3-4% driven by demand in emerging markets.

Innovation and New Applications

Research explores acetic acid derivatives with improved bioavailability for anti-inflammatory and antimicrobial applications. These innovations could increase demand for high-purity acetic acid inputs.

Price Dynamics

Average industrial acetic acid prices fluctuate between $400 and $600 per ton (2022 figures). Prices are impacted by raw material costs, mainly methanol, and global supply-demand factors.

Regulatory Impact

Stringent environmental standards impact production costs, especially in the European Union and North America, where emissions standards for chemical plants are strict ([4]).

How Does the Financial Trajectory Look?

Revenue Estimation

Given the modest pharmaceutical segment, revenue attributable purely to pharma applications is estimated at $500 million to $1 billion annually. The larger chemical market surpasses $40 billion globally, with acetic acid representing less than 2-3% of that total.

Profitability

Major producers report operating margins around 10-15%, reflecting stable demand but high capital and compliance costs.

Investment Outlook

Investments focus on:

  • Increasing production efficiency.
  • Developing high-value derivatives.
  • Expanding capacity in emerging markets.

Risks

  • Price volatility driven by raw material costs.
  • Regulatory risk affecting production methods.
  • Competitive pressure from alternative chemicals and solvents.

Summary Table

Aspect Data
Global market size (chemical segment) >$40 billion (2022)
Acetic acid demand (2020) 11.5 million metric tons
Key producers Eastman, Celanese, Mitsubishi
Price range (2022) $400 - $600 per ton
CAGR (next 5 years) 3-4%
Estimated pharma revenue $500 million – $1 billion
Operating margins 10-15%

Key Takeaways

  • The pharmaceutical application of acetic acid is limited but essential in diagnostics and chemical synthesis.
  • Industry growth is moderate, supported by demand in diagnostics and manufacturing.
  • Capacity expansion and innovation in derivatives could elevate future demand.
  • Price stability is influenced by raw materials and regulatory pressures.
  • The overall market remains small relative to the broader chemical industry but demonstrates consistent stability.

FAQs

1. Is acetic acid a primary drug in medicine?
No. It is used mainly in diagnostic procedures and as a chemical precursor, not as a standalone therapeutic.

2. Which industries are the largest consumers of acetic acid?
The chemical manufacturing sector dominates, with secondary use in pharmaceuticals, disinfectants, and plastics.

3. What regulatory challenges affect acetic acid production?
Environmental regulations like the EU's REACH and Clean Air Act in the US impose strict emissions standards, impacting manufacturing costs.

4. How does raw material price fluctuation impact acetic acid prices?
Most acetic acid is derived from methanol; fluctuations in methanol prices translate directly into acetic acid pricing.

5. What are the prospects for innovation involving acetic acid derivatives?
Research into bioavailable anti-inflammatory and antimicrobial derivatives could expand commercial applications.


References

[1] National Center for Biotechnology Information. (2022). Use of acetic acid in medical diagnostics. PubMed.
[2] IHS Chemical. (2021). Global acetic acid market report.
[3] ICIS. (2022). 2022 Acetic Acid Capacity and Market Outlook.
[4] European Chemicals Agency. (2022). Regulatory standards for chemical manufacturing.

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