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Last Updated: November 6, 2025

HYDROCORTISONE AND ACETIC ACID Drug Patent Profile


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Which patents cover Hydrocortisone And Acetic Acid, and what generic alternatives are available?

Hydrocortisone And Acetic Acid is a drug marketed by Bausch And Lomb, Cosette, Taro, and Wockhardt. and is included in four NDAs.

The generic ingredient in HYDROCORTISONE AND 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 HYDROCORTISONE AND ACETIC ACID
US Patents:0
Applicants:4
NDAs:4
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 3
Patent Applications: 5,074
What excipients (inactive ingredients) are in HYDROCORTISONE AND ACETIC ACID?HYDROCORTISONE AND ACETIC ACID excipients list
DailyMed Link:HYDROCORTISONE AND ACETIC ACID at DailyMed
Drug patent expirations by year for HYDROCORTISONE AND ACETIC ACID
Pharmacology for HYDROCORTISONE AND ACETIC ACID

US Patents and Regulatory Information for HYDROCORTISONE AND ACETIC ACID

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 HYDROCORTISONE AND ACETIC ACID acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 040097-001 Oct 31, 1994 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Wockhardt HYDROCORTISONE AND ACETIC ACID acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 040168-001 Aug 30, 1996 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Cosette HYDROCORTISONE AND ACETIC ACID acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 040609-001 Feb 6, 2006 AT RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Taro HYDROCORTISONE AND ACETIC ACID acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 088759-001 Mar 4, 1985 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 Hydrocortisone and Acetic Acid

Last updated: August 6, 2025

Introduction

Hydrocortisone and acetic acid are two commercially significant compounds with diverse therapeutic and industrial applications. Hydrocortisone, a corticosteroid, is widely used in dermatology and endocrinology, while acetic acid, particularly in its glacial form, serves both medicinal and industrial purposes. This report analyzes the current market dynamics contending with evolving regulatory landscapes, supply chain constraints, and technological advancements, and projects the financial trajectory for these compounds over the coming years.

Market Landscape and Key Drivers

Hydrocortisone Market Overview

Hydrocortisone, also known as cortisol, is a semi-synthetic corticosteroid with anti-inflammatory, immunosuppressive, and metabolic effects. The global hydrocortisone market is predominantly driven by dermatological, autoimmune, and hormonal disorder treatments. According to industry reports, the global corticosteroids market is projected to reach USD 8.3 billion by 2027, growing at a CAGR of around 4.2% [1].

Key Drivers:

  • Rising prevalence of autoimmune diseases such as rheumatoid arthritis and psoriasis.
  • Increasing demand for hormone replacement therapies.
  • Expanding geographies with unmet medical needs, notably in emerging markets.
  • Regulatory approvals for generic formulations lowering barriers to market entry.

Acetic Acid Market Overview

Acetic acid holds significance across industries: as a fundamental chemical in manufacturing vinegar, pharmaceuticals, and as a precursor in the production of synthetic fibers and plastics. The global acetic acid market is expected to reach USD 14.2 billion by 2028, growing at a CAGR of approximately 5.1% [2].

Key Drivers:

  • Growing usage in the production of vinyl acetate monomer (VAM) and acetic anhydride.
  • Rising adoption in the food industry as a preservative and flavoring agent.
  • Industrial growth in packaging and textiles sectors.
  • Advancements in sustainable production methods, including bio-based acetic acid, enhance market attractiveness.

Supply Chain Dynamics

Hydrocortisone Supply Chain

Hydrocortisone production relies heavily on chemical synthesis, often derived from precursor compounds in complex manufacturing processes. The supply chain has recently experienced disruptions owing to:

  • Raw material shortages, particularly in the synthesis of key intermediates.
  • Regulatory restrictions aimed at minimizing side effects and overuse.
  • Intellectual property rights influencing generic production.
  • Trade tensions impacting cross-border supply.

Acetic Acid Supply Chain

Acetic acid’s production is typically via methanol carbonylation, with China and the United States as dominant producers. Recent supply chain challenges include:

  • Fluctuations in methanol availability and pricing.
  • Environmental regulations impacting manufacturing sites.
  • Increased focus on bio-based production, which, while sustainable, faces scalability hurdles.
  • COVID-19 pandemic-induced logistical disruptions.

Regulatory and Patent Climate

Regulatory frameworks notably influence market growth. For hydrocortisone:

  • Stringent approval guidelines for biosimilar — or generic corticosteroids — maintenance of efficacy and safety.
  • Patent expirations in key markets (e.g., the US and Europe) have fostered generic entry, intensifying competition.

For acetic acid:

  • Environmental regulations target emissions and waste management.
  • Green chemistry initiatives promote the development of bio-acetic acid with potentially different regulatory pathways.

Technological Advances and R&D Trends

In hydrocortisone:

  • Advances in biosynthesis and semi-synthetic modifications improve efficacy and reduce side effects.
  • Custom delivery systems (e.g., topical gels, controlled-release formulations) expand application scope.

In acetic acid:

  • Bio-based fermentation processes offer sustainable alternatives.
  • Catalytic improvements increase process efficiency, reducing costs.
  • Research toward biodegradable materials enhances end-use markets.

Financial Projections and Investment Outlook

Hydrocortisone Market

Considering patent expiries and increasing generic competition, profit margins are under pressure, but high-volume demand keeps revenues robust. The projected compound annual growth rate (CAGR) of 4.2% suggests steady revenue streams in established markets. Strategic investments are focusing on:

  • Development of new formulations.
  • Expanding manufacturing capacity in emerging economies.
  • R&D in biosimilars and novel delivery platforms.

Acetic Acid Market

The acetic acid segment demonstrates resilience due to its widespread industrial application. With a CAGR forecast of 5.1%, companies investing in bio-based production and process efficiency improvements are poised for better margins. Key investment areas include:

  • Scaling bio-acetic acid manufacturing.
  • Upgrading existing facilities to meet environmental standards.
  • Diversification into downstream derivative products.

Emerging Opportunities and Risks

  • Opportunities: Growing demand in personalized medicine; sustainable production techniques; expansion into untapped markets.
  • Risks: Regulatory tightening; price volatility of raw materials; environmental compliance costs; geopolitical instability affecting supply routes.

Market Outlook and Strategic Recommendations

The evolving market landscape for hydrocortisone and acetic acid presents a balanced mix of opportunities and challenges. Firms should focus on:

  • Innovation to differentiate products, especially in delivery methods and formulations.
  • Strengthening supply chains via diversification and strategic partnerships.
  • Investing in sustainability initiatives, particularly in bio-based processes.
  • Monitoring regulatory changes to adapt quickly and maintain compliance.

Long-term growth hinges on embracing technological advances, diversifying product portfolios, and navigating complex regulatory environments effectively.

Key Takeaways

  • The hydrocortisone market remains resilient amidst rising demand for corticosteroid-based therapies, with growth driven by increasing autoimmune and inflammatory diseases, despite competitive pressures from generics.
  • Acetic acid’s industrial dominance is bolstered by expanding applications in plastics, textiles, and food, with bio-based production offering sustainable growth avenues.
  • Supply chain vulnerabilities, regulatory shifts, and environmental mandates are critical factors shaping market trajectories.
  • Technological innovations such as bio-synthesis and advanced delivery systems underpin ongoing growth prospects.
  • Strategic investments in R&D, sustainability, and supply chain resilience are essential for capturing market share in a competitive environment.

FAQs

1. What are the primary drivers influencing the growth of hydrocortisone and acetic acid markets?
The growth drivers include increasing prevalence of autoimmune and inflammatory diseases for hydrocortisone, and rising industrial application and sustainability initiatives fostering bio-based acetic acid.

2. How have patent expirations impacted the hydrocortisone market?
Patent expirations have enabled generic formulations to enter the market, intensifying competition while reducing prices and expanding access globally.

3. What environmental regulations affect acetic acid production?
Regulations focus on emissions, waste management, and the adoption of greener manufacturing practices, especially in regions with strict environmental standards.

4. What technological advances are shaping future opportunities?
Advances in biosynthesis for hydrocortisone and bio-fermentation for acetic acid are driving sustainable and efficient production methods.

5. What strategic actions should companies pursue to succeed in these markets?
Companies should invest in innovation, diversify supply chains, adopt sustainable practices, and monitor regulatory landscapes to maintain competitiveness.


Sources:

[1] MarketsandMarkets, "Corticosteroids Market," 2022.
[2] Fortune Business Insights, "Acetic Acid Market Size, Share & Industry Analysis," 2022.

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