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Last Updated: December 15, 2025

ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE - Generic Drug Details


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What are the generic sources for acetic acid, glacial; hydrocortisone; neomycin sulfate and what is the scope of freedom to operate?

Acetic acid, glacial; hydrocortisone; neomycin sulfate is the generic ingredient in one branded drug marketed by Bayer Pharms and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE
A01AB Antiinfectives and antiseptics for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A07AA Antibiotics
A07A INTESTINAL ANTIINFECTIVES
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
B05CA Antiinfectives
B05C IRRIGATING SOLUTIONS
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B Blood and blood forming organs
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D06AX Other antibiotics for topical use
D06A ANTIBIOTICS FOR TOPICAL USE
D06 ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D Dermatologicals
D07AA Corticosteroids, weak (group I)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XA Corticosteroids, weak, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
G01AD Organic acids
G01A ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01 GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G Genito-urinary system and sex hormones
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
J01GB Other aminoglycosides
J01G AMINOGLYCOSIDE ANTIBACTERIALS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
R02AB Antibiotics
R02A THROAT PREPARATIONS
R02 THROAT PREPARATIONS
R Respiratory system
S01AA Antibiotics
S01A ANTIINFECTIVES
S01 OPHTHALMOLOGICALS
S Sensory organs
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02AA Antiinfectives
S02A ANTIINFECTIVES
S02 OTOLOGICALS
S Sensory organs
S02AA Antiinfectives
S02A ANTIINFECTIVES
S02 OTOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03AA Antiinfectives
S03A ANTIINFECTIVES
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Pharms NEO-CORT-DOME acetic acid, glacial; hydrocortisone; neomycin sulfate SUSPENSION/DROPS;OTIC 050238-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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, Glacial; Hydrocortisone; and Neomycin Sulfate

Last updated: July 31, 2025

Introduction

The pharmaceutical industry is characterized by the continuous evolution of its raw materials and active pharmaceutical ingredients (APIs). Among these, acetic acid, glacial; hydrocortisone; and neomycin sulfate occupy significant niches owing to their diverse therapeutic and industrial applications. Understanding their market dynamics and financial trajectories provides critical insights for stakeholders, including manufacturers, investors, and policy-makers. This report delves into the key drivers, challenges, and market forecasts for these substances, offering a comprehensive overview rooted in current industry data and projections.


Market Overview

Acetic Acid, Glacial

Acetic acid, particularly in its pure, anhydrous form (glacial acetic acid), is essential across multiple sectors. While traditionally associated with industrial uses, a substantial portion finds usage in the pharmaceutical sector as a raw material or intermediate. The global demand for acetic acid is estimated at approximately 15 million metric tons annually, driven by its role in chemical synthesis, food preservation, and textiles (1).

In the pharmaceutical domain, acetic acid is primarily used in drug manufacturing processes, including the synthesis of antibiotics and as a solvent. The pharmaceutical segment’s growth influences the overall market expansion, although industrial applications predominate.

Hydrocortisone

Hydrocortisone, a corticosteroid, is a vital active ingredient in treating inflammatory and autoimmune conditions. Its global market was valued at over USD 1.2 billion in 2022, with an anticipated compound annual growth rate (CAGR) of approximately 4.5% through 2030 (2). Rising prevalence of autoimmune disorders, dermatological conditions, and the expanding geriatric population underpin the demand surge.

The drug’s versatility, availability in various formulations (creams, injections, tablets), and emerging biosimilar markets contribute to a resilient growth trajectory. Developed markets like North America and Europe dominate in terms of consumption, although emerging economies exhibit rapid expansion.

Neomycin Sulfate

Neomycin sulfate is an aminoglycoside antibiotic used primarily in topical and ophthalmic formulations. The market was valued at roughly USD 300 million in 2022, with a projected CAGR of approximately 3.8% over the next decade (3). This steady growth results from ongoing demand in wound care, ophthalmology, and combination therapies.

Despite its established status, the market faces challenges from antibiotic resistance concerns and stricter regulatory standards. Nonetheless, the continuous development of novel formulations and combination therapies sustains its demand levels.


Market Drivers

1. Rising Prevalence of Chronic Diseases and Autoimmune Disorders

The upward trend in autoimmune ailments, including rheumatoid arthritis, psoriasis, and inflammatory bowel disease, directly fuels demand for hydrocortisone. Additionally, infectious diseases requiring antibiotic intervention sustain the need for neomycin sulfate.

2. Aging Population and Geriatric Care

Globally, an aging demographic elevates the incidence of chronic and degenerative diseases. This demographic shift propels the pharmaceutical industry, notably corticosteroid usage, further underpinning hydrocortisone market growth.

3. Industrial and Pharmaceutical Manufacturing Growth

Industrial applications of acetic acid drive steady demand, positively influencing its market. Furthermore, pharmaceutical manufacturing expansions, particularly in emerging economies, increase the need for raw materials like acetic acid.

4. Technological Advances and Formulation Innovations

Innovation in drug delivery systems and combination therapies enhances therapeutic efficacy and expands market penetration. Such developments promote sustained demand for key APIs like hydrocortisone and neomycin sulfate.

5. Regulatory and Patent Expirations

Patent expirations in branded drugs facilitate market penetration by generic competitors, boosting accessibility and consumption. This factor particularly benefits hydrocortisone, with numerous biosimilar options.


Market Challenges

1. Stringent Regulatory Environment

Regulatory agencies across the globe enforce rigorous standards for API manufacturing, especially concerning purity, safety, and environmental impact. Compliance incurs substantial costs, potentially impacting profit margins.

2. Antibiotic Resistance and Stewardship Policies

Rising antibiotic resistance and global initiatives promoting responsible antibiotic use threaten certain antibiotics, including neomycin sulfate. Stricter prescribing policies may constrain market growth.

3. Raw Material Price Volatility

Fluctuations in the prices of raw materials, especially for acetic acid derived from petrochemical sources, complicate cost management and profit forecasts.

4. Competition from Biosynthesized and Alternative Compounds

Emerging biotechnological processes and synthetic alternatives create competitive pressures, particularly affecting traditional APIs.


Financial Trajectory and Future Outlook

Acetic Acid, Glacial

The acetic acid market's growth hinges on industrial expansion, with Asia-Pacific dominating demand owing to burgeoning manufacturing sectors in China, India, and Southeast Asia. The market is expected to exhibit a CAGR of approximately 4.2% until 2030, driven by increased chemical synthesis needs, rising demand in food preservation, and textiles (1).

Investments in green production methods, such as bio-based acetic acid, are projected to reshape market economics, aligning with sustainability initiatives. The pharmaceutical segment's contribution remains stable, supporting incremental revenue streams.

Hydrocortisone

Hydrocortisone’s market is anticipated to grow steadily at around 4.5% CAGR through 2030, propelled by increasing autoimmune and inflammatory conditions globally. The segment benefits from patent expirations leading to generic proliferation, which significantly impacts pricing and market accessibility.

Research into novel formulations, such as long-acting implants and combination products, offers additional revenue streams. Market expansion in emerging economies is substantial, benefiting from lower drug costs and improving healthcare infrastructure.

Neomycin Sulfate

Projected to grow at approximately 3.8% CAGR over the next decade, the neomycin sulfate market will sustain its relevance owing to its topical application niche. However, growth may plateau due to resistance issues and regulatory tightening.

Opportunities exist in developing combination therapies and improved delivery systems to counter resistance and improve compliance. The market's stability depends on ongoing innovation and regulatory alignment.


Implications for Stakeholders

Stakeholders should monitor regulatory developments impacting manufacturing standards and environmental policies, particularly for acetic acid and APIs with complex synthesis processes. Investment in sustainable production technologies, notably for acetic acid, can offset raw material price volatility and meet environmental compliance.

For pharmaceutical companies, diversifying formulation portfolios and exploring biosimilar pathways for hydrocortisone can optimize revenue. Strategic R&D focusing on resistance mitigation for antibiotics like neomycin sulfate also presents growth opportunities.

Emerging markets, especially Asia-Pacific, offer significant growth prospects owing to expanding healthcare infrastructure and affordability. Entry strategies should consider local regulatory landscapes, supply chain logistics, and partnership opportunities.


Key Takeaways

  • The global acetic acid market is expanding at a CAGR exceeding 4%, driven by industrial and pharmaceutical demands, with green production methods poised to influence future economics.
  • Hydrocortisone maintains a steady growth trajectory of around 4.5%, benefiting from aging populations and biosimilar proliferation.
  • Neomycin sulfate's market stability faces challenges from antibiotic resistance but remains viable through innovation in formulations.
  • Regulatory, environmental, and raw material cost considerations significantly shape market dynamics.
  • Emerging markets present lucrative opportunities through healthcare infrastructure investments and formulation diversification.

FAQs

  1. What factors are most influencing the growth of the hydrocortisone market?
    Rising global prevalence of autoimmune and inflammatory diseases, patent expirations enabling generics, and advancements in formulation technologies are primary growth drivers.

  2. How are environmental concerns impacting acetic acid manufacturing?
    Increasing emphasis on sustainable production has led to investments in bio-based acetic acid and stricter environmental regulations, influencing manufacturing processes and costs.

  3. What are the main challenges facing neomycin sulfate market expansion?
    Antibiotic resistance, regulatory pressures, and competition from alternative therapies constrain growth prospects, necessitating innovation in delivery and combination therapies.

  4. Which regions are expected to dominate the acetic acid market?
    Asia-Pacific, particularly China and India, will continue to lead in demand due to expanding industrial and chemical sectors.

  5. How might regulatory changes affect pharmaceutical APIs in the next decade?
    Stricter standards for purity, environmental impact, and manufacturing practices could increase compliance costs but also elevate market standards, benefiting quality-focused players.


Sources

  1. [1] MarketsandMarkets, "Acetic Acid Market by Type, Application, and Region – Global Forecast to 2030," 2022.
  2. [2] Grand View Research, "Hydrocortisone Market Size, Share & Trends," 2023.
  3. [3] Transparency Market Research, "Neomycin Sulfate Market Analysis," 2022.

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