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Last Updated: April 11, 2025

Hydrocortisone acetate; neomycin sulfate - Generic Drug Details


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What are the generic drug sources for hydrocortisone acetate; neomycin sulfate and what is the scope of patent protection?

Hydrocortisone acetate; neomycin sulfate is the generic ingredient in three branded drugs marketed by Pharmacia And Upjohn, Epic Pharma Llc, and Monarch Pharms, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Summary for hydrocortisone acetate; neomycin sulfate
US Patents:0
Tradenames:3
Applicants:3
NDAs:6
DailyMed Link:hydrocortisone acetate; neomycin sulfate at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for hydrocortisone acetate; 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
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
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 hydrocortisone acetate; neomycin sulfate

Showing 1 to 7 of 7 entries

Market Dynamics and Financial Trajectory for Hydrocortisone Acetate and Neomycin Sulfate

Introduction

Hydrocortisone acetate and neomycin sulfate are widely used in various medical formulations, particularly in topical and otic preparations, to treat a range of conditions including skin infections, allergic reactions, and bacterial infections of the external auditory canal. Here, we will delve into the market dynamics and financial trajectory of these drugs.

Market Size and Growth

The global market for hydrocortisone cream, which often includes hydrocortisone acetate, is substantial and growing. As of 2024, the global hydrocortisone cream market size is estimated to be USD 1352.2 million, with a compound annual growth rate (CAGR) of 6.5% projected from 2024 to 2031[3].

Regional Market Breakdown

  • North America: This region dominates the hydrocortisone cream market, accounting for over 40% of the global revenue with a market size of USD 540.88 million in 2024. It is expected to grow at a CAGR of 4.7% from 2024 to 2031[3].
  • Europe: Europe holds around 30% of the global revenue, with a market size of USD 405.66 million in 2024, and is expected to grow at a CAGR of 5.0% from 2024 to 2031[3].
  • Asia-Pacific: This region is expected to see significant growth, with a market share of around 23% and a CAGR of 8.5% from 2024 to 2031[3].
  • Latin America and Middle East & Africa: These regions also contribute to the market, though to a lesser extent, with market sizes of USD 67.61 million and USD 27.04 million respectively in 2024, and CAGRs of 5.9% and 6.2% from 2024 to 2031[3].

Market Drivers

Several factors drive the growth of the hydrocortisone acetate and neomycin sulfate market:

Increasing Prevalence of Skin Conditions

The high prevalence of skin conditions such as eczema, psoriasis, and allergic dermatitis drives the demand for hydrocortisone acetate-based creams and ointments[3].

Advanced Healthcare Infrastructure

Regions with sophisticated healthcare infrastructure, such as North America and Europe, contribute significantly to the market due to better access to healthcare services and higher awareness of skin health[3].

Growing Consumer Awareness

In emerging economies like China and India, increasing healthcare expenditure and growing consumer awareness of skin health are key drivers of market growth[3].

Market Restraints

Despite the growth, there are several restraints to consider:

Side Effects and Contraindications

Hydrocortisone acetate and neomycin sulfate can have side effects such as skin sensitization, ototoxicity, and nephrotoxicity, especially with prolonged use. These factors can limit their use in certain patient populations[2][4].

Regulatory Scrutiny

Strict regulatory guidelines and the need for clinical trials to ensure safety and efficacy can slow down market growth[2].

Financial Performance

The financial performance of hydrocortisone acetate and neomycin sulfate formulations is robust, driven by their widespread use:

Revenue Projections

The global hydrocortisone cream market is projected to expand significantly, with North America and Europe being the major contributors. The market is expected to reach new heights due to the increasing demand for topical and otic preparations[3].

Competitive Landscape

The market is competitive, with several key players such as Pfizer and Endo Pharmaceuticals offering various formulations that include hydrocortisone acetate and neomycin sulfate. The competition drives innovation and pricing strategies, impacting the financial trajectory of these drugs[2][5].

Product Formulations and Applications

Hydrocortisone acetate and neomycin sulfate are used in a variety of formulations:

Topical Preparations

Hydrocortisone acetate creams and ointments are widely used to treat skin conditions such as eczema, psoriasis, and allergic dermatitis. These preparations are available over-the-counter and by prescription[1][5].

Otic Suspensions

Combination products like Cortisporin® TC Otic, which include hydrocortisone acetate, neomycin sulfate, colistin sulfate, and thonzonium bromide, are used to treat superficial bacterial infections of the external auditory canal and infections of mastoidectomy and fenestration cavities[2].

Ophthalmic Preparations

Neomycin sulfate, in combination with polymyxin B sulfates and dexamethasone, is used in ophthalmic solutions to treat steroid-responsive inflammatory ocular conditions and bacterial infections[4].

Mechanism of Action and Pharmacology

Understanding the mechanism of action is crucial for appreciating the market dynamics:

Hydrocortisone Acetate

Hydrocortisone acetate acts by binding to the glucocorticoid receptor, leading to anti-inflammatory effects such as the inhibition of phospholipase A2, NF-kappa B, and other inflammatory transcription factors. It also promotes anti-inflammatory genes like interleukin-10[1].

Neomycin Sulfate

Neomycin sulfate is an aminoglycoside antibiotic that inhibits protein synthesis in bacteria by disrupting the normal cycle of ribosomal function. It is used to treat a wide variety of infections, including those in the external auditory canal and the eye[4].

Clinical Use and Safety

The clinical use and safety profile of these drugs are critical for their market success:

Indications and Contraindications

Hydrocortisone acetate and neomycin sulfate are indicated for various conditions, but they are contraindicated in patients with known hypersensitivity to these components. For example, Cortisporin® TC Otic is contraindicated in cases of suspected or known viral infections like herpes simplex or varicella zoster in the external auditory canal[2].

Adverse Reactions

Neomycin can cause ototoxicity, nephrotoxicity, and skin sensitization. Hydrocortisone acetate can suppress the body's defense mechanism against infection and may delay healing[2].

Key Takeaways

  • The global hydrocortisone cream market is growing, driven by increasing prevalence of skin conditions and advanced healthcare infrastructure.
  • Hydrocortisone acetate and neomycin sulfate are used in various formulations, including topical creams, otic suspensions, and ophthalmic solutions.
  • The mechanism of action of these drugs involves anti-inflammatory and antibacterial effects.
  • Despite the growth, the market faces restraints such as side effects and regulatory scrutiny.
  • The financial performance of these drugs is robust, with significant revenue projections.

Frequently Asked Questions (FAQs)

Q: What are the primary uses of hydrocortisone acetate? A: Hydrocortisone acetate is primarily used to treat corticosteroid-responsive dermatoses, endocrine disorders, immune conditions, and allergic disorders. It is commonly found in topical creams and ointments, as well as in otic suspensions[1][2].

Q: How does neomycin sulfate work? A: Neomycin sulfate is an aminoglycoside antibiotic that inhibits protein synthesis in bacteria by disrupting the normal cycle of ribosomal function. It is used to treat bacterial infections in various parts of the body, including the external auditory canal and the eye[4].

Q: What are the potential side effects of hydrocortisone acetate and neomycin sulfate? A: Hydrocortisone acetate can cause skin irritation, sensitization, and may suppress the body's defense mechanism against infection. Neomycin sulfate can cause ototoxicity, nephrotoxicity, and skin sensitization[2][4].

Q: Which regions dominate the hydrocortisone cream market? A: North America and Europe dominate the hydrocortisone cream market, with significant contributions from Asia-Pacific and other regions[3].

Q: What is the projected growth rate of the global hydrocortisone cream market? A: The global hydrocortisone cream market is projected to grow at a CAGR of 6.5% from 2024 to 2031[3].

Sources:

  1. DrugBank: Hydrocortisone: Uses, Interactions, Mechanism of Action.
  2. FDA: CORTISPORIN-TC- colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate suspension.
  3. Cognitive Market Research: Hydrocortisone Cream Market Report 2024 (Global Edition).
  4. DrugBank: Neomycin: Uses, Interactions, Mechanism of Action.
  5. Pfizer: CORTISPORIN Cream (neomycin and polymyxin B sulfates and hydrocortisone acetate cream, USP).

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