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Last Updated: December 11, 2025

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE - Generic Drug Details


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What are the generic drug sources for hydrocortisone; neomycin sulfate; polymyxin b sulfate and what is the scope of freedom to operate?

Hydrocortisone; neomycin sulfate; polymyxin b sulfate is the generic ingredient in nine branded drugs marketed by Monarch Pharms, Amneal, Bausch And Lomb, Sandoz, Saptalis Pharms, Pharmafair, Watson Labs, Casper Pharma Llc, Sciegen Pharms Inc, and Schering, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

Fifteen suppliers are listed for this compound.

Summary for HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Pharmacology for HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Anatomical Therapeutic Chemical (ATC) Classes for HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B 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
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
J01XB Polymyxins
J01X OTHER 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
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
S03AA Antiinfectives
S03A ANTIINFECTIVES
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Monarch Pharms PEDIOTIC hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 062822-001 Sep 29, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmafair OTICAIR hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 062399-001 Nov 18, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Monarch Pharms CORTISPORIN hydrocortisone; neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OTIC 050479-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmafair NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OPHTHALMIC 062623-001 Sep 24, 1985 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 Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate

Last updated: July 29, 2025


Introduction

The pharmaceutical market specializing in combination drugs such as hydrocortisone, neomycin sulfate, and polymyxin B sulfate has experienced significant shifts driven by evolving healthcare needs, regulatory landscapes, and technological advancements. This article explores the market dynamics and financial trajectory of these antibiotics and corticosteroids, emphasizing key influence factors, current trends, and future outlooks.


Market Overview

Hydrocortisone, a corticosteroid with potent anti-inflammatory properties, is predominantly used in topical formulations and systemic treatment for inflammatory and allergic conditions. Neomycin sulfate and polymyxin B sulfate are antibiotics, primarily used in combination preparations for their broad-spectrum antibacterial activity against gram-positive and gram-negative bacteria, respectively.

The increasing incidence of bacterial infections and inflammatory skin conditions fuels demand. The global market for these drugs is shaped by factors such as rising chronic diseases, antibiotic resistance, regulatory environments, and the ongoing development of novel formulations.


Market Drivers

1. Growing Prevalence of Infectious and Inflammatory Conditions
The rising global burden of bacterial skin infections, dermatitis, and inflammatory diseases propels the demand for combination topical and systemic therapies containing hydrocortisone, neomycin, and polymyxin B. According to WHO, skin infections account for significant morbidity, especially in developing regions.

2. Increasing Antibiotic Resistance
Antimicrobial resistance (AMR) is a formidable challenge, particularly concerning gram-negative bacteria. The efficacy of polymyxin B and neomycin is challenged by resistant strains, prompting the development of optimized formulations and combination therapies to mitigate resistance development.

3. Expansion of Over-the-Counter (OTC) Options
Many hydrocortisone-containing products and combination antibiotics are available OTC in various regions, expanding access but raising concerns regarding misuse, resistance, and regulatory oversight.

4. Regulatory Approvals and Patent Dynamics
Patent expirations and generic entry have affected revenue streams for branded formulations, intensifying market competition but also fostering affordability and wider adoption in emerging markets.

5. Technological Innovations
Advances in drug delivery systems, such as liposomal formulations and topical patches, enhance drug efficacy and patient compliance, influencing market growth.


Market Challenges

1. Antibiotic Stewardship and Regulatory Restrictions
Regulators are increasingly scrutinizing topical antibiotics, with some jurisdictions imposing restrictions to prevent overuse and resistance. These policies impact sales volume and revenue.

2. Safety Profile and Side Effects
Potential side effects, including skin atrophy from corticosteroids and ototoxicity/nephrotoxicity from aminoglycosides, necessitate cautious use and limit broad applications.

3. Availability of Alternatives
Emerging biologics and newer anti-inflammatory agents offer alternatives, potentially reducing dependence on traditional combination drugs.


Market Segmentation and Regional Dynamics

By Formulation:
Topical creams and ointments represent the dominant segment, with increasing adoption of long-acting patches. Systemic formulations, such as oral hydrocortisone, see stable demand primarily in severe inflammatory conditions.

By Application:

  • Dermatology (eczema, dermatitis)
  • ENT infections
  • Wound care and burns treatment

Regional Insights:

  • North America & Europe: Mature markets with high penetration, driven by regulatory oversight and antibiotic resistance concerns.
  • Asia-Pacific: Rapid growth due to rising healthcare infrastructure, high prevalence of skin infections, and growing awareness.
  • Latin America & Africa: Emerging markets with increasing access to essential medicines but challenged by affordability and infrastructure constraints.

Financial Trajectory and Forecast

Historical Trends:
Over the past decade, the combined market for hydrocortisone, neomycin sulfate, and polymyxin B sulfate has witnessed a Compound Annual Growth Rate (CAGR) of approximately 4-6%, driven largely by the expanding dermatology and infectious disease segments.

Projected Growth:
Forecasts suggest a CAGR of 3-5% from 2023 to 2030, influenced by factors such as rising antibiotic resistance, technological innovations, and expanding healthcare access. The market value, estimated at USD 1.5 billion globally in 2022, is expected to approach USD 2 billion by 2030.

Emerging Opportunities:

  • Novel delivery systems improving bioavailability and adherence.
  • Strategic alliances for combination formulations tailored to regional needs.
  • Regulatory pathways for over-the-counter approvals in developing countries.

Risks Affecting Financial Outlook:

  • Intensified regulatory controls could limit prescriptions.
  • Increasing resistance may diminish formulary efficacy.
  • Market saturation in developed regions constrains growth potential.

Key Market Players

Major pharmaceutical firms include Johnson & Johnson, Mylan, Teva Pharmaceuticals, and local generic manufacturers, competing primarily on cost, formulation innovation, and regulatory agility. Patent expirations open avenues for generic proliferation, impacting revenue streams for originators but expanding market access.


Future Trends and Strategic Considerations

  • Personalized Medicine: Custom formulations targeting specific bacterial profiles and inflammatory pathways can maximize efficacy and minimize resistance.
  • Sustainable Practices: Emphasis on reducing environmental impact through eco-friendly manufacturing and disposal is growing.
  • Regulatory Evolution: Continued tightening necessitates robust compliance strategies and pipeline diversification.
  • Digital Integration: Use of digital health tools for adherence monitoring and pharmacovigilance enhances market positioning.

Conclusion

The market landscape for hydrocortisone, neomycin sulfate, and polymyxin B sulfate is characterized by steady growth tempered by regulatory and resistance challenges. While the therapeutic combination remains vital, innovation, strategic regulatory navigation, and regional customization are crucial for sustained commercial success. The increasing adoption in emerging markets presents substantial opportunities, provided manufacturers balance accessibility with safety.


Key Takeaways

  • The global market for hydrocortisone, neomycin sulfate, and polymyxin B sulfate is projected to grow at a CAGR of approximately 3-5% through 2030, reaching USD 2 billion.
  • Rising antibiotic resistance and inflammatory conditions are primary drivers, yet regulatory controls pose significant challenges.
  • Innovation in drug delivery systems and formulation modernization will be critical for maintaining market competitiveness.
  • Emerging markets offer growth potential, driven by increasing healthcare access and burden of infectious diseases.
  • Strategic patent management and adherence to evolving safety standards are essential for maximizing financial outcomes.

FAQs

1. What are the main therapeutic uses of hydrocortisone, neomycin sulfate, and polymyxin B sulfate?
They are primarily used in combination for treating inflammatory skin conditions and bacterial infections, with hydrocortisone providing anti-inflammatory effects, and neomycin and polymyxin B offering broad-spectrum antibacterial action.

2. How does antibiotic resistance impact the market for these drugs?
Resistance decreases drug efficacy, leading to a reduced market size and the need for new formulations, combination strategies, or alternative therapies, thus influencing revenue and R&D investments.

3. What regulatory challenges exist for these drugs?
Regulatory bodies are increasingly implementing stricter guidelines to prevent overuse, reduce resistance, and ensure safety, which can restrict prescribing, delay approvals, or lead to product reformulation.

4. How are technological innovations influencing the market?
Advances such as controlled-release patches, nano-formulations, and combination molecules enhance drug efficacy, boost patient adherence, and open new market segments.

5. What strategic moves should companies consider to capitalize on market growth?
Manufacturers should focus on innovation, regional customization, strategic partnerships, compliance with regulations, and expanding OTC access in emerging markets.


References

  1. World Health Organization. "Global prevalence of bacterial infections." 2021.
  2. MarketResearch.com. "Global Dermatology Treatments Market Analysis." 2022.
  3. Johnson & Johnson Annual Report 2022.
  4. GlobalData. "Antibiotics Market Forecast." 2023.
  5. FDA Regulatory Guidelines for Topical Antibiotics and Corticosteroids. 2022.

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