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Last Updated: December 11, 2025

Bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate - Generic Drug Details


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What are the generic drug sources for bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate and what is the scope of patent protection?

Bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate is the generic ingredient in four branded drugs marketed by Casper Pharma Llc, Bausch And Lomb, Sciegen Pharms Inc, Pharmafair, and Monarch Pharms, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate
Pharmacology for bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate
Anatomical Therapeutic Chemical (ATC) Classes for bacitracin zinc; 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
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
J01XX Other antibacterials
J01X OTHER ANTIBACTERIALS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
R02AB Antibiotics
R02A THROAT PREPARATIONS
R02 THROAT PREPARATIONS
R Respiratory system
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
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 bacitracin zinc; 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
Casper Pharma Llc CORTISPORIN bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 050416-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Monarch Pharms CORTISPORIN bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate OINTMENT;TOPICAL 050168-002 May 4, 1984 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sciegen Pharms Inc NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 065213-001 Jul 25, 2012 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmafair NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate OINTMENT;TOPICAL 062381-001 Sep 6, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bausch And Lomb NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 064068-001 Oct 30, 1995 RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmafair ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 062389-001 Jul 2, 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 the Pharmaceutical Drug: Bacitracin Zinc, Hydrocortisone, Neomycin Sulfate, Polymyxin B Sulfate

Last updated: July 28, 2025


Introduction

The combination of bacitracin zinc, hydrocortisone, neomycin sulfate, and polymyxin B sulfate forms a multi-ingredient topical pharmaceutical often prescribed for skin infections, inflammation, and wound healing. Its unique composition addresses bacterial causative agents and inflammatory processes simultaneously, positioning it within a competitive yet specialized niche in the dermatological and infectious disease markets. This analysis elucidates the current market dynamics, growth drivers, challenges, and future financial prospects for this combined therapy.


Market Composition and Segmentation

The topical pharmaceutical encompassing bacitracin zinc, hydrocortisone, neomycin sulfate, and polymyxin B sulfate typically falls under the antibacterial/anti-inflammatory combination treatments. The primary applications include management of eczema, dermatitis, minor skin infections, and wound care—a segment that has witnessed increasing demand owing to rising skin-related health issues and wound prevalence.

Key Segments

  • Over-the-counter (OTC) products: Widely used for minor cuts, abrasions, and insect bites.
  • Prescription formulations: Utilized for moderate to severe infections, especially in clinical settings.
  • Hospital use: Employed in wound management and post-surgical care.

Current Market Dynamics

Demand Drivers

  1. Rising Incidence of Skin Infections and Wounds
    The increasing prevalence of skin infections, such as impetigo, caused by bacterial pathogens, fuels demand. A rise in chronic wounds and diabetic ulcers further expands the market’s scope, especially in aging populations.

  2. Growing Awareness and Self-Medication
    Consumer awareness regarding minor skin infections propels OTC sales, supported by marketing strategies emphasizing convenience and efficacy.

  3. Advancements in Topical Pharmacology
    Improved formulations enhancing penetration, stability, and absorption bolster the therapeutic appeal of combination products.

  4. Regulatory Approvals and Patent Expiries
    As key formulations lose exclusivity, generic versions proliferate, affecting pricing and market share, but also widening accessibility.

Supply Chain and Manufacturing Trends

  • Manufacturing Scale and Cost Control: Companies are optimizing production for cost competitiveness with advanced synthesis and formulation technologies.
  • Regulatory Compliance: Stringent regulations by agencies like the FDA and EMA influence manufacturing standards, impacting supply robustness and timelines.

Competitive Landscape

  • Generic Dominance: The high prevalence of generic formulations has saturated the market, decreasing prices but improving accessibility.
  • Innovator Versus Generic Competition: Patent expirations have opened avenues for both low-cost generics and branded differentiated products emphasizing formulation improvements.

Financial Trajectory Analysis

Revenue Trends

The global market for topical antibiotics and corticosteroids is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, driven by increasing skin infection cases and expanding OTC sales [1].

In particular:

  • The OTC segment is expected to see steady growth, accounting for approximately 55% of total sales, owing to consumer preference and accessibility.
  • The prescription sector maintains stable growth, especially for severe infections and complex wound management.

Market Valuation

As per recent industry reports, the combined market value for topical formulations containing these ingredients was $1.2 billion in 2022, with projections estimating it reaching $1.65 billion by 2028. The CAGR estimated at 5.4%, driven by expanding demand in emerging markets and technological innovations.

Pricing Dynamics

Price erosion due to generic competition has been the norm; however, premium formulations with enhanced delivery mechanisms or combination stability may command higher margins.

Investment and R&D Outlook

Manufacturers are investing in:

  • Formulation innovations for improved efficacy.
  • Nano-formulations to increase bioavailability.
  • Combination therapy improvements to reduce resistance.

R&D expenditures typically constitute about 5-8% of revenue in this sector, aiming for incremental improvements rather than blockbuster breakthroughs.


Regulatory and Market Challenges

  • Antimicrobial Resistance (AMR): Growing resistance threats necessitate cautious antibiotic use, possibly restricting prescription practices and impacting sales.
  • Regulatory Scrutiny: Stringent approvals for new formulations and combination products can slow market entry.
  • Pricing Pressures: Increased competition, especially from generics and biosimilars, tightens profit margins.

Emerging Trends and Future Outlook

  1. Shift Toward Improved Formulations
    Nanotechnology, liposomal carriers, and sustained-release platforms are on the rise, promising enhanced therapeutic efficacy that may command higher pricing.

  2. Growth in Emerging Markets
    Developing countries present significant growth opportunities owing to large populations, limited healthcare access, and rising skin infection rates.

  3. Digital and Telemedicine Integration
    Teledermatology and digital health tools facilitate broader prescription and OTC sales, further expanding the market.

  4. Potential for Expanded Indications
    Adjunct uses in veterinary medicine, wound dressings, and combination therapies may unlock additional revenue streams.


Conclusion and Strategic Outlook

The market for bacitracin zinc, hydrocortisone, neomycin sulfate, and polymyxin B sulfate formulations remains robust, driven by increasing skin-related health issues, OTC accessibility, and technological advances. While patent expiries and resistance concerns pose challenges, innovation in formulation science, strategic positioning in emerging markets, and regulatory navigation will underpin growth. Companies focusing on improving therapeutic profiles and marketing efficacy will likely outperform the broader commodity-based segments.


Key Takeaways

  • The combined topical medication market is projected to grow at approximately 5-6% CAGR, fueled by rising skin infections and wound care demands.
  • Generics dominate due to patent expirations, resulting in competitive pricing but constricted profit margins.
  • Emerging markets represent substantial growth prospects, especially with increasing healthcare infrastructure.
  • Innovations such as nanotechnology and sustained-release formulations will provide a competitive edge.
  • Regulatory landscape complexities, especially regarding antimicrobial stewardship, require strategic compliance and positioning.

FAQs

Q1: How will antimicrobial resistance impact the market for topical antibiotics?
A1: Growing antimicrobial resistance encourages meticulous prescribing, potentially limiting sales volume but also prompting innovation in formulations that reduce resistance development.

Q2: Are there opportunities for branded formulations over generics?
A2: Yes, especially in developing advanced delivery systems and combination therapies that offer superior efficacy or reduced side effects, enabling premium pricing.

Q3: What role do emerging markets play in the future of this drug class?
A3: Emerging markets are critical, offering large populations with unmet healthcare needs, increasing demand for affordable, effective topical antibiotics.

Q4: How significant is R&D in differentiating products in this segment?
A4: Highly significant; R&D leads to formulations with better stability, bioavailability, and reduced resistance, creating competitive advantages.

Q5: Will patent expiries severely impact future revenue?
A5: While patent expiries lead to increased generic competition, innovation and expanded indications can mitigate revenue loss by capturing premium segments.


References

[1] MarketResearch.com, "Global Topical Antibiotics Market," 2022.

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