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Last Updated: December 25, 2024

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


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

Bacitracin zinc; neomycin sulfate; polymyxin b sulfate is the generic ingredient in five branded drugs marketed by Pharmafair, Pharmaderm, Casper Pharma Llc, Dow Pharm, Bausch And Lomb, Padagis Us, Sciegen Pharms Inc, and Naska, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for bacitracin zinc; neomycin sulfate; polymyxin b sulfate
Pharmacology for bacitracin zinc; neomycin sulfate; polymyxin b sulfate
Anatomical Therapeutic Chemical (ATC) Classes for bacitracin zinc; neomycin sulfate; polymyxin b sulfate
A01AB Antiinfectives and antiseptics 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
B05CA Antiinfectives
B05C IRRIGATING SOLUTIONS
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B Blood and blood forming organs
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
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
S02AA Antiinfectives
S02A ANTIINFECTIVES
S02 OTOLOGICALS
S Sensory organs
S02AA Antiinfectives
S02A ANTIINFECTIVES
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; 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
Bausch And Lomb NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC bacitracin zinc; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 064064-001 Oct 30, 1995 AT RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sciegen Pharms Inc NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC bacitracin zinc; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 065088-001 Feb 6, 2004 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Casper Pharma Llc LUMI-SPORYN bacitracin zinc; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 050417-001 Approved Prior to Jan 1, 1982 AT RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Naska BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE bacitracin zinc; neomycin sulfate; polymyxin b sulfate OINTMENT;TOPICAL 062833-001 Nov 9, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dow Pharm NEO-POLYCIN bacitracin zinc; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 060647-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Bacitracin zinc; neomycin sulfate; polymyxin b sulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Neomycin Sulfate, Polymyxin B Sulfate, and Bacitracin Zinc

Introduction

The combination of neomycin sulfate, polymyxin B sulfate, and bacitracin zinc, commonly known as triple antibiotic ointment, is a widely used topical antimicrobial agent. This article delves into the market dynamics and financial trajectory of this drug combination, exploring its usage, market trends, and financial performance.

Market Overview

Demand and Usage

The demand for neomycin sulfate, polymyxin B sulfate, and bacitracin zinc is driven by their broad-spectrum antibacterial properties, making them essential for preventing and treating minor skin injuries and superficial eye infections. These antibiotics are used in various formulations, including ointments, creams, and eye drops, which are available over-the-counter (OTC) and by prescription[4].

Market Segmentation

The market for these antibiotics can be segmented into several categories:

  • OTC Market: Products like Neosporin and Polysporin are widely available in pharmacies and retail stores, catering to consumers seeking self-care solutions for minor cuts and scrapes.
  • Prescription Market: These antibiotics are also prescribed by healthcare professionals for more severe infections or specific medical conditions, such as conjunctivitis and keratitis[2][5].

Competitive Landscape

Key Players

The market is dominated by several key players:

  • Johnson & Johnson: Known for their Neosporin brand, which is a leading triple antibiotic ointment.
  • Bayer: Offers Polysporin, another popular brand that includes both triple and double antibiotic ointments.
  • Generic and Private Label Brands: Numerous generic and private label brands also compete in the market, offering similar formulations at competitive prices[4].

Market Share

The branded segment, led by Neosporin and Polysporin, holds a significant market share due to their strong brand recognition and marketing efforts. However, generic and private label brands are gaining traction due to their cost-effectiveness and similar efficacy.

Financial Performance

Revenue Trends

The revenue generated from the sale of neomycin sulfate, polymyxin B sulfate, and bacitracin zinc has been relatively stable over the years, driven by consistent demand for these essential antimicrobial agents. The OTC segment contributes significantly to the overall revenue, given the widespread availability and frequent use of these products.

Pricing Strategies

Pricing strategies vary between branded and generic products. Branded products like Neosporin tend to be priced higher due to their brand value and marketing expenses. Generic and private label products, on the other hand, are priced lower, making them more accessible to a broader consumer base.

Regulatory Environment

Approval and Compliance

These antibiotics are regulated by health authorities such as the FDA, which ensures their safety and efficacy through rigorous testing and approval processes. Compliance with regulatory standards is crucial for maintaining market presence and consumer trust[2][5].

Safety and Efficacy

The safety and efficacy of neomycin sulfate, polymyxin B sulfate, and bacitracin zinc are well-documented. However, there are potential side effects and contraindications, such as hypersensitivity reactions and the risk of superinfection, which must be monitored and managed[1][2].

Market Trends

Increasing Demand for Self-Care Products

There is a growing trend towards self-care and over-the-counter health products, which has positively impacted the demand for triple antibiotic ointments. Consumers are increasingly seeking convenient and effective solutions for minor health issues without the need for a prescription.

Rise of Generic and Private Label Brands

The market has seen a rise in generic and private label brands, which offer cost-effective alternatives to branded products. This trend is expected to continue, driven by consumer preference for affordable healthcare options.

Technological Advancements

Advancements in formulation technology have led to the development of more effective and user-friendly products. For example, some formulations now include additional ingredients like hydrocortisone to reduce inflammation, as seen in CORTISPORIN Ointment[5].

Challenges and Opportunities

Antibiotic Resistance

One of the significant challenges facing the market is the growing concern of antibiotic resistance. Prolonged use of these antibiotics can lead to the development of resistant bacterial strains, which may reduce their efficacy over time[2].

Expanding into New Markets

There is an opportunity to expand into emerging markets where access to healthcare is limited. These markets present a significant potential for growth, especially for affordable and effective antimicrobial agents.

Key Takeaways

  • Broad-Spectrum Efficacy: Neomycin sulfate, polymyxin B sulfate, and bacitracin zinc offer broad-spectrum antibacterial coverage, making them highly effective against a wide range of bacterial infections.
  • Market Segmentation: The market is segmented into OTC and prescription segments, with branded and generic/private label products competing in each segment.
  • Financial Stability: The revenue from these antibiotics has been relatively stable, driven by consistent demand.
  • Regulatory Compliance: Strict regulatory compliance is essential for maintaining market presence and ensuring consumer safety.
  • Market Trends: Increasing demand for self-care products and the rise of generic/private label brands are key trends shaping the market.

FAQs

Q: What are the active ingredients in triple antibiotic ointment? A: The active ingredients are neomycin sulfate, polymyxin B sulfate, and bacitracin zinc[4].

Q: What are the common uses of neomycin sulfate, polymyxin B sulfate, and bacitracin zinc? A: These antibiotics are used to prevent and treat minor skin injuries and superficial eye infections[2][4].

Q: Are there any potential side effects of using these antibiotics? A: Yes, potential side effects include hypersensitivity reactions, superinfection, and delayed wound healing[1][2].

Q: How do generic and private label brands impact the market? A: Generic and private label brands offer cost-effective alternatives, increasing competition and driving market growth[4].

Q: What are the regulatory requirements for these antibiotics? A: These antibiotics must comply with FDA regulations to ensure safety and efficacy[2][5].

Sources

  1. Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP - Package Insert[1].
  2. DailyMed: Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP[2].
  3. Prospective evaluation of topical antibiotics for preventing infections - PubMed[3].
  4. Neomycin/polymyxin B/bacitracin - Wikipedia[4].
  5. CORTISPORIN Ointment - Pfizer Labeling[5].

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