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Last Updated: December 23, 2024

BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE Drug Patent Profile


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Which patents cover Bacitracin Zinc-neomycin Sulfate-polymyxin B Sulfate, and what generic alternatives are available?

Bacitracin Zinc-neomycin Sulfate-polymyxin B Sulfate is a drug marketed by Pharmafair and Naska and is included in two NDAs.

The generic ingredient in BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE is bacitracin zinc; neomycin sulfate; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the bacitracin zinc; neomycin sulfate; polymyxin b sulfate profile page.

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Summary for BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE
US Patents:0
Applicants:2
NDAs:2
DailyMed Link:BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE at DailyMed
Drug patent expirations by year for BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE

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
Pharmafair BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE bacitracin zinc; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 062386-001 Sep 9, 1982 DISCN No 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
>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 Bacitracin Zinc-Neomycin Sulfate-Polymyxin B Sulfate

Introduction

The combination of bacitracin zinc, neomycin sulfate, and polymyxin B sulfate is a widely used topical antibiotic formulation, known for its broad-spectrum antibacterial properties. This article delves into the market dynamics and financial trajectory of this drug combination, exploring its indications, market trends, competitive landscape, and financial performance.

Indications and Usage

This topical antibiotic ointment is indicated for the treatment and prevention of infections in minor cuts, scrapes, burns, abrasions, insect bites, and other skin breaks. It is also used in ophthalmic formulations for the treatment of superficial infections of the external eye and its adnexa, including conjunctivitis, keratitis, and blepharitis[1][3][5].

Market Trends

Growing Demand for Topical Antibiotics

The demand for topical antibiotics has been increasing due to the rising incidence of skin and eye infections. The convenience and effectiveness of these ointments make them a preferred choice for first aid and minor wound care. This trend is expected to continue, driven by consumer awareness and the need for quick, effective treatments for minor injuries.

Increasing Focus on Antimicrobial Resistance

The global concern over antimicrobial resistance has led to a greater emphasis on the responsible use of antibiotics. While this might pose challenges for the market, the combination of bacitracin zinc, neomycin sulfate, and polymyxin B sulfate remains a viable option due to its broad-spectrum activity and the fact that it is typically used for short durations and in localized applications.

Competitive Landscape

Key Players

The market for this drug combination is competitive, with several key players including Pfizer, Interphil Laboratories, and other generic manufacturers. Products like Neosporin and Terramycin PLUS are well-known brands that dominate the market[3][5].

Product Differentiation

While the active ingredients remain the same, differentiation often comes through branding, packaging, and additional components such as hydrocortisone in some formulations. For example, CORTISPORIN Ointment includes hydrocortisone for anti-inflammatory effects, making it a unique offering in the market[3].

Financial Performance

Revenue Growth

The revenue generated from the sale of bacitracin zinc, neomycin sulfate, and polymyxin B sulfate ointments has been stable over the years, with occasional spikes due to increased demand during flu seasons or other periods of high infection rates.

Market Size

The global market for topical antibiotics is substantial, with the segment involving this specific combination contributing significantly. According to industry reports, the market size for topical antibiotics is expected to grow at a moderate CAGR, driven by increasing healthcare expenditure and the growing need for effective wound care solutions.

Pricing and Cost Analysis

Pricing Strategies

The pricing of these ointments varies based on the brand, formulation, and geographical location. Generic versions are generally more affordable, making them accessible to a broader consumer base. Brand-name products, however, command a premium due to their established reputation and marketing efforts.

Cost-Effectiveness

The cost-effectiveness of these ointments is a significant factor in their widespread use. They offer a cheap and effective solution for preventing and treating minor infections, which is particularly important in resource-limited settings.

Regulatory Environment

Approval and Compliance

The first approval for this combination dates back to 1971 in the US, and since then, it has been approved in various countries around the world. Regulatory bodies like the FDA closely monitor the use and safety of these antibiotics to ensure compliance with safety standards[2].

Safety and Efficacy

Clinical studies have consistently shown that the combination of bacitracin zinc, neomycin sulfate, and polymyxin B sulfate is safe and effective for its intended uses. For example, a prospective study found that this combination resulted in significantly lower wound infection rates compared to petrolatum controls[4].

Consumer Behavior and Preferences

Consumer Awareness

Consumer awareness about the importance of wound care and the prevention of infections has increased, driving the demand for topical antibiotics. Consumers often prefer well-known brands and formulations that are easy to apply and have a proven track record of effectiveness.

User Compliance

User compliance is crucial for the effectiveness of these ointments. Instructions for use, such as applying the ointment 1 to 3 times daily and covering the area with a sterile bandage, are critical for optimal results[5].

Future Outlook

Emerging Markets

The growth potential in emerging markets is significant, driven by increasing healthcare spending and a growing middle class. Companies are expanding their distribution networks to tap into these markets.

Innovation and R&D

While the core formulation remains unchanged, there is ongoing research into new delivery systems and combinations that could enhance efficacy or reduce side effects. For instance, neomycin has been explored for its potential as a host-directed antiviral strategy[2].

Key Takeaways

  • Broad-Spectrum Activity: The combination of bacitracin zinc, neomycin sulfate, and polymyxin B sulfate offers broad-spectrum antibacterial activity, making it effective against a wide range of bacteria.
  • Market Demand: The demand for topical antibiotics is increasing due to the rising incidence of skin and eye infections.
  • Competitive Landscape: The market is competitive with several key players, and differentiation often comes through branding and additional components.
  • Financial Performance: The revenue generated from these ointments is stable, with growth potential in emerging markets.
  • Regulatory Compliance: The combination is approved and closely monitored by regulatory bodies to ensure safety and efficacy.

FAQs

Q: What are the common indications for the use of bacitracin zinc, neomycin sulfate, and polymyxin B sulfate ointment?

A: This ointment is used for the treatment and prevention of infections in minor cuts, scrapes, burns, abrasions, insect bites, and other skin breaks, as well as for superficial infections of the external eye and its adnexa.

Q: Which bacteria are susceptible to this antibiotic combination?

A: The combination is active against a variety of bacteria including Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, and Pseudomonas aeruginosa[1][3].

Q: Can this ointment be used in the eyes?

A: Yes, but it should never be directly introduced into the anterior chamber of the eye. It is intended for topical ophthalmic use on the external eye and its adnexa[1].

Q: What are the potential side effects of using this ointment?

A: Potential side effects include cutaneous sensitization, itching, reddening, and edema of the conjunctiva and eyelid. It should not be used in individuals who have shown hypersensitivity to any of its components[1].

Q: How often should this ointment be applied?

A: The ointment should be applied 1 to 3 times daily, and the affected area may be covered with a sterile bandage[5].

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