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Last Updated: December 22, 2024

BACITRACIN ZINC AND POLYMYXIN B SULFATE Drug Patent Profile


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Which patents cover Bacitracin Zinc And Polymyxin B Sulfate, and what generic alternatives are available?

Bacitracin Zinc And Polymyxin B Sulfate is a drug marketed by Bausch And Lomb, Padagis Us, and Sciegen Pharms Inc. and is included in three NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Bacitracin Zinc And Polymyxin B Sulfate

A generic version of BACITRACIN ZINC AND POLYMYXIN B SULFATE was approved as bacitracin zinc; polymyxin b sulfate by BAUSCH AND LOMB on January 26th, 1995.

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Summary for BACITRACIN ZINC AND POLYMYXIN B SULFATE
Drug patent expirations by year for BACITRACIN ZINC AND POLYMYXIN B SULFATE
Recent Clinical Trials for BACITRACIN ZINC AND POLYMYXIN B SULFATE

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SponsorPhase
Glaxo WellcomeN/A
National Institute of Allergy and Infectious Diseases (NIAID)N/A

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Pharmacology for BACITRACIN ZINC AND POLYMYXIN B SULFATE

US Patents and Regulatory Information for BACITRACIN ZINC AND 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 BACITRACIN ZINC AND POLYMYXIN B SULFATE bacitracin zinc; polymyxin b sulfate OINTMENT;OPHTHALMIC 064046-001 Jan 26, 1995 AT RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Padagis Us BACITRACIN ZINC AND POLYMYXIN B SULFATE bacitracin zinc; polymyxin b sulfate OINTMENT;OPHTHALMIC 065022-001 Feb 27, 2002 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sciegen Pharms Inc BACITRACIN ZINC AND POLYMYXIN B SULFATE bacitracin zinc; polymyxin b sulfate OINTMENT;OPHTHALMIC 064028-001 Jan 30, 1995 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 AND POLYMYXIN B SULFATE Market Analysis and Financial Projection Experimental

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

Introduction

Bacitracin Zinc and Polymyxin B Sulfate is a widely used antimicrobial ointment, particularly in ophthalmic applications. This combination of antibiotics has been a staple in treating superficial bacterial infections of the eye and its adnexa. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Overview

The ophthalmic anti-infectives market, where Bacitracin Zinc and Polymyxin B Sulfate is a key player, is driven by the increasing incidence of eye infections and the need for effective treatments. This market segment is characterized by a mix of branded and generic products, with the latter dominating due to their cost-effectiveness and widespread acceptance[3].

Product Indications and Usage

Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment is indicated for the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by susceptible bacteria. This includes conditions such as conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, and blepharoconjunctivitis[2][3].

Competitive Landscape

The market for ophthalmic anti-infectives is competitive, with several pharmaceutical companies offering similar products. However, the combination of bacitracin zinc and polymyxin B sulfate remains a preferred choice due to its broad-spectrum antibacterial activity. Companies like Akorn, Inc. have launched generic versions of this ointment, which has helped in addressing market shortages and providing cost-effective alternatives[4].

Financial Performance

The financial performance of Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment is influenced by several factors:

Sales and Revenue

The sales of this ointment are steady, driven by its widespread use in both human and veterinary medicine. The launch of generic versions by companies like Akorn has helped in increasing market penetration and revenue. For instance, Akorn’s launch of Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment addressed a market shortage and expanded the company’s product portfolio[4].

Pricing and Cost-Effectiveness

The pricing of Bacitracin Zinc and Polymyxin B Sulfate ointment is generally competitive, especially with the availability of generic options. This cost-effectiveness is a significant factor in its market success, making it accessible to a broader range of patients and veterinarians.

Market Expansion

The market for this ointment is expanding due to increasing demand for ophthalmic anti-infectives. The launch of new products and formulations, such as those by Akorn, has helped in capturing a larger market share. Additionally, the growing awareness of eye health and the need for effective treatments contribute to the financial growth of this product[4].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of Bacitracin Zinc and Polymyxin B Sulfate. The product is approved through the Abbreviated New Drug Application (ANDA) process for human use and the Abbreviated New Animal Drug Application (ANADA) for veterinary use. Compliance with regulatory requirements ensures continuous market presence and revenue generation[2][4].

Challenges and Opportunities

Bacterial Resistance

One of the significant challenges facing this product is the potential for bacterial resistance. Prolonged use can lead to the overgrowth of nonsusceptible organisms, including fungi, which may impact sales and revenue. However, this also presents an opportunity for research and development into new formulations or combinations that can mitigate resistance[2].

Side Effects and Safety

While the ointment is generally well-tolerated, severe allergic reactions and other side effects can occur. Managing these risks through proper labeling, patient education, and monitoring can help maintain market trust and financial stability[5].

Future Outlook

The future outlook for Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment is positive, driven by:

Increasing Demand

The demand for ophthalmic anti-infectives is expected to rise due to an aging population and increased awareness of eye health.

Generic Market Growth

The generic market segment is likely to continue growing, providing cost-effective alternatives and driving revenue.

Innovative Formulations

Research into new formulations and combinations to address bacterial resistance and improve efficacy will be crucial for maintaining market leadership.

Key Takeaways

  • Broad-Spectrum Antibacterial Activity: Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment is effective against a wide range of gram-positive and gram-negative bacteria.
  • Competitive Market: The market is competitive, but the product remains a preferred choice due to its efficacy and cost-effectiveness.
  • Regulatory Compliance: Continuous compliance with regulatory requirements is essential for market presence.
  • Challenges and Opportunities: Managing bacterial resistance and side effects while exploring new formulations presents both challenges and opportunities.
  • Positive Future Outlook: The demand for ophthalmic anti-infectives and the growth of the generic market segment are expected to drive revenue.

FAQs

  1. What is Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment used for?

    • It is used for the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by susceptible bacteria.
  2. What are the active ingredients in Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment?

    • The active ingredients are bacitracin zinc and polymyxin B sulfate.
  3. What are the potential side effects of Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment?

    • Potential side effects include severe allergic reactions, superinfection, and other adverse reactions such as itching, skin rash, or nausea.
  4. Is Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment available in generic form?

    • Yes, it is available in generic form, which has helped in addressing market shortages and providing cost-effective alternatives.
  5. What is the regulatory status of Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment?

    • It is approved through the Abbreviated New Drug Application (ANDA) process for human use and the Abbreviated New Animal Drug Application (ANADA) for veterinary use.

Cited Sources

  1. Synapse by Patsnap - Bacitracin Zinc/Neomycin sulfate/Polymycin B sulfate[1].
  2. DailyMed - Bacitracin Zinc and Polymyxin B Sulfate ointment[2].
  3. Drugs.com - Bacitracin Polymyxin B: Package Insert / Prescribing Info[3].
  4. BioSpace - Akorn Animal Health Announces Launch of Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment[4].
  5. WebMD - Bacitracin/Polymyxin B ophthalmic - Uses, Side Effects, and More[5].

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