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Last Updated: December 22, 2024

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
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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Monarch Pharms CORTISPORIN bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate OINTMENT;TOPICAL 050168-002 May 4, 1984 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
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 ⤷  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; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Market Analysis and Financial Projection Experimental

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

Introduction

The combination of neomycin sulfate, polymyxin B sulfate, bacitracin zinc, and hydrocortisone is a widely used formulation in the pharmaceutical industry, particularly in ophthalmic and topical applications. This article delves into the market dynamics and financial trajectory of this drug combination.

Market Overview

The market for ophthalmic and topical antimicrobial and anti-inflammatory drugs is driven by the increasing prevalence of eye and skin infections, along with the growing need for effective treatments that combine both antimicrobial and anti-inflammatory properties.

Key Players

Several pharmaceutical companies, including Pfizer, Fougera, and others, are key players in this market. These companies invest heavily in research and development to improve formulations and expand their product lines[4].

Market Segmentation

The market can be segmented based on the type of application (ophthalmic vs. topical), the type of infection (bacterial, fungal, viral), and the geographic region.

Product Composition and Mechanism

Active Ingredients

  • Neomycin Sulfate: An aminoglycoside antibiotic effective against many gram-positive and gram-negative organisms by inhibiting protein synthesis.
  • Polymyxin B Sulfate: Effective against gram-negative organisms by increasing the permeability of the bacterial cell membrane.
  • Bacitracin Zinc: Effective against gram-positive and gram-negative organisms by interfering with bacterial cell wall synthesis.
  • Hydrocortisone: An anti-inflammatory hormone used to reduce inflammation and edema[2][3][4].

Indications and Usage

This drug combination is indicated for steroid-responsive inflammatory ocular conditions where there is a risk of bacterial infection. It is used in conditions such as conjunctivitis, corneal injuries, and chronic anterior uveitis[3][4][5].

Market Drivers

Increasing Prevalence of Infections

The rising incidence of bacterial infections, particularly in the eyes and skin, drives the demand for effective antimicrobial treatments.

Advancements in Formulations

Continuous improvements in the formulation of these drugs, such as the addition of hydrocortisone to reduce inflammation, enhance their market appeal.

Regulatory Approvals

Regulatory approvals and compliance with stringent safety standards are crucial for the market growth of these drugs. Recent updates and approvals from regulatory bodies like the FDA support the continued use and development of these formulations[2][3][5].

Market Restraints

Resistance and Superinfection

The potential for bacterial resistance and superinfection with prolonged use of these antibiotics can limit market growth. Monitoring and managing these risks are essential for sustained market presence[2][3].

Hypersensitivity and Side Effects

Hypersensitivity reactions and other side effects associated with the antibiotic components can also restrain market growth. Patient education and careful prescribing practices are necessary to mitigate these risks[3][4].

Financial Trajectory

Revenue Growth

The revenue from neomycin sulfate, polymyxin B sulfate, bacitracin zinc, and hydrocortisone formulations has shown steady growth over the years, driven by their widespread use in ophthalmic and topical applications.

Cost and Pricing

The cost of these drugs can vary based on the formulation, brand, and geographic location. Generally, generic versions are more affordable, contributing to higher sales volumes. However, branded products often command a premium due to their perceived quality and reliability[4].

Investment in R&D

Pharmaceutical companies continue to invest in research and development to improve the efficacy, safety, and delivery mechanisms of these drugs. This investment is reflected in the financial reports of these companies, showing a significant allocation to R&D activities.

Geographic Market Analysis

Global Market

The global market for these drugs is diverse, with significant demand in both developed and developing countries. Emerging markets, particularly in Asia and Latin America, are expected to drive future growth due to increasing healthcare spending and access to medications.

Regional Variations

Regional variations in regulatory requirements, healthcare policies, and patient preferences influence the market dynamics. For instance, in the United States, FDA approvals and compliance are critical, while in Europe, EMA regulations play a similar role[2][3].

Competitive Landscape

The competitive landscape is characterized by a mix of branded and generic products. Companies like Pfizer and Fougera dominate the branded segment, while generic manufacturers offer more affordable alternatives. The competition is intense, with companies focusing on product differentiation, marketing strategies, and distribution networks to gain market share[4].

Future Outlook

Innovations and Improvements

Future innovations, such as improved delivery systems (e.g., nanotechnology-based formulations) and enhanced efficacy profiles, are expected to drive market growth.

Expanding Indications

Potential expansion into new indications, such as treating infections in other body parts or combining with other therapeutic agents, could further boost the market.

Regulatory Environment

A favorable regulatory environment, with streamlined approval processes and supportive policies, will be crucial for the continued growth of this market segment.

Key Takeaways

  • The combination of neomycin sulfate, polymyxin B sulfate, bacitracin zinc, and hydrocortisone is a vital treatment for various ophthalmic and topical infections.
  • Market growth is driven by increasing infection prevalence, advancements in formulations, and regulatory approvals.
  • Challenges include bacterial resistance, superinfection, and hypersensitivity reactions.
  • The financial trajectory shows steady revenue growth, with significant investment in R&D.
  • The global market is diverse, with emerging markets expected to drive future growth.

FAQs

What are the active ingredients in neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment?

The active ingredients include neomycin sulfate, polymyxin B sulfate, and bacitracin zinc. In some formulations, hydrocortisone is also added for its anti-inflammatory properties[2][3][4].

What are the common indications for neomycin, polymyxin B, and bacitracin with hydrocortisone ophthalmic ointment?

This ointment is indicated for steroid-responsive inflammatory ocular conditions where there is a risk of bacterial infection, such as conjunctivitis, corneal injuries, and chronic anterior uveitis[3][4][5].

What are the potential side effects of using neomycin, polymyxin B, and bacitracin with hydrocortisone ophthalmic ointment?

Potential side effects include hypersensitivity reactions, superinfection, and other adverse reactions such as increased intraocular pressure and delayed healing[3][4].

Can neomycin, polymyxin B, and bacitracin with hydrocortisone ophthalmic ointment be used in patients with viral infections?

No, this ointment is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis and mycobacterial infections[3][4].

How does the combination of neomycin, polymyxin B, and bacitracin work against bacterial infections?

Neomycin inhibits protein synthesis, polymyxin B increases cell membrane permeability, and bacitracin interferes with cell wall synthesis, providing a broad spectrum of antibacterial activity[2][3][4].

Sources:

  1. CORTISPORIN® Ointment (neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone ointment, USP) - Pfizer.
  2. Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP - DailyMed.
  3. Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate Ophthalmic Ointment - DailyMed.
  4. Neomycin, Polymyxin B, Bacitracin, Hydrocortisone - Drugs.com.
  5. Neomycin sulfate, polymyxin b sulfate, bacitracin zinc, and hydrocortisone ophthalmic ointment - DailyMed.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.