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Last Updated: December 22, 2024

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE - Generic Drug Details


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

Gramicidin; neomycin sulfate; polymyxin b sulfate is the generic ingredient in four branded drugs marketed by Dow Pharm, Bausch And Lomb, Ipharm, Nordic Pharma, Watson Labs, Pharmafair, and Monarch Pharms, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Recent Clinical Trials for GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Chulalongkorn UniversityPhase 3

See all GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE clinical trials

Pharmacology for GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Anatomical Therapeutic Chemical (ATC) Classes for GRAMICIDIN; 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
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
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
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 GRAMICIDIN; 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
Nordic Pharma NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN gramicidin; neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OPHTHALMIC 065187-001 Oct 28, 2005 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN gramicidin; neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OPHTHALMIC 062788-001 Jun 11, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dow Pharm NEO-POLYCIN gramicidin; neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OPHTHALMIC 060427-001 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

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Neomycin Sulfate, Polymyxin B Sulfate, and Gramicidin

Introduction

The combination of neomycin sulfate, polymyxin B sulfate, and gramicidin is a potent antimicrobial solution widely used in ophthalmic and other topical applications. This article delves into the market dynamics, financial trajectory, and key aspects of these antibiotics.

Market Overview

The market for neomycin sulfate, polymyxin B sulfate, and gramicidin is driven by several factors, including the increasing incidence of bacterial infections, particularly in the eyes and skin, and the growing demand for over-the-counter antibiotic medications.

Market Size and Growth

As of 2023, the neomycin sulfate market was valued at USD 1.23 billion and is projected to reach USD 3.45 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 10.5% from 2024 to 2031[3].

Geographical Segmentation

The market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. The Asia-Pacific region is expected to show significant growth due to the increasing healthcare infrastructure and rising awareness of antibiotic treatments[3].

Clinical Pharmacology and Efficacy

Mechanism of Action

  • Neomycin Sulfate: An aminoglycoside antibiotic that inhibits protein synthesis by binding to ribosomal RNA, causing misreading of the bacterial genetic code. It is bactericidal for many gram-positive and gram-negative organisms[1][2][4].
  • Polymyxin B Sulfate: Increases the permeability of the bacterial cell membrane by interacting with phospholipid components, making it bactericidal for various gram-negative organisms[1][2][4].
  • Gramicidin: Forms channels through the bacterial cell membrane, increasing its permeability to inorganic cations and making it bactericidal for gram-positive organisms[1][2][4].

Microbial Coverage

Together, these antibiotics are effective against a wide range of microorganisms, including Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa[1][2][4].

Indications and Usage

Ophthalmic Use

Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution are indicated for the topical treatment of superficial infections of the external eye and its adnexa, such as conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, and blepharoconjunctivitis[1][2][4].

Clinical Efficacy

Studies have shown that the combination of these antibiotics is effective and safe for treating suspected bacterial corneal ulceration, with high rates of re-epithelialization and low rates of adverse reactions[5].

Market Drivers

Increasing Incidence of Infections

The rising incidence of skin and eye infections is a significant driver of the market. As the global population grows and urbanization increases, the demand for effective antibiotic treatments is on the rise[3].

Growing Healthcare Infrastructure

Developing healthcare infrastructure in emerging nations is another key factor driving the market. Improved access to healthcare services and increasing awareness of antibiotic treatments contribute to the growing demand for neomycin sulfate, polymyxin B sulfate, and gramicidin[3].

Over-the-Counter (OTC) Market

The availability of these antibiotics in OTC formulations, such as eye drops, ointments, and creams, further boosts market demand. Consumers increasingly seek convenient and effective treatments for minor infections, driving the sales of these products[3].

Market Challenges

Resistance and Side Effects

The development of antibiotic resistance and potential side effects, such as allergic reactions and toxicity, are challenges that the market faces. Continuous monitoring and research are necessary to mitigate these risks[1][2][4].

Regulatory Considerations

Adequate animal reproductive studies have not been conducted with neomycin, polymyxin B, or gramicidin, and their effects on human fertility and fetal development are unknown. This necessitates cautious use, especially in pregnant women[1][2][4].

Competitive Landscape

The competitive landscape of the neomycin sulfate market is characterized by several key players, including pharmaceutical companies and generic drug manufacturers. The market is analyzed using Porter’s Five Forces, which includes the bargaining power of buyers, suppliers, the threat of new entrants, the threat of substitutes, and the degree of competition within the market[3].

Financial Projections

The financial trajectory of the neomycin sulfate market is promising, with a projected growth rate of 10.5% CAGR from 2024 to 2031. This growth is driven by the increasing demand for antibiotic treatments, expanding healthcare infrastructure, and the rising incidence of bacterial infections[3].

Key Takeaways

  • The neomycin sulfate market is expected to grow significantly, driven by increasing demand for antibiotic treatments.
  • The combination of neomycin sulfate, polymyxin B sulfate, and gramicidin is effective against a wide range of bacterial infections.
  • The market faces challenges such as antibiotic resistance and potential side effects.
  • Continuous research and development are crucial to maintaining the efficacy and safety of these antibiotics.

FAQs

What are the primary indications for neomycin sulfate, polymyxin B sulfate, and gramicidin ophthalmic solution?

The primary indications include the topical treatment of superficial infections of the external eye and its adnexa, such as conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, and blepharoconjunctivitis[1][2][4].

How do neomycin sulfate, polymyxin B sulfate, and gramicidin work?

Neomycin inhibits protein synthesis, polymyxin B increases cell membrane permeability, and gramicidin forms channels through the cell membrane, all leading to the death of bacterial cells[1][2][4].

What is the projected market size of the neomycin sulfate market by 2031?

The neomycin sulfate market is projected to reach USD 3.45 billion by 2031, growing at a CAGR of 10.5% from 2024 to 2031[3].

Are there any contraindications for using neomycin sulfate, polymyxin B sulfate, and gramicidin?

Yes, this product is contraindicated in individuals who have shown hypersensitivity to any of its components[1][2][4].

What are the potential side effects of neomycin sulfate, polymyxin B sulfate, and gramicidin?

Potential side effects include allergic reactions, toxicity, and impairment of fertility, although the latter is not fully understood[1][2][4].

Sources

  1. Drugs.com: Neomycin, Polymyxin B, Gramicidin: Package Insert / Prescribing Info.
  2. DailyMed: Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution.
  3. Market Research Intellect: Neomycin Sulfate Market Size, Share & Trends [2031].
  4. DailyMed: Neomycin sulfate, polymyxin b sulfate and gramicidin solution/ drops.
  5. British Journal of Ophthalmology: The efficacy and safety of topical polymyxin B, neomycin and gramicidin.

More… ↓

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