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Last Updated: December 22, 2024

NEOMYCIN SULFATE; POLYMYXIN B SULFATE - Generic Drug Details


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What are the generic sources for neomycin sulfate; polymyxin b sulfate and what is the scope of patent protection?

Neomycin sulfate; polymyxin b sulfate is the generic ingredient in five branded drugs marketed by Glaxosmithkline, Alcon, Watson Labs, Xgen Pharms, Monarch Pharms, and Allergan, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

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

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

SponsorPhase
University of MiamiN/A
Bascom Palmer Eye InstituteN/A
Azidus BrasilPhase 3

See all NEOMYCIN SULFATE; POLYMYXIN B SULFATE clinical trials

Pharmacology for NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Anatomical Therapeutic Chemical (ATC) Classes for 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
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 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
Alcon STATROL neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OPHTHALMIC 050456-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs NEOMYCIN AND POLYMYXIN B SULFATE neomycin sulfate; polymyxin b sulfate SOLUTION;IRRIGATION 062664-001 Apr 8, 1986 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline NEOSPORIN neomycin sulfate; polymyxin b sulfate CREAM;TOPICAL 050176-002 Jan 14, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xgen Pharms NEOMYCIN AND POLYMYXIN B SULFATE neomycin sulfate; polymyxin b sulfate SOLUTION;IRRIGATION 065108-001 Jan 31, 2006 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Allergan POLY-PRED neomycin sulfate; polymyxin b sulfate; prednisolone acetate SUSPENSION/DROPS;OPHTHALMIC 050081-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alcon STATROL neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OPHTHALMIC 062339-001 Nov 30, 1984 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

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

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

Introduction

Neomycin sulfate and polymyxin B sulfate are widely used antibiotics, particularly in topical and irrigation solutions, due to their broad-spectrum antibacterial properties. Here, we delve into the market dynamics and financial trajectory of these antibiotics.

Market Size and Growth

The neomycin sulfate market has been experiencing significant growth, driven by several key factors. 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].

Applications and Products

Neomycin sulfate is utilized in various forms, including tablets, ointments, injections, topical solutions, and powders. These products are categorized into several segments such as antibacterial treatments, topical applications, gastrointestinal infections, and surgical infections. The broad application spectrum contributes to the market's steady expansion[3].

Geographical Distribution

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

Drivers of Market Growth

Several factors are driving the growth of the neomycin sulfate market:

Rising Incidence of Bacterial Infections

The increasing incidence of skin, eye, and ear infections is a major driver. Neomycin sulfate is a key component in many topical antibiotic formulations, making it essential for treating these infections[3].

Growing Awareness and Healthcare Infrastructure

Improved healthcare infrastructure in emerging nations and growing awareness of the importance of treating bacterial infections promptly are also significant factors. This awareness has led to an increased demand for over-the-counter antibiotic medications containing neomycin sulfate[3].

Veterinary Use

Neomycin sulfate is also used extensively in veterinary medicine to treat bacterial infections in animals, further contributing to market growth[3].

Competitive Landscape

The neomycin sulfate market is competitive, with several major pharmaceutical companies involved, including Pfizer, Merck, Novartis, Mylan, Teva, Sun Pharmaceutical, Glenmark, Cipla, Sandoz, and Zydus Cadila. These companies are continually developing new formulations and improving existing ones, which enhances the market's attractiveness[3].

Porter’s Five Forces Analysis

A Porter’s Five Forces analysis highlights the following:

  • Buyers' Bargaining Power: Moderate to high due to the availability of multiple brands and formulations.
  • Suppliers' Bargaining Power: Moderate, as there are several suppliers of raw materials and intermediates.
  • Threat of New Entrants: Low to moderate, given the regulatory hurdles and the need for significant investment in research and development.
  • Threat of Substitutes: Low, as neomycin sulfate and polymyxin B sulfate have unique properties that make them difficult to replace with other antibiotics.
  • Degree of Competition: High, due to the presence of multiple established players and the ongoing development of new products[3].

Financial Performance and Projections

The financial performance of the neomycin sulfate market is robust, with a significant increase in value expected over the forecast period. Here are some key financial metrics:

  • Current Market Value: USD 1.23 billion as of 2023.
  • Projected Market Value: USD 3.45 billion by 2031.
  • CAGR: 10.5% from 2024 to 2031[3].

Clinical and Commercial Significance

Neomycin sulfate and polymyxin B sulfate are clinically significant due to their broad-spectrum antibacterial activity. They are used in various clinical settings, including:

  • Urinary Bladder Irrigation: To prevent bacteriuria and gram-negative rod septicemia associated with indwelling catheters[2].
  • Topical Applications: In ointments, creams, and eye drops to treat skin and eye infections[2][4].
  • Otic and Ophthalmic Preparations: In combination with other antibiotics and corticosteroids to treat infections and inflammatory conditions in the ear and eye[4].

Regulatory and Safety Considerations

While these antibiotics are effective, there are regulatory and safety considerations to be aware of:

  • Systemic Absorption: Neomycin and polymyxin B can be absorbed systemically, especially in patients with impaired renal function or when used on open wounds, which can lead to toxicity such as ototoxicity, nephrotoxicity, and neuromuscular blockade[2].
  • Resistance and Overgrowth: The use of these antibiotics can lead to the overgrowth of nonsusceptible organisms, including fungi, and the development of resistant bacteria[2].

Conclusion

The market for neomycin sulfate and polymyxin B sulfate is poised for significant growth, driven by increasing demand for antibacterial treatments, expanding healthcare infrastructure, and the broad application spectrum of these antibiotics. However, it is crucial to consider the regulatory and safety aspects to ensure their safe and effective use.

Key Takeaways

  • The neomycin sulfate market is projected to grow from USD 1.23 billion in 2023 to USD 3.45 billion by 2031.
  • The market is driven by the rising incidence of bacterial infections, growing awareness of antibiotic treatments, and expanding healthcare infrastructure.
  • Neomycin sulfate and polymyxin B sulfate are used in various clinical settings, including urinary bladder irrigation, topical applications, and otic and ophthalmic preparations.
  • Regulatory and safety considerations, such as systemic absorption and the risk of resistance and overgrowth, must be carefully managed.

FAQs

What are the primary applications of neomycin sulfate and polymyxin B sulfate?

Neomycin sulfate and polymyxin B sulfate are primarily used in urinary bladder irrigation, topical applications (such as ointments and creams), and in otic and ophthalmic preparations to treat various bacterial infections.

What is the projected growth rate of the neomycin sulfate market?

The neomycin sulfate market is expected to grow at a CAGR of 10.5% from 2024 to 2031.

Which regions are driving the growth of the neomycin sulfate market?

The Asia-Pacific region is expected to be a significant driver of growth due to increasing healthcare infrastructure and rising awareness of antibiotic treatments.

What are the potential risks associated with the use of neomycin sulfate and polymyxin B sulfate?

Potential risks include systemic absorption leading to toxicity such as ototoxicity, nephrotoxicity, and neuromuscular blockade, as well as the overgrowth of nonsusceptible organisms and the development of resistant bacteria.

Which companies are major players in the neomycin sulfate market?

Major players include Pfizer, Merck, Novartis, Mylan, Teva, Sun Pharmaceutical, Glenmark, Cipla, Sandoz, and Zydus Cadila.

Sources

  1. Setiawati et al. - "Development and validation method for simultaneous quantification of neomycin sulfate and polymyxin B sulfate by HPLC-ELSD" - Journal of Applied Pharmaceutical Science, 2020.
  2. Drugs.com - "Neomycin and Polymyxin B Sulfates: Package Insert / Prescribing Info".
  3. Market Research Intellect - "Neomycin Sulfate Market Size, Share & Trends [2031]".
  4. DrugBank Online - "Neomycin: Uses, Interactions, Mechanism of Action".

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