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Last Updated: December 23, 2024

NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE - Generic Drug Details


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

Neomycin sulfate; polymyxin b sulfate; prednisolone acetate is the generic ingredient in one branded drug marketed by Allergan and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE
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
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
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
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL 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
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
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
>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; PREDNISOLONE ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Neomycin Sulfate, Polymyxin B Sulfate, and Prednisolone Acetate

Introduction

The combination of neomycin sulfate, polymyxin B sulfate, and prednisolone acetate is commonly found in ophthalmic preparations, such as POLY-PRED and MAXITROL, which are used to treat ocular inflammation associated with infections. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Overview

The ophthalmic anti-infective and anti-inflammatory market is a niche but significant segment within the broader pharmaceutical industry. These drugs are essential for managing various ocular conditions, including bacterial infections and inflammatory responses.

Demand Drivers

  • Increasing Prevalence of Ocular Infections: The rise in ocular infections, particularly those caused by bacteria, drives the demand for effective anti-infective and anti-inflammatory treatments[2][4].
  • Aging Population: An aging population is more susceptible to ocular conditions, contributing to increased demand for these medications.
  • Advancements in Healthcare: Improvements in healthcare infrastructure and access to medical services also boost the demand for specialized ophthalmic treatments.

Key Players and Market Share

The market for neomycin sulfate, polymyxin B sulfate, and prednisolone acetate is dominated by a few key players, including pharmaceutical companies that manufacture and distribute these combination products.

  • Manufacturers: Companies such as Allergan (now part of AbbVie) and Novartis are prominent in this market, producing well-known brands like POLY-PRED and MAXITROL[2][4].

Financial Performance

The financial performance of these drugs can be gauged through several metrics:

Revenue Trends

  • The revenue generated from these ophthalmic preparations has been relatively stable, with occasional growth driven by increased demand and new product launches.
  • For example, POLY-PRED, a combination product containing prednisolone acetate, neomycin sulfate, and polymyxin B sulfate, has maintained a steady market presence due to its effectiveness in treating ocular inflammation and infections[2].

Cost and Pricing

  • The cost of these medications can vary based on the formulation, dosage, and brand. Generally, these ophthalmic suspensions and ointments are priced moderately, making them accessible to a wide range of patients.
  • Pricing strategies often involve balancing the need for profitability with the necessity of keeping the medication affordable for patients, especially in regions with limited healthcare budgets[2][5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of these drugs.

Approval and Compliance

  • These medications must comply with stringent regulatory requirements, including those set by the FDA. For instance, MAXITROL and POLY-PRED have undergone rigorous clinical trials and have been approved for specific indications[4][2].

Safety and Efficacy Monitoring

  • Regulatory bodies continuously monitor the safety and efficacy of these drugs. Any adverse reactions or concerns about long-term use can impact market dynamics and financial performance[1][4].

Therapeutic Indications and Usage

Understanding the therapeutic indications and usage patterns is vital for assessing market dynamics.

Ocular Inflammation and Infections

  • These combination products are primarily used to treat ocular inflammation associated with bacterial infections. They are effective against a range of microorganisms, including Staphylococcus aureus, Escherichia coli, and Hemophilus influenzae[1][2].

Dosage and Administration

  • The dosage and administration guidelines for these medications are critical. For example, POLY-PRED is typically administered as 1-2 drops every 3-4 hours, with a maximum therapeutic course of 20 mL[2].

Challenges and Risks

Several challenges and risks can impact the market dynamics and financial trajectory of these drugs.

Side Effects and Contraindications

  • Prolonged use of these medications can lead to side effects such as increased intraocular pressure, cataracts, and corneal perforation. They are contraindicated in fungal, viral, or mycobacterial infections[1][2].

Resistance and Superinfection

  • The risk of bacterial resistance and superinfection is a significant concern. Monitoring for secondary infections and adjusting treatment accordingly is essential[1][2].

Future Outlook

The future outlook for neomycin sulfate, polymyxin B sulfate, and prednisolone acetate combination products is influenced by several factors.

Innovations and New Formulations

  • Continuous innovation in formulation and delivery systems can enhance patient compliance and efficacy, potentially driving market growth.
  • For example, new ophthalmic suspensions with improved stability and bioavailability could emerge, offering better treatment outcomes[4].

Market Expansion

  • Expanding into new markets, particularly in regions with growing healthcare needs, can provide opportunities for revenue growth.
  • Partnerships and collaborations between pharmaceutical companies and local healthcare providers can facilitate market penetration[2].

Key Takeaways

  • The market for neomycin sulfate, polymyxin B sulfate, and prednisolone acetate is driven by the increasing prevalence of ocular infections and the aging population.
  • Key players dominate the market, with a focus on maintaining revenue through stable demand and occasional growth.
  • Regulatory compliance and safety monitoring are critical for market dynamics.
  • Future growth opportunities lie in innovations, new formulations, and market expansion.

FAQs

1. What are the primary indications for neomycin sulfate, polymyxin B sulfate, and prednisolone acetate combination products?

These products are primarily indicated for treating ocular inflammation associated with bacterial infections.

2. What are the potential side effects of prolonged use of these medications?

Prolonged use can lead to increased intraocular pressure, cataracts, corneal perforation, and other complications.

3. Can these medications be used during pregnancy?

These medications should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

4. How do regulatory bodies impact the market dynamics of these drugs?

Regulatory bodies monitor safety and efficacy, and any adverse reactions or concerns can impact market dynamics and financial performance.

5. What are the future growth opportunities for these combination products?

Future growth opportunities include innovations in formulation and delivery systems, and expanding into new markets, particularly in regions with growing healthcare needs.

Cited Sources:

  1. RxList: POLY-PRED (Prednisolone, Neomycin and Polymyxin B) - RxList
  2. eMPR: POLY-PRED Prescription & Dosage Information - MPR - eMPR.com
  3. DrugBank: Polymyxin B: Uses, Interactions, Mechanism of Action - DrugBank
  4. FDA: MAXITROL* (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension)
  5. DailyMed: NEOMYCIN and POLYMYXIN B SULFATES and BACITRACIN ZINC with HYDROCORTISONE ACETATE ophthalmic ointment

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