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Last Updated: December 22, 2024

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


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

Dexamethasone; neomycin sulfate; polymyxin b sulfate is the generic ingredient in four branded drugs marketed by Novartis, Pharmafair, Sandoz, Bausch And Lomb, Padagis Us, Harrow Eye, and Alcon Pharms Ltd, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Seventeen suppliers are listed for this compound.

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

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

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

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

Pharmacology for DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Anatomical Therapeutic Chemical (ATC) Classes for DEXAMETHASONE; 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
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
D07AB Corticosteroids, moderately potent (group II)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XB Corticosteroids, moderately potent, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D10AA Corticosteroids, combinations for treatment of acne
D10A ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10 ANTI-ACNE 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 DEXAMETHASONE; 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
Bausch And Lomb NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE dexamethasone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 064063-001 Jul 25, 1994 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Padagis Us NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE dexamethasone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 062938-001 Jul 31, 1989 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis DEXACIDIN dexamethasone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 062566-001 Feb 22, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch And Lomb DEXASPORIN dexamethasone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OPHTHALMIC 064135-001 Sep 13, 1995 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Harrow Eye MAXITROL dexamethasone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OPHTHALMIC 050023-002 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz MAXITROL dexamethasone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 050065-002 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  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

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

Market Dynamics and Financial Trajectory of Neomycin, Polymyxin B, and Dexamethasone Ophthalmic Preparations

Introduction

Neomycin, polymyxin B, and dexamethasone ophthalmic preparations are widely used to treat bacterial infections of the eye and reduce inflammation. This combination is available in various forms, including ointments and eye drops, and is marketed under several brand names such as Maxitrol and Dexasporin.

Market Overview

The ophthalmic antibiotic market, which includes neomycin, polymyxin B, and dexamethasone combinations, is driven by the increasing incidence of eye infections and the need for effective treatments. Here are some key points about the market:

Demand and Usage

  • The demand for these ophthalmic preparations is steady due to their efficacy in treating bacterial eye infections and reducing inflammation. They are commonly prescribed for conditions such as conjunctivitis and corneal ulcers[1][3][5].

Competitive Landscape

  • The market is competitive with multiple manufacturers, including Bausch & Lomb, Perrigo, Sandoz, and Valeant, each offering their own versions of the medication. This competition can influence pricing and market share[4].

Regulatory Environment

  • These medications are subject to strict regulatory oversight. They must comply with FDA guidelines and are monitored for safety and efficacy. Any changes in regulatory policies can impact the market dynamics[2][3].

Financial Trajectory

Revenue and Sales

  • The revenue generated from neomycin, polymyxin B, and dexamethasone ophthalmic preparations is significant due to their widespread use. However, exact revenue figures are not publicly disclosed for each manufacturer. The market size can be estimated by looking at the overall ophthalmic antibiotic market, which has been growing steadily[4].

Pricing and Cost

  • The pricing of these medications can vary based on the manufacturer, form (ointment or suspension), and region. For instance, Maxitrol ophthalmic ointment by Alcon Labs is priced differently compared to generic versions by Perrigo or Sandoz[4].

Drug Shortages

  • Periodic drug shortages, often due to manufacturing issues or increased demand, can impact the financial trajectory. For example, in 2016, there were shortages reported due to manufacturing delays and increased demand, which could have affected sales and revenue[4].

Product Forms and Strengths

The medication is available in two primary forms:

Ophthalmic Ointment

  • This form is commonly used for its prolonged action and ease of application. It contains 3.5 mg of neomycin, 10,000 units of polymyxin B, and 0.1% dexamethasone per gram[1][2][5].

Ophthalmic Suspension (Eye Drops)

  • The suspension form is also widely used and contains the same active ingredients in a concentration of 3.5 mg/10,000 units/0.1% per milliliter[1][3].

Side Effects and Safety Concerns

While the medication is effective, it comes with potential side effects and safety concerns that can influence market dynamics:

Common Side Effects

  • Common side effects include eye itching or irritation, swelling, redness, and temporary blurred vision. These side effects can affect patient compliance and satisfaction[1][3].

Serious Side Effects

  • Serious side effects such as severe allergic reactions, elevated eye pressure, glaucoma, and vision loss can lead to regulatory scrutiny and impact sales. Patients must be monitored closely for these adverse reactions[1][3].

Contraindications

The medication is contraindicated in several conditions, including:

Viral and Fungal Infections

  • It is not effective against viral or fungal infections and can exacerbate conditions like herpes simplex keratitis[2][3].

Hypersensitivity

  • Patients with known or suspected hypersensitivity to any of the ingredients should avoid using this medication[2][3].

Impact on Patient Care

The availability and efficacy of neomycin, polymyxin B, and dexamethasone ophthalmic preparations significantly impact patient care:

Treatment Outcomes

  • Effective treatment of bacterial eye infections reduces the risk of complications and improves patient outcomes. This positive impact on healthcare can drive demand and reinforce market position[1].

Patient Compliance

  • The ease of use and minimal side effects of these medications can enhance patient compliance, which is crucial for the success of any pharmaceutical product[1][3].

Future Outlook

Market Growth

  • The market for ophthalmic antibiotics is expected to grow due to increasing incidence of eye infections and an aging population. This growth can be driven by new formulations, improved delivery systems, and expanding into new markets[4].

Innovation and R&D

  • Continuous research and development in ophthalmic treatments can lead to new products and formulations that may compete with or complement existing neomycin, polymyxin B, and dexamethasone preparations[4].

Key Takeaways

  • Market Demand: Steady demand driven by the need for effective treatments for bacterial eye infections.
  • Competitive Landscape: Multiple manufacturers with various brand names and generic options.
  • Regulatory Oversight: Strict compliance with FDA guidelines.
  • Financial Trajectory: Significant revenue, influenced by pricing, drug shortages, and market competition.
  • Patient Care: Positive impact on treatment outcomes and patient compliance.

Frequently Asked Questions (FAQs)

Q: What are the common side effects of neomycin, polymyxin B, and dexamethasone ophthalmic preparations? A: Common side effects include eye itching or irritation, swelling, redness, and temporary blurred vision[1].

Q: Are there any serious side effects associated with this medication? A: Yes, serious side effects can include severe allergic reactions, elevated eye pressure, glaucoma, and vision loss[1][3].

Q: What are the contraindications for using neomycin, polymyxin B, and dexamethasone ophthalmic preparations? A: The medication is contraindicated in viral and fungal infections, mycobacterial infections, and in patients with known or suspected hypersensitivity to any of the ingredients[2][3].

Q: How do drug shortages impact the market for neomycin, polymyxin B, and dexamethasone ophthalmic preparations? A: Drug shortages can affect sales and revenue due to manufacturing issues or increased demand, leading to temporary unavailability of the product[4].

Q: What is the future outlook for the market of neomycin, polymyxin B, and dexamethasone ophthalmic preparations? A: The market is expected to grow due to increasing incidence of eye infections and an aging population, with potential for new formulations and innovations[4].

Cited Sources:

  1. WebMD: Neomycin/Polymyxin B/Dexamethasone ophthalmic - Uses, Side Effects, and More.
  2. DailyMed: Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment.
  3. DailyMed: Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension.
  4. ASHP: Drug Shortage Detail: Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment.
  5. DailyMed: Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone Ophthalmic Ointment USP.

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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.