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Last Updated: December 22, 2024

NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE Drug Patent Profile


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Which patents cover Neomycin Sulfate-dexamethasone Sodium Phosphate, and what generic alternatives are available?

Neomycin Sulfate-dexamethasone Sodium Phosphate is a drug marketed by Alcon Pharms Ltd and Pharmafair and is included in two NDAs.

The generic ingredient in NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE is dexamethasone sodium phosphate; neomycin sulfate. There are thirty-nine drug master file entries for this compound. Additional details are available on the dexamethasone sodium phosphate; neomycin sulfate profile page.

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Summary for NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE
US Patents:0
Applicants:2
NDAs:2
Clinical Trials: 1
DailyMed Link:NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE at DailyMed
Drug patent expirations by year for NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE
Recent Clinical Trials for NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE

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SponsorPhase
Huro Biotech Joint Stock CompanyN/A
Vietstar Biomedical ResearchN/A

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US Patents and Regulatory Information for NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alcon Pharms Ltd NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate; neomycin sulfate SOLUTION/DROPS;OPHTHALMIC 062714-001 Jul 21, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pharmafair NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate; neomycin sulfate SOLUTION/DROPS;OPHTHALMIC 062539-001 Jan 10, 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

NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Neomycin Sulfate-Dexamethasone Sodium Phosphate

Introduction

Neomycin sulfate-dexamethasone sodium phosphate is a topical corticosteroid-antibiotic combination used primarily in ophthalmic and otic preparations to treat various inflammatory and infectious conditions. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Overview

The market for ophthalmic and otic preparations is driven by the increasing prevalence of eye and ear infections, as well as inflammatory conditions. The combination of neomycin sulfate and dexamethasone sodium phosphate addresses both bacterial infections and inflammation, making it a valuable treatment option.

Demand Drivers

  • Increasing Prevalence of Infections: The rise in bacterial infections, particularly in the eyes and ears, drives the demand for effective treatments like neomycin sulfate-dexamethasone sodium phosphate[1][4].
  • Aging Population: An aging population is more susceptible to ocular and otic conditions, further increasing the demand for these medications.
  • Advancements in Healthcare: Improvements in healthcare infrastructure and access to medical services also contribute to the growing demand.

Competitive Landscape

The market for neomycin sulfate-dexamethasone sodium phosphate is competitive, with several pharmaceutical companies producing similar formulations.

Key Players

  • Major pharmaceutical companies such as Novartis, Pfizer, and generic drug manufacturers are key players in this market.
  • The presence of generic versions of the drug also influences market dynamics, as they offer cost-effective alternatives.

Product Differentiation

  • While the active ingredients remain the same, differentiation often comes through formulation (e.g., ophthalmic solution vs. ointment), packaging, and brand reputation[1][5].

Financial Trajectory

The financial performance of neomycin sulfate-dexamethasone sodium phosphate can be analyzed through several key metrics.

Revenue Growth

  • The revenue from these medications has seen steady growth due to the consistent demand for treatments of ocular and otic infections.
  • Market research indicates that the ophthalmic and otic drug market is expected to continue growing, driven by the increasing prevalence of target conditions and advancements in healthcare[1].

Pricing Strategies

  • Pricing is a critical factor, with branded products generally commanding higher prices than generic alternatives.
  • The cost-effectiveness of generic versions can impact the market share of branded products, influencing overall revenue.

Cost Structure

  • The cost of production includes the cost of active ingredients (neomycin sulfate and dexamethasone sodium phosphate), manufacturing, and distribution.
  • Regulatory compliance and quality control measures also add to the overall cost[3].

Regulatory Environment

Regulatory approvals and compliance play a significant role in the market dynamics of neomycin sulfate-dexamethasone sodium phosphate.

Approval Process

  • The drug must meet stringent regulatory standards set by bodies such as the FDA and the USP (United States Pharmacopeia)[3][5].
  • Compliance with these standards ensures the safety and efficacy of the product.

Safety and Efficacy

  • Clinical trials, such as the one comparing the efficacy and safety of polymyxin sulfate/neomycin sulfate/dexamethasone phosphate with polymyxin sulfate/neomycin sulfate, demonstrate the importance of regulatory oversight in ensuring product safety and efficacy[2].

Side Effects and Safety Concerns

The safety profile of neomycin sulfate-dexamethasone sodium phosphate is a critical factor in its market dynamics.

Common Side Effects

  • Cutaneous sensitization and allergic reactions, including anaphylactic symptoms, are potential side effects of neomycin sulfate[1][4].
  • Sulfite sensitivity, particularly in asthmatic patients, is another concern due to the presence of sodium bisulfite as a preservative[1].

Long-Term Risks

  • Long-term use of neomycin can lead to systemic absorption and risks such as neurotoxicity, ototoxicity, and nephrotoxicity, especially in patients with renal impairment[4].

Market Trends

Several trends are shaping the market for neomycin sulfate-dexamethasone sodium phosphate.

Generic Competition

  • The availability of generic versions of the drug has increased competition, affecting the market share of branded products.
  • Generic manufacturers often offer lower prices, making the treatment more accessible but potentially reducing revenue for branded products[1].

Innovations in Formulations

  • Innovations in formulation, such as improved delivery systems or combination products, can enhance patient compliance and treatment outcomes.
  • For example, the development of ophthalmic ointments in addition to solutions provides more options for patients and healthcare providers[5].

Global Expansion

  • The global expansion of pharmaceutical companies into emerging markets can increase the reach and revenue of neomycin sulfate-dexamethasone sodium phosphate.
  • However, this also involves navigating different regulatory environments and market conditions.

Key Takeaways

  • Consistent Demand: The market for neomycin sulfate-dexamethasone sodium phosphate is driven by the consistent demand for treatments of ocular and otic infections.
  • Competitive Landscape: The market is competitive, with both branded and generic products available.
  • Regulatory Compliance: Strict regulatory standards ensure the safety and efficacy of the product.
  • Safety Concerns: Potential side effects and long-term risks must be carefully managed.
  • Innovations and Expansion: Innovations in formulations and global expansion can enhance market performance.

FAQs

Q: What are the primary uses of neomycin sulfate-dexamethasone sodium phosphate?

A: This combination is used to treat steroid-responsive inflammatory ocular conditions where there is a risk of bacterial infection, as well as certain otic infections.

Q: What are the common side effects of neomycin sulfate-dexamethasone sodium phosphate?

A: Common side effects include cutaneous sensitization, allergic reactions, and sulfite sensitivity, particularly in asthmatic patients.

Q: How does the presence of generic versions affect the market for neomycin sulfate-dexamethasone sodium phosphate?

A: Generic versions increase competition, potentially reducing the market share and revenue of branded products but making the treatment more accessible due to lower prices.

Q: What are the regulatory requirements for neomycin sulfate-dexamethasone sodium phosphate?

A: The drug must comply with standards set by regulatory bodies such as the FDA and the USP to ensure safety and efficacy.

Q: What are the long-term risks associated with the use of neomycin sulfate-dexamethasone sodium phosphate?

A: Long-term use can lead to systemic absorption and risks such as neurotoxicity, ototoxicity, and nephrotoxicity, especially in patients with renal impairment.

Sources

  1. RxList: Neodecadron (Neomycin and Dexamethasone): Side Effects, Uses ...
  2. PubMed: Dexamethasone phosphate in antibiotic ear drops for the ...
  3. USP: Neomycin Sulfate and Dexamethasone Sodium Phosphate solution
  4. DrugBank: Neomycin: Uses, Interactions, Mechanism of Action
  5. USP: Neomycin Sulfate and Dexamethasone Sodium Phosphate Ophthalmic Ointment

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