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Last Updated: December 22, 2024

NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE Drug Patent Profile


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When do Neomycin Sulfate And Dexamethasone Sodium Phosphate patents expire, and when can generic versions of Neomycin Sulfate And Dexamethasone Sodium Phosphate launch?

Neomycin Sulfate And Dexamethasone Sodium Phosphate is a drug marketed by Bausch And Lomb and is included in one NDA.

The generic ingredient in NEOMYCIN SULFATE AND 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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US Patents and Regulatory Information for NEOMYCIN SULFATE AND 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
Bausch And Lomb NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate; neomycin sulfate SOLUTION/DROPS;OPHTHALMIC 064055-001 Oct 30, 1995 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 AND DEXAMETHASONE SODIUM PHOSPHATE Market Analysis and Financial Projection Experimental

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

Introduction

Neomycin sulfate and dexamethasone sodium phosphate are key components in various ophthalmic formulations, particularly in treatments for ocular infections and inflammatory conditions. Understanding the market dynamics and financial trajectory of these drugs is crucial for stakeholders in the pharmaceutical and medical device industries.

Market Size and Growth

The global ophthalmic drug delivery devices market, which includes formulations containing neomycin sulfate and dexamethasone sodium phosphate, is projected to grow significantly. By 2031, the market is expected to reach USD 577.33 million, growing at a Compound Annual Growth Rate (CAGR) of 6.17% from 2023 to 2031[1].

Regional Market Analysis

North America

North America is the largest market shareholder for ophthalmic drug delivery devices, including those containing neomycin sulfate and dexamethasone sodium phosphate. This region is expected to exhibit a CAGR of 5.07% during the forecast period. The growing prevalence of ocular disorders such as glaucoma, age-related macular degeneration (AMD), and cataracts drives this growth. For instance, the prevalence of cataracts increased by 9.42% and glaucoma by 12.66% in North America between 2016 and 2019[1].

Europe

Europe is anticipated to be the fastest-growing market, driven by the presence of key companies and emerging start-ups. These entities are driving technological advancements and integrating digital solutions with ophthalmic drug delivery devices[1].

Product Segmentation

Eye Drops

The eye drops segment, which includes formulations like Neodecadron (neomycin sulfate-dexamethasone sodium phosphate), dominates the global market. This segment is expected to exhibit a CAGR of 4.92% over the forecast period. Eye drops are preferred due to their ease of bulk manufacturing, handling, and higher patient tolerance. However, technological advancements in other formulations and difficulties in usage, especially among geriatric patients, may limit their growth[1].

Sales Channels

Direct Sales

The direct sales segment, which involves sales of ophthalmic drug delivery devices to pharmaceutical companies, holds the highest market share. This segment is predicted to exhibit a CAGR of 6.15% over the forecast period. Direct sales are often conducted through partnerships or contracts, ensuring compatibility and regulatory compliance between the device and the drug before commercialization[1].

Clinical Use and Efficacy

Neomycin Sulfate and Dexamethasone Sodium Phosphate

Neomycin sulfate and dexamethasone sodium phosphate are combined in ophthalmic solutions to treat bacterial infections and inflammatory conditions. Dexamethasone sodium phosphate, a synthetic glucocorticoid, reduces inflammation, while neomycin sulfate, an antibiotic, targets susceptible microorganisms such as Staphylococcus aureus, Escherichia coli, and Haemophilus influenzae[2].

Clinical Studies

Studies have shown that the addition of dexamethasone phosphate to antibiotic formulations significantly enhances treatment efficacy. For example, in patients with acute bacterial otitis externa, the combination of polymyxin B/neomycin with dexamethasone phosphate reduced swelling and improved symptom scores more effectively than the antibiotic alone[3].

Regulatory Approval and Compliance

FDA Approval

Ophthalmic drug delivery devices, including those containing neomycin sulfate and dexamethasone sodium phosphate, must meet stringent regulatory requirements. For instance, pre-filled drug delivery systems are considered combination devices and require FDA approval before commercialization. The FDA ensures that these devices are compatible with multiple drugs of similar forms and meet safety standards[1][4].

Technological Advancements

Nanotechnology

Nanotechnology is a significant driver in the ophthalmic drug delivery market, enabling targeted drug delivery, minimal wastage, and continuous drug release. This technology can penetrate barriers like the cornea and replace invasive procedures, opening new market opportunities[1].

Key Players and Emerging Companies

Established companies like Becton, Dickinson and Company, Schott AG, Gerresheimer AG, and Nipro Corporation, along with emerging companies such as Congruence Medical Solutions LLC, are driving market growth through technological advancements and product innovations[1].

Financial Trajectory

The financial trajectory for neomycin sulfate and dexamethasone sodium phosphate formulations is positive, driven by increasing demand for ophthalmic treatments. The base year market size for ophthalmic drug delivery devices was USD 336.83 million in 2022, and it is forecasted to reach USD 577.33 million by 2031[1].

Challenges and Limitations

Despite the growth, there are challenges such as the difficulty in using eye drops among geriatric patients and the need for continuous technological advancements to stay competitive. Additionally, regulatory compliance and the approval process can be complex and time-consuming[1].

Key Takeaways

  • The global ophthalmic drug delivery devices market is growing at a CAGR of 6.17% and is expected to reach USD 577.33 million by 2031.
  • North America is the largest market shareholder, driven by the prevalence of ocular disorders.
  • Eye drops, including those containing neomycin sulfate and dexamethasone sodium phosphate, dominate the market.
  • Direct sales to pharmaceutical companies are the primary sales channel.
  • Clinical studies support the efficacy of combining dexamethasone phosphate with antibiotics.
  • Regulatory compliance is crucial for market entry.
  • Technological advancements, including nanotechnology, are driving market growth.

FAQs

Q: What is the projected market size for ophthalmic drug delivery devices by 2031?

A: The global ophthalmic drug delivery devices market is expected to reach USD 577.33 million by 2031[1].

Q: Which region is the largest market shareholder for ophthalmic drug delivery devices?

A: North America is the largest market shareholder for ophthalmic drug delivery devices[1].

Q: What are the key components in Neodecadron ophthalmic solution?

A: Neodecadron contains neomycin sulfate and dexamethasone sodium phosphate[2].

Q: How does the addition of dexamethasone phosphate affect treatment efficacy in ophthalmic infections?

A: The addition of dexamethasone phosphate significantly reduces swelling and improves symptom scores in patients with bacterial infections[3].

Q: What technological advancements are driving the ophthalmic drug delivery market?

A: Nanotechnology is a significant driver, enabling targeted drug delivery and continuous release[1].

Sources

  1. Straits Research: Ophthalmic Drug Delivery Devices Market Size & Demand | 2031
  2. RxList: Neodecadron (Neomycin and Dexamethasone): Side Effects, Uses ...
  3. PubMed: Dexamethasone phosphate in antibiotic ear drops for the ...
  4. FDA: Pharmacology Review(s) - accessdata.fda.gov
  5. USP: Neomycin Sulfate and Dexamethasone Sodium Phosphate solution

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