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Last Updated: December 22, 2024

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE Drug Patent Profile


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Which patents cover Dexamethasone Sodium Phosphate Preservative Free, and when can generic versions of Dexamethasone Sodium Phosphate Preservative Free launch?

Dexamethasone Sodium Phosphate Preservative Free is a drug marketed by Amneal, Fresenius Kabi Usa, and Somerset Theraps Llc. and is included in three NDAs.

The generic ingredient in DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE is dexamethasone sodium phosphate. There are thirty-nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dexamethasone Sodium Phosphate Preservative Free

A generic version of DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE was approved as dexamethasone sodium phosphate by HIKMA on September 7th, 1982.

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Summary for DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
Drug patent expirations by year for DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
Recent Clinical Trials for DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE

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

SponsorPhase
King's College LondonN/A
City, University of LondonN/A
Guy's and St Thomas' NHS Foundation TrustN/A

See all DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE clinical trials

Pharmacology for DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE

US Patents and Regulatory Information for DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE dexamethasone sodium phosphate INJECTABLE;INJECTION 208690-001 Aug 22, 2018 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE dexamethasone sodium phosphate INJECTABLE;INJECTION 040491-001 Apr 11, 2003 AP RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Somerset Theraps Llc DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE dexamethasone sodium phosphate INJECTABLE;INJECTION 207442-001 Apr 19, 2018 AP RX 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

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dexamethasone Sodium Phosphate Preservative Free

Market Overview

Dexamethasone Sodium Phosphate Preservative Free is a versatile and widely used corticosteroid with a broad range of therapeutic applications. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Therapeutic Applications

Dexamethasone Sodium Phosphate is utilized in treating various medical conditions, including allergic disorders, cerebral edema, collagen disorders, and inflammatory diseases such as asthma and arthritis. Its immunosuppressive effects make it crucial in managing autoimmune diseases and preventing organ rejection post-transplantation[3][4][5].

Market Size and Growth

The global Dexamethasone Sodium Phosphate market has been experiencing significant growth. As of 2023, the market size was substantial, and it is projected to grow at a notable Compound Annual Growth Rate (CAGR) from 2024 to 2031. The 4 mg/ml segment of Dexamethasone Sodium Phosphate accounted for a noticeable share of the global market and is expected to continue growing significantly[1].

Regional Analysis

The market is segmented into major regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region has its own revenue share and current trends, with the Asia Pacific region often showing high growth potential due to increasing healthcare demands and improving economic conditions[1].

Application Segments

The drug is used across various end-use industries, with the hospital segment expected to expand at a significant CAGR throughout the forecast period. Other key application areas include outpatient clinics and research institutions, where its use in treating inflammatory and immune-mediated conditions is prevalent[1][3].

Key Drivers

Several factors drive the growth of the Dexamethasone Sodium Phosphate market:

  • Therapeutic Versatility: The drug's wide range of therapeutic applications, including its critical role in managing inflammatory and immune-mediated conditions, contributes to its market growth[3].
  • COVID-19 Impact: The drug's effectiveness in mitigating severe COVID-19 cases escalated its demand during the pandemic, further boosting its market position[3].
  • Chronic Disorders: The rising incidence of chronic and autoimmune disorders has increased the adoption of Dexamethasone Sodium Phosphate in healthcare settings[3].

Market Trends

  • Research and Development: There is a significant focus on improving drug delivery systems and exploring novel applications, fostering innovation in the market. This includes advancements in injectable and oral formulations[3].
  • Cost-Effectiveness: The drug's availability in multiple formulations, such as injections, tablets, and creams, enhances its market appeal due to its cost-effectiveness and adaptability for both acute and chronic medical situations[3].

Competitive Landscape

Key companies such as AuroMedics and Mylan are focusing on strategy building to strengthen their product portfolios and expand their business in the global market. These companies are investing in research and development to improve their market position and meet the increasing demand for Dexamethasone Sodium Phosphate[1].

Financial Trajectory

Revenue Forecast

The global Dexamethasone Sodium Phosphate market is forecasted to experience revenue growth from 2025 to 2031. The base year for these calculations is 2023, with historical data from 2019 to 2023 providing a comprehensive understanding of market trends and growth rates[1].

Capital Expenditure and Operating Expenses

Setting up a Dexamethasone Sodium Phosphate manufacturing plant involves significant capital expenditure (CapEx) and operating expenses (OpEx). The project economics include detailed analyses of income projections, taxation, depreciation, liquidity analysis, profitability analysis, payback period, Net Present Value (NPV), and sensitivity analysis. These financial metrics are crucial for investors and manufacturers to make informed decisions[3].

Profitability and ROI

The profitability of Dexamethasone Sodium Phosphate is influenced by factors such as product price, capacity, production, and supply-demand dynamics. The report provides insights into the expected ROI and NPV, helping stakeholders understand the financial viability of investing in this market[1][3].

Regulatory Environment

The regulatory landscape plays a critical role in shaping the market trajectory of Dexamethasone Sodium Phosphate. The drug is available as an FDA-approved product in various forms, and its inclusion on the 503B Bulks List is under consideration. Regulatory approvals and compliance with Current Good Manufacturing Practices (CGMP) are essential for maintaining market presence[4].

Challenges and Opportunities

Challenges

  • Regulatory Developments: Changes in regulatory policies can impact the market negatively.
  • Safety Concerns: Continuous monitoring of safety profiles is necessary to maintain market trust.
  • Competition: The presence of other corticosteroids and generic alternatives can pose competitive challenges[3].

Opportunities

  • Expanding Therapeutic Uses: Ongoing research could uncover new therapeutic applications, expanding the market.
  • Emerging Markets: Growing healthcare needs in emerging economies offer significant growth opportunities.
  • Innovative Delivery Systems: Advancements in drug delivery systems can enhance patient compliance and treatment outcomes[3].

Key Takeaways

  • Diverse Therapeutic Applications: Dexamethasone Sodium Phosphate is used in treating a wide range of medical conditions.
  • Significant Market Growth: The market is expected to grow at a notable CAGR from 2024 to 2031.
  • Regional Variations: Market dynamics vary by region, with the Asia Pacific region showing high growth potential.
  • Financial Viability: The drug offers a profitable investment opportunity with a promising ROI and NPV.
  • Regulatory Compliance: Adherence to regulatory standards is crucial for market success.

FAQs

Q: What are the primary therapeutic applications of Dexamethasone Sodium Phosphate?

A: The primary therapeutic applications include treating allergic disorders, cerebral edema, collagen disorders, and inflammatory diseases such as asthma and arthritis.

Q: Which segment of the Dexamethasone Sodium Phosphate market is expected to grow significantly?

A: The 4 mg/ml segment is expected to experience significant growth in the near future.

Q: How has the COVID-19 pandemic impacted the market for Dexamethasone Sodium Phosphate?

A: The pandemic has escalated the demand for Dexamethasone Sodium Phosphate due to its effectiveness in mitigating severe COVID-19 cases.

Q: What are the key drivers of the Dexamethasone Sodium Phosphate market?

A: The key drivers include its therapeutic versatility, the rising incidence of chronic and autoimmune disorders, and its cost-effectiveness.

Q: What are the major challenges facing the Dexamethasone Sodium Phosphate market?

A: The major challenges include regulatory developments, safety concerns, and competition from other corticosteroids and generic alternatives.

Sources

  1. Cognitive Market Research: Dexamethasone Sodium Phosphate Injection Market Report 2024.
  2. Synapse by PatSnap: Dexamethasone Sodium Phosphate - Drug Targets, Indications.
  3. IMARC Group: Dexamethasone Sodium Phosphate Manufacturing Plant Project Report 2024.
  4. University of Maryland, Baltimore: Dexamethasone sodium phosphate.
  5. DailyMed by FDA: Dexamethasone Sodium Phosphate Injection, USP.

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