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Last Updated: December 23, 2024

PARASAL SODIUM Drug Patent Profile


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Which patents cover Parasal Sodium, and when can generic versions of Parasal Sodium launch?

Parasal Sodium is a drug marketed by Panray and is included in one NDA.

The generic ingredient in PARASAL SODIUM is aminosalicylate sodium. There are three drug master file entries for this compound. Additional details are available on the aminosalicylate sodium profile page.

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Summary for PARASAL SODIUM
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 92
Patent Applications: 6
DailyMed Link:PARASAL SODIUM at DailyMed
Drug patent expirations by year for PARASAL SODIUM

US Patents and Regulatory Information for PARASAL SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Panray PARASAL SODIUM aminosalicylate sodium TABLET;ORAL 006811-011 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Panray PARASAL SODIUM aminosalicylate sodium TABLET;ORAL 006811-006 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

PARASAL SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sodium Phenylbutyrate (PARASAL SODIUM)

Introduction to Sodium Phenylbutyrate

Sodium phenylbutyrate, often marketed under the brand name Parasal, is a crucial medication used in the treatment of urea cycle disorders (UCDs) and maple syrup urine disease (MSUD). These conditions are rare genetic disorders that affect the body's ability to break down ammonia, a toxic substance that can accumulate and cause severe health issues.

Market Size and Growth

The global sodium phenylbutyrate market is projected to experience significant growth over the coming years. Here are some key financial projections:

  • Current Market Size: The market was valued at US$ 1.92 billion in 2023[1].
  • Projected Market Size: It is expected to reach US$ 3.02 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.7% during the forecast period from 2023 to 2030[1].

Drivers of Market Growth

Several factors are driving the growth of the sodium phenylbutyrate market:

Increasing Incidence of UCDs and MSUD

  • The estimated incidence of UCDs is 1 in 8,500 births, according to the Centers for Disease Control and Prevention (CDC). This increasing incidence contributes to the growing demand for sodium phenylbutyrate[1].

Rising Awareness and Government Support

  • There is a rising awareness about the benefits of sodium phenylbutyrate for treating UCDs and MSUD. Government support initiatives and newborn screening programs also play a significant role in driving market growth[1].

Advanced Healthcare Infrastructure

  • Regions with advanced healthcare infrastructure, such as North America and Europe, are expected to dominate the market. The presence of major market players and the availability of advanced healthcare facilities in these regions further support market growth[1].

Regional Insights

North America

  • North America is expected to dominate the global sodium phenylbutyrate market due to the presence of major market players and advanced healthcare facilities. The growing patient population and newborn screening programs in this region are key contributors to market growth[1].

Europe

  • Europe is anticipated to be the second-largest market for sodium phenylbutyrate, driven by rising healthcare expenditure and a well-developed healthcare system[1].

Asia Pacific

  • The Asia Pacific region is expected to grow at a high rate over the next few years. Factors such as improving healthcare infrastructure, rising medical tourism, and increasing healthcare spending are likely to offer lucrative opportunities for market players in this region[1].

Product Form and Demand

Current Dominance

  • The tablets segment currently dominates the sodium phenylbutyrate market. However, the oral powder formulation is anticipated to witness higher demand in the coming years due to its ease of administration and patient compliance[1].

Challenges and Restraints

Regulatory Approvals

  • Stringent regulatory approvals can hamper market growth. The process of obtaining approvals is often lengthy and costly, which can delay the entry of new products into the market[1].

High R&D Costs

  • High research and development costs associated with drug development are another significant challenge. These costs can be prohibitive for smaller manufacturers, limiting market entry and competition[1].

Key Players and Competitive Landscape

Major Market Players

  • Companies such as Horizon Therapeutics plc, Ammonett Pharma LLC, Medison Pharma Ltd., Modern Dietetics Inc., Synageva BioPharma Corp., and Swedish Orphan Biovitrum AB (Sobi) are key players in the sodium phenylbutyrate market. These companies are investing in R&D activities to develop enhanced formulations and gain a competitive edge[1].

R&D and Strategic Initiatives

  • Key players are focusing on R&D to improve product formulations and expand their market share. New product launches, acquisitions, and partnerships are also common strategies to stay competitive in the market[1].

Recent Developments

New Product Launches

  • There has been a focus on launching new and improved formulations of sodium phenylbutyrate. These new products aim to enhance patient compliance and treatment outcomes[1].

Acquisitions and Partnerships

  • Companies are engaging in acquisitions and partnerships to strengthen their market position and expand their product portfolios. These strategic moves help in leveraging resources and expertise to drive innovation and growth[1].

Illustrative Statistics

  • Market Growth Rate: The global sodium phenylbutyrate market is expected to grow at a CAGR of 6.7% from 2023 to 2030[1].
  • Incidence of UCDs: The estimated incidence of UCDs is 1 in 8,500 births, highlighting the ongoing demand for treatment options like sodium phenylbutyrate[1].

Quotes from Industry Experts

"The increasing incidence of urea cycle disorders and the rising awareness about the benefits of sodium phenylbutyrate are driving the growth of this market. Advanced healthcare infrastructure and government support initiatives are also crucial factors." - Industry Analyst[1].

Conclusion

The sodium phenylbutyrate market is poised for significant growth driven by the increasing incidence of UCDs and MSUD, rising awareness, and government support. While challenges such as stringent regulatory approvals and high R&D costs exist, key players are actively investing in R&D and strategic initiatives to drive market expansion.

Key Takeaways

  • The global sodium phenylbutyrate market is projected to reach US$ 3.02 billion by 2030.
  • The market is driven by the increasing incidence of UCDs and MSUD.
  • North America is expected to dominate the market, followed by Europe.
  • The oral powder formulation is anticipated to gain higher demand in the coming years.
  • Key players are focusing on R&D and strategic initiatives to enhance market share.

FAQs

What is sodium phenylbutyrate used for?

Sodium phenylbutyrate is used to treat urea cycle disorders (UCDs) and maple syrup urine disease (MSUD), which are rare genetic disorders affecting the body's ability to break down ammonia.

What is the current market size of sodium phenylbutyrate?

The global sodium phenylbutyrate market was valued at US$ 1.92 billion in 2023.

What is the projected growth rate of the sodium phenylbutyrate market?

The market is expected to grow at a CAGR of 6.7% from 2023 to 2030.

Which region is expected to dominate the sodium phenylbutyrate market?

North America is expected to dominate the global sodium phenylbutyrate market due to the presence of major market players and advanced healthcare facilities.

What are the main challenges facing the sodium phenylbutyrate market?

Stringent regulatory approvals and high research and development costs are significant challenges facing the market.

Sources

  1. Coherent Market Insights: Sodium Phenylbutyrate Market Size, Trends and Forecast to 2030.
  2. Patsnap Synapse: Sparsentan - Drug Targets, Indications, Patents.
  3. Future Market Insights: Pharmaceutical Grade Sodium Chloride Market Analysis to 2034.
  4. Maximize Market Research: Global Pentosan Polysulfate Sodium Market.

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