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Last Updated: December 22, 2024

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container, and when can generic versions of Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container launch?

Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container is a drug marketed by B Braun, Fresenius Kabi Usa, and Hospira. and is included in four NDAs.

The generic ingredient in HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is heparin sodium. There are seventy-seven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container

A generic version of HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER was approved as heparin sodium by HOSPIRA on April 28th, 1983.

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Summary for HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Drug patent expirations by year for HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Recent Clinical Trials for HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

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

SponsorPhase
Prevail Infoworks, IncPhase 2
Vaneltix Pharma, Inc.Phase 2
The First Affiliated Hospital with Nanjing Medical UniversityN/A

See all HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER clinical trials

Pharmacology for HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

US Patents and Regulatory Information for HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER heparin sodium INJECTABLE;INJECTION 019042-001 Mar 29, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER heparin sodium INJECTABLE;INJECTION 018916-010 Jun 23, 1989 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER heparin sodium INJECTABLE;INJECTION 019953-001 Jul 20, 1992 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER heparin sodium INJECTABLE;INJECTION 212441-001 Jul 24, 2020 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

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Heparin Sodium Market Dynamics and Financial Trajectory

Market Size and Forecast

The Heparin Sodium market is poised for significant growth, driven by several key factors. As of 2024, the market size was valued at USD 5.76 billion and is projected to reach USD 9.72 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.2% during the forecast period[1].

Global Market Drivers

Several drivers are propelling the growth of the Heparin Sodium market:

Rising Prevalence of Cardiovascular Diseases

The increasing prevalence of cardiovascular diseases worldwide is a major driver. Heparin sodium is a critical anticoagulant used in the treatment and prevention of thromboembolic events linked to these disorders[1].

Advancements in Drug Delivery and Production

Ongoing developments in drug delivery methods and pharmaceutical production processes are enhancing the safety and effectiveness of heparin sodium formulations, leading to improved patient outcomes and product quality[1].

Growing Healthcare Expenditure

Increasing healthcare spending, particularly in emerging nations, is making modern medical therapies like heparin sodium more accessible. This trend is expected to support market expansion in these regions[1].

Regulatory Support and Approval

Strict regulatory guidelines governing the usage and production of pharmaceuticals ensure the safety and quality of heparin sodium products. Regulatory approvals for novel formulations and indications further aid market growth[1].

Challenges and Restraints

Despite the positive outlook, there are several challenges that could impact the market:

Safety Concerns

Heparin-induced thrombocytopenia (HIT) and allergic responses are significant safety concerns that could reduce the usage of heparin sodium, especially in specific patient populations[1].

Price Volatility

Changes in the cost of raw materials, such as pig mucosa, can affect manufacturers' profit margins and market pricing[1].

Competition from Generic Manufacturers

The expiration of patents on some heparin sodium formulations has led to increased competition from generic manufacturers, which could limit revenue for branded products and drive down prices[1].

Regional Analysis

The global Heparin Sodium market is segmented into several regions:

North America

Expected to hold the largest market share during the forecast period, driven by the presence of significant players and increased investments in research and development[1].

Asia Pacific

This region is anticipated to grow at the fastest rate due to its continuously increasing healthcare infrastructure, economic development, and increasing private and public initiatives. The aging population and the prevalence of cardiovascular disorders are key factors contributing to this growth[4].

Company Strategies and Investments

Companies like Qilian International are making strategic shifts to capitalize on the growing demand for heparin sodium:

Qilian International's Strategic Pivot

Qilian International is reducing its investment in the oxytetracycline sector due to declining market demand and increasing production costs. Instead, the company is increasing its investment in heparin sodium research, production, and market development to address the high market demand. This move is expected to open up new revenue channels and diversify risk[2].

Expansion into Licorice Products

In addition to heparin sodium, Qilian International is also expanding into licorice-based products to broaden its market share and enhance profitability. This move aligns with the growing demand for natural and herbal health products[2].

Product Specifications and Uses

Heparin Sodium in 0.9% Sodium Chloride Injection is a commonly used product:

Product Description

This sterile, nonpyrogenic solution is prepared from Heparin Sodium USP derived from porcine intestinal mucosa. It is indicated as an anticoagulant to maintain catheter patency and is administered by intravenous injection[3].

Clinical Applications

Heparin sodium is critical in various medical applications, including surgeries and the treatment of thromboembolic events. Its use is essential in maintaining catheter patency and preventing blood clot formation[3].

Financial Implications

The financial trajectory of heparin sodium is promising:

Revenue Growth

The market's projected growth to USD 9.72 billion by 2031 indicates a strong financial outlook. This growth is supported by increasing healthcare expenditure and the expanding demand for anticoagulant therapies[1].

Diversification and Risk Management

Companies diversifying into heparin sodium production are likely to mitigate risks associated with declining markets in other sectors, such as oxytetracycline. This diversification can lead to enhanced long-term financial health and profitability[2].

Industry Insights and Quotes

Industry experts highlight the critical role of heparin sodium in healthcare:

"Heparin sodium is a critical anticoagulant used widely in surgeries and for treating various medical conditions. As the demand for healthcare services continues to rise globally, this area is poised for steady growth."[2]

Statistics and Forecasts

  • Market Size: USD 5.76 billion in 2024, projected to reach USD 9.72 billion by 2031[1].
  • CAGR: 4.2% during the forecast period 2024-2031[1].
  • Regional Growth: Asia Pacific region expected to grow at the fastest rate due to increasing healthcare infrastructure and economic development[4].

Key Takeaways

  • The Heparin Sodium market is driven by the rising prevalence of cardiovascular diseases and advancements in drug delivery and production.
  • Growing healthcare expenditure and regulatory support are key factors contributing to market growth.
  • Safety concerns and price volatility are significant challenges.
  • Companies are diversifying into heparin sodium production to capitalize on the growing demand.
  • The market is expected to reach USD 9.72 billion by 2031, growing at a CAGR of 4.2%.

FAQs

1. What is the projected market size of Heparin Sodium by 2031? The Heparin Sodium market is projected to reach USD 9.72 billion by 2031[1].

2. What are the main drivers of the Heparin Sodium market? The main drivers include the rising prevalence of cardiovascular diseases, advancements in drug delivery and production, growing healthcare expenditure, and regulatory support[1].

3. Which region is expected to grow at the fastest rate in the Heparin Sodium market? The Asia Pacific region is expected to grow at the fastest rate due to its increasing healthcare infrastructure, economic development, and growing demand for anticoagulant therapies[4].

4. What are the safety concerns associated with Heparin Sodium? Heparin-induced thrombocytopenia (HIT) and allergic responses are significant safety concerns associated with Heparin Sodium[1].

5. How is Qilian International adjusting its investment strategy related to Heparin Sodium? Qilian International is increasing its investment in Heparin Sodium research, production, and market development, while reducing investment in the oxytetracycline sector due to declining market demand and increasing production costs[2].

Cited Sources

  1. Verified Market Research - Heparin Sodium Market Size, Forecast[1]
  2. Stock Titan - Qilian International plans to adjust industrial investment[2]
  3. B. Braun USA - 1,000 Units Heparin in 0.9% Sodium Chloride Injection, 2 Units mL[3]
  4. Maximize Market Research - Heparin Market - Dynamics, Impacts and Forecasts 2024-2030[4]

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