HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile

When do Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container patents expire, and what generic alternatives are available?

Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container is a drug marketed by B Braun and Hospira and is included in four NDAs.

The generic ingredient in HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% 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 25,000 Units In Dextrose 5% In Plastic Container

A generic version of HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as heparin sodium by HOSPIRA on April 28^th, 1983.

Summary for HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	2
NDAs:	4
Finished Product Suppliers / Packagers:	3
Clinical Trials:	98
DailyMed Link:	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

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

Sponsor	Phase
Vaneltix Pharma, Inc.	Phase 2
Prevail Infoworks, Inc	Phase 2
The First Affiliated Hospital with Nanjing Medical University	N/A

See all HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

Pharmacology for HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Drug Class

Anti-coagulant Unfractionated Heparin

US Patents and Regulatory Information for HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% 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 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	019134-001	Mar 29, 1985		DISCN	No	No
Hospira	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	019339-004	Mar 27, 1985	AP	RX	No	No
B Braun	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	019952-004	Jul 20, 1992	AP	RX	Yes	Yes
B Braun	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	019952-005	Jul 20, 1992	AP	RX	Yes	Yes
Hospira	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	019339-002	Mar 27, 1985	AP	RX	No	No

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Heparin Sodium in 5% Dextrose Injection

Introduction to Heparin Sodium in 5% Dextrose Injection

Heparin sodium in 5% dextrose injection is a sterile, nonpyrogenic solution used as an anticoagulant, derived from porcine intestinal mucosa. This medication is administered intravenously and is crucial in various medical applications, including the prevention and treatment of thrombosis and embolism[3][4].

Market Size and Forecast

The heparin sodium market is experiencing significant growth, driven by its essential role in healthcare. As of 2024, the heparin sodium market 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[5].

Key Drivers of Market Growth

Increasing Demand in Healthcare

The global demand for heparin sodium is driven by its critical applications in medical settings. It is used in various procedures, including cardiac surgeries, dialysis, and the treatment of deep vein thrombosis. The increasing incidence of cardiovascular diseases and the growing need for anticoagulant therapies are major drivers of this market[2][5].

Strategic Investments by Companies

Companies like Qilian International are adjusting their industrial investments to capitalize on the growing demand for heparin sodium. Qilian International plans to significantly increase its investment in heparin sodium research, production, and market development, which is expected to enhance the company's competitiveness and profitability[2].

Product Specifications and Variations

Heparin sodium in 5% dextrose injection is available in various strengths and container sizes. For example, B. Braun Medical Inc. offers this solution in 500 mL and 250 mL EXCEL® IV containers, with strengths of 25,000 units per 500 mL and 100 units per mL, respectively. These solutions are free from natural rubber latex, PVC, and DEHP, ensuring safety and compliance with medical standards[3][4].

Market Trends and Consumer Preferences

Shift Towards Biomedical Raw Materials

The market is witnessing a shift towards biomedical raw materials like heparin sodium due to their critical role in healthcare. This trend is driven by the increasing need for effective anticoagulants and the growing awareness of the importance of these materials in medical treatments[2].

Diversification and Expansion

Companies are diversifying their product lines to include heparin sodium and other related products. For instance, Qilian International is expanding into licorice-based products to broaden its market share and enhance profitability. This diversification strategy helps in mitigating risks associated with declining demand in other sectors, such as oxytetracycline[2].

Financial Trajectory

Revenue Growth

The financial trajectory for heparin sodium in 5% dextrose injection is promising due to the strong market outlook. The projected growth from USD 5.76 billion in 2024 to USD 9.72 billion by 2031 indicates a solid revenue stream for companies investing in this sector. This growth is expected to offset losses from declining markets in other pharmaceutical sectors[5].

Cost Management and Efficiency

Companies are focusing on cost management and efficiency to optimize their investments. Qilian International's decision to reduce investment in the oxytetracycline sector, which has seen declining demand and increasing production costs, is a strategic move to cut down operational costs and enhance long-term financial health[2].

Competitive Landscape

The competitive landscape in the heparin sodium market is characterized by strategic investments and diversification. Companies like Qilian International and B. Braun Medical Inc. are positioning themselves to capitalize on the growing demand for heparin sodium. This involves enhancing production capabilities, expanding market reach, and ensuring compliance with stringent medical standards[2][3].

Regulatory and Compliance Aspects

Heparin sodium products must adhere to strict regulatory standards. The solutions are standardized for use as anticoagulants, and their potency is determined by biological assays using USP reference standards. Compliance with these standards is crucial for maintaining product safety and efficacy[3][4].

Environmental and Operational Costs

Increasing environmental protection standards are impacting production costs in the pharmaceutical industry. Companies are facing escalating operational costs due to these standards, which necessitates strategic adjustments in investment and resource allocation. The shift towards heparin sodium production is partly driven by the need to manage these costs effectively[2].

Consumer and Market Insights

Growing Demand for Natural Health Products

In addition to the demand for heparin sodium, there is a growing consumer preference for natural and herbal health products. This trend is driving companies to invest in licorice-based products and other natural remedies, which can complement the revenue streams from heparin sodium[2].

Market Expansion and Diversification

The expansion into new product lines and sectors, such as financial technology and software development, is a strategic move to diversify revenue streams. While this is less traditional for pharmaceutical companies, it offers potential for growth and risk mitigation[2].

Challenges and Opportunities

Challenges in Production and Supply Chain

The production of heparin sodium involves complex processes, including the derivation from porcine intestinal mucosa. Ensuring a stable supply chain and maintaining high-quality standards are significant challenges. However, these challenges also present opportunities for innovation and improvement in production techniques[3][4].

Opportunities in Emerging Markets

Emerging markets offer significant opportunities for the growth of the heparin sodium market. Increasing healthcare spending and the growing need for anticoagulant therapies in these regions can drive market expansion and revenue growth[5].

Key Takeaways

• The heparin sodium market is projected to grow from USD 5.76 billion in 2024 to USD 9.72 billion by 2031, driven by its critical role in healthcare.
• Companies are strategically investing in heparin sodium production and market development to capitalize on growing demand.
• Diversification into related products, such as licorice-based products, is a key strategy to enhance market share and profitability.
• Compliance with regulatory standards and management of operational costs are crucial for maintaining competitiveness.
• Emerging markets present significant opportunities for market expansion and revenue growth.

FAQs

What is the primary use of heparin sodium in 5% dextrose injection?

Heparin sodium in 5% dextrose injection is primarily used as an anticoagulant to prevent and treat thrombosis and embolism.

Which companies are significantly investing in heparin sodium production?

Companies like Qilian International and B. Braun Medical Inc. are making significant investments in heparin sodium research, production, and market development.

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

The heparin sodium market is projected to grow at a CAGR of 4.2% from 2024 to 2031.

Why are companies diversifying their product lines to include heparin sodium?

Companies are diversifying to capitalize on the growing demand for heparin sodium, mitigate risks associated with declining demand in other sectors, and enhance profitability.

What are the key challenges in the production of heparin sodium?

Key challenges include ensuring a stable supply chain, maintaining high-quality standards, and managing operational costs due to increasing environmental protection standards.

Sources

1. Health Products and Food Branch Inspectorate - Heparin Sodium in 5% Dextrose Injection
2. Qilian International plans to adjust industrial investment
3. B. Braun USA - 25,000 Units Heparin in 5% Dextrose Injection, 50 Units mL
4. B. Braun USA - 25,000 Units Heparin in 5% Dextrose Injection, 100 Units mL
5. Verified Market Research - Heparin Sodium Market Size, Forecast