HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Heparin Sodium 5,000 Units In Sodium Chloride 0.9% In Plastic Container, and when can generic versions of Heparin Sodium 5,000 Units In Sodium Chloride 0.9% In Plastic Container launch?

Heparin Sodium 5,000 Units In Sodium Chloride 0.9% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in HEPARIN SODIUM 5,000 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 5,000 Units In Sodium Chloride 0.9% In Plastic Container

A generic version of HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER was approved as heparin sodium by HOSPIRA on April 28^th, 1983.

Summary for HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	98
DailyMed Link:	HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% 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 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for HEPARIN SODIUM 5,000 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 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	019042-004	Mar 29, 1985		DISCN	No	No

HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Heparin Sodium

Introduction to Heparin Sodium

Heparin sodium, a widely used anticoagulant, has been a cornerstone in medical treatments for over 90 years. Its applications span various medical conditions, including cardiovascular and lung diseases, making it a crucial component in healthcare settings.

Global Market Size and Growth

The global heparin market has demonstrated robust growth, driven by increasing demand for anticoagulant therapies. As of 2022, the global heparin market size exceeded USD 5.49 billion and is projected to reach approximately USD 9.24 billion by 2032, growing at a CAGR of 5.40% during the forecast period from 2023 to 2032[4].

Regional Market Outlook

North America is currently the largest market for heparin sodium, driven by the high prevalence of cardiovascular diseases and an aging population. The U.S. heparin market, in particular, was valued at over USD 535.4 million in 2019 and is expected to grow at a CAGR of over 7.2% between 2020 and 2026[1].

Drivers of Market Growth

Prevalence of Cardiovascular Diseases

The increasing incidence of cardiovascular diseases is a significant driver of the heparin sodium market. Cardiovascular conditions require anticoagulant therapy, making heparin sodium an essential medication in these treatments[4].

Growing Healthcare Expenditure

Rising healthcare spending, especially in emerging nations, has made modern medical therapies like heparin sodium more accessible. This trend is expected to support market expansion in these regions[5].

Regulatory Support and Approval

Strict regulatory guidelines ensure the safety and quality of heparin sodium products. Regulatory approvals for new formulations and indications further aid market growth[5].

Advancements in Drug Delivery Methods

Ongoing developments in drug delivery methods and pharmaceutical production processes are enhancing the safety and effectiveness of heparin sodium formulations, improving patient outcomes and product quality[5].

Product Innovations and Convenience

Companies like Fresenius Kabi have introduced innovative product presentations to enhance convenience and patient safety. For example, Fresenius Kabi offers low concentration heparin sodium in sodium chloride injection in ready-to-use Freeflex® IV bags, which are designed to minimize drug errors and ensure patient safety[3].

Company Strategies and Investments

Qilian International's Strategic Pivot

Qilian International is adjusting its industrial investment strategy by reducing investment in the oxytetracycline sector, which has seen a decline in market demand and pricing, and increasing investment in heparin sodium. This move is driven by the high demand for heparin sodium in healthcare settings and its critical role as a biomedical raw material[2].

Diversification into Licorice Products

In addition to heparin sodium, Qilian International is expanding into licorice-based products to tap into the growing demand for natural and herbal health products. This diversification strategy aims to broaden the company's market share and enhance profitability[2].

Challenges and Limitations

Safety Concerns

Heparin-induced thrombocytopenia (HIT) and allergic responses are significant safety concerns associated with heparin sodium. These adverse effects can reduce the usage of heparin sodium, particularly in certain patient populations[5].

Price Volatility

Changes in the cost of raw materials, such as pig mucosa, can impact manufacturers' profit margins and cause market pricing issues. This volatility can affect the overall market dynamics[5].

Competition from Generic Manufacturers

The expiration of patents on some heparin sodium formulations has led to increased competition from generic manufacturers. This competition can limit the revenue potential for branded products and drive down prices[5].

Financial Trajectory

The financial trajectory for heparin sodium is positive, driven by the growing demand for anticoagulant therapies. Here are some key financial indicators:

• Market Size: The global heparin sodium market was valued at USD 5.76 billion in 2024 and is projected to reach USD 9.72 billion by 2031, growing at a CAGR of 4.2%[5].
• Revenue Growth: The U.S. heparin market is expected to grow at a CAGR of over 7.2% between 2020 and 2026, driven by the increasing adoption of low molecular weight heparin[1].

Key Takeaways

• The global heparin sodium market is growing rapidly due to the increasing prevalence of cardiovascular diseases and advancements in drug delivery methods.
• Companies are innovating product presentations to enhance convenience and safety.
• Strategic investments in heparin sodium production and research are expected to drive market growth.
• Safety concerns and price volatility are key challenges that need to be addressed.
• Diversification into related products, such as licorice-based products, can help companies broaden their market share.

FAQs

Q: What is the current market size of the global heparin sodium market? A: The global heparin sodium market was valued at USD 5.76 billion in 2024[5].

Q: What is the projected growth rate of the heparin sodium market? A: The heparin sodium market is projected to grow at a CAGR of 4.2% from 2024 to 2031[5].

Q: Why is the demand for heparin sodium increasing? A: The demand is increasing due to the growing prevalence of cardiovascular diseases and advancements in drug delivery methods[4][5].

Q: What are the main challenges facing the heparin sodium market? A: Safety concerns such as HIT and allergic responses, price volatility, and competition from generic manufacturers are significant challenges[5].

Q: How are companies like Qilian International strategizing in the heparin sodium market? A: Companies are increasing investments in heparin sodium research and production, and diversifying into related products like licorice-based products to enhance market share and profitability[2].

Cited Sources

1. U.S. Heparin Market Forecasts 2026 | Statistics Report - GMI Insights
2. Qilian International plans to adjust industrial investment - Stock Titan
3. Fresenius Kabi Introduces Low Concentration Heparin Sodium in Sodium Chloride Injection in Ready-to-Use Freeflex® IV Bags - BioSpace
4. Heparin Market Size to Attain USD 9.24 Billion by 2032 - Precedence Research
5. In-Depth Industry Outlook: Heparin Sodium Market Size, Forecast - Verified Market Research