HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Container, and when can generic versions of Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Container launch?

Heparin Sodium 2,000 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 2,000 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 2,000 Units In Sodium Chloride 0.9% In Plastic Container

A generic version of HEPARIN SODIUM 2,000 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 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	4
Clinical Trials:	98
DailyMed Link:	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for HEPARIN SODIUM 2,000 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 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER clinical trials

Pharmacology for HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Drug Class

Anti-coagulant Unfractionated Heparin

US Patents and Regulatory Information for HEPARIN SODIUM 2,000 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
Hospira	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	018916-011	Jun 23, 1989	AP	RX	Yes	Yes
B Braun	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	019042-002	Mar 29, 1985		DISCN	No	No
B Braun	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	019953-002	Dec 15, 2023		RX	Yes	Yes
Fresenius Kabi Usa	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	212441-002	Jul 24, 2020	AP	RX	No	No

The Heparin Sodium Market: Dynamics and Financial Trajectory

Introduction to Heparin Sodium

Heparin sodium is a crucial anticoagulant widely used in medical procedures and treatments for various conditions, including cardiovascular diseases and surgical interventions. Its importance in healthcare is underscored by its growing demand and the subsequent market dynamics.

Market Size and Growth Projections

The heparin sodium market is experiencing significant growth, driven by several key factors. As of 2023, the global heparin market was valued at approximately USD 7.51 billion and is projected to reach USD 9.46 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 2.6% during the forecast period of 2025-2032[4].

Another projection indicates that the heparin sodium market was valued at USD 5.76 billion in 2024 and is expected to reach USD 9.72 billion by 2031, with a CAGR of 4.2% during the forecast period of 2024-2031[5].

Key Drivers of Market Growth

Increasing Incidences of Chronic Diseases

The rising number of cases of chronic diseases, such as cardiovascular conditions, is a major driver of the heparin sodium market. As the global population ages and lifestyle factors contribute to increased health issues, the demand for anticoagulants like heparin sodium is expected to rise[4].

Growing Number of Surgical Procedures

An increase in surgical procedures, particularly those requiring anticoagulation therapy, is another significant factor driving market growth. Improved healthcare infrastructure and advancements in medical technologies are contributing to this trend[4].

Enhancements 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. These advancements are improving patient outcomes and product quality, thereby propelling market growth[5].

Regulatory Support and Approval

Strict guidelines and regulatory approvals for novel formulations and indications of heparin sodium ensure the safety and quality of the final product. This regulatory support is further aiding market growth[5].

Regional Market Dynamics

North America

North America is anticipated to lead the heparin market due to better awareness of anticoagulation treatments, the presence of improved healthcare infrastructure, and robust research and development activities. The substantial patient population in North America and the introduction of new heparin products, such as B. Braun Medical Inc.'s Heparin Sodium 2,000 units in 0.9% Sodium Chloride Injection, are expected to boost market demand in the region[1][4].

Other Regions

Other regions, including Europe, Asia Pacific, Latin America, and the Middle East & Africa, are also expected to contribute to the growth of the heparin sodium market. Growing healthcare expenditure, especially in emerging nations, is making modern medical therapies like heparin sodium more accessible, supporting market expansion in these regions[4].

Challenges and Constraints

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 specific patient populations[5].

Price Volatility

Changes in the cost of raw materials, such as pig mucosa, used in the manufacturing of heparin sodium can impact manufacturers' profit margins and cause market pricing issues[5].

Competition from Generic Manufacturers

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

Strategic Moves by Companies

Qilian International

Qilian International is adjusting its industrial investment strategy to focus more on heparin sodium research, production, and market development. This move is aimed at addressing the high market demand for heparin sodium and diversifying the company's revenue streams. Additionally, Qilian is expanding into licorice-based products to capture the growing market for natural health solutions[2].

Product Innovations and Launches

B. Braun Medical Inc.

The introduction of new heparin products, such as B. Braun Medical Inc.'s Heparin Sodium 2,000 units in 0.9% Sodium Chloride Injection, underscores the company's commitment to enhancing supply security and meeting the growing demand for heparin in North America. This product is supplied in single-dose flexible plastic containers and is part of a broader range of heparin premixed bags produced by B. Braun[1].

Storage and Handling

Heparin sodium solutions, such as those in 0.9% sodium chloride injection, are supplied in single-dose flexible plastic containers in various sizes and concentrations. These solutions must be stored at controlled room temperatures (20°C to 25°C or 68°F to 77°F) and protected from freezing[3].

Financial Trajectory

The financial trajectory of the heparin sodium market is promising, with significant growth projected over the next decade. The market's value is expected to increase from USD 7.51 billion in 2023 to USD 9.46 billion by 2032, driven by the factors mentioned above. Companies like Qilian International are also expected to benefit from their strategic investments in heparin sodium, potentially opening up new revenue channels and diversifying risk[2][4].

Key Takeaways

• The heparin sodium market is growing significantly due to increasing chronic diseases, rising surgical procedures, and advancements in drug delivery and production.
• North America is expected to lead the market due to better healthcare infrastructure and robust research and development.
• Safety concerns, price volatility, and competition from generic manufacturers are key challenges facing the market.
• Companies are making strategic moves to invest in heparin sodium research, production, and market development.
• New product launches and innovations are enhancing supply security and meeting growing demand.

Frequently Asked Questions (FAQs)

1. What is the projected market size of the heparin sodium market by 2032? The heparin sodium market is projected to reach USD 9.46 billion by 2032, growing at a CAGR of 2.6% during the forecast period of 2025-2032[4].

2. What are the main drivers of the heparin sodium market growth? The main drivers include increasing incidences of chronic diseases, growing number of surgical procedures, enhancements in drug delivery and production, and regulatory support and approval[4][5].

3. Which region is expected to lead the heparin market? North America is anticipated to lead the heparin market due to better awareness of anticoagulation treatments, improved healthcare infrastructure, and robust research and development activities[1][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[5].

5. How are companies like Qilian International strategizing in the heparin sodium market? Qilian International is increasing its investment in heparin sodium research, production, and market development, and also expanding into licorice-based products to diversify its revenue streams and capture growing market trends[2].

Cited Sources:

1. Global Heparin Market to Reach ~USD 15 Billion by 2030 - DelveInsight, PR Newswire.
2. Qilian International plans to adjust industrial investment - StockTitan.
3. Heparin Sodium in 0.45% Sodium Chloride Injection - Pfizer Medical Information.
4. Heparin Market Size, Growth & Trends Report - SkyQuest.
5. In-Depth Industry Outlook: Heparin Sodium Market Size, Forecast - Verified Market Research.