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Last Updated: April 9, 2025

HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Heparin Sodium 1,000 Units In Dextrose 5% In Plastic Container, and when can generic versions of Heparin Sodium 1,000 Units In Dextrose 5% In Plastic Container launch?

Heparin Sodium 1,000 Units In Dextrose 5% In Plastic Container is a drug marketed by Mcgaw and is included in one NDA.

The generic ingredient in HEPARIN SODIUM 1,000 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 1,000 Units In Dextrose 5% In Plastic Container

A generic version of HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% 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 DEXTROSE 5% IN PLASTIC CONTAINER
Drug patent expirations by year for HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Recent Clinical Trials for HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

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

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

See all HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Mcgaw HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER heparin sodium INJECTABLE;INJECTION 019130-001 Dec 31, 1984 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Heparin Sodium Market Dynamics and Financial Trajectory

Market Overview

The heparin sodium market is poised for significant growth, driven by several key factors. Heparin sodium, an essential anticoagulant, is widely used in various medical conditions, including cardiovascular diseases, pregnancy complications, and surgeries. Here’s a detailed look at the market dynamics and financial trajectory of heparin sodium.

Market Size and Forecast

The heparin sodium market is projected to experience substantial growth in the coming years. By 2027, the market size is estimated to reach $2.4 billion, growing at a CAGR of 3.6% during the forecast period 2022-2027[1]. In a broader context, the global heparin market is expected to reach approximately $9.72 billion by 2031, growing at a CAGR of 4.2% from 2024 to 2031[5].

Segment Analysis

By Ailment Curation

The heparin sodium market can be segmented based on the ailments it treats. The cardiovascular segment, which includes conditions such as deep vein thrombosis (DVT), peripheral artery disease (PAD), and antiphospholipid syndrome, held the largest share in 2021. This dominance is attributed to the increasing incidence of these conditions, exacerbated by factors like smoking, obesity, and a rise in serious injuries[1].

By Geography

Geographically, the market is segmented into North America, Europe, Asia-Pacific, South America, and the Rest of the World. North America held the largest share with 35% of the overall market in 2021, driven by factors such as a high prevalence of sports injuries, intensification of cardiovascular diseases, and a well-developed healthcare infrastructure[1].

However, the Asia-Pacific region is expected to be the fastest-growing segment over the forecast period, driven by the swelling population in countries like India and China, and significant investments in healthcare and research and development[1].

Market Drivers

Technological Breakthroughs

Technological advancements in drug delivery methods and pharmaceutical production processes are enhancing the safety and effectiveness of heparin sodium formulations. These developments are improving patient outcomes and product quality, thereby propelling market growth[5].

Escalation in Blood Anomalies

The increasing incidence of blood anomalies such as thrombosis is boosting the demand for heparin sodium. This trend is particularly evident in the cardiovascular segment, where heparin sodium is crucial for preventing clot formation[1].

Growing Healthcare Expenditure

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

Market Challenges

Side Effects and 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].

Supply Chain and Price Volatility

The supply chain for heparin sodium can be hampered by various factors, including the volatility in the cost of raw materials like pig mucosa. This price volatility 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 revenue potential for branded products and drive down prices[5].

Recent Developments and Launches

B. Braun’s New Product Launch

In February 2024, B. Braun Medical Inc. launched a new Heparin Sodium 2,000 units in 0.9% Sodium Chloride Injection, 1,000 mL (2 units/mL). This product is part of B. Braun’s portfolio of Heparin premixed bags and is manufactured using EXCEL® IV Containers, prioritizing patient and environmental safety[3][4].

Qilian International’s Strategic Pivot

Qilian International is adjusting its industrial investment strategy by increasing its focus 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[2].

Geographical Growth

North America

North America is a significant market for heparin sodium, driven by a substantial patient population and the launch of new heparin products. For instance, B. Braun’s recent product launch is expected to enhance supply security by manufacturing pharmaceuticals in the U.S.[4].

Asia-Pacific

The Asia-Pacific region is anticipated to be the fastest-growing segment due to the increasing demand for improved healthcare setups in countries like India and China. Significant investments in research and development, along with a swelling population, are driving this growth[1].

Key Players and Strategies

Companies like B. Braun and Qilian International are playing crucial roles in the heparin sodium market. B. Braun is expanding its Heparin portfolio to serve diverse healthcare needs, while Qilian International is diversifying its investments to capture the growing demand for heparin sodium and other healthcare products[2][3].

Regulatory Support and Approval

Strict regulatory guidelines governing the production and usage of heparin sodium ensure the safety and quality of the final product. Regulatory approvals for new formulations and indications further support market growth by providing assurance to healthcare providers and patients[5].

R&D Efforts

Continuous research and development efforts are critical for the heparin sodium market. These efforts lead to breakthroughs in drug delivery methods and pharmaceutical production processes, enhancing product quality and patient outcomes[5].

"Technological advancements in drug delivery methods and pharmaceutical production processes are enhancing the safety and effectiveness of heparin sodium formulations, which is propelling market growth"[5].

Financial Implications

The financial trajectory of the heparin sodium market is promising, with significant growth projected over the next several years. The market's expansion is driven by increasing healthcare expenditure, technological advancements, and the growing incidence of blood anomalies.

Revenue Streams

Companies investing in heparin sodium are expected to see substantial returns. For example, Qilian International’s strategic pivot towards heparin sodium and licorice products is aimed at diversifying revenue streams and capturing growing market demands[2].

Cost and Pricing

The cost of raw materials, such as pig mucosa, can impact the pricing of heparin sodium. However, the overall market growth is expected to offset these challenges, ensuring a stable financial outlook for manufacturers[5].

Key Takeaways

  • The heparin sodium market is projected to reach $2.4 billion by 2027, growing at a CAGR of 3.6% during the forecast period.
  • The cardiovascular segment is the largest and fastest-growing segment due to increasing incidences of cardiovascular diseases.
  • North America holds the largest market share, but the Asia-Pacific region is expected to be the fastest-growing segment.
  • Technological breakthroughs, growing healthcare expenditure, and escalating blood anomalies are key market drivers.
  • Safety concerns, supply chain issues, and competition from generic manufacturers are significant challenges.
  • Recent product launches and strategic investments by companies like B. Braun and Qilian International are driving market growth.

FAQs

1. What is the projected market size of the heparin sodium market by 2027?

The heparin sodium market is estimated to reach $2.4 billion by 2027[1].

2. Which segment holds the largest share in the heparin sodium market?

The cardiovascular segment holds the largest share in the heparin sodium market[1].

3. What are the key drivers of the heparin sodium market?

Key drivers include technological breakthroughs, escalation in blood anomalies, and growing healthcare expenditure[1][5].

4. Which region is expected to be the fastest-growing segment in the heparin sodium market?

The Asia-Pacific region is expected to be the fastest-growing segment due to increasing demand for improved healthcare setups and significant investments in research and development[1].

5. What are the major challenges facing the heparin sodium market?

Major challenges include side effects and safety concerns, supply chain issues, and competition from generic manufacturers[5].

Sources:

  1. IndustryARC, Heparin Sodium Market - Forecast(2024 - 2030)
  2. Stocktitan, Qilian International plans to adjust industrial investment
  3. PR Newswire, B. Braun Launches Heparin Sodium 2,000 Units in 0.9% Sodium Chloride Injection
  4. PR Newswire, Global Heparin Market to Reach ~USD 15 Billion by 2030
  5. Verified Market Research, In-Depth Industry Outlook: Heparin Sodium Market Size, Forecast

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