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Last Updated: December 12, 2025

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


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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-three 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 28th, 1983.

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  • What is the 5 year forecast for HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER?
  • What are the global sales for HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER?
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Summary for HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Drug patent expirations by year for HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Recent Clinical Trials for HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

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SponsorPhase
Fondation de l'AvenirPHASE4
University Hospital, ToursPHASE4
Region SkanePHASE4

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

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
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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Heparin Sodium 2,000 Units in Sodium Chloride 0.9% in Plastic Container

Last updated: August 4, 2025

Introduction

Heparin sodium 2,000 units administered in sodium chloride 0.9% via plastic containers represents a critical segment within anticoagulant therapies, particularly in hospitals and outpatient settings. Its widespread use in preventing and treating thromboembolic disorders, alongside its growing demand amid expanding healthcare infrastructure across emerging economies, shapes the current and future market landscape. This comprehensive analysis assesses the market dynamics, key growth drivers, challenges, competitive landscape, and financial trajectory of this pharmaceutical product.

Market Overview

Heparin, a naturally derived anticoagulant, commands a significant share in the injectable anticoagulation market. The product's formulation—2,000 units in 0.9% sodium chloride—favors stability, compatibility, and ease of administration, cementing its widespread utilization.

The global anticoagulant market is projected to grow at a CAGR of approximately 7-8% over the next five years, driven by the rising incidence of cardiovascular diseases (CVD), expanding geriatric populations, and increasing adoption of invasive procedures necessitating anticoagulation therapy [1].

Market Drivers

Rising Prevalence of Cardiovascular Disorders

According to the World Health Organization (WHO), CVD remains the leading cause of death worldwide, accounting for an estimated 17.9 million fatalities annually. This surge directly correlates with increased demand for anticoagulants like heparin [2].

Growth in Surgical and Diagnostic Procedures

As minimally invasive and complex surgeries rise globally, the need for intraoperative anticoagulants to prevent thrombotic events increases. Cardiac, orthopedic, and vascular surgeries significantly contribute to heparin consumption.

Expanding Healthcare Infrastructure

Emerging markets are investing heavily in healthcare facilities, expanding access to intravenous medications such as heparin. Urbanization, increased healthcare expenditure, and government initiatives accelerate market penetration.

Advancements in Formulation and Packaging

The transition to user-friendly plastic containers improves safety, reduces contamination risks, and aligns with regulatory expectations, increasing clinical adoption rates.

Regulatory Approvals and Guidelines

Reinforced clinical guidelines and approval by agencies such as the FDA and EMA for various indications stimulate physician confidence and prescription rates. Continuous updates in dosing protocols favor standardized pharmaceutical products.

Market Challenges and Restraints

Availability of Alternatives

The emergence of low-molecular-weight heparins (LMWHs) and novel oral anticoagulants (NOACs) offer simplified dosing, reduced monitoring, and fewer bleeding complications, posing a competitive threat [3].

Price Sensitivity and Market Saturation

Generic versions and price competition constrain profit margins, especially in price-sensitive markets like India and Southeast Asia.

Regulatory Complexities

Regulatory hurdles related to manufacturing standards, stability profiles, and container closure systems can delay product launches or lead to increased compliance costs.

Safety and Side Effect Concerns

Heparin's risk for heparin-induced thrombocytopenia (HIT) necessitates careful monitoring and may limit its use in certain patient cohorts.

Competitive Landscape

The market is characterized by a mix of global pharma giants and regional manufacturers. Key players include:

  • Bristol-Myers Squibb/Johnson & Johnson
  • Pfizer Inc.
  • Baxter International
  • Novartis AG
  • Fresenius Kabi

Generic manufacturers dominate the segment, offering cost-effective options that intensify price competition.

Financial Trajectory and Market Forecast

Current Revenue Metrics

The global heparin market was valued at approximately USD 3 billion in 2022, with injectable forms like 2,000 units in saline representing a sizable portion. North America accounts for roughly 40% of revenues, driven by high surgical volumes and advanced healthcare infrastructure [4].

Projected Growth and Revenue Potential

Forecasted CAGR of 7-8% suggests that the market could reach USD 5.5-6 billion by 2028. The segment for Heparin Sodium 2,000 Units in Sodium Chloride is expected to grow proportionally, driven by:

  • Increased hospital admissions
  • Rising volume of surgeries
  • Regulatory approvals expanding indications

Pricing Trends

Unit prices are expected to decline in volume-driven markets due to generic proliferation but may stabilize or increase marginally in developed regions with stringent quality standards.

Impact of Biotechnological Innovations

Advancements in manufacturing and formulation processes promise cost reductions, while innovations in safe infusion systems could improve adoption and compliance.

Regulatory and Market Access Outlook

Stringent safety monitoring and pharmacovigilance are paramount. Countries such as the US, EU, and Japan enforce rigorous standards, impacting pricing and reimbursement strategies. Harmonization efforts and inclusion in essential medicines lists facilitate broader access.

Conclusion

The market for Heparin sodium 2,000 units in sodium chloride 0.9% in plastic containers is poised for sustained growth, undergirded by global healthcare demands and technological advancements. Competition from alternative anticoagulants remains a notable challenge; however, the proven efficacy, safety, and familiarity of heparin position it as a staple in anticoagulation therapy.

Key Takeaways

  • Growing Demand: The rising burden of CVD and procedural volumes underpin sustained demand growth.
  • Competitive Dynamics: Generics and low-cost manufacturers intensify price competition; innovation and quality standards are key differentiators.
  • Market Expansion Opportunities: Emerging markets, driven by healthcare infrastructure development, present expansive growth prospects.
  • Regulatory Considerations: Compliance with safety standards and active pharmacovigilance influence market access and profitability.
  • Future Trends: Shifts toward improved formulation, delivery systems, and combination therapies are likely to influence market share and revenue streams.

FAQs

  1. What factors influence the pricing of Heparin sodium in plastic containers?
    Pricing is influenced by manufacturing costs, competitive pressures from generics, regulatory compliance expenses, and regional market dynamics.

  2. How do alternative anticoagulants impact the Heparin market?
    Emerging alternatives like LMWHs and NOACs offer convenience and safety benefits, leading to potential shifts in prescribing patterns and market share.

  3. What are the key regulatory challenges faced by manufacturers?
    Manufacturers must adhere to strict quality standards, demonstrate stability and safety, and navigate complex approval processes across diverse jurisdictions.

  4. Which regions present the highest growth potential for Heparin sodium?
    Emerging markets in Asia-Pacific, Latin America, and Africa offer significant expansion opportunities due to increasing healthcare investments and population needs.

  5. How does technological innovation affect future market prospects?
    Advancements in formulation, packaging, and infusion systems can enhance safety, compliance, and usability, contributing to market growth.

References

  1. Global Market Insights. (2022). Anticoagulants Market Analysis.
  2. WHO. (2021). Cardiovascular Diseases Fact Sheet.
  3. Market Research Future. (2022). Injectable Anticoagulants Market Outlook.
  4. IQVIA. (2022). Global Pharmaceuticals Market Data.

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