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Last Updated: April 24, 2025

SODIUM HEPARIN Drug Patent Profile


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When do Sodium Heparin patents expire, and when can generic versions of Sodium Heparin launch?

Sodium Heparin is a drug marketed by Abraxis Pharm and Baxter Hlthcare and is included in two NDAs.

The generic ingredient in SODIUM HEPARIN 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 Sodium Heparin

A generic version of SODIUM HEPARIN was approved as heparin sodium by HOSPIRA on April 28th, 1983.

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Summary for SODIUM HEPARIN
US Patents:0
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 2
Clinical Trials: 81
DailyMed Link:SODIUM HEPARIN at DailyMed
Drug patent expirations by year for SODIUM HEPARIN
Recent Clinical Trials for SODIUM HEPARIN

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

SponsorPhase
Prevail Infoworks, IncPhase 2
Vaneltix Pharma, Inc.Phase 2
First Affiliated Hospital Xi'an Jiaotong UniversityN/A

See all SODIUM HEPARIN clinical trials

US Patents and Regulatory Information for SODIUM HEPARIN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Abraxis Pharm SODIUM HEPARIN heparin sodium INJECTABLE;INJECTION 017033-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Abraxis Pharm SODIUM HEPARIN heparin sodium INJECTABLE;INJECTION 017033-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Baxter Hlthcare SODIUM HEPARIN heparin sodium INJECTABLE;INJECTION 017036-001 Mar 4, 1988 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 3 of 3 entries

Sodium Heparin Market Dynamics and Financial Trajectory

Market Overview

The sodium heparin market is poised for significant growth, driven by several key factors. Here is a comprehensive look at the market dynamics and financial trajectory of sodium heparin.

Market Size and Growth

  • The global heparin market, which includes sodium heparin, was valued at USD 7.56 billion in 2023 and is projected to grow at a CAGR of 2.7% from 2024 to 2030, reaching USD 9.03 billion by 2030[1].
  • Specifically, the heparin sodium market was valued at USD 5.76 billion in 2024 and is expected to reach USD 9.72 billion by 2031, growing at a CAGR of 4.2% during the forecast period[4].

Key Drivers

Increasing Prevalence of Chronic Diseases

  • The rising prevalence of chronic diseases, such as cardiovascular diseases (CVD), cancer, chronic respiratory diseases, and diabetes, is a major driver for the heparin sodium market. These diseases often require anticoagulant therapy, which heparin sodium provides[1][4].

Growing Demand for Anticoagulants

  • The increasing demand for anticoagulants in the prevention and treatment of thromboembolic events linked to cardiovascular disorders is driving the market growth. Heparin sodium is a commonly used anticoagulant in these scenarios[4].

Advancements 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, leading to improved patient outcomes and product quality[4].

Growing Healthcare Expenditure

  • Increasing healthcare spending, particularly in emerging nations, is making modern medical therapies like heparin sodium more accessible, supporting market expansion in these regions[4].

Regulatory Support

  • Strict guidelines and regulatory approvals for novel formulations and indications ensure the safety and quality of heparin sodium products, further aiding market growth[4].

Market Segments

By Type

  • The market is segmented into heparin sodium and heparin calcium, with heparin sodium being the dominant type due to its widespread use in anticoagulation therapy[2].

By Application

  • Heparin sodium is used in various applications, including anticoagulation therapy, medical devices, and biomaterials. Anticoagulation therapy remains the primary application, driven by the need to prevent and treat thromboembolic events[2].

By Geography

  • North America holds the largest market share, driven by rising patient awareness, high disease burden, proactive government measures, technological advancements, and improvements in healthcare infrastructure. The Asia Pacific region is also expected to grow significantly due to increasing healthcare infrastructure and economic development[1][3][4].

Financial Trajectory

Revenue Growth

  • The heparin sodium market is expected to see steady revenue growth, with the global market projected to reach USD 9.72 billion by 2031. This growth is supported by increasing demand and advancements in healthcare infrastructure[4].

Key Players

  • Major players in the heparin sodium market include Pfizer Inc., Sanofi, Dr. Reddy’s Laboratories Ltd., GlaxoSmithKline plc, and Fresenius SE & Co. KGaA. These companies are driving market growth through innovative products and strategic expansions[1][2].

Regional Performance

  • North America, led by the U.S., continues to dominate the market due to its high disease burden and advanced healthcare infrastructure. The Asia Pacific region, however, is expected to grow at the fastest rate due to its expanding healthcare sector and increasing prevalence of chronic diseases[1][3].

Challenges and Restraints

Safety Concerns

  • Safety concerns such as heparin-induced thrombocytopenia (HIT) and allergic responses can reduce the usage of heparin sodium, particularly in specific patient populations[4].

Price Volatility

  • Changes in the cost of raw materials, such as pig mucosa, can impact manufacturers’ profit margins and market pricing, creating volatility in the market[4].

Competition from Generic Manufacturers

  • The expiration of patents on some heparin sodium formulations has led to increased competition from generic manufacturers, which can limit the revenue potential for branded products and drive down prices[4].

End-Use Outlook

Inpatient and Outpatient Segments

  • The inpatient segment is expected to register significant growth due to advancements in wound healing equipment and effective insurance and reimbursement policies. This aligns with the healthcare landscape's focus on improved treatment outcomes and financial support[1].

Regional Insights

Asia Pacific Growth

  • The Asia Pacific region is anticipated to fuel the growth of the heparin market due to its continuously increasing healthcare infrastructure, economic development, and increasing private and public initiatives. The aging population and the availability of more patients with cardiovascular disorders are key factors contributing to this growth[3].

Key Takeaways

  • The heparin sodium market is driven by the increasing prevalence of chronic diseases, advancements in drug delivery and production, and growing healthcare expenditure.
  • North America dominates the market, but the Asia Pacific region is expected to grow rapidly.
  • Safety concerns, price volatility, and competition from generic manufacturers are key challenges.
  • The inpatient segment is expected to see significant growth due to advancements in healthcare infrastructure and financial support.

FAQs

What is the projected growth rate of the heparin sodium market from 2024 to 2031?

The heparin sodium market is expected to grow at a CAGR of 4.2% from 2024 to 2031[4].

Which region dominates the heparin sodium market?

North America currently dominates the heparin sodium market, driven by high disease burden and advanced healthcare infrastructure[1][4].

What are the primary applications of heparin sodium?

The primary applications of heparin sodium include anticoagulation therapy, medical devices, and biomaterials[2].

What are the key challenges facing the heparin sodium market?

Key challenges include safety concerns such as HIT and allergic responses, price volatility of raw materials, and competition from generic manufacturers[4].

Which companies are major players in the heparin sodium market?

Major players include Pfizer Inc., Sanofi, Dr. Reddy’s Laboratories Ltd., GlaxoSmithKline plc, and Fresenius SE & Co. KGaA[1][2].

Sources

  1. Grand View Research: Heparin Market Size, Share & Growth Analysis Report, 2030.
  2. Market Research Intellect: Heparin (Heparin Sodium and Heparin Calcium) Market Size, Scope.
  3. Maximize Market Research: Heparin Market - Dynamics, Impacts and Forecasts 2024-2030.
  4. Verified Market Research: In-Depth Industry Outlook: Heparin Sodium Market Size, Forecast.

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