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Last Updated: January 2, 2025

Tinzaparin sodium - Generic Drug Details


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What are the generic sources for tinzaparin sodium and what is the scope of freedom to operate?

Tinzaparin sodium is the generic ingredient in one branded drug marketed by Leo Pharma As and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for tinzaparin sodium.

Summary for tinzaparin sodium
Recent Clinical Trials for tinzaparin sodium

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

SponsorPhase
Imperial College LondonPhase 4
Michalis KaramouzisPhase 3
National Cancer Institute, FrancePhase 3

See all tinzaparin sodium clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for tinzaparin sodium

US Patents and Regulatory Information for tinzaparin sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leo Pharma As INNOHEP tinzaparin sodium INJECTABLE;INJECTION 020484-001 Jul 14, 2000 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Tinzaparin sodium Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Tinzaparin Sodium

Introduction to Tinzaparin Sodium

Tinzaparin sodium, marketed under the brand name Innohep, is a low molecular weight heparin (LMWH) used primarily for the treatment of deep vein thrombosis (DVT) and the prevention of postoperative venous thromboembolism, especially in patients undergoing orthopedic or general surgery[4][5].

Global Low Molecular Weight Heparin Market Overview

The global low molecular weight heparin market, which includes tinzaparin sodium, is projected to grow significantly. By 2024, the market is expected to reach USD 4.43 billion and is anticipated to grow at a CAGR of 6.60% to reach USD 6.10 billion by 2029[1].

Market Drivers

Several factors are driving the growth of the LMWH market, including:

Increased Prevalence of Blood Disorders Worldwide

The rising incidence of blood disorders such as deep vein thrombosis, pulmonary embolism, and acute coronary syndrome is a major driver. These conditions are more common in aging populations, and the global geriatric population is increasing[1].

Introduction of LMWH Anticoagulants

The introduction and widespread adoption of LMWHs like tinzaparin sodium have revolutionized anticoagulant therapy due to their efficacy, safety profile, and ease of administration compared to unfractionated heparin[1].

Market Restraints

Despite the growth, there are several restraints to consider:

Adverse Effects of Low Molecular Weight Heparin

Tinzaparin sodium, like other LMWHs, can cause adverse effects such as bleeding, bruising, and renal impairment, which can limit its use in certain patient populations. For instance, patients with severe renal impairment may experience a reduced clearance of tinzaparin sodium, increasing the risk of bleeding[2][4].

Competitive Landscape

The LMWH market is moderately competitive with several key players:

Major Players

Companies such as Aspen Holdings, Changzhou Qianhong Bio-Pharma, B. Braun Medical, Inc., Pfizer, Inc., and Dr. Reddy's Laboratories Limited are major players in the market. These companies are involved in the production and distribution of various LMWH products, including tinzaparin sodium[1].

Geographical Segmentation

The market is segmented geographically, with different regions showing varying growth rates:

North America: Largest Market

North America is expected to dominate the LMWH market due to the high prevalence of blood disorders, a growing geriatric population, and a high number of product approvals. For example, the United States has a significant population aged 65 and above, which is expected to increase from 17.3% in 2022 to 22% by 2040[1].

Asia-Pacific: Fastest Growing Region

The Asia-Pacific region is anticipated to be the fastest-growing market for LMWHs, driven by increasing healthcare expenditure, a growing elderly population, and improving healthcare infrastructure[1].

Product Type and Application Segmentation

The LMWH market is segmented by product type and application:

Product Type

Tinzaparin sodium is one of the key products in the LMWH market, alongside other products like enoxaparin, dalteparin, and fondaparinux. Each of these products has its own market share and growth trajectory[1].

Application

Tinzaparin sodium is primarily used for the treatment of deep vein thrombosis, acute coronary syndrome, and pulmonary embolism. Its use in these applications drives a significant portion of the market revenue[1].

Financial Trajectory

The financial trajectory of tinzaparin sodium, as part of the broader LMWH market, is positive:

Market Size and Growth

The global LMWH market, which includes tinzaparin sodium, is expected to grow from USD 4.43 billion in 2024 to USD 6.10 billion by 2029, at a CAGR of 6.60%. This growth is driven by increasing demand for anticoagulant therapies and the expanding use of LMWHs in various clinical settings[1].

Revenue Contribution

Tinzaparin sodium contributes a significant portion of the revenue within the LMWH market. Its efficacy, safety profile, and widespread adoption ensure a steady revenue stream for the manufacturers.

Porter's Five Forces Analysis

Understanding the competitive dynamics through Porter's Five Forces Analysis is crucial:

Threat of New Entrants

The threat of new entrants is moderate due to the presence of established players and the need for significant investment in research and development to enter the market[1].

Bargaining Power of Buyers/Consumers

The bargaining power of buyers is relatively low due to the specialized nature of the product and the limited number of alternatives available for certain conditions[1].

Bargaining Power of Suppliers

The bargaining power of suppliers is moderate, as the raw materials required for the production of LMWHs, such as porcine intestinal mucosa, are available from multiple sources[1].

Threat of Substitute Products

The threat of substitute products is low, as LMWHs like tinzaparin sodium have a unique profile that makes them preferred over other anticoagulants in many clinical scenarios[1].

Intensity of Competitive Rivalry

The intensity of competitive rivalry is high due to the presence of several major players and the ongoing competition for market share[1].

Key Takeaways

  • The global LMWH market, including tinzaparin sodium, is expected to grow significantly, reaching USD 6.10 billion by 2029.
  • North America dominates the market, while the Asia-Pacific region is the fastest-growing.
  • Tinzaparin sodium is used primarily for DVT, ACS, and pulmonary embolism.
  • The market is driven by the increasing prevalence of blood disorders and the introduction of LMWH anticoagulants.
  • Adverse effects and renal impairment are significant restraints.
  • The competitive landscape is moderately competitive with several key players.

FAQs

What is the current market size of the global Low Molecular Weight Heparin Market?

The global Low Molecular Weight Heparin Market size is expected to reach USD 4.43 billion in 2024[1].

Who are the major players in the Low Molecular Weight Heparin Market?

Major players include Aspen Holdings, Changzhou Qianhong Bio-Pharma, B. Braun Medical, Inc., Pfizer, Inc., and Dr. Reddy's Laboratories Limited[1].

What are the primary applications of tinzaparin sodium?

Tinzaparin sodium is primarily used for the treatment of deep vein thrombosis, acute coronary syndrome, and pulmonary embolism[4][5].

How does renal impairment affect the use of tinzaparin sodium?

Patients with renal impairment may experience reduced clearance of tinzaparin sodium, increasing the risk of bleeding. Severe renal impairment can result in a 24% reduction in tinzaparin sodium clearance[2][3].

What is the expected growth rate of the Low Molecular Weight Heparin Market?

The market is expected to grow at a CAGR of 6.60% from 2024 to 2029[1].

Cited Sources

  1. Global Low Molecular Weight Heparin Market Size & Share Analysis - Mordor Intelligence
  2. Innohep® Rx only - (tinzaparin sodium injection) - FDA
  3. Innohep® Rx only - (tinzaparin sodium injection) - FDA
  4. Tinzaparin (subcutaneous route) - Mayo Clinic
  5. Tinzaparin: Uses, Interactions, Mechanism of Action - DrugBank Online

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