FONDAPARINUX SODIUM - Generic Drug Details

What are the generic drug sources for fondaparinux sodium and what is the scope of patent protection?

Fondaparinux sodium is the generic ingredient in two branded drugs marketed by Mylan Ireland Ltd, Dr Reddys Labs Ltd, Eugia Pharma, Hangzhou Zhongmei, Hengrui Pharma, and Scinopharm Taiwan, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for fondaparinux sodium. Seven suppliers are listed for this compound.

Summary for FONDAPARINUX SODIUM

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	24
Patent Applications:	557
What excipients (inactive ingredients) are in FONDAPARINUX SODIUM?	FONDAPARINUX SODIUM excipients list
DailyMed Link:	FONDAPARINUX SODIUM at DailyMed

Recent Clinical Trials for FONDAPARINUX SODIUM

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

Sponsor	Phase
National Medical Research Center for Therapy and Preventive Medicine	Phase 4
Prairie Education and Research Cooperative	N/A
American College of Phlebology	N/A

See all FONDAPARINUX SODIUM clinical trials

Pharmacology for FONDAPARINUX SODIUM

Drug Class	Factor Xa Inhibitor
Mechanism of Action	Factor Xa Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FONDAPARINUX SODIUM

B01AX	Other antithrombotic agents
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

US Patents and Regulatory Information for FONDAPARINUX SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hangzhou Zhongmei	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	216493-003	Aug 19, 2024	AP	RX	No	No
Hangzhou Zhongmei	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	216493-002	Aug 19, 2024	AP	RX	No	No
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	021345-004	May 28, 2004	AP	RX	Yes	Yes
Scinopharm Taiwan	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	208615-001	Nov 14, 2018	AP	RX	No	No
Hangzhou Zhongmei	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	216493-001	Aug 19, 2024	AP	RX	No	No
Hengrui Pharma	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	206812-002	May 15, 2018	AP	RX	No	No
Dr Reddys Labs Ltd	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	091316-001	Jul 11, 2011	AP	RX	No	No

Expired US Patents for FONDAPARINUX SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	021345-001	Dec 7, 2001	4,818,816

EU/EMA Drug Approvals for FONDAPARINUX SODIUM

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan IRE Healthcare Limited	Arixtra	fondaparinux sodium	EMEA/H/C/000403 1.5-mg/0.3-ml and 2.5-mg/0.5-ml solution for injectionPrevention of venous thromboembolic events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery.Prevention of VTE in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery.Prevention of VTE in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and / or acute respiratory disorders, and / or acute infectious or inflammatory disease.Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.2.5-mg/0.5-ml solution for injectionTreatment of unstable angina or non-ST-segment-elevation myocardial infarction (UA/NSTEMI) in adult patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated.infarction (STEMI) in adult patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy.5-mg/0.4-ml, 7.5-mg/0.6-ml and 10-mg/0.8-ml solution for injectionTreatment of adults with acute deep-vein thrombosis (DVT) and treatment of acute pulmonary embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.	Authorised	no	no	no	2002-03-20
Glaxo Group Ltd.	Quixidar	fondaparinux sodium	EMEA/H/C/000404 1.5 mg/0.3 ml and 2.5 mg/0.5 ml, solution for injection:, Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery., Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1)., Prevention of Venous Thromboembolic Events (VTE) in medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease., , 2.5 mg/0.5 ml, solution for injection:, Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4.4 and 5.1)., Treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy., , 5 mg/0.4 ml, 7.5 mg/0.6 ml and 10 mg/0.8 ml solution for injection:, Treatment of acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.,	Withdrawn	no	no	no	2002-03-21

FONDAPARINUX SODIUM Market Analysis and Financial Projection Experimental

Fondaparinux Sodium Market Dynamics and Financial Trajectory

Introduction to Fondaparinux Sodium

Fondaparinux sodium is a synthetic anticoagulant used primarily for the prevention and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as for managing non-ST elevation acute coronary syndromes. Here, we delve into the market dynamics and financial trajectory of this crucial medication.

Market Size and Growth Projections

The global fondaparinux market is anticipated to experience significant growth over the coming years. By 2030, the market is projected to reach USD 965.91 million, growing at a CAGR of 6.7% from its base year value of USD 574.94 million[3].

Key Drivers of Market Growth

Several factors are driving the growth of the fondaparinux market:

Impact of COVID-19 Pandemic

The COVID-19 pandemic significantly increased the demand for anticoagulants like fondaparinux due to the high prevalence of thrombosis among COVID-19 patients, especially those in intensive care units (ICUs). Studies have shown that the prevalence of thrombosis in COVID-19 patients was 22% and increased to 43% after ICU admission[1][4].

Growing Geriatric Population

The increasing geriatric population is a major driver. By 2050, one in six people worldwide is expected to be aged above 65 years, a demographic more susceptible to chronic illnesses such as cardiovascular diseases[3][4].

Rising Prevalence of Cardiovascular Diseases

Cardiovascular diseases are on the rise globally. For instance, in the UK, there are about 7.6 million people with heart and circulatory disorders, a number expected to increase with an aging population[4].

Research and Development Activities

Ongoing research and development activities aimed at broadening the applications of fondaparinux are expected to propel market growth. Studies have shown that fondaparinux sodium may have a higher rate of successful thromboprophylaxis compared to low molecular weight heparin in certain patient groups[1][4].

Market Segmentation

The fondaparinux market is segmented based on several criteria:

Product Type

The market is divided into branded and generic segments. Generic versions of fondaparinux have dominated the market since the patent expiry of the branded drug Arixtra in 2002. Companies like Dr. Reddy’s Laboratories, Apotex, and Mylan N.V. have introduced generic versions, driving market growth[2][3].

Route of Administration

Fondaparinux is administered subcutaneously, which is a key factor in its use for preventing DVT and PE[2].

End-Users

The primary end-users include hospitals, specialty clinics, and other healthcare facilities. The increasing number of surgeries and hospitalizations due to cardiovascular diseases and other conditions is driving demand in these segments[3].

Geographical Distribution

North America holds a significant market share due to the high prevalence of thrombosis, increasing geriatric population, and proactive approaches in product approvals and research funding. Asia Pacific, particularly China, is also expected to grow rapidly due to its large population base and increasing healthcare expenditure[2][4].

Financial Trajectory

Current Market Size

As of the latest forecasts, the fondaparinux market is valued at USD 574.94 million and is expected to reach USD 965.91 million by 2030[3].

Revenue Growth

The market is projected to grow at a CAGR of 6.7% during the forecast period from 2023 to 2030. This growth is driven by the increasing demand for anticoagulants, the rise in generic versions, and expanding research and development activities[3].

Cost-Effectiveness

Fondaparinux sodium has been shown to be cost-effective compared to other anticoagulants like enoxaparin. For instance, it can save up to USD 155 per patient over a 5-year period[5].

Key Players and Market Competition

The fondaparinux market is moderately competitive with major players such as Dr. Reddy’s Laboratories Ltd., Aurobindo Pharma Ltd, GSK plc, Viatris, Inc., and Jiangsu Hengrui Pharmaceuticals Co., Ltd. These companies are engaging in strategic alliances, mergers, and acquisitions to strengthen their global presence[1][2].

Challenges and Limitations

Despite the positive growth prospects, the market faces some challenges:

Lack of Awareness

A lack of awareness among people regarding venous thromboembolism (VTE) conditions may hinder market growth. Educational initiatives by government and non-government organizations are crucial to address this issue[1][4].

Regulatory Framework

The approval process for generic versions of fondaparinux can be complex and time-consuming. For example, the Government of Canada's Generic Submissions Under Review (GSUR) list includes fondaparinux, indicating ongoing regulatory activities[4].

Regional Outlook

North America

North America is expected to hold a significant market share due to the increasing burden of cardiovascular diseases and proactive approaches in product approvals and research funding[2][4].

Asia Pacific

The Asia Pacific region, particularly China, is expected to grow rapidly due to its large population base, increasing healthcare expenditure, and the presence of local active pharmaceutical ingredients manufacturers and contract research organizations[2][3].

Key Takeaways

• The fondaparinux market is driven by the COVID-19 pandemic's impact on thrombosis prevalence, the growing geriatric population, and rising cardiovascular diseases.
• Generic versions of fondaparinux dominate the market due to their cost-effectiveness and bioequivalence to branded products.
• North America and Asia Pacific are key regions driving market growth.
• Ongoing research and development activities are expected to broaden the applications of fondaparinux.
• The market faces challenges such as lack of awareness about VTE conditions and complex regulatory frameworks.

FAQs

What is the current market size of the fondaparinux market?

The fondaparinux market is valued at USD 574.94 million as of the base year and is expected to reach USD 965.91 million by 2030[3].

Who are the key players in the fondaparinux market?

Key players include Dr. Reddy’s Laboratories Ltd., Aurobindo Pharma Ltd, GSK plc, Viatris, Inc., and Jiangsu Hengrui Pharmaceuticals Co., Ltd[1][2].

What are the primary drivers of the fondaparinux market growth?

The primary drivers include the COVID-19 pandemic's impact, the growing geriatric population, rising prevalence of cardiovascular diseases, and increasing research and development activities[1][3][4].

What is the expected CAGR of the fondaparinux market?

The fondaparinux market is expected to grow at a CAGR of 6.7% during the forecast period from 2023 to 2030[3].

How does fondaparinux compare to other anticoagulants in terms of cost-effectiveness?

Fondaparinux sodium has been shown to be cost-effective compared to enoxaparin, with potential savings of up to USD 155 per patient over a 5-year period[5].

Cited Sources:

1. Mordor Intelligence: Fondaparinux Market Size | Mordor Intelligence
2. PR Newswire: Fondaparinux Market Size To Reach $686.3 Million By 2024
3. Data Bridge Market Research: Global Fondaparinux Market – Industry Trends and Forecast to 2030
4. Mordor Intelligence: Fondaparinux Market Size & Share Analysis - Mordor Intelligence
5. PubMed: A cost-effectiveness analysis of fondaparinux sodium compared with enoxaparin sodium for prophylaxis against venous thromboembolism in patients undergoing major orthopaedic surgery.