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, Brightgene, Dr Reddys Labs Ltd, Eugia Pharma, Hangzhou Zhongmei, Hengrui Pharma, and Scinopharm Taiwan, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for FONDAPARINUX SODIUM

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	25
Patent Applications:	5,840
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
Hospital of Southern Jutland	PHASE4
University of Aarhus	PHASE4
Aalborg University Hospital	PHASE4

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
Eugia Pharma	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	206918-004	Dec 26, 2017	AP	RX	No	No
Hangzhou Zhongmei	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	216493-002	Aug 19, 2024		DISCN	No	No
Scinopharm Taiwan	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	208615-003	Nov 14, 2018	AP	RX	No	No
Eugia Pharma	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	206918-002	Dec 26, 2017	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

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/0004031.5-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/0004041.5 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

Market Dynamics and Financial Trajectory for FONDAPARINUX SODIUM

Last updated: July 27, 2025

Introduction

Fondaparinux sodium, a synthetic pentasaccharide anticoagulant, has cemented its role in preventing and treating thromboembolic events. Its unique mechanism—selective factor Xa inhibition—has positioned it as a preferred alternative to traditional anticoagulants like heparin and warfarin in various clinical settings. As the landscape of anticoagulant therapy evolves, understanding the market dynamics and financial prospects of fondaparinux sodium becomes essential for pharmaceutical stakeholders, healthcare providers, and investors.

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Pharmacological Profile and Clinical Applications

Fondaparinux sodium, marketed under brands such as Arixtra, was developed by specialized glycosaminoglycan synthesis, offering advantages like predictable pharmacokinetics, reduced monitoring requirements, and lower bleeding risks compared to unfractionated heparin. It is approved for various indications:

• Venous Thromboembolism (VTE) prevention post-orthopedic and general surgeries.
• Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) treatment.
• Reduced risk of ischemic complications in unstable angina or non-ST elevation myocardial infarction (NSTEMI).

Its expanding clinical utility, supported by multiple guidelines, drives sustained demand momentum in hospital settings globally.

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Market Dynamics

Competitive Landscape

Fondaparinux faces competition from newer oral anticoagulants—Direct Oral Anticoagulants (DOACs) such as apixaban, rivaroxaban, and dabigatran—which offer convenience through oral administration and do not require parenteral delivery or routine monitoring. Nonetheless, fondaparinux retains significant market share due to its proven efficacy, safety profile, and specific clinical niches.

Regulatory Approvals and Off-Label Uses

While initially approved for specific indications, ongoing clinical trials and real-world evidence have expanded its off-label use in complex cases, reinforcing market penetration. Regulatory agencies in major markets like the US, EU, and emerging economies continuously review its safety and efficacy data, potentially paving new approval pathways for expanded indications.

Market Drivers

• Rise in aging population and chronic cardiovascular conditions heighten anticoagulant therapy utilization.
• Growing surgical volumes, particularly in orthopedics and cardiovascular procedures, escalate prophylactic use.
• Increasing awareness and adherence to clinical guidelines supporting fondaparinux use.
• Healthcare infrastructure development in emerging markets enhances access.

Market Challenges

• Competition from DOACs that are easier to administer.
• Cost considerations, particularly in lower-income regions where the higher price point of fondaparinux may limit usage.
• Economic impact of biosimilars and generics once patents expire, potentially decreasing prices and margins.
• Safety concerns, such as bleeding risks, though lower than traditional anticoagulants, still influence prescribing behaviors.

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Financial Trajectory

Revenue Analysis

Global sales of fondaparinux have demonstrated steady growth over the past decade, bolstered by expanding indications and procedural applications. According to market research, the global fondaparinux market was valued at approximately USD 1.2 billion in 2022, with an annual growth rate (CAGR) projected around 7-8% through 2028.

Market Segmentation

• Geographic distribution: North America remains the largest market, driven by high healthcare expenditure and advanced medical infrastructure. Europe follows, with Asia-Pacific exhibiting the fastest growth due to increasing healthcare investments and aging populations.

• Indication-based segmentation: VTE prophylaxis remains the primary revenue driver, with expanding use in cardiology and post-surgical care supporting incremental growth.

Pricing Trends

Pricing strategies are influenced by regional factors, reimbursement policies, and competitive pressures. While in higher-income markets, fondaparinux commands premium pricing, cost-containment pressures in emerging markets may influence discounts and tender-based purchases.

R&D and Pipeline Opportunities

Investments in clinical trials exploring new indications—such as stroke prevention or cancer-associated thrombosis—could significantly impact future revenue streams. Collaborations with biotech firms and academic institutions are underway to expand the drug's therapeutic scope.

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Regulatory and Patent Landscape

The original patent for fondaparinux expired or is nearing expiration in multiple jurisdictions, paving the way for biosimilars and generics, which could disrupt revenue streams but also expand market access. Regulatory bodies are evaluating label extensions based on new clinical evidence, and approvals in emerging markets could drive significant volume growth.

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Future Outlook

The financial trajectory of fondaparinux sodium is poised for moderate growth, driven by demographic trends, clinical adoption, and geographic expansion. However, the increasing competition from oral anticoagulants necessitates continuous differentiation through clinical data and tailored therapeutic strategies.

Key factors influencing future revenue include:

• Market penetration in emerging economies.
• Regulatory approvals for new indications.
• Development and commercialization of biosimilars and formulations.
• Advances in personalized medicine, potentially optimizing patient-specific therapy protocols.

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Key Market Segments and Investment Opportunities

1. Emerging Markets: Rapidly expanding healthcare infrastructure and rising procedural volumes make regions like Asia-Pacific highly attractive for growth.
2. Biotech Collaborations: Partnerships targeting new indications or formulations can diversify revenue streams.
3. Biosimilar Development: Strategic investments in biosimilars can offer near-term revenue opportunities post-patent expiry.
4. Digital Health Integration: Incorporation of monitoring tools to optimize anticoagulation management enhances clinical outcomes and marketability.

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Risks and Considerations

• Market saturation in mature economies may temper growth.
• Pricing pressures and reimbursement challenges could impact margins.
• Clinical competition from emerging oral anticoagulants continues to shape prescribing habits.
• Regulatory hurdles for new indications and biosimilar approval processes may delay market entry.

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Conclusion

Fondaparinux sodium maintains a resilient position within the anticoagulant market, driven by its clinical profile and specific niche applications. While faced with emerging oral alternatives and market pressures, strategic expansion into emerging markets, clinical innovation, and biosimilar proliferation support a cautiously optimistic financial outlook. Stakeholders should monitor regulatory trends and technological innovations that may redefine competitive dynamics in the coming years.

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Key Takeaways

• Steady Growth: The global fondaparinux market experienced consistent expansion, with a CAGR of approximately 7-8%, driven by procedural demand and demographic shifts.
• Competitive Positioning: Despite competition from DOACs, fondaparinux’s unique advantages sustain its relevance in hospital settings.
• Emerging Markets: Rapid infrastructural development and aging populations promote growth in Asia-Pacific and Latin America.
• Patent and Biosimilars: Patent expirations open opportunities for biosimilar entrants, impacting pricing and market share.
• Innovation Opportunities: Clinical trials exploring new indications and combination therapies may unlock future revenue streams.

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FAQs

1. How does fondaparinux sodium compare to other anticoagulants in clinical efficacy?
Fondaparinux offers comparable or superior efficacy in VTE prophylaxis and treatment with a favorable bleeding profile, particularly in certain patient populations, due to its selective factor Xa inhibition.

2. What are the primary markets driving fondaparinux sales?
North America and Europe dominate, but Asia-Pacific is emerging rapidly due to expanding healthcare infrastructure and aging demographics.

3. How will patent expiries impact the market for fondaparinux sodium?
Expiry of patents is likely to lead to biosimilar and generic competition, reducing prices and increasing access, especially in cost-sensitive markets.

4. What are potential opportunities for pharmaceutical companies in this space?
Developing biosimilars, expanding indications through clinical trials, and integrating digital health solutions can maximize market penetration and revenue.

5. What challenges could hinder the growth of fondaparinux?
Competition from oral anticoagulants, cost constraints, regulatory hurdles, and clinical safety concerns could limit expanded adoption.

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References

[1] MarketWatch. "Global Fondaparinux Market Size and Forecast," 2022.
[2] IQVIA. "Anticoagulant Market Trends," 2022.
[3] FDA. "Clinical Approvals and Label Extensions," 2023.
[4] European Medicines Agency (EMA). "Market Authorization for Fondaparinux," 2023.
[5] GlobalData Healthcare. "Pipeline Analysis of Anticoagulant Drugs," 2023.