Fondaparinux sodium - Generic Drug Details

What are the generic 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
Viborg Regional Hospital	PHASE4
Horsens Hospital	PHASE4
Regional Hospital Gdstrup	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
Scinopharm Taiwan	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	208615-002	Nov 14, 2018	AP	RX	No	No
Brightgene	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	218312-001	Dec 18, 2024		DISCN	No	No
Eugia Pharma	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	206918-001	Dec 26, 2017	AP	RX	No	No
Dr Reddys Labs Ltd	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	091316-002	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

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: December 25, 2025

Executive Summary

Fondaparinux Sodium is a synthetic pentasaccharide anti-coagulant used predominantly for preventing and treating thromboembolic events. As a critical anticoagulant agent, it occupies a significant niche within thrombosis management, strengthening the portfolio of anticoagulant therapies alongside enoxaparin, rivaroxaban, and warfarin. This report synthesizes the current market landscape, key drivers, challenges, and future financial trajectories based on recent industry data, regulatory developments, and market trends.

Introduction

• Therapeutic Class: Anticoagulant, specifically a selective Factor Xa inhibitor.
• Market Status: Branded primarily under the trade name Arixtra (manufactured by GlaxoSmithKline), with biosimilar and generic developments emerging.
• Approval and Availability: Approved by multiple regulatory agencies, including the FDA (2004) and EMA (European Medicines Agency, 2003).

---

What Are the Market Dynamics Influencing Fondaparinux Sodium?

1. Therapeutic Demand and Clinical Adoption

Aspect	Details
Prevalence of Thromboembolic Disorders	Globally, venous thromboembolism (VTE) affects approximately 1-2 per 1,000 people annually, with higher risk in postoperative, cancer, and immobilized patients.
Clinical Guidelines	Favoring LMWH (Low Molecular Weight Heparins) and direct oral anticoagulants (DOACs); however, fondaparinux remains preferred in HIT (Heparin-Induced Thrombocytopenia) cases and for certain surgeries.
Market Penetration	Established in hospitals, especially for orthopedic, cardiology, and oncology indications, with expanding outpatient use.

Implication: Growing global VTE prevalence bolsters demand, sustained by clinical guideline endorsement, though competition from DOACs influences market share.

---

2. Regulatory Environment and Patent Landscape

Key Factor	Impact
Patent Status	Original patent expired in the U.S. (2012) and Europe (2011). Generics and biosimilars are initiating market entry.
Regulatory Barriers	Stringent regulatory requirements for biosimilar approvals (EMA, FDA), affecting entry timing and market expansion.
New Approvals and Indications	Additional approvals for specific patient populations (e.g., cancer-associated thrombosis) are expanding therapeutic scope.

Implication: Patent expiries open avenues for generics, intensifying price competition and impacting revenue streams.

---

3. Competitive Landscape

Competing Agents	Market Share (Estimated)	Notes
Enoxaparin (Lovenox)	~40-45%	Dominant LMWH with established clinician familiarity.
Rivaroxaban (Xarelto)	~20%	Oral direct Factor Xa inhibitor, increasing preference due to ease of use.
Dabigatran (Pradaxa)	~10-12%	Oral direct thrombin inhibitor.
Other LMWHs and Heparins	Remaining ~20-30%	Including dalteparin and bemiparin, with regional variations.
Biosimilars and Generics	Growing segment	Lead to price reductions; e.g., Sandoz’s biosimilar launched in 2021 in Europe.

Implication: Market share is consolidating, with oral agents gaining ground over injectable fondaparinux, but the latter retains niche advantages in specific settings.

---

4. Pricing Dynamics

Factor	Effect
Pricing of Original Brand	Premium due to brand recognition, formulation complexity.
Generic/Biosimilar Entry	Downward pressure on prices, estimated reduction of 30-50%.
Reimbursement Policies	Varying access; reimbursement restrictions in some regions constrain market growth.

Forecast: Price erosion expected to influence revenue trajectories, with generics/ biosimilars achieving 40-60% price reductions within five years post-patent expiry.

---

5. Manufacturing and Supply Chain Factors

Aspect	Influence
Manufacturing Complexity	Synthetic process requiring high purity standards; affects production costs.
Supply Chain Stability	Vulnerable to geopolitical and global health disruptions, potentially impacting availability.

Implication: Cost considerations influence pricing strategies and profit margins, especially for biosimilars.

---

Financial Trajectory Analysis

Current Revenue and Market Size

Metric	Data	Source
Global Market Size (2022)	USD 350-400 million	MarketWatch [1], Grand View Research [2]
Annual Growth Rate (CAGR)	4-6% over the next five years	IQVIA, Verified Markets Reports [3]
Leading Regions	North America (40%), Europe (30%), Asia-Pacific (20%), Rest of World (10)	IQVIA [4]

Projected Revenue Trends (2023-2028)

Year	Estimated Global Revenue (USD Million)	Notes
2023	370-410	Stable growth, pending generic entry
2024	390-440	Market expansion, new indications
2025	410-470	Biosimilar penetration increasing
2026	430-500	Price erosion from biosimilars
2027	440-520	Market saturation in developed regions
2028	450-550	Emerging markets uptake

Factors Influencing Financial Trajectory

Driver	Effect
Patent Expiry	Anticipated in 2023-2024 in key markets, leading to biosimilar competition.
Regulatory Approvals	Expansion into new indications enhances revenue streams.
Competitive Substitution	Shift toward oral anticoagulants may dampen injectable fondaparinux sales.
Healthcare Policies	Cost-containment measures and reimbursement decisions influence adoption rates.

Potential Revenue Risks

Risk Factor	Impact
Biosimilar market entry delay	Maintains high prices longer, boosting revenue temporarily.
Fast biosimilar adoption	Rapid price reductions may halve revenue in 3-5 years post-entry.
Regulatory hurdles in emerging markets	Slows global expansion, limiting revenue potential.

---

Comparison with Competitor Therapies

Therapy Type	Advantages	Disadvantages
Fondaparinux Sodium	High specificity, no HIT risk, renal clearance suitable for some patients	Injectable, costlier than oral agents, patent expiry leading to competition
LMWH (e.g., Enoxaparin)	Well-established, safety profile	Need for injection, potential HIT risk
Oral DOACs (e.g., Rivaroxaban)	Oral administration, convenient	Higher bleeding risk in certain populations, fewer reversal agents (though reversing agents are now available)
Warfarin	Cost-effective, long history of use	Monitoring required, food/drug interactions

---

Future Market Opportunities and Challenges

Opportunities

• Expanded Indications: Deep vein thrombosis (DVT), pulmonary embolism (PE), cancer-associated thrombosis.
• Emerging Markets: Expanding healthcare infrastructure and increasing VTE awareness.
• Biosimilar Adoption: Cost-effective alternatives speeding market expansion.
• Combination Therapy: Integration with other anticoagulants or thrombosis management protocols.

Challenges

• Pricing Pressure: Biosimilar competition reducing margins.
• Market Penetration of Oral Agents: Preference for oral anticoagulants may limit injectable schmarket growth.
• Regulatory Hurdles: Lingering approval delays in some regions.
• Clinical Practice Patterns: Variability influencing adoption rates.

---

Conclusion

Fondaparinux Sodium remains a key players in the anticoagulant segment, especially for specific patient populations. However, patent expiries, increased biosimilar activity, and the rising popularity of oral anticoagulants are reshaping its market dynamics. Its future financial trajectory will largely depend on patent strategies, regulatory approvals for new indications, competitive positioning, and regional market developments.

---

Key Takeaways

• The global market for Fondaparinux Sodium is currently estimated at USD 370-410 million (2022), with a CAGR of 4-6% projected over the next five years.
• Patent expiry in key regions (2012-2014) has paved the way for biosimilar entry, leading to intensified price competition.
• Major competitive threats include oral anticoagulants such as rivaroxaban, which are favored for their ease of use.
• Expanding indications and emerging markets present growth opportunities, while biosimilar price erosion remains a significant challenge.
• Strategic positioning, including innovation, expanding approvals, and biosimilar adoption, will be crucial for maximizing future revenue potential.

---

FAQs

1. What are the main therapeutic advantages of Fondaparinux Sodium over traditional heparins?
Fondaparinux offers high specificity for Factor Xa, no risk of HIT, subcutaneous administration, and predictable pharmacokinetics, reducing the need for routine monitoring.

2. How does the patent expiry impact the market for Fondaparinux Sodium?
Patent expiry allows generic and biosimilar manufacturers to enter the market, leading to price reductions, increased competition, and potential revenue decline for original manufacturers.

3. What is the outlook for biosimilar versions of Fondaparinux Sodium?
Biosimilars are expected to gain market share within 3-5 years of patent expiry, introducing cost competition but also opening markets in regions with pricing constraints.

4. Which regions hold the largest share of Fondaparinux Sodium sales?
North America and Europe dominate, with growing markets in Asia-Pacific driven by healthcare infrastructure expansion and rising VTE awareness.

5. Will oral anticoagulants fully replace injectable drugs like Fondaparinux?
While oral agents are increasingly preferred for their convenience, injectables like Fondaparinux retain importance in specific clinical scenarios, particularly when oral agents are contraindicated or unavailable.

---

References

[1] MarketWatch, "Worldwide Anticoagulants Market Size and Growth," 2022
[2] Grand View Research, "Market Insights: Anticoagulants," 2022
[3] IQVIA, "Global Pharmaceuticals Market Trends," 2022
[4] IQVIA, "Regional Market Share Data," 2022