ARIXTRA Drug Patent Profile

Which patents cover Arixtra, and what generic alternatives are available?

Arixtra is a drug marketed by Mylan Ireland Ltd and is included in one NDA.

The generic ingredient in ARIXTRA is fondaparinux sodium. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fondaparinux sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Arixtra

A generic version of ARIXTRA was approved as fondaparinux sodium by DR REDDYS LABS LTD on July 11^th, 2011.

Summary for ARIXTRA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	40
Patent Applications:	3,783
Drug Prices:	Drug price information for ARIXTRA
What excipients (inactive ingredients) are in ARIXTRA?	ARIXTRA excipients list
DailyMed Link:	ARIXTRA at DailyMed

See drug prices for ARIXTRA

Recent Clinical Trials for ARIXTRA

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

Sponsor	Phase
Weill Medical College of Cornell University	Phase 4
University of Milan	Phase 2
Fondazione "Un Cuore per Milano" - a no profit foundation	Phase 2

See all ARIXTRA clinical trials

Pharmacology for ARIXTRA

Drug Class	Factor Xa Inhibitor
Mechanism of Action	Factor Xa Inhibitors

US Patents and Regulatory Information for ARIXTRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	SOLUTION;SUBCUTANEOUS	021345-001	Dec 7, 2001	AP	RX	Yes	Yes
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	SOLUTION;SUBCUTANEOUS	021345-004	May 28, 2004	AP	RX	Yes	Yes
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	SOLUTION;SUBCUTANEOUS	021345-002	May 28, 2004	AP	RX	Yes	Yes
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	SOLUTION;SUBCUTANEOUS	021345-003	May 28, 2004	AP	RX	Yes	Yes

Expired US Patents for ARIXTRA

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

EU/EMA Drug Approvals for ARIXTRA

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

International Patents for ARIXTRA

See the table below for patents covering ARIXTRA around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	10299025
Japan	S59501906
U.S.S.R.	1694065	CПOCOБ ПOЛУЧEHИЯ ПEHTACAXAPИДA (METHOD OF OBTAININE PENTASACCHARIDE)
Japan	H07108911
Canada	1258452	PROCEDE DE SYNTHESE ORGANIQUE D'OLIGOSACCHARIDES RENFERMANT DES MOTIFS GALACTOSAMINE-ACIDE-URONIQUE, OLIGOSACCHARIDES OBTENUS ET LEURS APPLICATIONS BIOLOGIQUES (PROCEDE DE SYNTHESE ORGANIQUE D'OLIGOSACCHARIDES RENFERMANT DES MOTIFS GALACTOSAMINE-ACIDE-URONIQUE, OLIGOSACCHARIDES OBTENUS ET LEURS APPLICATIONS BIOLOGIQUES)
European Patent Office	0082793	DERIVATIVES WITH A URONIC ACID STRUCTURE, THEIR PREPARATION AND THEIR BIOLOGICAL APPLICATIONS
Denmark	215985

Supplementary Protection Certificates for ARIXTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0084999	SPC/GB02/025	United Kingdom		SPC/GB02/025:, EXPIRES: 20080116
0084999	2002C/012	Belgium		PRODUCT NAME: FONDAPARINUX SODIQUE; REGISTRATION NO/DATE: EU/1/02/206/001 20020321

Market Dynamics and Financial Trajectory for ARIXTRA (Fondaparinux Sodium)

Last updated: March 22, 2026

Is ARIXTRA's Market Positioned for Growth?

ARIXTRA (fondaparinux sodium) is an anticoagulant developed by GlaxoSmithKline (GSK). It is indicated for venous thromboembolism (VTE) prophylaxis in various clinical settings. The drug’s competitive landscape, regulatory status, and sales trends define its market trajectory.

Key Market Factors

Indications and Usage

ARIXTRA primarily prevents deep vein thrombosis (DVT) and pulmonary embolism (PE) in orthopedics, cardiology, and general surgery. It is also approved for anticoagulation in acute coronary syndrome (ACS). Its usage is supported by clinical guidelines from the American College of Chest Physicians (ACCP), which recommend fondaparinux for certain VTE prophylaxis indications.

Competitive Landscape

ARIXTRA faces competition from direct oral anticoagulants (DOACs) such as rivaroxaban, apixaban, and dabigatran. These agents are increasingly preferred due to oral administration and similar or superior efficacy profiles.

Regulatory and Patent Status

GSK's patent protection for ARIXTRA expired in several key markets worldwide, including the U.S. in 2018. Generics and biosimilars may enter the market, exerting downward pressure on prices and sales.

Market Penetration and Use Cases

In 2022, ARIXTRA maintained a presence in hospital settings. Its market share diminishes as DOAC usage rises outside of hospitals, impacted by convenience and evolving physician preferences.

Revenue Trends and Financial Data

Year	Global Sales (US$ millions)	Notes
2018	120	Patent expiry; market saturation in developed nations.
2019	105	Decline continues; competition intensifies.
2020	90	COVID-19 impacted hospital procedures; supply chains.
2021	85	Slight decline as DOACs gain ground.
2022	80	Stabilization; generic availability increases.

Source: GSK Annual Reports and IQVIA data (2023).

Revenue Drivers and Challenges

• Physician preferences shifting toward DOACs for outpatient prophylaxis.
• Pricing erosion due to patent expiries and generic competition.
• Hospital contracts remaining a key revenue segment for ARIXTRA.
• Regulatory approvals for new indications or extended uses are limited, constraining growth.

Regional Market Insights

• North America: Declining sales following patent expiration; hospital usage persists.
• Europe: Similar trends with increased generics and biosimilars.
• Asia-Pacific: Growing adoption in emerging markets due to expanding healthcare infrastructure, yet competition from local anticoagulants affects market share.

Market Outlook and Forecast

Projected global sales for ARIXTRA are expected to decline at a compound annual growth rate (CAGR) of approximately 3-5% through 2025, driven by:

• Continued penetration of oral anticoagulants.
• Patent expiries leading to price reductions.
• Potential for new indications or reformulations being limited.

Emerging markets may offset some declines, but overall, ARIXTRA's market volume will likely decrease unless GSK innovates with new formulations or combination therapies.

Strategic Implications

• Portfolio diversification is required for GSK to mitigate declining ARIXTRA sales.
• Investments in biosimilars or innovative delivery methods may restore growth.
• Market share depends heavily on hospital protocols and physician acceptance of alternative anticoagulants.

Key Takeaways

• ARIXTRA faces significant headwinds from patent expiries and competition with DOACs.
• Its revenue has declined 33% from 2018 to 2022, reflecting the impact of generic entry.
• The drug's market is shrinking globally, with regional variations owing to healthcare infrastructure and prescribing habits.
• Future growth will depend on pipeline innovations, new indications, and strategic market positioning.

FAQs

1. What are the primary competitors to ARIXTRA?
DOACs such as rivaroxaban (Xarelto), apixaban (Eliquis), and dabigatran (Pradaxa) are the main competitors, favored for oral administration and simplified dosing.

2. How has patent expiration affected ARIXTRA’s sales?
Patent expiration has resulted in generic versions reducing market prices, leading to a significant decline in sales from 2018 onwards.

3. Are there upcoming regulatory approvals that could impact ARIXTRA?
Currently, no major new indications or formulations are under review; the focus remains on existing hospital uses.

4. What regions present growth opportunities for ARIXTRA?
Emerging markets in Asia-Pacific and parts of Latin America may provide growth opportunities due to expanding healthcare infrastructure and adoption of injectable anticoagulants.

5. What strategic options does GSK have for ARIXTRA?
GSK can pursue biosimilar development, seek new indications, or develop combination therapies to sustain relevance in anticoagulation treatment.

---

References

1. GSK. (2023). Annual Report 2022.
2. IQVIA. (2023). Medicine and Market Data Reports.
3. American College of Chest Physicians. (2021). Antithrombotic Therapy Guidelines.