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. Seven 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:	63
Clinical Trials:	40
Patent Applications:	2,939
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
Fondazione "Un Cuore per Milano" - a no profit foundation	Phase 2
University of Milan	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	INJECTABLE;SUBCUTANEOUS	021345-001	Dec 7, 2001	AP	RX	Yes	Yes
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	021345-004	May 28, 2004	AP	RX	Yes	Yes
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	021345-002	May 28, 2004	AP	RX	Yes	Yes
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	INJECTABLE;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	INJECTABLE;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/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

International Patents for ARIXTRA

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

Country	Patent Number	Title	Estimated Expiration
Belgium	898096
New Zealand	212094	ACID MUCOPOLYSACCHARIDES AND PHARMACEUTICAL COMPOSITIONS
Japan	H0565517
France	2528854

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

ARIXTRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: ARIXTRA

Overview of ARIXTRA (Fondaparinux Sodium)

ARIXTRA, manufactured by the GSK group of companies, is a branded drug containing fondaparinux sodium, an anticoagulant used primarily to prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), especially during knee and hip replacement surgeries. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth Projections

The global fondaparinux market, dominated by ARIXTRA, is projected to reach USD 686.3 million by 2024. This growth is driven by several key factors, including the increasing geriatric population and the rising prevalence of thrombosis[1][3][4].

Patent Expiry and Generic Competition

The patent for fondaparinux expired in 2002, but due to the complexity of manufacturing the active molecule, generic competition was limited until 2011. Generic manufacturers such as Alchemia Ltd. and Apotex, Inc. received Abbreviated New Drug Application (ANDA) approvals in 2011, marking the beginning of significant generic competition[1][3][4].

Market Share and Dominance

As of 2015, generics and authorized generics of ARIXTRA dominated the market with a share of over 65%. This dominance is expected to continue as more generic versions enter the market. Companies like Dr. Reddy's, Apotex, Inc., and Mylan N.V. have been instrumental in driving this growth through their generic offerings[1][3][4].

Regional Market Dynamics

North America

North America held the largest market share in 2015, driven by an increasing geriatric population, rising prevalence of thrombosis, and the introduction of low-cost generics in the U.S. Awareness initiatives by government and non-government organizations for DVT and PE have also contributed to the market growth in this region[1][3][4].

China

China is expected to be a significant driver for the market due to its large population, rising disposable income, and increasing burden of chronic diseases. The presence of local active pharmaceutical ingredients manufacturers and contract research organizations has attracted foreign investments, leading to a projected Compound Annual Growth Rate (CAGR) of 21.2% until 2024[1][3][4].

Impact of Generic Drugs on Branded ARIXTRA

The introduction of generic drugs has significantly impacted the branded version of ARIXTRA. The branded drug is anticipated to witness a declining growth rate due to its high cost and the availability of low-cost generic alternatives. Despite this, ARIXTRA remains a key player in the market, albeit with diminishing market share[1][3][4].

Mergers and Acquisitions

The fondaparinux market is characterized by a series of mergers and acquisitions. For instance, GlaxoSmithKline divested its thrombosis brands, including ARIXTRA, to Aspen for £0.7 billion in 2013. This move was part of GSK's strategy to focus on products with higher growth potential[2].

In another significant move, Dr. Reddy's Laboratories Ltd. acquired the Intellectual Property Rights (IPRs) of fondaparinux sodium from Alchemia Ltd. for USD 17.5 million in July 2016. Mylan N.V. also purchased the branded and generic versions of fondaparinux sodium from Aspen Global, Inc. for USD 225 million in September 2014[3].

Financial Performance

The financial performance of companies involved in the fondaparinux market reflects the market dynamics. For example, Aspen's acquisition of thrombosis brands, including ARIXTRA, has been part of their broader strategy. However, the financial statements of Aspen indicate that while these acquisitions have contributed to their revenue, the overall financial performance can be volatile. In 2023, Aspen reported a decrease in consolidated earnings and headline earnings per share compared to the previous year[5].

Key Players

The fondaparinux market is dominated by a few key players, including Dr. Reddy's Laboratories, Inc., GSK group of companies, Mylan N.V., and Alchemia. These companies have been actively involved in manufacturing, marketing, and distributing both branded and generic versions of fondaparinux[1][3][4].

Conclusion

The market for ARIXTRA and its generic counterparts is driven by the need for effective anticoagulants, particularly in surgical settings. The introduction of generic drugs has significantly altered the market landscape, favoring low-cost alternatives over the branded version. As the market continues to grow, driven by demographic and healthcare trends, companies are likely to focus on strategic acquisitions and the development of generic versions to maintain their market presence.

Key Takeaways

• The global fondaparinux market is expected to reach USD 686.3 million by 2024.
• Generic versions dominate the market, with over 65% share as of 2015.
• North America and China are key regions driving market growth.
• Branded ARIXTRA faces declining growth due to high costs and generic competition.
• Mergers and acquisitions are common in this market, influencing financial trajectories.
• Key players include Dr. Reddy's Laboratories, GSK, Mylan N.V., and Alchemia.

FAQs

Q: What is the primary use of ARIXTRA (fondaparinux sodium)? A: ARIXTRA is primarily used to prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), especially during knee and hip replacement surgeries.

Q: When did the patent for fondaparinux expire? A: The patent for fondaparinux expired in 2002.

Q: Why was there a delay in generic competition for fondaparinux? A: The active molecule of fondaparinux is highly complex to manufacture, which delayed generic competition until 2011 when generic manufacturers received Abbreviated New Drug Application approvals.

Q: Which regions are driving the growth of the fondaparinux market? A: North America and China are the key regions driving the growth of the fondaparinux market.

Q: What is the impact of generic drugs on the branded version of ARIXTRA? A: The branded version of ARIXTRA is expected to witness a declining growth rate due to the high cost and the availability of low-cost generic alternatives.

Sources

1. PR Newswire - Fondaparinux Market Size To Reach $686.3 Million By 2024
2. GSK - GlaxoSmithKline reaches agreement with Aspen to divest thrombosis brands and related manufacturing site for £0.7 billion
3. PR Newswire - Fondaparinux Market Analysis by Product (Branded/Generic), and Segment Forecasts to 2024
4. Grand View Research - Fondaparinux Market Size To Reach $686.3 Million By 2024
5. Aspen Reports - Annual Financial Statements 2023