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Last Updated: May 21, 2024

ARIXTRA Drug Patent Profile


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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 11th, 2011.

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Drug patent expirations by year for ARIXTRA
Drug Prices for ARIXTRA

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Recent Clinical Trials for ARIXTRA

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

SponsorPhase
Weill Medical College of Cornell UniversityPhase 4
University of MilanPhase 2
Fondazione "Un Cuore per Milano" - a no profit foundationPhase 2

See all ARIXTRA clinical trials

Pharmacology for ARIXTRA
Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Ireland Ltd ARIXTRA fondaparinux sodium INJECTABLE;SUBCUTANEOUS 021345-004 May 28, 2004 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Ireland Ltd ARIXTRA fondaparinux sodium INJECTABLE;SUBCUTANEOUS 021345-002 May 28, 2004 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Ireland Ltd ARIXTRA fondaparinux sodium INJECTABLE;SUBCUTANEOUS 021345-003 May 28, 2004 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ARIXTRA

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

Country Patent Number Title Estimated Expiration
France 2521566 ⤷  Try a Trial
New Zealand 212094 ACID MUCOPOLYSACCHARIDES AND PHARMACEUTICAL COMPOSITIONS ⤷  Try a Trial
Japan H0565517 ⤷  Try a Trial
Netherlands 300093 ⤷  Try a Trial
Australia 581167 ⤷  Try a Trial
Japan H05262783 ⤷  Try a Trial
Australia 558472 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARIXTRA

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

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