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
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	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

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
Luxembourg	90928
Canada	1263381	DISACCHARIDES FORMES DE MOTIFS A STRUCTURE GLUCOSAMINE ET ACIDE URONIQUE, LEUR PREPARATION ET LEUR APPLICATIONS BIOLOGIQUES (DISACCHARIDES BASED ON GLUCOSAMINE AND URONIC ACID STRUCTURAL UNITS; PREPARATION THEREOF AND BIOLOGICAL APPLICATIONS USING THE SAME)
Germany	3272110
Ireland	832525
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)
Japan	S59501906
New Zealand	212094	ACID MUCOPOLYSACCHARIDES AND PHARMACEUTICAL COMPOSITIONS

Supplementary Protection Certificates for ARIXTRA

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