FONDAPARINUX SODIUM - Generic Drug Details

What are the generic drug 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, Dr Reddys Labs Ltd, Eugia Pharma, Hangzhou Zhongmei, Hengrui Pharma, and Scinopharm Taiwan, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for fondaparinux sodium. Seven suppliers are listed for this compound.

Summary for FONDAPARINUX SODIUM

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	24
Patent Applications:	557
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
National Medical Research Center for Therapy and Preventive Medicine	Phase 4
Prairie Education and Research Cooperative	N/A
American College of Phlebology	N/A

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
Hengrui Pharma	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	206812-002	May 15, 2018	AP	RX	No	No
Scinopharm Taiwan	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	208615-002	Nov 14, 2018	AP	RX	No	No
Hengrui Pharma	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	206812-001	May 15, 2018	AP	RX	No	No
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	021345-002	May 28, 2004	AP	RX	Yes	Yes
Dr Reddys Labs Ltd	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	091316-002	Jul 11, 2011	AP	RX	No	No
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	021345-003	May 28, 2004	AP	RX	Yes	Yes
Scinopharm Taiwan	FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	208615-003	Nov 14, 2018	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/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