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Last Updated: January 30, 2023

Fondaparinux sodium - Generic Drug Details


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Summary for fondaparinux sodium
Recent Clinical Trials for fondaparinux sodium

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

SponsorPhase
National Medical Research Center for Therapy and Preventive MedicinePhase 4
Prairie Education and Research CooperativeN/A
American College of PhlebologyN/A

See all fondaparinux sodium clinical trials

Pharmacology for fondaparinux sodium
Drug ClassFactor Xa Inhibitor
Mechanism of Action Factor Xa Inhibitors

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
Scinopharm Taiwan FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 208615-002 Nov 14, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hengrui Pharma FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 206812-001 May 15, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Ireland Ltd ARIXTRA fondaparinux sodium INJECTABLE;SUBCUTANEOUS 021345-003 May 28, 2004 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hengrui Pharma FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 206812-003 May 15, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hengrui Pharma FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 206812-004 May 15, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 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 injection, , Prevention 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 injection, , Treatment 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 injection, , Treatment 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

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