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Last Updated: November 2, 2024

FONDAPARINUX SODIUM Drug Patent Profile


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Which patents cover Fondaparinux Sodium, and when can generic versions of Fondaparinux Sodium launch?

Fondaparinux Sodium is a drug marketed by Dr Reddys Labs Ltd, Eugia Pharma, Hangzhou Zhongmei, Hengrui Pharma, and Scinopharm Taiwan. and is included in five NDAs.

The generic ingredient in FONDAPARINUX SODIUM 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 Fondaparinux Sodium

A generic version of FONDAPARINUX SODIUM was approved as fondaparinux sodium by DR REDDYS LABS LTD on July 11th, 2011.

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Summary for FONDAPARINUX SODIUM
US Patents:0
Applicants:5
NDAs:5
Finished Product Suppliers / Packagers: 6
Raw Ingredient (Bulk) Api Vendors: 48
Clinical Trials: 24
Patent Applications: 296
What excipients (inactive ingredients) are in FONDAPARINUX SODIUM?FONDAPARINUX SODIUM excipients list
DailyMed Link:FONDAPARINUX SODIUM at DailyMed
Drug patent expirations by year 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 ActionFactor Xa Inhibitors
Anatomical Therapeutic Chemical (ATC) Classes for FONDAPARINUX SODIUM

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
Dr Reddys Labs Ltd FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 091316-001 Jul 11, 2011 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Scinopharm Taiwan FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 208615-002 Nov 14, 2018 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 206918-003 Dec 26, 2017 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Ltd FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 091316-004 Jul 11, 2011 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hangzhou Zhongmei FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 216493-004 Aug 19, 2024 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Scinopharm Taiwan FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 208615-004 Nov 14, 2018 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 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

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