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 |
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 |
Pharmacology for FONDAPARINUX SODIUM
| Drug Class | Factor Xa Inhibitor |
| Mechanism of Action | Factor 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 | |||
| Eugia Pharma | FONDAPARINUX SODIUM | fondaparinux sodium | INJECTABLE;SUBCUTANEOUS | 206918-004 | Dec 26, 2017 | 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 |
