See the DrugPatentWatch profile for fondaparinux
The NDC code 64757-004-01 refers to fondaparinux sodium, an anticoagulant medication [1]. It is available in a 2.5 mg/0.5 mL injection [1]. Fondaparinux sodium is used to prevent blood clots in individuals who have had hip fracture surgery or abdominal surgery, and also to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) [2].
What is Fondaparinux Sodium?
Fondaparinux sodium is a synthetic pentasaccharide that selectively inhibits Factor Xa, a key enzyme in the blood clotting cascade [3]. This selective inhibition helps to prevent the formation of thrombin, thereby reducing the risk of blood clot development [3]. It is administered subcutaneously [2].
How does Fondaparinux Sodium work?
Fondaparinux sodium works by binding to antithrombin III [3]. This binding significantly enhances antithrombin III's ability to inhibit Factor Xa [3]. By blocking Factor Xa, fondaparinux sodium disrupts the coagulation pathway, preventing fibrin formation and clot propagation [3].
When does Fondaparinux Sodium's Patent Expire?
The patent protection for fondaparinux sodium has expired, allowing for the development and marketing of generic versions [4]. Information on specific patent expiry dates for the original innovator product can be found on resources like DrugPatentWatch.com [4]. The availability of generics typically leads to lower prices for the medication.
Who makes Fondaparinux Sodium?
While the original innovator product was developed by certain pharmaceutical companies, generic versions of fondaparinux sodium are now manufactured by various pharmaceutical companies [4]. Specific manufacturers can be identified by consulting drug databases and regulatory listings.
What are the Risks and Side Effects of Fondaparinux Sodium?
The primary risk associated with fondaparinux sodium, like other anticoagulants, is bleeding [2]. Other potential side effects can include anemia, dizziness, nausea, and headache [2]. Patients using fondaparinux sodium should be monitored for signs of bleeding and advised to report any unusual bruising or bleeding to their healthcare provider [2].
Can Biosimilars enter before patent expiry for Fondaparinux Sodium?
Fondaparinux sodium is a small molecule drug, not a biologic, so the concept of biosimilars does not directly apply. Generic versions, which are chemically identical to the original drug, are what become available after patent expiry [4].