Edoxaban?

Edoxaban Overview

Edoxaban is an oral anticoagulant medication, also known as a direct factor Xa inhibitor, used to prevent and treat blood clots. Developed by Daiichi Sankyo, it was first approved in Japan in 2011 and later in the United States in 2015 [1]. The U.S. Food and Drug Administration (FDA) approved Eliquis (edoxaban), a brand name for the medication, to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation (NVAF) patients.

How Long Does Exclusivity Last?

Edoxaban's U.S. patent expires in 2027 [2], giving the manufacturer exclusivity until then. However, according to DrugPatentWatch.com, a generic version of Eliquis has already been approved in some countries [3]. This suggests that generic versions may be available before the U.S. patent expires, potentially increasing competition and reducing healthcare costs.

What Side Effects Are Patients Asking About?

Common side effects associated with edoxaban include major bleeding, gastrointestinal bleeding, and an increased risk of stroke when used in patients with mechanical valves [4]. Patients should discuss their individual risks and benefits with their healthcare provider.

Can Biosimilars Enter Before Patent Expiry?

In the United States, the Biologics Price Competition and Innovation Act (BPCIA) of 2009 allows biosimilars (similar but not identical medications) to be approved and marketed before the original product's patent expires [5]. However, the availability of biosimilars for edoxaban is not yet confirmed.

When Does Patent Exclusivity Expire?

The U.S. patent for edoxaban expires in 2027, at which point generic versions of the medication may become available.

Sources

[1] Daiichi Sankyo. (n.d.). Eliquis (edoxaban) Product Information.

[2] DrugPatentWatch.com. (n.d.). Eliquis.

[3] DrugPatentWatch.com. (n.d.). Edoxaban Generic Entry Event.

[4] U.S. National Library of Medicine. (n.d.). Eliquis.

[5] U.S. Food and Drug Administration. (n.d.). Biosimilars.