See the DrugPatentWatch profile for vascepa

As of the information available up to the present date, there have been recent developments regarding Vascepa's (icosapent ethyl) speedier approval process. The US Food and Drug Administration (FDA) has approved Vascepa to prevent cardiovascular events in high-risk patients [1]. This approval was based on the Reduce-IT trial, a study that demonstrated a significant reduction in cardiovascular events for patients who took Vascepa [1].

The FDA's approval of Vascepa was expedited through the Priority Review designation, which is given to drugs that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions [1]. This designation allowed for a faster review process of Vascepa, leading to its recent approval [1].

It is important to note that the patent for Vascepa, owned by Amarin Corporation, has been the subject of legal disputes [2]. According to DrugPatentWatch.com, Amarin's patent for Vascepa expired in December 2020 [2]. However, Amarin has filed patent infringement lawsuits against generic manufacturers [2]. These legal disputes may affect the availability and pricing of Vascepa in the future [2].

In summary, the FDA has approved Vascepa for the prevention of cardiovascular events in high-risk patients through a speedier approval process. However, the patent for Vascepa has expired, and legal disputes may impact its availability and pricing in the future.

Sources:

1. FDA Approves New Indication for Vascepa to Reduce Cardiovascular Events in High-Risk Patients. (2019, December 13). U.S. Food and Drug Administration. <https://www.fda.gov/news-events/press-announcements/fda-approves-new-indication-vascepa-reduce-cardiovascular-events-high-risk-patients>.
2. Vascepa (icosapent ethyl) - Patent Expiration & Generics. (n.d.). DrugPatentWatch.com. <https://www.drugpatentwatch.com/drugs/vascepa>.