How has vascepa affected you?

How long has Vascepa been on the market?

Vascepa is a prescription medication containing purified eicosapentaenoic acid, or EPA. It received FDA approval in 2012 for patients with very high triglycerides. In 2019, regulators expanded its indication to include patients with established cardiovascular disease or diabetes plus other risk factors.

When does Vascepa's patent expire?

Vascepa's primary patents cover the composition and use of icosapent ethyl and run through December 2030. Some patents are already under challenge in court. Companies such as Hikma Pharmaceuticals and Dr. Reddy's have filed abbreviated new drug applications seeking to launch generics sooner.

Why are companies challenging Vascepa's patents?

Hikma and Dr. Reddy's each claim the patents are invalid because they cover obvious subject matter or lack novelty. Courts have already ruled that several patents are invalid, but appeals are continuing. The auscultatory result of these lawsuits will determine whether generic versions can enter the market before 2030.

How does Vascepa compare to other omega-3 products?

Vascepa contains only EPA in ethyl-ester form. Most other over-the-counter omega-3 supplements contain both EPA and DHA. Studies in the REDUCE-IT trial showed cardiovascular benefit with Vascepa alone, while trials of EPA plus DHA mixtures have often failed to show benefit.