Vascepa is a prescription medication that contains the active ingredient eicosapentaenoic acid (EPA) and is used to lower high levels of triglycerides in adults. According to Drug Patent Watch [1], Vascepa was first approved by the FDA in 2012 and has been protected by patents that have prevented generic competition. However, in December 2019, the FDA approved the first generic version of Vascepa, which is expected to be significantly cheaper than the brand name product [2].

The generic version of Vascepa, which is made by Dr. Reddy's Laboratories, was approved based on bioequivalence studies that demonstrated it is as safe and effective as the brand name product [2]. The generic version contains the same active ingredient, dosage form, and strength as Vascepa, and it is expected to be priced significantly lower than the brand name product [2].

A study published in Open Heart [3] evaluated the efficacy of EPA-only therapy in reducing cardiovascular events. The study concluded that EPA-only therapy significantly reduced the risk of major cardiovascular events, including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and unstable angina requiring hospitalization, compared to placebo. However, the study did not compare the efficacy of Vascepa to generic versions of EPA-only therapy.

In conclusion, while Vascepa has been protected by patents preventing generic competition, the recent approval of a generic version of Vascepa is expected to provide a cheaper alternative that is equally safe and effective. A study has shown that EPA-only therapy, which is the active ingredient in Vascepa, is effective in reducing the risk of major cardiovascular events. However, further studies are needed to directly compare the efficacy of Vascepa to generic versions of EPA-only therapy.

Sources:
[1] https://www.drugpatentwatch.com/p/tradename/VASCEPA
[2] https://endpts.com/fda-approves-the-first-generic-for-amarins-vascepa-but-is-a-launch-imminent/
[3] https://openheart.bmj.com/content/8/1/e001616