Vascepa is a prescription drug used to reduce the risk of cardiovascular events in adults with elevated triglyceride levels. According to DrugPatentWatch [1], Vascepa is a brand-name drug that contains the active ingredient icosapent ethyl. It was first approved by the FDA in 2012 and is manufactured by Amarin Pharma Inc.
Recently, Amarin Pharma Inc. lost a patent appeal for Vascepa, which means that generic versions of the drug will be allowed to enter the market. As reported by FiercePharma [2], the U.S. Court of Appeals for the Federal Circuit ruled that the patents protecting Vascepa were invalid, paving the way for generic drug manufacturers to produce and sell their own versions of the drug.
The FDA has already approved the first generic version of Vascepa, which is expected to be much cheaper than the brand-name drug. According to the FDA [3], the generic version of Vascepa, called icosapent ethyl capsules, was approved in November 2020 and is manufactured by Dr. Reddy's Laboratories.
It is important to note that generic drugs are required by law to be bioequivalent to the brand-name drug, meaning that they contain the same active ingredient and are absorbed into the body at the same rate. However, generic drugs may contain different inactive ingredients, which can affect factors such as taste, texture, and shelf life.
In summary, the generic versions of Vascepa are expected to be bioequivalent to the brand-name drug, but may contain different inactive ingredients. The approval of generic versions of Vascepa is expected to increase competition and lower the cost of the drug for patients.
Sources:
[1] https://www.drugpatentwatch.com/p/tradename/VASCEPA
[2] https://www.fiercepharma.com/marketing/it-s-confirmed-amarin-loses-patent-appeal-protecting-blockbuster-hopeful-vascepa-from
[3] https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/first-generic-drug-approvals