Amarin Corp Plc (AMRN)

[ralphey]

check this out

Benecard comes right out and days HIKMA's version is for CAD - DIRECT INFRINGEMENT !!!

https://www.benecard.com/generic-for-vascepa-capsules-approved/

May 22, 2020

The U.S. FDA has approved Hikma Pharmaceuticals’ icosapent ethyl 1g capsules as a generic for Amarin’s Vascepa® (icosapent ethyl). The products are prescription-only fish oil derivatives indicated to reduce cardiovascular (CV) risks in certain patient populations.

Specifically, icosapent ethyl is approved as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients who have elevated triglyceride (TG) levels (≥ 150mg/dL) and established CV disease, or who have diabetes mellitus and two or more additional risk factors for CV disease. It is also approved as an adjunct to diet to reduce TG levels in adult patients who have severe (≥ 500mg/dL) hypertriglyceridemia.

Recommended dosing for icosapent ethyl is 2g twice daily, taken with food. Capsules should be swallowed whole. Prior to treatment, the patient’s lipid levels should be assessed, and any additional causes of high triglyceride levels should be identified and managed as appropriate. Patients should engage in appropriate nutritional intake and physical activity before starting icosapent ethyl, and this should continue during treatment.

Although the FDA has granted approval for Hikma’s generic, Amarin is currently in the process of appealing the invalidation of six Vascepa patents. Should Hikma or another generic manufacturer launch an equivalent to Vascepa before a final legal determination is made, they would do so at risk and could be held liable for damages due to patent infringement if Amarin wins its appeal.

Hikma has not announced launch or pricing plans for its icosapent ethyl 1g capsules.

Vascepa first received FDA approval in 2012 and is available in 0.5g capsules as well as 1g capsules.