Study, I think the word "generic" is causing confusion. Ignore that word. Amarin has a product. Hikma is selling an identical product. Our CVD method of use patents prevent Hikma from selling it's product for the CVD indication. (In theory) We have the right to sell icosapent ethyl for the CVD indication. No one else does until our patents expire. It doesn't matter what we call our icosapent ethyl product.
The "skinny label", created by the Hatch Waxman act, did not strike a balance. In an attempt to end the practice of "evergreening", congress inadvertently just pushed down on the other side of the scale.
I don't know where Italy stands on reimbursement.
I hope this is useful.
Sleven,