CC, so the FDA approval for Hikma included the FDA verifying and examining the raw material or product they wish to sell as generic V? I am sure they did not open a few capsules of Vascepa and send that to the FDA.
The fact that Amarin gets V from third party manufacturers means these Generic companies can get it as well. Contracts or not.
Another thing I was thinking about that I tried to research without much luck was the amount of statin use in Europe. I did find that in Denmark there had been a 32-fold increase in statin sales from 1998 to 2015 but yet the overall went down since in 1998 there were only patent protected statins available whereas by 2015 it was virtually all cheap generic statins. I did find that statin use is much more prevalent in the UK than in the rest of Europe but could not find hard numbers.
The reason the statin thing interests me is that it would be the perfect market that Vascepa fits into. That is what R-I provides. And, if there is a lot of statin use in Europe now that would bode well for Vascepa penetration into Europe. Conversely, if statin sales in Europe are poor that could be a real drag on Vascepa sales there.
And, I really don't see Amarin trying to get into the generic market here in the U.S. as anything that would yield much fruit.