My apologies to the board...Re several Typos in my earlier post which made a complicated subject more complicated..
The idea behind the post is that even if the Appeals court decides in favor of the generics..and invalidates Amarin's patents and allows the generics..(Hikma and Reddi) (H&R) to sell generic V in the USA; The generics may have won very little and Amarin might have lost very little..Posters might contemplate what that translates to in terms of Amarin's value..
What H&R have won is the right to sell generic V for the Marine (very high trig label) but what H&R have not won is the right to market generic V for the REDUCE-IT CVD event reduction label..Now just so you posters understand; I realize H&R probably have their sights set on the R-I indication which they believe they can capture via "Off labeling"..IMO that is not going to happen. H&R's scheme is going to run into some unanticipated road blocks..not from Amarin but from Lovaza (L) and generic lovaza (GL)
Lovaza (GL)..L and GL both have an FDA very high trig indication and usage label.. The L and GL FDA labels are identical to the H&R GV FDA labels..(word for word). So as far as the drug plans are concerned, these drugs are considered identical..H&R by the court rulings are unable to say.."Pick us because we come with CVD event risk reduction.. Because H&R have not won that right in court..And please understand the drug plans are not going cut H&R any slack..Any attempt on the part of H&R to sell for the R_I indication will be deemed an infringement on Amarin's patents.
How do we know the drug plans will not cut H&R any slack? Amarin knows from experience...Even this year, Brand Vascepa was listed as Tier 4 (most expensive) on most drug plans..And that is after the FDA label expansion to include the REDUCE-IT results..Reason...is, the label expansion by the FDA was delayed to late December 2019..This was after the the Tier designations were made for 2020...and most drug plans have blithely ignored the R_I results and will do so until the next Medicare enrollment periods in Nov of 2020..Why...because it saves the drug plans money..So as you read this, Amarin is still competing with Generic L because the drug plans are only crediting Vascepa for the MARINE indication..and that will not change until next year..For H&R, things are even bleaker..They will not be getting the R-I upgrade next year. They will see their scripts converted to Gen L unless they can beat Gen Ls price and to do that they will be throwing away most of their profit..
In the meantime Vascepa will be getting the R-I CVD label indication and they will no longer be competing with Gen L...Because Gen L does not have the R-I label expansion..Brand Vascepa will not have any competition and will be most likely Tier 2..
":>) JL
