Replies to post #302769 on Amarin Corp Plc (AMRN)

[juslin]

Does that mean they are off the hook if insurance companies switch brand V for generic?

[oneragman]

Anfla, I don't see the FDA allowing that. I believe the label has to be the same. Think of this, since the approval of the RI indication, the label was updated not just for the indications, but the risks. So now the generics can sell the drug based on the MARINE indication, leaving out all the risks and the FDA is going to be ok with that, knowing it will be used in the RI indication? The risks...that is why I believe the full label will be required.

[circuitcity]

I like your thinking, before getting super ecstatic and ahead of ourselves, we need to find out WHAT EXACTLY trigged infringement in Teva case? Label? Sales rev? Promotion material? What is it or what combination?

Same time, this is still very and very encouraging for amrn, in any case, this absolutely worth trying and has a decent chance to win against generics. Why can’t amrn set the precedent if amrn case is dramatically different from teva? (Not saying they are different, actually they are pretty damn similar, all I am saying right here is to cover our base).

Finally, this skinny label infringement topic seems like a grey area that why the teva case has gone back and forth and with a split vote (Gsk won round 1, teva won round 2, and now Gsk won round 3 (2-1) and still going as teva indicated.

So this litigation can go on for a very long time, and that is what amrn desperately needs given where we are. From generic side, are they going to launch by late nov? I think they are thinking very hard right now but eventually I guess Hikma will launch with very small supply though just to keep their exclusivity. Also they need to call their supplier ccsb? to slow down or pause the expansion project for sure. Regardless, this teva case kind of make amrn current marine case moot (as BB and North have been swaying??). Going forward, it is still a big mess, especially for amrn actually because it is a one drug company. So I personally still suggest BO; settlement is possible but may be too much a task for JT and he should be tired now.

[sts66]

Generic V will also (or has already) gotten AB status. And what happened to the general belief that generics don't promote their drugs? Even if Hikma tells docs GV is not approved for CVD that does nothing to stop pharmacies from swapping GV for V, and it doesn't stop insurers from requiring generic substitution if one exists.