Replies to post #302851 on Amarin Corp Plc (AMRN)

[Cardiologymd]

Looks like amarin needs to pull out marine label and ambush generics like gsk did

[Dancing in the dark]

"FDA sent Teva a letter in response to the de-listing of certain GSK patents from the Orange Book ..."

Sure would like to read that letter, is it public information? Who requested the "de-listing" and under what circumstances did the de-listing occur?

[sts66]

GSK's original patent for hypertension expired, Teva file ANDA, started selling the generic, then GSK had a patent re-issued including the CHF indication. Why FDA wouldn't require Hikma to have identical label as V, including R-IT, which they required Teva to do, is not clear to me - that GSK/Teva case is weird. Is it because in that case a patent expired but was replaced with a new one?