Replies to post #437149 on Amarin Corp Plc (AMRN)

[Chromosome]

Winning the CVS contract means one of two things, either of which is a good outcome.

1) their cost structure is competitive with genetics which now seems to be even more realistic. This would portend more future formulary wins.

2) fear of legal liability for infringement. This could also dissuade others from covering generics.

My overall sense is it’s likely the first option. Also Tat, those damages could be quite significant and hot the generics where it hurts.

To me it makes sense to cede the market back to AMRN, let it develop the market and reap the benefits for a while and then let the generics take over. In the meantime the next formulation should be tested and likely FDA approved.
JMO

[Number sleven]

Tatsumaki, Hatch Waxman did create the "skinny label" in section 8. It is legal to obtain an ANDA approval through this pathway. FDA doesn't police those labels for infringement. That has been left to the courts. Hatch Waxman isn't a safe harbor that allows generic infringement without consequences. The court doesn't have the authority to mandate a label change. Take a look at the ruling in GSK v Teva.
Sleven,