Replies to post #89165 on Amarin Corp Plc (AMRN)

[couldbebetter]

If this is the case does this not bring back the takeover angle because now the generic threat is moved back to 2025?

[Biobillionair]

Yep- thanks for posting Sam.
BB

[Biobillionair]

All-

AMRN retains exclusivity on Vascepa beyond 2024 (assuming 3 years add back due to FDA delays under Hatch-Waxman)

I'm not sure this SunTrust analysts understands H-W or he worded in such a way for investors to understand, but there isn't going to be any adding to NCE. There will, IMO, be an exclusion of receiving a ANDA that references (RLD) Vascepa for the next 4 years (starting from June OB). The FDA has clearly been defined as the gateway to patent infringement, this is new and is entirely based on Cooper decision. The overall effect is nil on the generic industry as a whole, accept for those that intended to file a ANDA and paragraph IV using V as the RLD. Those generic filers would also be the same companies unlawfully informed of the FDA's legal intent to not appeal Moss NCE decision.

Generic filers will first petition the FDA to receive their applications, prior to initiating legal actions against the FDA. So despite what the good doctor JL thinks...V will get extended exclusivity depending on when the FDA will receive ANDA referencing V. Generics could file paragraph iv's 6-26-2016...assuming they would be received. Last paragraph iv update was 8-4. FDAlawblog prematurely called another update on Monday...never happened.

I will file a complaint if "V" receives a paragraph iv prior to 6-2020, and my complaint will be received and acted on.

BB