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Re: concapk post# 221738

Tuesday, 10/29/2019 7:52:39 PM

Tuesday, October 29, 2019 7:52:39 PM

Post# of 429280
Isn't this how real life would play out??

-Generics get label to sell IPE for >500 TG's for less than 12 day dosing.

-AMRN gets full sNDA label.

-World goes berserk, all want V, AMRN prices at the $1500/yr level

-Social media takes over, and broadcasts: "Hey - you know how you can get cheap V? Just tell your doc that its generic for super-high TG's. Same exact molecule, and its available that way only because some generic company found a loophole in a Vascepa patent. But its the same exact stuff!!!! Just have him write it that way!

-Docs think about it, know the hassle with reimbursement. Size up some patients who don't have good insurance coverage, and say to themselves - WTF - it really is the same stuff, don't know how this generic got that done, but it is approved and I can write the Rx off label, because its approved for humans and I write off label for all kinds of other meds, this one is a pretty safe drug anyways, I write V for some patients already, and I know that brand label ad insert covers all the indications, tells me what I'm doing and what to look for as I follow the patient - I'm not flying blind. My butt is covered. I can save my patients $1000/year!

-Word of mouth per social media amplifies that line of thought about 100,000 times, and V is in the corner watching Dr. Reddy's cheap ester of fish oil EPA become a great blue-plate-special hour topic of conversation at Del Boca Vista (Phase III), and grab large market share.

Anybody think that WON'T happen in this hyper-price conscious society?? Seems like a pretty good bet to me, and a reason for the generics to take this to trial in the event they can get a non-inducement argument through. If they do, this AMRN franchise is at severe risk, IMO.

Somebody please shoot down this scenario. Will a pharmacy refuse to fill a generic Rx that is for more than 12 days? Or refuse refills after than time? That seems like the only backstop if the generic wins this narrow application.
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