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Re: None

Thursday, 11/17/2011 8:04:10 PM

Thursday, November 17, 2011 8:04:10 PM

Post# of 424047
"FDA confers five years of Hatch-Waxman exclusivity to AMR101 as a new chemical entity, a generic could be on the market much sooner than 2021"

IO/Stock_inv - The above info is incorrect.

If AMR101 gets the NCE status (I think it will ...Lovaza has considered as 1 moiety by FDA not 2 active moieties EPA and DHA - see CP), then it will have a 8 year exclusivity period.

5 year NCE + 30 month stay (on any para IV for listed orange book patent) + 6 month PED exclusivity

So exclusivity of 8 years

Take an average yearly sales of $1.5 billion (conservative IMO considering Lovaza sells for $1 billion for the smallest indication)

Assume 33% profit (after partnership royalty) = 0.5 billion

$4 billion in 8 years

For patent expirations of various products one of the following companies: Glaxo/Pfizer/Abbot may buy this company IMO
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