I think there is some level of merit in Scottmo comments around certain missing patents making any proposed deal clean and relatively more straight forward. However, it doesn't remove the fact that Elmiron patent expired in January 2010 and no other generic manufacture has stepped up go through the rigorous FDA review process required.
Assuming we meet our P3 endpoints, a generic manufacture would have an immediate incentive to go after the non-patented OA applications on their proposed generic label. The only problem being they need to spend the next 3 to 5 years testing their formula (stage 1) in an attempt to produce an equivalent to Bene (which they won't be able to achieve) so then resign themselves to spending the next +5 years going through their own trials to show the generic formula is just or more effective (stage 2).
But guess what we've just reached US$10B sales in year 2, $15B in year 3.............before they even get out of stage 1 or commit multiple $Bs to seeking approval of a formula for a limited label generic.
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