It’ll be one or the other—we probably won’t see both kinds of FoB’s for the same reference drug in the same market.
That makes sense from an economic standpoint even if it is not a necessary statutory outcome.
IF substitutability turns on the degree of certainty demonstrated by the applicant, I would expect both substitutable and non-substitutable results, absent applicant holding out for substitutable.
Non-substitutable status would be an economic failure if others were substitutable.
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There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)