If you create a totally new reformulation of a generic drug then...

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    If you create a totally new reformulation of a generic drug then the patent on the first reformulation won't apply to the new reformulation. This issue from a drug development perspective is the new reformulation is a new drug as far as the regulators are concerned and you would have to take your new reformulation through the whole clinical development process again from scratch (Phase 1-3 trials). Generic drug manufacturers don't do this, the just make a copy of the approved formulation (once the patent expires) and do a quick study to show the two formulations are bio-equivalent.
 
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