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by tivert 1050 days ago
> As long as a molecule has been approved before (through a New Drug Application), all follow-on drugs get approved through an ANDA (Abbreviated New Drug Application).

But there are shenanigans that can happen there. IIRC, to get a new generic approved, you have to demonstrate it's the same as the existing generics, which requires a supply of that drug. Years ago I read a company (it might have been one of Martin Shkreli's) that played a trick with that:

1. they manufactured a generic drug,

2. put extreme restrictions on its supply chain so no competitor could get ahold of enough of their product to do the equivalency testing, and

3. jacked up the price to an extreme degree.