In the US, you still have to get FDA approval to sell drugs that claim to be reformulations of another manufacturer’s product. This isn’t entirely baseless - demonstrating your version’s bioequivalency to the original is part of the process, which doesn’t seem like an unreasonable thing to require.<p>Unfortunately, the whole approval process still costs in the low $millions at a minimum &amp; so for out of patent drugs that are a pain to manufacture, and&#x2F;or have small numbers of patients, they just aren’t financially viable once you factor in the approval costs.<p>Part of what you see when a drug company steps in and jacks up the prices like this is that the new owners know that the FDA approval process combined with their pre-existing manufacturing capability gives them an expensive moat to bridge for other companies that isn’t justified by the size of the market, so if they’re willing to take the reputational hit that the previous owners weren’t then they can jack up the prices enormously since the patients have no-where else to go.