The real manufacturing cost is of course lower than the old $177/month cost.
These cases from the last 1-2 decades are always because of FDA regulations. The drug is out of patent, any manufacturer is allowed to make it, but the FDA regulations for actually starting up manufacturing are so difficult and time consuming that whoever is left as the only manufacturer of a rare drug can crank up the price from $177 to $43k, and ride on that profit wave for a few years while FDA processes competitors applications.
These cases from the last 1-2 decades are always because of FDA regulations. The drug is out of patent, any manufacturer is allowed to make it, but the FDA regulations for actually starting up manufacturing are so difficult and time consuming that whoever is left as the only manufacturer of a rare drug can crank up the price from $177 to $43k, and ride on that profit wave for a few years while FDA processes competitors applications.
More sad detail here: https://slatestarcodex.com/2015/09/24/the-problems-with-gene...