5 ms·
The drug isn't patented anymore. Apparently the issue is that you need to conduct trials if you want to have permission to make a copy of the drug and to do so
by andrewpi 11y ago
The drug isn't patented anymore. Apparently the issue is that you need to conduct trials if you want to have permission to make a copy of the drug and to do so you need a supply to compare your new copy with and that was hard to purchase.
- go1979 11y agoI'm surprised about the drug trial bit. I thought generics didn't need to have new trials .. they just need to have the exact same formulation. The oddness is that they need to "reverse engineer" the formulation themselves. The pill's color, shape and markings couldn't be copied though. Can anyone knowledgeable on this critique what I wrote? I got my info during a tour of a generic drug manufacturer's plant a looooong time ago.
- MichaelGG 11y agoI believe the generic maker must show bioequivalency to make sure the thing they are making works the same as the thing the other manufacturer was making. There's probably numerous ways that making a complicated medicine can be screwed up.