3 ms·
Can anyone explain me the evergreening - even if new patent is granted for new molecule the old molecule should be free. So why is nobody producing them?
by venomsnake 11y ago
Can anyone explain me the evergreening - even if new patent is granted for new molecule the old molecule should be free. So why is nobody producing them?
- mschuster91 11y agoBecause no one is interested in spending billions to get a generic insulin through FDA or other regulatory agencies. Too much profit is to be made.
- venomsnake 11y agoIIRC you don't need to spend billions to get it trough FDA. That is the whole point of the generic. That the molecule is already approved and tested.
- akiselev 11y agoYou don't need to spend money on phase 1-3 trials for safety and efficacy of the molecule but you do still need to spends tens of millions of dollars to prove that the generic drug you are manufacturing behaves like the original, within a margin of error, and that you can maintain that quality control in the future.
- 0xcde4c3db 11y agoIt depends. Sometimes it's simply more profitable to produce something else. Sometimes the market is too small to justify the bioequivalence studies. Sometimes the FDA mysteriously changes its mind on the safety of a drug the same day the patent expires [1]. [1] http://www.npr.org/sections/health-shots/2013/04/17/177602393/why-fdas-rejection-generic-oxycontin-may-have-side-effects http://www.npr.org/sections/health-shots/2013/04/17/17760239...