Cardioprotection thread, page-841

Since the original formulation of bisantrene has never been approved by any current regulator it is not possible to for a generics manufacturer to just launch a generic version of bisantrene. Even if they wanted to sell the original formulation they would need to take it through the full new drug approval process. Generic drug manufacturers just don’t do this.

To answer your larger question, yes we have managed to find a whole range of new things out about bisantrene and how to best make it that will help protect our IP. I am not very worried that someone will make their own formulation of bisantrene (well not for a long time), the bigger risk is that someone will decide to make their own new molecule that works the same way as bisantrene. While this risk can’t be reduced directly, there are regulatory approaches that make it very difficult for someone to fast follow behind us.

I have to say if we reach the point that others are trying to copy bisantrene then we will have already succeeded. Unless bisantrene is selling in the billions nobody is going to bother copying it.