Replies to post #122720 on Biotech Values

[DewDiligence]

There are surprisingly few cases where FDA orphan exclusivity ends up being commercially consequential. In many cases, an orphan drug has patent protection that runs longer then the 7 years of orphan exclusivity. (Absent patent protection, 5-year H-W exclusivity for an NME is only two years shorter than the US orphan-exclusivity period.) In many other cases, the expected US sales are too low to generate strong interest from competitors.