Biotech Values

[DewDiligence]

>MNTA – If the patent is overturned within a few months (likely) and no generics are approved within 6 months of that (also likely imo), does the 6 month exclusivity period expire? mnta has stated this is the case.<

The clock for 180-day exclusivity is triggered by either a non-appealable legal ruling in favor of the patent challenger or a product launch by the challenger—whichever comes first. Hence, the guidance from MNTA is consistent with the statutes.