Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

CW has said on multiple occasions that MNTA either has first-filer status or shared first-filer status. For Paragraph-IV challenges, it’s the submission date (not the FDA’s acceptance date for review) that determines first-filer status, and CW claims that MNTA submitted on the first day possible (as explained in my previous post).

All this is probably moot in any case because the FDA can say that nobody is entitled to 180-day exclusivity insofar as no one was able to launch within 30 months.