Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

The 180-day notice period will delay the launch of FoBs for older biologics, where the 12-year exclusivity period has already expired. However, for FoBs of newer biologics, where the 12-year exclusivity period has not expired, the 180-day notice period will have no effect; this is because the FoB sponsor can provide notice upon receiving tentative FDA approval (i.e. approval to launch pending the expiration of the 12-year exclusivity period) rather than waiting until receiving final FDA approval.