MNTA strongly agrees with SNY’s Citizen Petition insofar as it demands that a generic Lovenox replicate all of the heparin chains in branded Lovenox rather than merely matching the molecular weight and FIIa/FXa activity of the branded drug.
Thus, SNY’s CP plays to MNTA’s competitive advantage relative to Teva and Amphastar, the other ANDA filers; if the FDA concurs with SNY’s CP, it increases the likelihood that the FDA will approve only the generic from NVS/MNTA rather than approving multiple generics.
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”