1. It is fully substitutable for Sanofi’s branded product.
2. The indication is DVT prevention, which is Lovenox’s main market. The FDA evidently “carved out” the ACS indication, which was protected by Hatch-Waxman marketing exclusivity until 5/16/10: #msg-43243987. Inasmuch as 5/16/10 has already passed, I think NVS/MNTA’s approval will soon be expanded to include ACS.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”