Biotech Values

[DewDiligence]

Do you know of any other companies besides HSP (plus Ampa and TEVA) that have submitted an ANDA for any dose/form of Lovenox? Are ANDA submissions generally well known or public?

Those three are the only known Lovenox filers. (HSP’s known ANDA is for the vial formulation of Lovenox only.)

Since branded Lovenox is no longer protected by an Orange Book patent, a Lovenox ANDA can be submitted by anybody without generating an FDA announcement. Still, would-be filers can plainly see the IP barricade that ensnared Amphastar, which presumably dampens the enthusiasm for others to try to enter this market.