In the recent UBS presentation RS stated that
MNTA and subsequently the FDA provided the pathway for approval of generic Lovenox... ie. MNTA provided the roadmap.
Amphastar filed its ANDA in 2003... Momenta filed their ANDA in 2005.
RS states MNTA's ANDA raised the standards and allowed the FDA to be comfortable w/ approving a generic Lovenox.
Also 'the work' MNTA did is work that can be replicated given the means, time, dollars and expertise, however the methods MNTA used to identify structures, to ensure sameness w/ Lovenox are patented and "We will defend our IP."
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