I do not expect Teva to obtain FDA approval for generic Lovenox ever.
Warning: I certainly do not understand this stuff as well as DD, biomaven or some others. (This is an understatement.)
I did reread the FDA response to the CP for the criteria of approval of a gL.
I would liken the problem of duplicating L to developing some complex industrial process. Edison finding a filament for the light bulb or Robert Mauer's quest to send light over a glass fiber. Each had many variables that had to be managed to come up with a single working solution. You had to have the right material(s), right mix, right temperature, ph, cooking time, curing time etc etc. And in each those cases, there were multiple solutions that would function. In both cases they eventually found A workable solution.
To create a "same" enoxiparin sodium, the generic company needs to manage all the variables to a SINGLE solution - "sameness" - not just a workable solution.
Small deviations in materials, mix, conditions or time will negate sameness. Chains get cut at different points leaving different ends, differing in vivo activity, chains of differing da, differing HIT* antibodies (heparin-induced thrombocytopenia), differing chain composition, etc.
All of this leads me to the conclusion that tL may not get approved in the US for years. I am not yet with DD on "never" but I do not buy the imminent approval thesis.
Reminder - I am NOT a scientist much less one skilled in this area. :-)
I would be interested in the views of others, especially those who think they understand the science.
ij
* Which the literature already suggests is higher in non-Lovenox enoxiparin sodium analogs.
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