Right. The lower molecular weight of Lupenox suggests that it was depolymerized in a different way than enoxaparin, and that some of the "junk"* found in enoxaparin got tossed. Then the only way to get enoxaparin would be to add some "junk" back to achieve equivalence. You'd most likely be adding back to a different underlying structure. Needless to say, this is inefficient & would be quite a feat; even Momenta probably can't do it, much less Teva/ItalFarmaco. I refuse to believe the FDA would even consider Lupenox. Would they send out a minor deficiency letter if T-enox was Lupenox? I think they'd outright reject it.
* As has been discussed, "junk" in this case means material found in enoxaparin which has not been proven to be a contributor to enoxaparin's efficacy.
Regards, RockRat
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