MNTA reverse engineers(takes various batches of Lovenox from Sanofi) and tries to find out what should be 1. Starting Material 2. Process & Process conditions to manufacture final product so when they manufacture it, they get equivalent product to Sanofi's(within band of variance on all important markers)
Both the above parameters can add a characteristic structural signature to the final product.
In this case they are saying that process(oxidation or oxidation followed by treatment with an acid) results in a characteristic structural signature to Lovenox(or the intermediate heparin used to make Lovenox).
They also apparently found that absence of this structural signature leads to risk of coloration and hence reduced shelf life.
Assume 1) Teva or Amphastar's generic does not have this characteristic structural signature(and process of oxidation). Then their ANDA probably will not get approved because their product is not equivalent to Sanofi's
2) Teva or Amphastar's generic suppliers have this oxidation built into their process but do not test for this characteristic structural signature] in their heparin. In this case they have not fully characterized their product and hence ANDA is not approvable.
3) Teva or Amphastar generic suppliers have this oxidation built into their process and also testing for this characteristic structural signature in the end. Then it is likely they maybe infringing on this MNTA patent.
I am starting to think the blocking value of these characterization patents has been underestimated by market.Anybody? North400000?
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