Is this really so? Couldn't this constitute another approved generic in the context of lowering MNTAs royalty rate? Or would the sole approved generic designation apply to each of the specific product formulations?
Re: MNTA HSP / Lovenox ANDA’s (follow-up to #msg-33960572)
The modus operandi on HSP’s JPM webcast today was don’t ask, don’t tell. By this I mean that no investors in the audience asked about Lovenox and HSP did not volunteer anything.
Insofar as the vial formulation represents only 1% of Lovenox’s US sales, I continue to find it odd that HSP has submitted a Lovenox ANDA for the vial formulation only.
The 300mg vial formulation, which was reviewed by the FDA under a separate ANDA from the Lovenox prefilled syringes, represents less than 1% of US Lovenox sales. That’s presumably the reason this approval did not even garner a PR from NVS or MNTA.
Note: HSP is among the companies who submitted an ANDA for the 300mg Lovenox vial. However, even if HSP or another company got FDA approval for the 300mg vial and launched the product, this would not be counted as a second FDA-approved generic in the market when computing MNTA’s share of NVS’ profit from selling Lovenox prefilled syringes. In other words, the Lovenox 300mg vial and the Lovenox prefilled syringes can be considered entirely separate products for financial purposes.
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