Biotech Values

[DewDiligence]

MNTA – The 180-day exclusivity clock for generic Lovenox started on 10/2/08 with the formal mandate from the appellate court invalidating Snafu’s US patent, according to MNTA’s PR today. Thus, the 180 days end on 4/1/09, which fits in rather well with the anticipated FDA review schedule for the MNTA/Sandoz ANDA, assuming of course that the FDA does not come back with a new request.

(Amphastar was the first-to-file an ANDA for generic Lovenox, and hence Amphastar and its partner WPI would have marketing exclusivity through 4/1/09 if the FDA were to grant approval of their ANDA before 4/1/09. There’s no indication that such an approval is likely, however.)